Public Meeting Binder

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Board Meeting

November 15, 2017

NOTE: Pursuant to the Open Meetings Law at La. R.S. 42:16, the Board may, upon 2/3 affirmative vote of those members present and voting, enter into executive session for the limited purposes of (1) discussion of the character, professional competence, or physical or mental health of a licensee, (2) investigative proceedings regarding allegations of misconduct, (3) strategy sessions or negotiations with respect to litigation, (4) discussions regarding personnel matters, or other purposes itemized at La. R.S. 42:17.

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Table of Contents

1 – A. Table of Contents 002 1 – B. Meeting Notice & Arrangements 004 1 – C. Acronyms 005 1 – D. Agenda 009 2. Invocation & Pledge of Allegiance 3. Quorum Call 4. Call for Additional Agenda Items & Adoption of Agenda 5. Consideration of Minutes from Previous Meetings ~ August 23, 2017 011 6. Report on Action Items 036 7. Confirmation of Acts 8. Opportunity for Public Comment * Statement of Purpose & Mission of Board 9. Special Orders of the Day A. Presentation of Pharmacists Gold Certificates B. Annual Election of Officers 10. Committee Reports A. Finance – Mr. Pitre 038 • Review of Interim Report for Fiscal Year 2017-2018 039 • Consideration of Proposed Budget for Fiscal Year 2018-2019 049 B. Application Review – Mr. Soileau 058 • Consideration of Committee Recommendations Re Applications C. Reciprocity – Ms. Hall 059 D. Violations – Mr. Bond 060 • Consideration of Proposed Voluntary Consent Agreements 061 E. Impairment – Mr. Rabb 081 • Consideration of Committee Recommendations re Applications • Consideration of Additions to Board’s Roster of Approved Addictionists 082 F. Reinstatement – Ms. Melancon 085 • Consideration of Committee Recommendations re Applications G. Tripartite 086 H. Regulation Revision – Mr. McKay 087 • Consideration of Legislative Proposal 2018-B ~ Controlled Dangerous Substance (CDS) License for Third-Party Logistics (3PL) Providers 088 I. Executive Committee – Mr. Aron 090 • Consideration of Proposed Policies re Applications for New Pharmacy Permits 091 • Consideration of Revisions to Policy & Procedure Manuals 099 • Consideration of Recognition of Interprofessional Continuing Education 113 • Consideration of Approval of Pharmacy Inspection Blueprints 115 • Consideration of Approval of Contract for Accounting Services 182 • Consideration of Approval of Additional Technician Certification Examination 183 11. Staff Reports J. Assistant Executive Director – Mr. Fontenot 184 • Quarterly Report from Prescription Monitoring Program (PMP) 185 • Consideration of Requests for Waivers from PMP Reporting Rule 191

Board Meeting Binder November 15, 2017 Page 2 of 2

11. Staff Reports (cont.) K. General Counsel – Mr. Finalet 251 • Consideration of Proposed Voluntary Consent Agreements 252 L. Executive Director – Mr. Broussard 268 • Narrative Report 269 • Internal Reports  Census – Compliance Division 274  Census – Credentials Division 275  Credentials Div. – Licensure Activity Report 280  Credentials Div. – Application Activity Report 281  Credentials Div. – Exceptions Report 282 • Examinations Report – MPJE 284 • Examinations Report – NAPLEX 304 • Legislative Auditor’s Report for Fiscal Year 2016-2017 326 • Restoring Board Immunity Act (H.R. 3446) 389 • Summaries of RBI from two different sources 413 • U.S. Dept. of Labor Grant to study occupational licensing in the states 420 • NCSL Grant Plan to study occupational licensing in the states 421 • Federal Trade Commission (FTC) review of occupation licensing 424 12. Review of Louisiana Attorney General Opinion No. 17-0076 – Mr. Randal Johnson Louisiana Independent Pharmacies Association 446 13. Discussion of Letter to Attorney General & Dept. of Insurance re Pharmacy Benefit Managers – Mr. Mannino 458 14. Request for Waiver of Licensure Renewal Fee for Military Spouse – Lt. Col Charlton Meginley 463 15. Petition for Additional Testing Opportunity by Applicant for Pharmacist Licensure 471 16. Announcements 478 17. Recess

Addendum

10. Committee Reports I. Executive Committee > Request from Dept. of Corrections re Automated Medication Systems 480

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

M E M O R A N D U M

To: Board Members & Staff

From: Malcolm Broussard

Date: November 10, 2017

Re: Board Meeting Schedule & Arrangements

The next quarterly meeting of the Board and certain of its committees will be held at the Board office on November 14-16, 2017. The schedule of events is as follows:

Tuesday, November 14, 2017 0800 Application Review Committee Boardroom 0900 Reinstatement Committee Boardroom 1200 Committee Luncheon Boardroom 1300 Impairment Committee Boardroom 1600 Finance Committee Boardroom 1700 Executive Committee Boardroom

Wednesday, November 15, 2017 0900 Board Meeting Boardroom

Thursday, November 16, 2017 0730 Annual Portrait Session Boardroom 0830 Administrative Hearing Boardroom

You should have received your hotel reservation confirmations from Ms. Kelley Villeneuve via email. If you have any questions about those arrangements, please contact her directly at [email protected] or 225.925.6498. Most of your meeting materials have been posted in the Boardroom Library. You may access the library by visiting our website at www.pharmacy.la.gov, selecting the Login link at the right-sided margin of the horizontal menu bar, and entering your log-in and password information. At the Boardroom Library Lobby, select the link for the Main Reading Room, and then the 11-15-2017 link for the board meeting. I anticipate completion of all the committee and board meeting materials by the Sunday before the meeting; we will advise you when all of the materials have been posted. Your annual portrait session is scheduled for Thursday morning; please prepare accordingly. There is only one case scheduled for the administrative hearing; we anticipate your departure well before noon on Thursday. Acronyms

AACP American Association of Colleges of Pharmacy AAPS American Association of Pharmaceutical Scientists AAPT American Association of Pharmacy Technicians ACA American College of Apothecaries ACCME Accreditation Council for Continuing Medical Education ACCP American College of Clinical Pharmacy ACE Advisory Committee on Examinations (NABP) ACPE Accreditation Council for Pharmacy Education ADA American Dental Association ADC automated dispensing cabinet ADS automated dispensing system AFDO Association of Food & Drug Officials AFPE American Foundation for Pharmaceutical Education AIHP American Institute of the History of Pharmacy AMA American Medical Association AMCP Academy of Managed Care Pharmacy AMS automated medication system APEC Australian Pharmacy Examining Council APhA American Pharmacists Association APPE advanced pharmacy practice experience ASAE American Society of Association Executives ASAP American Society for Automation in Pharmacy ASCP American Society of Consultant Pharmacists ASHP American Society of Health-System Pharmacists ASPL American Society for Pharmacy Law AVMA American Veterinary Medical Association AWARxE NABP consumer protection program BNDD Bureau of Narcotics and Dangerous Drugs BPS Board of Pharmacy Specialties CAC Citizen Advocacy Center CCAPP Canadian Council for Accreditation of Pharmacy Programs CCGP Commission for Certification in Geriatric Pharmacy CDC Centers for Disease Control and Prevention CDER Center for Drug Evaluation and Research CDTM collaborative drug therapy management CDS controlled dangerous substances CE continuing education CFR Code of Federal Regulations CHPA Consumer Healthcare Products Association CLEAR Council on Licensure, Enforcement and Regulation CMI consumer medication Information CMS Centers for Medicare and Medicaid Services CPD continuing professional development CPhA Canadian Pharmacists Association CPPA Center for Pharmacy Practice Accreditation CPSC Consumer Product Safety Commission DEA Drug Enforcement Administration DEQ La. Department of Environmental Quality DHH La. Department of Health and Hospitals

Revised 2014-0501 DME durable medical equipment DMEPOS durable medical equipment, prosthetics, orthotics, and supplies DNV Det Norske Veritas (Norwegian accreditation organization) DSM disease state management EDK emergency drug kit ELTP Electronic Licensure Transfer Program (NABP) EPA Federal Environmental Protection Agency EPCS Electronic Prescribing of Controlled Substances (DEA) ETS Educational Testing Service EU European Union ExCPT Examination for the Certification of Pharmacy Technicians FARB Federation of Associations of Regulatory Boards FBI Federal Bureau of Investigation FD&C Federal Food, Drug & Cosmetic Act FDA Federal Food & Drug Administration FIP Federation Internationale Pharmaceutique FMI Food Marketing Institute FPGEC Foreign Pharmacy Graduate Examination Committee (NABP) FPGEE Foreign Pharmacy Graduate Equivalency Examination (NABP) FSBPT Federation of State Boards of Physical Therapy FSMB Federation of State Medical Boards FRC Foreign Pharmacy Graduate Equivalency Examination Review Committee (NABP) FTC Federal Trade Commission GPhA Generic Pharmaceutical Association GPO US Government Printing Office gTLD generic top level domain (Internet addresses) HCFA Health Care Financing Administration HDMA Healthcare Distribution Management Association HIPAA Health Insurance Portability and Accountability Act (of 1996) HIPDB Healthcare Integrity and Protection Data Bank HMO health maintenance organization IACP International Academy of Compounding Pharmacists ICANN Internet Corporation for Assigned Numbers and Names ICPT Institute for the Certification of Pharmacy Technicians IDOI Internet Drug Outlet Identification (NABP) INEOA International Narcotic Enforcement Officers Association IOM Institute of Medicine IPPE introductory pharmacy practice experience ISMP Institute for Safe Medication Practices JCPP Joint Commission of Pharmacy Practitioners LAMP Louisiana Academy of Medical Psychologists LANP Louisiana Association of Nurse Practitioners LAPA Louisiana Academy of Physician Assistants LBP Louisiana Board of Pharmacy LDA Louisiana Dental Association LIPA Louisiana Independent Pharmacies Association LPA Louisiana Pharmacists Association LPTA Louisiana Physical Therapy Association LPTB Louisiana Physical Therapy Board LSBD Louisiana State Board of Dentistry LSBME Louisiana State Board of Medical Examiners

Revised 2014-0501 LSBN Louisiana State Board of Nursing LSBOE Louisiana State Board of Optometry Examiners LSBPNE Louisiana State Board of Practical Nurse Examiners LSBVM Louisiana State Board of Veterinary Medicine LSBWDD Louisiana State Board of Wholesale Drug Distributors LSHP Louisiana Society of Health-System Pharmacists LSMS Louisiana State Medical Society LSNA Louisiana State Nurses Association LTC long term care LTCF long term care facility LVMA Louisiana Veterinary Medical Association MPJE Multistate Pharmacy Jurisprudence Examination (NABP) MRC MPJE Review Committee (NABP) NABP National Association of Boards of Pharmacy NABP-F National Association of Boards of Pharmacy Foundation NABPLAW National Association of Boards of Pharmacy – Law Database NACDS National Association of Chain Drug Stores NAMSDL National Alliance for Model State Drug Laws NAPLEX North American Pharmacist Licensure Examination (NABP) NAPRA National Association of Pharmacy Regulatory Authorities (Canada) NASCSA National Association of State Controlled Substance Authorities NASPA National Alliance of State Pharmacy Associations NASPER National All Schedules Prescription Electronic Reporting Act NCC MERP National Coordinating Council for Medication Error Reporting and Prevention NCPA National Community Pharmacists Association NCPDP National Council for Prescription Drug Programs NCPIE National Council on Patient Information and Education NCPO National Conference of Pharmaceutical Organizations NCSBN National Council of State Boards of Nursing NCVHS National Committee on Vital and Health Statistics NDC National Drug Code NDMA Nonprescription Drug Manufacturing Association NIPCO National Institute for Pharmacist Care Outcomes NISPC National Institute for Standards in Pharmacist Credentialing NOCA National Organization for Competency Assurance NPA National Pharmacy Association NPC National Pharmaceutical Council NPDB National Practitioner Data Bank NPTA National Pharmacy Technician Association NRC NAPLEX Review Committee (NABP) Federal Nuclear Regulatory Commission OAL Optometry Association of Louisiana OBRA Omnibus Budget Reconciliation Act OIG Office of Inspector General ONDCP Office of National Drug Control Policy ONDD Office of Narcotics and Dangerous Drugs OSHA Occupational Safety and Health Administration PARE Pharmacy Assessment, Remediation and Evaluation (NABP) PBM pharmacy benefit management PCAB Pharmacy Compounding Accreditation Board PCCA Professional Compounding Centers of America

Revised 2014-0501 PCMA Pharmaceutical Care Management Association PCOA Pharmacy Curriculum Outcomes Assessment (NABP) PDMA Prescription Drug Marketing Act PEBC Pharmacy Examining Board of Canada PhRMA Pharmaceutical Research and Manufacturers of America PMP Prescription Monitoring Program PMP-i Prescription Monitoring Program Interconnect (NABP) PTCB Pharmacy Technician Certification Board PTCE Pharmacy Technician Certification Examination PTEC Pharmacy Technician Educators Council RFID/EPC Radio Frequency Identification / Electronic Product Code SAMSHA Federal Substance Abuse & Mental Health Services Administration TJC The Joint Commission TOEFL Test of English as a Foreign Language TOEFL iBT Test of English as a Foreign Language Internet-based Test TSE Test of Spoken English URAC Utilization Review Accreditation Commission USP United States Pharmacopeia / United States Pharmacopeial Convention USP DI US Pharmacopeia Dispensing Information USP-NF US Pharmacopeia – National Formulary VAWD Verified-Accredited Wholesale Distributors (NABP) Vet-VIPPS Veterinary-Verified Internet Pharmacy Practice Sites (NABP) VIPPS Verified Internet Pharmacy Practice Sites (NABP) VPP Verified Pharmacy Practice (NABP) WHO World Health Organization WHPA World Health Professions Alliance

Revised 2014-0501 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

NOTICE IS HEREBY GIVEN that a meeting of the Board has been ordered and called for 9:00 a.m. on Wednesday, November 15, 2017 at the Board office, for the purpose to wit: A G E N D A NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official. Revised 11-13-2017

1. Call to Order 2. Invocation & Pledge of Allegiance 3. Quorum Call 4. Call for Additional Agenda Items & Adoption of Agenda 5. Consideration of Minutes from Previous Meeting – August 23, 2017 6. Report on Action Items 7. Confirmation of Acts 8. Opportunity for Public Comment 9. Special Orders of the Day A. Presentation of Pharmacist Gold Certificates PST.009331 – James Benedict Collins (issued 11-29-1967) B. Annual Election of Board Officers 10. Committee Reports A. Finance – Mr. Pitre • Consideration of Interim Report for Fiscal Year 2017-2018 • Consideration of Proposed Budget for Fiscal Year 2018-2019 B. Application Review – Mr. Soileau • Consideration of Committee Recommendations re Applications C. Reciprocity – Ms. Hall D. Violations – Mr. Bond • Consideration of Proposed Voluntary Consent Agreements E. Impairment – Mr. Rabb • Consideration of Committee Recommendations re Applications F. Reinstatement – Ms. Melancon • Consideration of Committee Recommendations re Applications G. Tripartite – Mr. Moore H. Regulation Revision – Mr. McKay • Consideration of Legislative Proposal 2018-B ~ Controlled Dangerous Substance (CDS) License for Third-Party Logistics Providers I. Executive – Mr. Aron • Consideration of Proposed Policies re Applications for Pharmacy Permits • Consideration of Additional Revisions to Policy & Procedure Manuals • Consideration of Recognition of Interprofessional Continuing Education • Consideration of Approval of Pharmacy Inspection Blueprints • Consideration of Approval of Contract for Accounting Services • Consideration of Approval of Additional Technician Certification Examination 11. Staff Reports J. Assistant Executive Director – Mr. Fontenot • Consideration of Requests for Waivers from PMP Reporting Requirement K. General Counsel – Mr. Finalet • Consideration of Proposed Voluntary Consent Agreements

Board Meeting November 15, 2017 Page 2 of 2

11. Staff Reports (cont.) L. Executive Director – Mr. Broussard 12. Review of Louisiana Attorney General Opinion 17-0076 – Mr. Randal Johnson, Louisiana Independent Pharmacies Association 13. Discussion of Letter to Attorney General & Dept. of Insurance re Pharmacy Benefit Managers – Mr. Mannino 14. Request for Waiver of Licensure Renewal Fee for Military Spouse – Lt. Col. Charlton J. Meginley 15. Petition for Additional Testing Opportunity by Applicant for Pharmacist Licensure 16. Announcements 17. Recess

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Consideration of Minutes from Previous Meetings

NOTE: Pursuant to the Open Meetings Law, at LRS 42:6.1, the committee may, upon 2/3 affirmative vote of those members present and voting, enter into executive session for the limited purposes of (1) discussion of the character, professional competence, or physical or mental health of a licensee, (2) investigative proceedings regarding allegations of misconduct, (3) strategy sessions or negotiations with respect to litigation, or (4) discussions regarding personnel matters.

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Minutes

Regular Meeting Wednesday, August 23, 2017 at 9:00 a.m. & Administrative Hearing Wednesday, August 23, 2017 at 2:30 p.m.

Location: Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700

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Table of Contents

Wednesday, August 23, 2017 – Board Meeting

Agenda Item No. Description Page No.

1. Call to Order 04 2. Invocation & Pledge of Allegiance 04 3. Quorum Call 04 4. Call for Additional Agenda Items & Adoption of Agenda 05 5. Consideration of Minutes from Previous Meetings 05 6. Report on Action Items 06 7. Confirmation of Acts 06 8. Opportunity for Public Comment 06 * Statement of Purpose 06 9. Special Orders of the Day 06 10. Committee Reports A. Finance 07 B. Application Review 07 C. Reciprocity 07 D. Violations 08 E. Impairment 10 F. Reinstatement 11 G. Tripartite 12 H. Regulation Revision 12 I. Executive 14 11. Staff Reports J. Assistant Executive Director 15 K. General Counsel 17 L. Executive Director 17 12. Request for Approval of Life Safety Training Program – EMS Safety Services, Inc. 20 13. Request for Approval of Alternative Pharmacist Verification Methodology in Central Fill System – Brookshire Grocery Co. 20 14. Request for Revision of Rules for Telepharmacy – Cardinal Health 20 15. Request for Revision of Pharmacist Licensure Requirements for PGY2 Residents – Ochsner Health System 19 16. Request for Exception to USP <800> Standards Enforcement – Lloyd’s Remedies Pharmacy 19 17. Announcements 20 18. Recess 20

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Table of Contents

Wednesday, August 23, 2017 – Administrative Hearing

Agenda Item No. Description Page No. A. Call to Order 21 B. Quorum Call 21 C. Call for Additional Agenda Items & Adoption of Agenda 21 D. Opportunity for Public Comment 21 * Appearances 21 E. Formal Hearings 22 F. Adjourn 24

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A regular meeting of the Louisiana Board of Pharmacy was held on Wednesday, August 23, 2017 in the Boardroom of the Board’s office, located at 3388 Brentwood Drive in Baton Rouge, Louisiana. The meeting was held pursuant to public notice, each member received notice, and public notice was properly posted.

1. Call to Order Mr. Carl Aron, President, called the meeting to order at 9:10 a.m.

2. Invocation & Pledge Mr. Aron called upon Mr. Brian Bond, and he delivered the invocation. Mr. Richard Mannino then led the group in the Pledge of Allegiance.

3. Quorum Call Mr. Aron called upon the Secretary, Mr. Bond, to call the roll to establish a quorum.

Members Present: Mr. Carl W. Aron Mr. Brian A. Bond Mr. Allen W. Cassidy, Jr. Ms. Jacqueline L. Hall Mr. Richard M. Indovina, Jr. Mr. Richard Mannino Ms. Chris B. Melancon Ms. Diane G. Milano Mr. Ronald E. Moore Mr. Blake P. Pitre Mr. T. Morris Rabb Mr. Don L. Resweber Mr. Douglas E. Robichaux Mr. Richard A. Soileau Dr. Raymond J. Strong Mr. Rhonny K. Valentine

Members Absent: Mr. Marty R. McKay

Staff Present: Mr. Malcolm J. Broussard, Executive Director Mr. Carlos M. Finalet, III, General Counsel Mr. M. Joseph Fontenot, Assistant Executive Director

Guests: Mr. Errol Duplantis – Lloyd’s Remedies Dr. Fallon Nicolosi – Ochsner Health System Ms. Julie Floyd – Office of the Legislative Auditor Ms. Susan Caudle – Line Avenue Compounding Pharmacy Ms. L. Shay McLaughlin – Office of the Legislative Auditor

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Ms. Emily Dixon – Office of the Legislative Auditor Mr. Ted Carmichael – Pharmacist Gold Certificate recipient Ms. Judy Carmichael Mr. Nick Cahanin – NACDS Mr. Russell Champagne – Kolder, Champagne, Slaven & Co. Ms. Penny Scruggins – Kolder, Champagne, Slaven & Co. Mr. Ben J. Sims – Brookshire Grocery Co. Mr. Jim Cousineau – Brookshire Grocery Co. Mr. Mark Sullivan – Brookshire Grocery Co. Mr. Joey Sturgeon – Silvergate Pharmaceuticals Ms. Mary Staples – NACDS Ms. MaryBeth Wilkerson – La. State Medical Society Mr. Alvin Crane – Pharmacist Gold Certificate recipient Ms. Rosa Crane Ms. Tammie Koelz – Walgreen Pharmacies Ms. Michele Fuselier – La. Pharmacists Association Mr. Jeff Gaude – Walgreen Pharmacies Mr. Michael Bourg – Pharmaceutical Specialties Ms. Ginny Martinez – Harris, DeVille & Associates Mr. William McCullar – Pharmacist Gold Certificate recipient Dr. Shanna Hampton – Pharmacist Ms. Amy Jones – Pharmacy Technician Mr. Merrill Patin – Pharmaceutical Specialties Dr. Deborah Simonson – Ochsner Health System Dr. Nicole LaCoste – Ochsner Health System Dr. Stephanie Anders – Ochsner Health System Mr. Ben McCullar – Visitor Mr. Lawrence Pourciau – Pharmacist Gold Certificate recipient Mr. Adam Chesler – Cardinal Health Mr. Robert Lancon – Adams & Reese

Mr. Bond certified 16 of the 17 members were present, constituting a quorum for the conduct of official business.

4. Call for Additional Agenda Items & Adoption of Agenda Mr. Aron asked if there were any additional agenda items but none were requested. With no further requests for amendment, and with no objection, the Board adopted the posted agenda dated August 9, 2017. Mr. Aron then requested authority from the members to reorder the agenda as necessary for the purpose of accommodating certain guests and/or reports. There were no objections to that request.

5. Consideration of Minutes Mr. Aron reminded the members they had received the draft minutes from the Regular Board Meeting on May 10, 2017, and the Administrative Hearing on May 10-11, 2017, both of which were held in Baton Rouge, Louisiana. With no objections, he waived the reading of the draft minutes. With no requests for amendment or any objection to their approval, Mr. Aron declared the minutes were approved as presented. Mr. Bond

- 5 – reminded the members to sign the Minute Book.

6. Report on Action Items Mr. Aron called on Mr. Broussard for the report. Mr. Broussard directed the members to a copy of the report in their meeting binder. There were no questions from the members.

7. Confirmation of Acts Pursuant to Mr. Aron’s declaration that the officers, committees, and executive director had attended to the business of the Board since their last meeting in accordance with policies and procedures previously approved by the Board, Mr. Moore moved, Resolved, that the actions taken and decisions made by the Board officers, Board committees, and Executive Director in the general conduct and transactions of Board business since May 10, 2017 are approved, adopted, and ratified by the entire Board. The motion was adopted after a unanimous vote in the affirmative.

8. Opportunity for Public Comment Mr. Aron reminded the members and guests the Open Meetings Law requires all public bodies to provide an opportunity for public comment at all meetings and for each agenda item upon which a vote is to be taken. He solicited general comments on non- agenda items from the guests present, and one guest requested the opportunity to ask a question. Ms. Susan Caudle identified herself as a pharmacist at Line Avenue Compounding Pharmacy in Shreveport, La. She referenced the scheduled discussion on the agenda item relative to USP Chapter 800 for hazardous drugs. She requested the Board consider the appointment of an ad hoc committee composed of board members and stakeholders to review the requirements of the new federal standards for the handling of hazardous drugs in health care settings. At the conclusion of her remarks, President Aron indicated he would appoint such a committee.

* Statement of Purpose Mr. Aron reminded the members of the purpose and mission of the Board of Pharmacy by reciting the relevant portion of the Louisiana Pharmacy Practice Act. He urged the members to keep their legislative mandate in mind as they considered all the matters before them.

9. Special Orders of the Day Mr. Aron noted there were four pharmacists present to receive their Pharmacist Gold Certificates, commemorating 50 years of licensed practice. He made those presentations to the following pharmacists.  PST.009230 – Theodore Schwartz Carmichael, issued 08-30-1967;  PST.009269 – William Wayne McCullar, issued 08-30-1967;  PST.009289 – Lawrence Daryl Pourciau, issued 08-30-1967; and  PST.009333 – Alvin Dale Crane, issued 11-29-1967. The members congratulated each of the recipients with standing ovations.

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10. Committee Reports A. Finance Committee Mr. Aron called upon Mr. Pitre for the committee report. Mr. Pitre directed the members to the Final Report for Fiscal Year 2016-2017 in their meeting binder. Mr. Aron then recognized Mr. Russell Champagne, CPA and Ms. Penny Scruggins, CPA, both from Kolder, Champagne, Slaven & Co. Mr. Champagne reviewed the report and offered his assessment of the Board’s fiscal status and financial operations. There were no questions from the members. Mr. Pitre informed the members the committee had met the previous day to review that report and voted to recommend its approval by the Board. He then moved, Resolved, to approve the Final Report for Fiscal Year 2016-2017, subject to legislative audit. The motion was adopted after a unanimous vote in the affirmative. Mr. Pitre then directed the members to the Proposed Budget Amendment No. 1 for Fiscal Year 2017-2018 in their meeting binder. He noted the committee had also reviewed that document during their meeting the previous day and had offered no suggested amendments to that proposal. He then moved, Resolved, to approve the Proposed Budget Amendment No. 1 for Fiscal Year 2017-2018. The motion was adopted after a unanimous vote in the affirmative. Finally, he expressed his appreciation to the other committee members for their ongoing efforts. Mr. Aron expressed his appreciation to Mr. Champagne and Ms. Scruggins for their ongoing assistance and long tenure as the Board’s accounting firm.

B. Application Review Committee Mr. Aron called upon Mr. Soileau for the committee report. Mr. Soileau reported the committee had met the previous day to consider four referrals from the staff – three applicants for a pharmacy technician candidate registration and one applicant for a pharmacist license. Following their interview and deliberation, the committee authorized the issuance of the pharmacist license, directed one of the technician candidate applicants to reinstate her Texas technician credential before any further consideration of her application, and then recommended the denial of the two remaining applications for a technician candidate registration. Both of the applications recommended for denial were scheduled for a future administrative hearing. Finally, Mr. Soileau expressed his appreciation to the other members of the committee for their ongoing efforts.

C. Reciprocity Committee Mr. Aron called upon Ms. Hall for the committee report. She reported the staff had evaluated 69 applications for pharmacist licensure by reciprocity since the last Board meeting and that none of them contained information that warranted a committee level review. In conformance with policies and procedures previously approved by the Board, the staff approved the applications and issued the credentials.

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Finally, she closed the report with appreciation to the other committee members for their ongoing efforts.

D. Violations Committee Mr. Aron called upon Mr. Bond for the committee report. Mr. Bond reported the committee held preliminary hearings on June 14-15, 2017 to consider their posted agenda which included 28 cases: 10 pharmacists, 6 pharmacy technicians, and 12 pharmacy permits. Prior to the meeting, the committee authorized continuances for 2 of the respondents. After interviews and deliberations, the committee took no action on 8 of the respondents and issued non-disciplinary letters of noncompliance to 4 of the respondents. The committee refused to offer one respondent a proposed consent agreement and instead directed staff to proceed to an administrative hearing. The committee offered proposed voluntary consent agreements to the remaining 12 respondents. Two of the respondents initially accepted their proposed agreements and then requested reconsideration; those cases have been scheduled for a future committee meeting. Since two of the remaining 10 respondents have two separate cases, there were 12 proposed consent agreements to be considered that day. Mr. Bond then presented the following proposals to the members for their consideration.

B&B Pharmacy Enterprises, LLC d/b/a Highland Health Mart Pharmacy [Baton Rouge, LA] (PHY.006687) Mr. Bond moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $2,500 plus administrative and investigative costs.

Christopher Wesley Kidwell (CPT.007999) Mr. Bond moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand and directed its publication in its quarterly newsletter; and further, assessed administrative and investigative costs.

Ashley Simon Seiber (CPT.013762) Mr. Bond moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board suspended the certificate for one year and stayed the execution of the suspension, then placed the certificate on probation for one year, effective August 23, 2017, subject to certain terms enumerated in the consent agreement; and further, assessed administrative costs.

K&B Louisiana Corporation d/b/a Rite Aid Pharmacy No. 15067 [Shreveport, LA] (PHY.003040) Mr. Bond moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $1,000 plus administrative and investigative costs.

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Caremark, LLC d/b/a CVS Specialty Pharmacy [Redlands, CA] (PHY.005587) Mr. Bond moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $5,000 plus administrative and investigative costs.

Talisha Lachel Causey (CPT.010234) Mr. Bond moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board revoked the certificate; and further, permanently prohibited the acceptance of any future reinstatement application or any application for any other credential issued by the Board.

Steven’s Pharmacy, Inc. d/b/a Steven’s Pharmacy [Port Allen, LA] (PHY.004535 & CDS.038660-PHY– Case No. 17-0106) Mr. Bond moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $5,000 plus administrative and investigative costs.

Steven Walter Gough (PST.013199 – Case No. 17-0107) Mr. Bond moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand; and further, assessed administrative costs.

Steven’s Pharmacy, Inc. d/b/a Steven’s Pharmacy [Port Allen, LA] (PHY.004535 & CDS.038660-PHY– Case No. 16-0219) Mr. Bond moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board suspended the permit for five years and stayed the execution of the suspension, then placed the permit on probation for five years, beginning at the end of the current probationary term scheduled to conclude on October 1, 2017, subject to certain terms enumerated in the consent agreement; and further, assessed a fine of $25,000 plus administrative and investigative costs.

Steven Walter Gough (PST.013199 – Case No. 16-0220) Mr. Bond moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board suspended the license for an indefinite period of time, effective July 10, 2017; and further, conditioned the acceptance of any future reinstatement application upon the satisfaction of certain requirements identified in the consent agreement; and further, assessed administrative costs.

Rx Care of LA, Inc. d/b/a Benzer Pharmacy [Vivian, LA] (PHY.006524 & CDS.041729-PHY) Mr. Bond moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote. The Board assessed a fine of $10,000 plus administrative and investigative costs.

Caron Rae Dressler Oden (PST.017247) Mr. Bond moved to approve the - 9 –

proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Warning; and further, assessed administrative costs.

Mr. Bond reported the committee will meet on September 6 to consider that docket, which included 5 pharmacists, 4 pharmacy technicians, 6 pharmacy permits, and one applicant for a pharmacy permit. Finally, Mr. Bond concluded his report with appreciation to the other committee members for their ongoing efforts.

E. Impairment Committee Mr. Aron called upon Mr. Rabb for the committee report. Mr. Rabb reported the committee met the previous day to consider 8 referrals from the staff – 2 applications for reinstatement of pharmacist licenses, 2 applications for probation modification from pharmacists, one application for a pharmacy intern registration, one application for a pharmacy technician candidate registration (which was later withdrawn), and 2 appearances for informal conference from a pharmacist and pharmacy technician. They also considered professional credentials and letters of interest from three addiction medicine specialists for approval and placement on the Board’s Roster of Approved Addictionists. Following their interviews of the applicants and subsequent deliberations, the committee deferred further consideration of the applicant for the pharmacy intern registration and the pharmacist present for an informal conference, pending their completion of medical treatment. Mr. Rabb then presented the following files to the members for their consideration.

Stephanie Ann Richards (PST.015339) Mr. Rabb moved to approve the respondent’s request for reinstatement of the previously-suspended license. The motion was adopted after a unanimous vote in the affirmative. The Board reinstated the license and restored it to active and unrestricted status.

James Edward Helou (PST.019129) Mr. Rabb moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board granted the respondent’s request for reinstatement of the previously suspended license, converted the duration of the suspensive period from an indefinite term to a term of five years and stayed the execution of the suspension, then placed the license on probation for five years effective August 23, 2017, subject to certain terms enumerated in the consent agreement.

Stephen Leonard Collins (PST.011311) Mr. Rabb moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board granted the respondent’s request for early termination of the previously-imposed probationary period originally scheduled to conclude on November 18, 2020, and further, the immediate conversion of his license to voluntary inactive status.

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Kacie Dore Keith (PST.020248) Mr. Rabb moved to approve the respondent’s request for modification of previously-imposed probationary terms. The motion was adopted after a unanimous vote in the affirmative. The Board removed Article 2-e from her August 10, 2016 Probation Board Order which had restricted her from accepting an appointment as the pharmacist-in-charge at a pharmacy.

Pattie Jo Bullard (CPT.013594) Mr. Rabb moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board suspended the certificate for five years and stayed the execution of the suspension, then placed the certificate on probation for five years, effective August 23, 2017, subject to certain terms enumerated in the consent agreement.

Mr. Rabb reported the committee had received letters of interest from three addiction medicine specialists seeking enrollment on the Board’s Roster of Approved Addictionists. Following the committee’s review of their professional credentials, the committee voted to recommend the addition of all three physicians to the Board’s roster. Mr. Rabb then moved, Resolved, to approve the August 23, 2017 edition of the Board’s Roster of Approved Addictionists for the remainder of Fiscal Year 2017-2018. The motion was adopted after a unanimous vote in the affirmative. Finally, Mr. Rabb closed his report with appreciation to his fellow committee members for their work the previous day and for the ongoing staff support.

F. Reinstatement Committee Mr. Aron called upon Ms. Melancon for the committee report. Ms. Melancon reported the committee met the previous day to consider 7 referrals from the staff – 4 applications for reinstatement of credentials from two pharmacists and two pharmacy technicians, 2 petitions for modification of previous orders from one pharmacist and one pharmacy, and one petition for the return of a pharmacist license from voluntary inactive status to active status. Following their interviews and deliberations the committee voted to authorize the removal of a non-disciplinary restriction on the pharmacy permit; that action did not require Board approval. The committee also voted to recommend the denial of reinstatement for one of the pharmacy technicians; that case was scheduled for a future administrative hearing. Ms. Melancon then presented the following files to the members for their consideration.

Charles Wendell Alford (PST.013050) Ms. Melancon moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board granted respondent’s request for reinstatement of the previously lapsed license, suspended it for two years and stayed the execution of the suspension, then placed the license on

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probation for two years, effective August 23, 2017, subject to certain terms enumerated in the consent agreement.

Judy Lynn Armstrong (CPT.004262) Ms. Melancon moved to approve the respondent’s request for reinstatement of the previously-lapsed certificate. The motion was adopted after a unanimous vote in the affirmative. The Board reinstated the certificate and restored it to active and unrestricted status.

Donna Fragala White (PST.013041) Ms. Melancon moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board granted the respondent’s request for reinstatement of the previously-lapsed license, contingent upon the satisfaction of certain requirements identified in the consent agreement.

Harvey Lee Smith, Jr. (PST.020467) Ms. Melancon moved to approve the respondent’s request for early termination of the previously-imposed probationary period which was scheduled to conclude on February 13, 2019. The motion was adopted after a unanimous vote in the affirmative. The Board removed all probationary terms and restored the license to active and unrestricted status.

Lisa Michelle Posik (PST.017061) Ms. Melancon moved to approve the respondent’s request to return her pharmacist license from voluntary inactive status to active status. The motion was adopted after a unanimous vote in the affirmative. The Board restored the license to active and unrestricted status.

Ms. Melancon closed her report with appreciation to the other committee members for their work the previous day.

G. Tripartite Committee Mr. Aron called upon Mr. Moore for the committee report. Mr. Moore noted the committee had not met since March 2016 and therefore no report was available.

At this point, Mr. Aron declared a brief recess. It was noted the members recessed at 10:35 am and reconvened at 11:15 am.

H. Regulation Revision Committee Since the committee chair, Mr. Marty McKay, was absent, Mr. Aron called on Mr. Broussard to present the committee report. Mr. Broussard noted the committee had not met since the last Board meeting; however, there had been two public hearings on multiple regulatory projects. He indicated the members needed to consider the comments and testimony offered at those hearings to determine whether any additional revisions were necessary and to determine the future course of those projects.

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With respect to Regulatory Project 2017-1 ~ Pharmacy Internship Requirement, the Board convened a public hearing on May 30, 2017. The one commentator had no requests for changes to the original proposed rule. Following their consideration of that comment and further discussion concerning implementation of the rule, Mr. Moore moved, Resolved, to request the executive director transmit an appropriate reply to the commentator at the May 30 public hearing, to then compile and transmit the Second Report to the Joint Legislative Oversight Committee on Health & Welfare, and to then publish the original proposal as a Final Rule in the Louisiana Register, with an effective date of January 1, 2018. The motion was adopted after a unanimous vote in the affirmative. With respect to Regulatory Project 2017-2 ~ Equivalent Drug Product Interchange, the Board convened a public hearing on May 30, 2017. There were two commentators, only one of which requested specific changes to the proposed rule; the other commentator offered information but had no comments on the proposed rule. Following their consideration of the commentator’s requests, Mr. Cassidy moved, Resolved, to request the executive director transmit an appropriate reply to the commentator at the May 30 public hearing, to then compile and transmit the Second Report to the Joint Legislative Oversight Committee on Health & Welfare, and to then publish the original proposal as a Final Rule in the Louisiana Register. The motion was adopted after a unanimous vote in the affirmative. With respect to Regulatory Project 2015-9 ~ Pharmacy Technicians, the Board convened a second public hearing on June 26 to receive comments on four sets of revisions of the original proposed rule approved by the Board during their March 14 meeting. There was one comment offered, which reiterated their earlier comment on the original proposal that had not been accepted by the Board during their March meeting. Mr. Broussard reviewed the history of the regulatory project, beginning with the original emergency rule in November 2015, through the current proposal originally published in January 2017 and then revised in March 2017. Following their consideration of that comment, Mr. Indovina then moved, Resolved, to request the executive director transmit an appropriate reply to the commentator at the June 26 public hearing, to then compile and transmit the Second Report to the Joint Legislative Oversight Committee on Health & Welfare, and to then publish the original proposal as once revised as a Final Rule in the Louisiana Register, with an effective date of January 1, 2018. Prior to the vote, Mr. Mannino offered a substitute motion to table the original motion. That motion failed following a roll call vote, with Mr. Mannino and Ms. Milano voting in the affirmative. Prior to voting on the original motion, Mr. Aron solicited public comments. Mr. Nick Cahanin, representing the National Association of Chain Drug Stores (NACDS), offered information about the legislative resolutions adopted during the 2017 Legislature. Ms. Mary Staples, also representing NACDS, offered additional information concerning

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similar activities on this topic with other state boards of pharmacy. Mr. Pitre then moved the previous question. With no objections to that request, Mr. Aron requested a roll call vote on the original motion. The motion was adopted after a majority vote in the affirmative; Mr. Mannino and Ms. Milano objected. With respect to Regulatory Project 2016-6 ~ Marijuana Pharmacy, the Board convened a second public hearing on June 26 to receive comments on the 16 sets of revisions of the original proposed rule approved by the Board during their March 14 meeting. There was one request for additional change, to reverse one of the 16 sets of revisions relative to the permitted dosage forms, to change the gelatin-based chewable back to edible dosage forms. Since the change to gelatin-based chewable was requested by the legislative sponsor, Mr. Aron determined the Board would not make that change. He directed the appropriate reply to the commentator and the filing of the Second Report to the Joint Legislative Committee on Health & Welfare. Since that committee did not intervene, the Board published the Final Rule in the August 20, 2017 edition of the Louisiana Register, with an immediate effective date. Mr. Broussard then responded to questions from several members about the implementation plan for the marijuana pharmacy permit. Mr. Broussard closed the committee report with the observation of twelve topics still remaining on their standing agenda, with additional referrals anticipated before the end of that day.

At this point, Mr. Aron declared a luncheon recess. It was noted the members recessed at 12:50 pm and then reconvened at 1:45 pm.

I. Executive Committee Mr. Aron reported the committee had met the previous day to consider the items on their posted agenda. In particular, the committee reviewed the legislation adopted during the 2017 Legislature, a series of blueprints for pharmacy inspections, a proposed amendment of a recent policy statement relative to transfer of prescription information, a cooperative endeavor agreement with the Office of Facility Planning & Control relative to the office building renovation project, the annual financial audit, and a request to review the Board’s current rule relative to centralized prescription dispensing. With respect to Act 220 of the 2017 Legislature, the Board was asked to interpret that law relative to the inclusion of veterinary drug products. Following a brief discussion, Mr. Moore moved, Resolved, the Board, having reviewed the legislative history of Act 220 of the 2017 Legislature, is of the belief that the inclusion of veterinary drug products was not intended, and therefore, will not aggressively seek the reporting of price information for veterinary drug products. The motion was adopted after a unanimous vote in the affirmative. With respect to the series of pharmacy inspection blueprints, the committee requested staff distribute the documents to the members and

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request the members review those documents prior to their next meeting, and to schedule those documents for consideration during the next Board meeting scheduled for November 15, 2017. With respect to the Board’s recent policy statement relative to the transfer of prescription information for unfilled prescriptions between pharmacies, the committee reconsidered that policy in light of a recently announced policy statement from the U. S. Drug Enforcement Administration (DEA) on that same topic. Following a short discussion, Mr. Rabb moved, Resolved, to approve the proposed revision of Board Policy PPM.I.A.22 ~ Transfer of Prescription Information Between Pharmacies. The motion was adopted after a unanimous vote in the affirmative. With respect to the office building renovation project, the committee reviewed the previously-executed cooperative endeavor agreement with the Office of Facility Planning & Control in the Div. of Administration. Mr. Aron directed the members to a copy of that agreement in their meeting binder; and further, he reminded them their budget amendment adopted earlier that day included detailed information on the scheduled renovations. With respect to the annual financial audit which was already in process, Mr. Aron informed the members of their need to adopt a different version of the Management’s Representation Letter than the one they previously adopted. Mr. Rabb then moved, Resolved, that the Board approve the Management’s Representation Letter for the 2017 Audit by the auditors, Pinell & Martinez, LLC, and further, to authorize the President and Secretary to execute that document on our behalf. The motion was adopted after a unanimous vote in the affirmative. With respect to §1141 of the Board’s rules relative to centralized prescription dispensing, the committee received information from the staff concerning several requests for interpretation of that rule in light of several contemporary models of centralized operations due to lack of clarity of the rule as it was originally written in 2013. Mr. Aron referred the topic to the Board’s Regulation Revision Committee. Finally, Mr. Aron closed his report with appreciation for the other committee members and their work the previous day.

11. Staff Reports J. Report of Assistant Executive Director Mr. Aron called upon Mr. Fontenot for his report. Mr. Fontenot directed the members to the quarterly report for the Prescription Monitoring Program, reviewing transaction data, registration counts, and search data. He then directed the members to the new requests for exemption from the PMP reporting requirements. Mr. Moore moved, Resolved, to authorize the issuance of PMP reporting waivers to: > PHY.006472-NR – Advanced Pharmacy (SC); > PHY.007147-IR – AlphaMed Pharmacy (LA); > PHY.007433-NR – BrooksideRx (NE);

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> PHY.006678-NR – CarePoint Pharmacy (IL); > PHY.007423-NR – Carepoint Pharmacy (IL); > PHY.006649-NR – Carie Boyd’s Prescription Shop (TX); > PHY.007242-NR – Cedra Pharmacy (NY); > PHY.007492-NR – Chemistry Rx (PA); > PHY.007469-NR – Choice Rx Pharmacy (FL): > PHY.001060-HOS – Christus Health Southwestern La. (LA); > PHY.007387-HOS – Cobalt Rehabilitation Hospital – N.O. (LA); > PHY.006760-NR – Conversio Health (CA); > PHY.007493-NR – Cottrill’s Pharmacy (NY); > PHY.007426-HOS – Curahealth Hospital New Orleans (LA); > PHY.007215-NR – Decillion Healthcare (OH); > PHY.006978-NR – Diplomat Specialty Infusion Group (NC); > PHY.007265-NR – Diplomat Specialty Infusion Group (AZ); > PHY.007175-NR – Diplomat Specialty Infusion Group (IA); > PHY.000269-HOS – East Carroll Parish Hospital Pharmacy (LA); > PHY.007280-NR – Geesons Pharmacy (TX); > PHY.007498-NR – Geneva Pharmacy (NE); > PHY.006880-NR – Genoa Healthcare (MO); > PHY.006862-IR – Genoa, a QoL Healthcare Company (LA); > PHY.007164-NR – Heartland Medical (KS); > PHY.007001-IR – Lafayette General Pinhook Pharmacy (LA); > PHY.007232-HOS – Lafayette General Southwest Pharmacy (LA); > PHY.006389-HOS – Lafayette Surgical Specialty Hospital (LA); > PHY.007499-HOS – Lakeview Regional Medical Center (LA); > PHY.007372-NR – Life Tree Pharmacy (PA); > PHY.006903-NR – LMC Medical Supplies (FL); > PHY.006883-NR – Matlock Pharmacy (TX); > PHY.007491-NR – MediSuite Pharmacy (NC); > PHY.007005-HOS – North Oaks Rehabilitation Hospital Pharmacy (LA); > PHY.007515-NR – Paragon Healthcare (TX); > PHY.007203-NR – Pathstone Health Services (FL); > PHY.007048-NR – Physician Specialty Pharmacy (FL); > PHY.007487-HOS – Physicians Medical Center (LA); > PHY.007504-NR – RTS Americas (IL); > PHY.007095-IR – Rx 2 Geaux Pharmacy (LA); > PHY.006848-NR – Soleo Health (PA); > PHY.007177-NR – Synergy Pharmacy Services (FL); > PHY.006478-HOS – The NeuroMedical Center Rehabilitation Hospital Pharmacy (LA); > PHY.005533-HOS – Touro Infirmary Hospital Pharmacy (LA); > PHY.001833-HOS – Union General Hospital Pharmacy (LA); > PHY.007434-NR – VitalRx (AL); > PHY.007457-NR – Walgreens Pharmacy #02445 (FL); and > PHY.007093-NR – Woodland Hills Pharmacy (CA)

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once they have executed the standard consent agreement for that purpose. The motion was adopted after a unanimous vote in the affirmative. Mr. Pitre then moved, Resolved, to deny the request from PHY.005096-NR, held by ZooPharm in Laramie, WY for a waiver from the PMP reporting requirements. The motion was adopted after a unanimous vote in the affirmative. Mr. Fontenot then reported on the implementation plan for Act 76 of the 2017 Legislature, which requires the Board to issue PMP access privileges to all practitioners (except veterinarians) automatically upon the initial issuance of their state CDS license or upon the renewal of that license. Finally, Mr. Fontenot indicated completion of his report.

K. Report of General Counsel Mr. Aron called upon Mr. Finalet for his report. Mr. Finalet then presented the following files to the members for their consideration.

Jamie Marie Wilson (CPT.009950) Mr. Rabb moved to approve the proposed voluntary consent agreement. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand; and further, assessed a fine of $250 plus administrative costs.

Kaitlyn Marie Zimmerman (PTC.025251) Mr. Cassidy moved to accept the voluntary surrender of the credential. The motion was adopted after a unanimous vote in the affirmative. The Board accepted the voluntary surrender, resulting in the active suspension of the registration for an indefinite period of time, effective July 20, 2017.

Jason Warren Dupeire (PST.018298) Mr. Cassidy moved to accept the voluntary surrender of the credential. The motion was adopted after a unanimous vote in the affirmative. The Board accepted the voluntary surrender, resulting in the active suspension of the license for an indefinite period of time, effective July 26, 2017.

Summer Michelle Eichelberger (PTC.025120) Mr. Cassidy moved to accept the voluntary surrender of the credential. The motion was adopted after a unanimous vote in the affirmative. The Board accepted the voluntary surrender, resulting in the active suspension of the registration for an indefinite period of time, effective August 21, 2017.

Finally, Mr. Finalet indicated the completion of his report.

L. Report of Executive Director Mr. Aron called upon Mr. Broussard for the report. Mr. Broussard directed the members to his report in the meeting binder. He reviewed the

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following topics: • Meeting Activity • Reports  Internal Reports Census Reports – Credentials & Compliance Divisions Production Reports – Credentials Division Exceptions Report  External Reports Administrative and Legislative Agency Reports Mr. Pitre moved, Resolved, to approve the Board’s Annual Report for Fiscal Year 2016-2017, and further, to request the executive director to send a copy to the Office of the Governor, and further, to post a copy on the Board’s website. The motion was adopted after a unanimous vote in the affirmative. • Examinations MPJE NAPLEX PARE PTCB • Operations Credentials Division Compliance Division Administrative Division • State Activities La. Legislature La. State Board of Medical Examiners La. State Board of Nursing La. Dept. of Health – Office of Public Health La. Dept. of Agriculture & Forestry • Regional & National Activities National Association of Boards of Pharmacy (NABP) NABP-AACP District 6 MALTAGON ACPE (Accreditation Council for Pharmacy Education) DEA (U.S. Drug Enforcement Administration) CDC (U.S. Centers for Disease Control & Prevention) • International Activities International Pharmaceutical Federation (FIP) .Pharmacy gTLD Mr. Aron requested Mr. Broussard to review the recent decision by the ACPE Board of Directors to place ULM School of Pharmacy’s accreditation on probation. He reviewed the four accreditation standards cited by ACPE in its accreditation decision. Mr. Aron requested Mr. Broussard to review the recent MPJE and NAPLEX examination results for both schools of pharmacy as well as the most recent data for - 18 –

the PTCB test. Finally, Mr. Broussard indicated the completion of his report.

At this point, Mr. Aron indicated his intent to re-order the agenda to accommodate certain guests.

16. Request for Exception to USP <800> Standards Enforcement – Mr. Errol Duplantis, Lloyd’s Remedies Pharmacy Mr. Aron invited Mr. Duplantis to explain his request. Mr. Duplantis introduced two representatives from Humco Pharmaceutical Group, who informed the members about a group of their firm’s products, concentrated topical formulations of hormonal drug products. The representatives suggested their products did not warrant the level of risk management apparently required by the standards identified in USP <800>. Mr. Duplantis suggested the USP standards were excessively stringent and would require significant financial investment from pharmacies; and further, he suggested that several pharmacies would decline to make those investments, resulting in fewer pharmacies preparing those products for patients, resulting in medication access issues for patients. Mr. Aron invited Ms. Caudle to expand upon her earlier comments. She suggested the USP standards were based on faulty science, would result in medication access issues as described earlier, and requested the Board to further study the issue before adopting the USP <800> standards as presented. Mr. Indovina informed the members the standards were applicable to a wider range of licensees than the pharmacy compounders represented at the meeting. Mr. Aron suggested there were enough concerns raised to warrant further study by the Board. He referred the matter to the Regulation Revision Committee with instructions to invite stakeholders to review the issue and then report back to the Board.

15. Request for Revision of Pharmacist Licensure Requirements for PGY2 Residents – Dr. Stephanie Anders, Ochsner Health System Mr. Aron invited Dr. Anders to explain her request. She explained the pharmacy residency concept, illustrating the first year (PGY1) residency and second year (PGY2) residency programs. She then explained the difficulty experienced by applicants for PGY2 residency programs in Louisiana, citing the reciprocity requirements for pharmacist licensure. She mentioned a few states which provide alternative licensure options for PGY2 residents. She requested the Board to consider alternative licensure requirements for PGY2 residency applicants. Mr. Aron recognized Dr. Deborah Simonson, Vice President for Pharmacy Affairs at Ochsner Health System, and a former member of the Board. She requested the Board refer the issue to its Regulation Revision Committee for development of a regulatory or legislative proposal to make the requested changes. Mr. Aron requested Mr. Broussard to review the pharmacist licensure requirements and he explained the reciprocity requirements and some suggested changes that would remedy the issue raised by the representatives from Ochsner Health System. Mr. Aron referred the matter to the Regulation Revision Committee with instructions to review the statutory licensure requirements and draft a legislative proposal for the Board’s consideration prior to the next legislative session.

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13. Request for Approval of Alternative Pharmacist Verification Methodology in Central Fill System – Mr. Jim Cousineau, Mr. Mark Sullivan, & Mr. Ben Sims, Brookshire Grocery Co. Mr. Aron invited the representatives to explain their request. Mr. Sullivan began by reviewing the presentation materials provided to the members prior to the members. He responded to several questions from the members. Mr. Finalet suggested the provisions of §1203.A.1.c would not prohibit a nonresident pharmacy from obtaining an Automated Medication System (AMS) registration from the Board. The significance of that credential is the authority for electronic product verification within §1217.C of that chapter of rules. Mr. Aron suggested the firm review those rules to ensure their compatibility for the requested authority, and then to apply for the AMS registration. The representatives expressed their appreciation to the Board for its favorable resolution of their request.

14. Request for Revision of Rules for Telepharmacy – Dr. Adam Chesler, Cardinal Health Mr. Aron invited Dr. Chesler to explain his request. Dr. Chesler directed the members to a copy of a regulatory proposal in their meeting binder to amend some sections of the Board’s rules for the telepharmacy permit. In particular, he suggested the mileage radius to the next closest pharmacy be reduced from 20 miles to 10 miles, and he also suggested the section requiring a telepharmacy to close when another pharmacy opened in that same area be modified to insert an exception when the telepharmacy is dispensing less than 200 prescriptions per day. He presented some data describing health care facilities in several Louisiana communities. He responded to questions from several members about different aspects of the telepharmacy rule. Mr. Aron referred the request to the Regulation Revision Committee for their review of the request, development of a proposal, and report back to the Board.

12. Request for Approval of Life Safety Training Program – EMS Safety Services, Inc. Mr. Aron requested Mr. Broussard describe the request. Mr. Broussard reported the firm had satisfied all requirements previously established for the approval of such programs. Mr. Moore moved, Resolved, to approve the Basic Life Support training program offered by EMS Safety Services, Inc. for pharmacists and pharmacy interns seeking to qualify for a medication administration registration. The motion was adopted after a unanimous vote in the affirmative.

17. Announcements Mr. Aron directed the members to the announcements in their meeting binder.

18. Recess Having completed the tasks itemized on the posted agenda, with no further business pending before the Board, and without objection, Mr. Aron recessed the meeting at 4:40 p.m.

* * * * *

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An Administrative Hearing was convened on Wednesday, August 23, 2017 in the Boardroom of the Board’s office, located at 3388 Brentwood Drive in Baton Rouge, Louisiana. The hearing was held pursuant to public notice, each member received notice, each respondent received notice (unless specifically stated otherwise in the official transcript), and public notice was properly posted.

A. Call to Order Mr. Aron called the hearing to order at 4:55 p.m.

B. Quorum Call Mr. Aron called upon Secretary Bond and he called the roll. After doing so, he certified Mr. McKay, Ms. Melancon, and Mr. Rabb were absent; however, the remaining 14 members were present, constituting a quorum for the conduct of official business.

C. Call for Additional Agenda Items & Adoption of Agenda Mr. Aron asked if there were any additional agenda items, and none were requested. With no objection, the Board adopted the posted agenda, dated August 10, 2017. He then requested authority to re-order the agenda as may become necessary, and there were no objections to that request.

D. Opportunity for Public Comment Mr. Aron reminded the members and guests the Open Meetings Law requires all public bodies to provide an opportunity for public comment at all meetings and prior to the vote on each agenda item. He solicited comments from the guests, but none were offered.

Appearances Mr. Aron indicated he would serve as the Hearing Officer. Ms. Celia Cangelosi was introduced as the Prosecuting Attorney for the first case relative to the pharmacy technician candidate and Mr. Carlos Finalet as the Prosecuting Attorney for the second case relative to the pharmacy. Ms. Susan Erckle served as the Official Recorder, and Mr. Malcolm Broussard as the Hearing Clerk. Without objection, Mr. Aron waived the reading of the posted agenda and instead directed the insertion thereof into these minutes. The posted agenda is re-created here.

A G E N D A NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official. Revised 08-10-2017

A. Call to Order

B. Quorum Call

C. Call for Additional Agenda Items & Adoption of Agenda

D. Opportunity for Public Comment

E. Formal Hearings

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01. PTC.021994 – Kristen Je’Nay Williams Case No. 15-0350

02. PHY.006167 – Benecard Central Fill of PA, LLC d/b/a Benecard Central Fill [Mechanicsburg, PA] Case No. 17-0124

F. Adjourn

E. Formal Hearings

Kristen Je’Nay Williams (PTC.021994) Ms. Cangelosi appeared for the Board. Mr. Kris Parret introduced himself as counsel for the respondent and then introduced the respondent, Ms. Williams. Ms. Cangelosi offered an opening statement during which she indicated both parties had agreed to the admission of Board Exhibits 1 through 16 as well as the proposed Findings of Fact which she recited for the record. Mr. Parret presented an opening statement and then Ms. Williams presented a verbal statement. She then responded to questions from several members of the hearing panel. Ms. Cangelosi proffered proposed findings of fact and conclusions of law, but deferred to the Board for its own order. Mr. Parret offered a closing statement, then tendered the matter to the hearing panel for its consideration. Mr. Moore moved to enter into executive session for the purpose of deliberating the disciplinary matter and discussing the respondent’s professional competency. The motion for executive session was adopted after a unanimous roll call vote in the affirmative.

It was noted the hearing panel entered executive session at 5:40 p.m. and then reconvened in open session at 6:20 p.m. Mr. Aron reported no decision was made during the executive session.

Mr. Moore moved, Resolved, that the hearing panel, having heard the testimony and considered the evidence, accept the Findings of Fact as proposed by the Prosecuting Attorney, adopt them as our own, and then enter them into the hearing record. The motion was adopted after a unanimous vote in the affirmative. Mr. Moore then moved, Resolved, that the hearing panel accept the Conclusions of Law as proposed by the Prosecuting Attorney, adopt them as our own, and then enter them into the hearing record. The motion was adopted after a unanimous vote in the affirmative. Mr. Moore then moved, Resolved, that the hearing panel enter the following order at this time: It is ordered, adjudged, and decreed that Louisiana Pharmacy Technician Candidate Registration No. 21994, held by Kristen Je’Nay Williams, shall be and is hereby suspended for an indefinite period of time, effective on the entry of this order, and further, should the respondent successfully complete the pharmacy technician certification - 22 –

examination administered by the Pharmacy Technician Certification Board on or before May 31, 2018, the Board may issue a pharmacy technician certificate to the respondent, and further, the pharmacy technician certificate shall be suspended for five years effective on the date of issuance with the execution thereof stayed, then placed on probation for five years effective on the date of issuance, subject to the following terms of probation: (1) Respondent shall not violate or be found guilty of violating any local, state, or federal pharmacy laws or laws regarding controlled dangerous substances. (2) Respondent shall pay the following assessments: (a) the administrative hearing fee of $250; and (b) the investigative and hearing costs, including the costs of the prosecuting attorney, and the official recorder. Prior to the vote, Mr. Resweber moved to amend the proposed order for the purpose of extending the suspension, stay, and probation to any other credential issued by the Board during the five year period. The amendment was adopted after a unanimous vote in the affirmative. The amended motion was then adopted after a unanimous vote in the affirmative.

Benecard Central Fill of PA, LLC d/b/a Benecard Central Fill of PA [Mechanicsburg, PA] (PHY.006167) Mr. Finalet appeared for the Board and noted the absence of the respondent or counsel. After verifying the absence of the respondent, Mr. Aron ruled the hearing would proceed as scheduled in the form of a default proceeding. Mr. Finalet presented an opening statement, no witnesses, and five exhibits. He then presented a closing statement and offered proposed findings of fact, conclusions of law, and board order, following which he tendered the matter to the hearing panel for its consideration. Mr. Soileau moved to enter into executive session for the purpose of deliberating the disciplinary matter and discussing the respondent’s professional competency. The motion for executive session was adopted after a unanimous roll call vote in the affirmative.

It was noted the hearing panel entered executive session at 6:40 p.m. and then reconvened in open session at 6:50 p.m. Mr. Aron reported no decision was made during the executive session.

Mr. Robichaux moved, Resolved, that the hearing panel, having heard the testimony and considered the evidence, accept the Findings of Fact as proposed by the Prosecuting Attorney, adopt them as our own, and then enter them into the hearing record. The motion was adopted after a unanimous vote in the affirmative. Mr. Robichaux then moved, Resolved, that the hearing panel accept the Conclusions of Law as

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proposed by the Prosecuting Attorney, adopt them as our own, and then enter them into the hearing record. The motion was adopted after a unanimous vote in the affirmative. Mr. Robichaux then moved, Resolved, that the hearing panel enter the following order at this time: It is ordered, adjudged, and decreed that Louisiana Pharmacy Permit No. 6167, held by Benecard Central Fill of PA, LLC d/b/a Benecard Central Fill of PA [Mechanicsburg, PA], shall be and is hereby suspended for an indefinite period of time, effective on the entry of this order, and further, the respondent shall pay the following assessments: (1) A fine of $5,000; (2) The administrative hearing fee of $250; and (3) The investigative and hearing costs, including the costs of the prosecuting attorney, and the official recorder; and It is further ordered the acceptance of any future application for the reinstatement of this permit, or any application for any other credential issued by the Board, shall be conditioned upon the satisfaction of the following terms: (1) Respondent shall not submit such application until the respondent has satisfied its obligation for the 4th Period of 2015 to the Louisiana Medicaid Assistance Trust Fund at the Louisiana Dept. of Health; (2) Respondent shall have paid all assessments levied herein; and (3) Respondent shall have no pending legal or disciplinary matters against the firm in any jurisdiction; The motion was adopted after a unanimous vote in the affirmative.

Mr. Finalet indicated completion of the cases scheduled for that day. Mr. Aron expressed his appreciation to Ms. Erckle for her recording services that day.

F. Adjourn Having completed the tasks itemized on the posted agenda, with no further business pending before the Board, and without objection, Mr. Aron adjourned the hearing at 6:55 p.m.

Respectfully submitted,

______Brian A. Bond Secretary

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Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Report on Action Items

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

November 15, 2017

Agenda Item 6: Report on Action Items

During the report from the Finance Committee at your last meeting, you approved the Final Report for Fiscal Year 2016-2017 as well as the Proposed Budget Amendment for Fiscal Year 2017-2018. We filed those items on August 30 with the Joint Legislative Oversight Committee on Health & Welfare as well as the Legislative Fiscal Office and the Legislative Auditor.

During the report from the Regulation Revision Committee at your last meeting, you evaluated the comments and testimony received on several regulatory proposals. In particular: • With respect to Regulatory Project 2017-1 ~ Internship Requirements, you evaluated the one comment offered during the May 30 public hearing and determined no revisions were necessary. You directed the completion of the regulatory project. We compiled and submitted the Second Report to the Joint Legislative Oversight Committee on Health & Welfare on September 27. With no intervention by that committee, we submitted the Final Rule for publication in the November 20, 2017 edition of the Louisiana Register, with a delayed effective date of January 1, 2018. • With respect to Regulatory Project 2017-2 ~ Equivalent Drug Product Interchange, you evaluated the one comment offered during the May 30 public hearing and determined no revisions were necessary. You directed the completion of the regulatory project. We compiled and submitted the Second Report to the Joint Legislative Oversight Committee on Health & Welfare on September 27. With no intervention by that committee, we submitted the Final Rule for publication in the November 20, 2017 edition of the Louisiana Register, with an immediate effective date. • With respect to Regulatory Project 2015-9 ~ Pharmacy Technicians, you evaluated the one comment offered during the June 26 public hearing and determined no additional revisions were necessary. You directed the completion of the regulatory project. We compiled and submitted the Second Report to the Joint Legislative Oversight Committee on Health & Welfare on November 6. In the event there is no further intervention, we anticipate submitting the Final Rule for publication in the December 20, 2017 edition of the Louisiana Register, with a delayed effective date of January 1, 2018. In addition, you also received a presentation concerning the implementation of the Final Rule for Regulatory Project 2016-6 ~ Marijuana Pharmacy. We posted the Solicitation of Applications for Marijuana Pharmacy Permits on August 31. By November 1, we had received 40 applications for the 9 marijuana pharmacy permits to be issued. We have scheduled a 3-day meeting of the Application Review Committee on November 20-22 for their interviews and deliberations of the applications and development of recommendations for each of the 9 regions. We have scheduled a 3-day meeting of the Board on January 3-5, 2018 to review the applications and determine the successful applicant in each of the 9 regions.

During the report from the Executive Director at your last meeting, you approved the Annual Report for Fiscal Year 2016-2017 and then directed its filing and publication. We submitted the report to the Office of the Governor, the Joint Legislative Oversight Committee on Health & Welfare, the Legislative Research Library, the State Library, and the Legislative Auditor. We then posted the report on the Board’s website.

Respectfully submitted, Malcolm J Broussard Executive Director Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Finance Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Finance Committee

Interim Report Fiscal Year 2017-2018

November 15, 2017

Blake P. Pitre Chair Louisiana Board of Pharmacy FY 2017-2018 Statement of Assets, Liabilities, Equity

FY 16-17 FY 17-18 Q4 06/30/2017 Q1 09/30/2017 ASSETS > Current Assets * Cash General Operations Whitney Bank 160,985.43 161,026.00 Iberia Bank 648,018.98 332,360.00 Hurricane Relief Fund - Whitney Bank 83,389.04 83,410.00 Reserve Funds General Account 1,235,544.47 1,235,658.00 OPEB Account 1,198,137.48 1,196,639.00 Pension Account 1,760,670.05 1,758,388.00 * Total Cash 5,086,745.45 4,767,481.00

* Prepaid Expenses 6,600.00 7,031.00

* Accounts Receivable 14,593.74 8,000.00

* Accrued Interest Receivable 0.00 6,967.00

Total Current Assets 5,107,939.19 4,789,479.00

> Fixed Assets Land: Lot 5-A, Towne Center Business Park 709,079.90 709,079.90 Land: Lot 1-A-2, Leonard Place Subdivision 295,860.00 295,860.00 Office Building - 3388 Brentwood Drive 1,057,861.29 1,057,861.29 Office Equipment 224,348.23 224,348.23 Furniture 157,808.58 163,127.00 Software: Licensure & Website 408,560.00 408,560.00 Accumulated Depreciation (887,718.31) (902,211.00) Total Fixed Assets 1,965,799.69 1,956,625.42

TOTAL ASSETS 7,073,738.88 6,746,104.42

DEFERRED OUTFLOWS OF RESOURCES 1,215,759.00 1,215,759.00

TOTAL ASSETS & DEFERRED OUTFLOWS 8,289,497.88 7,961,863.42

LIABILITIES > Current Liabilites Accounts payable 4,975.76 0.00 Accrued salaries and benefits 41,249.33 0.00 Unemployment taxes payable 73.35 67.00 State taxes withheld 3,772.92 3,730.00 Deferred compensation withheld 50.00 0.00 Compensated absences (ST) 56,822.31 56,822.00 PES fee payable 400.00 600.00 Total Current Liabilities 107,343.67 61,219.00 Louisiana Board of Pharmacy FY 2017-2018 Statement of Assets, Liabilities, Equity

FY 16-17 FY 17-18 Q4 06/30/2017 Q1 09/30/2017 LIABILITIES (cont.) > Long Term Liabilities Compensated absences (LT) 64,263.96 64,263.96 Other Post Employment Benefits (OPEB) Payable 1,209,508.00 1,209,508.00 Net Pension Liability 5,336,594.00 5,336,594.00 Total Long Term Liabilities 6,610,365.96 6,610,365.96

TOTAL LIABILITIES 6,717,709.63 6,671,584.96

DEFERRED INFLOWS OF RESOURCES 78,386.00 78,386.00

EQUITY Fund Balance at End of Prior Fiscal Year (881,161.96) (672,443.17) Fund Balance - designated 209,220.00 209,220.00 Invested in Fixed Assets 1,965,799.69 1,956,625.42 Net Income/Loss 199,544.52 (281,510.00) TOTAL EQUITY 1,493,402.25 1,211,892.25

TOTAL LIABILITIES, DEFERRED INFLOWS, & EQUITY 8,289,497.88 7,961,863.42 Louisiana Board of Pharmacy FY 2017-2018 Statement of Revenue, Expenses, and Budget Performance Revenue FY 16-17 FY 17-18 FY 17-18 Q4 06/30/2017 Q1 09/30/2017 Budget (A#1)

Licensing Fees Pharmacist License Application Fee 178,800.00 30,900.00 180,000.00 Pharmacist License Reciprocity Application Fee 50,850.00 11,250.00 50,000.00 Pharmacist License Renewal Fee 831,200.00 2,450.00 830,000.00 Pharmacy Intern Registration Application Fee 3,030.00 1,510.00 3,000.00 Pharmacy Technician Candidate Registration Fee 42,975.00 9,375.00 40,000.00 Pharmacy Technician Certificate Application Fee 54,800.00 13,100.00 55,000.00 Pharmacy Technician Certificate Renewal Fee 339,350.00 8,150.00 335,000.00 Pharmacy Permit Application & Renewal Fee 281,325.00 10,875.00 290,000.00 AMS (Automated Medication System) Registration Fee 19,950.00 1,500.00 20,000.00 DME (Durable Medical Equipment) Permit Fee 86,700.00 74,625.00 85,000.00 EDK (Emergency Drug Kit) Permit Fee 12,025.00 1,250.00 12,000.00 CDS (Controlled Dangerous Substance) License Fee 472,545.00 95,785.00 470,000.00 Credential Reinstatement Fee 28,400.00 6,190.00 30,000.00 Delinquent Renewal Fee for Licenses (people) 19,105.00 2,855.00 9,000.00 Delinquent Renewal Fee for Permits (places) 3,462.50 4,338.00 12,000.00

Sales of Goods & Services Product Charge for Duplicate Credentials 4,420.00 780.00 4,400.00 Product Charge for Pharmacist Original Certificate 6,300.00 2,420.00 6,300.00 Product Charge for Pharmacist Silver Certificate 300.00 200.00 300.00 Product Charge for Law Book & Supplement 255.00 60.00 2,500.00 Product Charge for Official List of Licensees 18,150.00 4,650.00 15,000.00 Product Charge for Document Copies 289.50 243.00 200.00 Service Charge for Document Certification 4,200.00 1,200.00 4,600.00 Service Charge for Inspection Services for U.S. CPSC 2,400.00 0.00 2,000.00 Service Charge for PNT Practical Experience 0.00 100.00 0.00 Disposal of Assets 0.00 0.00 0.00

Administrative Fees Administrative Fee for NSF Items 425.00 75.00 500.00 Administrative Fee for Handling & Mailing 169.00 216.00 200.00

Enforcement Activities Administrative Hearing Fee 20,950.00 8,550.00 22,000.00 Fines 211,750.00 57,750.00 200,000.00 Cost Recoveries 9,805.28 5,433.00 10,000.00

Prescription Monitoring Program (PMP) PMP Assessments 519,100.00 100,180.00 520,000.00

Miscellaneous Miscellaneous Revenue 5,047.50 109.00 1,000.00

TOTAL REVENUE 3,228,078.78 456,119.00 3,210,000.00 Louisiana Board of Pharmacy FY 2017-2018 Statement of Revenue, Expenses, and Budget Performance

Expenses FY 16-17 FY 17-18 FY 17-18 Q4 06/30/2017 Q1 09/30/2017 Budget (A#1) Operations Equipment Rentals 15,169.70 3,691.00 16,500.00 Equipment Maintenance 2,793.92 2,163.00 3,000.00 Telephone 16,410.53 4,646.00 15,000.00 Printing 26,962.56 10,042.00 28,000.00 Postage 50,033.28 25,009.00 53,000.00 Dues & Subscriptions 11,871.81 9,669.00 12,500.00 Financial Service Charges 59,196.40 2,949.00 60,000.00 Office Meeting Expenses 608.55 967.00 1,000.00 Office Supply Expenses 21,596.15 5,510.00 22,000.00 Utilities 9,402.63 2,060.00 9,700.00 Civil Service Assessments (DSCS) 5,805.00 6,663.00 6,700.00 Office Insurance (ORM) 10,595.00 11,546.00 11,600.00 Depreciation of Fixed Assets 60,720.98 14,493.00 60,000.00 Acquisitions 4,543.62 0.00 20,000.00 Miscellaneous Expenses 0.00 0.00 0.00 Personal Services Salaries for Employees 1,337,023.83 321,109.00 1,480,000.00 Wages for Temporary Labor 5,782.52 3,821.00 40,000.00 Payroll Taxes (FICA & FUTA) 22,260.29 5,185.00 30,000.00 Health Insurance Premiums (SEGBP) 158,756.68 41,729.00 178,000.00 Pension Plan Premiums (LASERS) 663,901.70 115,675.00 568,500.00 Other Post-Employment Benefits (OPEB) 37,479.00 0.00 40,000.00 Board Member Per Diem 29,175.00 3,675.00 30,000.00 Professional Services Accounting & Expense Reimbursement 24,315.10 14,357.00 30,000.00 Legal & Expense Reimbursement 63,491.30 4,303.00 60,000.00 Information Systems 113,146.50 88,487.00 132,000.00 Prescription Monitoring Program 82,400.00 12,400.00 100,000.00 Property Management 28,130.25 7,396.00 393,500.00 Staff Expenses Executive Director 4,838.79 1,350.00 10,000.00 Assistant Executive Director 5,782.27 660.00 10,000.00 General Counsel 8,595.85 2,173.00 10,000.00 Compliance Officer - Travel 5,074.12 678.00 6,000.00 Compliance Officer - Rental Cars 12,602.75 1,952.00 13,000.00 Compliance Officer - Fuel for Rental Cars 3,835.70 553.00 4,000.00 Compliance Officer - Conference Travel Expenses 6,001.16 5,036.00 12,000.00 House Staff Travel & Education 0.00 0.00 1,000.00 Mileage 19,092.87 4,389.00 20,000.00 Board Expenses Board Meetings 16,543.17 2,903.00 17,000.00 Committee Meetings 3,853.40 811.00 8,000.00 Conference Travel Expenses 22,563.37 0.00 23,000.00 Mileage - Members & President 13,528.71 2,636.00 17,000.00 President's Expenses 8,322.79 367.00 8,000.00

TOTAL EXPENSES 2,992,207.25 741,053.00 3,560,000.00 Louisiana Board of Pharmacy FY 2017-2018 Summary of Income Fund Balance Changes

Summary

FY 16-17 FY 17-18 FY 17-18 Q4 06/30/2017 Q1 09/30/2017 Budget (A#1)

Income Statement

Total Revenue 3,228,078.78 456,119.00 3,210,000.00

Total Expenses 2,992,207.25 741,053.00 3,560,000.00

Net Ordinary Income 235,871.53 (284,934.00) (350,000.00)

Other Income & Expenses

Investment (36,327.01) 3,424.00 0.00

Reserve Acounts 0.00 0.00 350,000.00

Net Income 199,544.52 (281,510.00) 0.00

FY 16-17 FY 17-18 FY 17-18 Q4 06/30/2017 Q1 09/30/2017 Budget (A#1) Fund Balance

Beginning Fund Balance 1,293,857.73 1,493,402.25 1,493,402.25

Total Income 3,191,751.77 459,543.00 3,210,000.00

Total Expenses 2,992,207.25 741,053.00 3,560,000.00

Ending Fund Balance 1,493,402.25 1,211,892.25 1,143,402.25

Reservations of Fund Balance 1,750,000.00 1,750,000.00 1,750,000.00

Unreserved Fund Balance (256,597.75) (538,107.75) (606,597.75)

Notes on Reservation of Fund Balance Net Pension Liability 1,000,000.00 1,000,000.00 1,000,000.00 Other Post Employment Benefits 500,000.00 500,000.00 500,000.00 Continuing Payroll Obligations 150,000.00 200,000.00 200,000.00 Land & Building Maintenance 100,000.00 50,000.00 50,000.00 Total 1,750,000.00 1,750,000.00 1,750,000.00 Louisiana Board of Pharmacy FY 2017-2018 Schedule A - Hurricane Katrina/Rita Pharmacy Relief Fund

Statement of Assets, Liabilities & Equity FY 16-17 FY 17-18 Q4 06/30/2017 Q1 09/30/2017 ASSETS Current Assets Hancock Bank - Checking Account 83,389 83,410

TOTAL ASSETS 83,389 83,410

LIABILITIES Current Liabilites 0 0

EQUITY Retained Earnings 83,389 83,389 Net Income 0 21

TOTAL LIABILITIES & EQUITY 83,389 83,410

Statement of Receipts & Disbursements FY 16-17 FY 17-18 Q4 06/30/2017 Q1 09/30/2017 RECEIPTS FEMA - Funds for payment of claims 8,920,812 8,920,812 FEMA - Administrative allowance 81,103 81,103 Pharmacies - reversal of claims 430,138 430,138 Interest income 22,314 22,335

TOTAL RECEIPTS 9,454,367 9,454,388

DISBURSEMENTS Claims paid to pharmacies 8,920,812 8,920,812 Reversed claim funds returned 430,138 430,138 Reversed administrative allowance returned 7,338 7,338 Interest earned on reversed admin. allowance returned 12,690 12,690

TOTAL DISBURSEMENTS 9,370,978 9,370,978

FUND BALANCE 83,389 83,410

Note: These funds are held in an account separate and apart from the Board's operating funds. Further, all recordkeeping is kept separate from the Board's general fund records. At the conclusion of the audit exposure period, any funds remaining will be transferred to the Board's operating account.

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Finance Committee

Proposed Budget for Fiscal Year 2018-2019

November 15, 2017

DRAFT Blake P. Pitre Chair

Louisiana Board of Pharmacy FY 2018-2019 ~ Original Budget Worksheet

Revenue FY 16-17 FY 17-18 FY 17-18 FY 18-19 Actual (A) Q1 9/30/2017 Budget (A#1) Proposed Notes Licensing Fees 4206 PST License Application Fee 178,800.00 30,900.00 180,000.00 180,000.00 1 4153 PST License Reciprocity Fee 50,850.00 11,250.00 50,000.00 52,500.00 2 4201 PST License Renewal Fee 831,200.00 2,450.00 830,000.00 830,000.00 3 4350 PNT Registration Application Fee 3,030.00 1,510.00 3,000.00 3,000.00 4 4208 PTC Registration Application Fee 42,975.00 9,375.00 40,000.00 42,500.00 5 4152 CPT Certificate Application Fee 54,800.00 13,100.00 55,000.00 55,000.00 6 4204 CPT Certificate Renewal Fee 339,350.00 8,150.00 335,000.00 340,000.00 7 4301 PHY Permit Fees 281,325.00 10,875.00 290,000.00 285,000.00 8 4304 AMS Registration Fees 19,950.00 1,500.00 20,000.00 20,000.00 9 4306 DME Permit Fees 86,700.00 74,625.00 85,000.00 85,000.00 10 4303 EDK Permit Fees 12,025.00 1,250.00 12,000.00 12,000.00 11 4302 CDS License Fees 472,545.00 95,785.00 470,000.00 475,000.00 12 4205+ Credential Reinstatement Fees 28,400.00 6,190.00 30,000.00 30,000.00 13 4252+ Delinquent Renewal Fees (people) 13,400.00 2,855.00 12,000.00 13,000.00 14 4251+ Delinquent Renewal Fees (places) 9,167.50 4,338.00 9,000.00 9,000.00 15

Sales of Goods and Services 4452 Duplicate Credential 4,420.00 780.00 4,400.00 4,000.00 16 4459 PST Original Certificate 6,300.00 2,420.00 6,300.00 6,300.00 17 4453 PST Silver Certificate 300.00 200.00 300.00 300.00 18 4402 Law Book & Supplement 255.00 60.00 2,500.00 0.00 19 4461 Official List of Licensees 18,150.00 4,650.00 15,000.00 18,000.00 20 4462 Document Copies 289.50 243.00 200.00 200.00 21 4460 Document Certification 4,200.00 1,200.00 4,600.00 4,500.00 22 4458 Inspection Services 2,400.00 0.00 2,000.00 2,000.00 23 4466 PNT Practical Experience Reports 0.00 100.00 0.00 0.00 24 4457 Disposal of Assets 0.00 0.00 0.00 0.00 25

Administrative Fees 4454 NSF Items 425.00 75.00 500.00 500.00 26 4463 Handling & Mailing 169.00 216.00 200.00 200.00 27

Enforcement Actions 4102 Administrative Hearing Fee 20,950.00 8,550.00 22,000.00 22,000.00 28 4501 Fines 211,750.00 57,750.00 200,000.00 200,000.00 29 4502 Cost Recoveries 9,805.28 5,433.00 10,000.00 10,000.00 30

Prescription Monitoring Program 4660 Assessments 519,100.00 100,180.00 520,000.00 520,000.00 31 4455 Miscellaneous DRAFT5,047.50 109.00 1,000.00 1,000.00 32 TOTAL REVENUE 3,228,078.78 456,119.00 3,210,000.00 3,221,000.00 33 Louisiana Board of Pharmacy FY 2018-2019 ~ Original Budget Worksheet

Expenses FY 16-17 FY 17-18 FY 17-18 FY 18-19 Actual (A) Q1 9/30/2017 Budget (A#1) Proposed Notes Operations 5321 Equipment Rentals 15,169.70 3,691.00 16,500.00 17,000.00 34 5330 Equipment Maintenance 2,793.92 2,163.00 3,000.00 3,000.00 35 5370 Telephone 16,410.53 4,646.00 15,000.00 16,000.00 36 5305 Printing 26,962.56 10,042.00 28,000.00 28,000.00 37 5300 Postage 50,033.28 25,009.00 53,000.00 53,000.00 38 5190 Dues & Subscriptions 11,871.81 9,669.00 12,500.00 12,000.00 39 5381 Financial Service Charges 59,196.40 2,949.00 60,000.00 60,000.00 40 5260 Office Meeting Expenses 608.55 967.00 1,000.00 1,000.00 41 5280 Office Supplies 21,596.15 5,510.00 22,000.00 22,000.00 42 5390 Utilities 9,402.63 2,060.00 9,700.00 10,000.00 43 5125 Civil Service Assessment (DSCS) 5,805.00 6,663.00 6,700.00 7,000.00 44 5230 Office Insurance (ORM) 10,595.00 11,546.00 11,600.00 12,000.00 45 5180 Depreciation of Fixed Assets 60,720.98 14,493.00 60,000.00 60,000.00 46 5105 Acquisitions 4,543.62 0.00 20,000.00 25,000.00 47 5270 Miscellaneous 0.00 0.00 0.00 0.00 48 Personal Services 5350 Salaries for Employees 1,337,023.83 321,109.00 1,480,000.00 1,590,000.00 49 5296 Wages for Temporary Labor 5,782.52 3,821.00 40,000.00 20,000.00 50 5290 Payroll Taxes (FICA + FUTA) 22,260.29 5,185.00 30,000.00 32,000.00 51 5220 Health Insurance (SEGBP) 158,756.68 41,729.00 178,000.00 191,000.00 52 5340 Pension Plan (LASERS) 663,901.70 115,675.00 568,500.00 640,000.00 53 5400 OPEB 37,479.00 0.00 40,000.00 40,000.00 54 5152 Board Member Per Diem 29,175.00 3,675.00 30,000.00 30,000.00 55 Professional Services 5110 Accounting 24,315.10 14,357.00 30,000.00 30,000.00 56 5250 Legal 63,491.30 4,303.00 60,000.00 60,000.00 57 5295 Information Systems 113,146.50 88,487.00 132,000.00 130,000.00 58 5600 Prescription Monitoring Program 82,400.00 12,400.00 100,000.00 100,000.00 59 5297 Property Management 28,130.25 7,396.00 393,500.00 30,000.00 60 Staff Expenses 5361 Executive Director 4,838.79 1,350.00 10,000.00 10,000.00 61 5373 Assistant Executive Director 5,782.27 660.00 10,000.00 10,000.00 62 5365 General Counsel 8,595.85 2,173.00 10,000.00 10,000.00 63 5363 Compliance Officer - Field Travel 5,074.12 678.00 6,000.00 6,000.00 64 5371 Compliance Officer - Rental Cars 12,602.75 1,952.00 13,000.00 13,000.00 65 5372 Compliance Officer - Fuel 3,835.70 553.00 4,000.00 4,000.00 66 5368 Compliance Officer - Conference 6,001.16 5,036.00 12,000.00 12,000.00 67 5366 House Staff - Education & Travel 0.00 0.00 1,000.00 1,000.00 68 5362++Mileage - entire staff 19,092.87 4,389.00 20,000.00 20,000.00 69 Board Expenses 5153 Meeting ExpensesDRAFT16,543.17 2,903.00 17,000.00 17,000.00 70 5155 Committee Expenses 3,853.40 811.00 8,000.00 8,000.00 71 5154 Conference Travel Expenses 22,563.37 0.00 23,000.00 23,000.00 72 5151+ Mileage - Members & President 15,568.71 2,636.00 17,000.00 17,000.00 73 5286++President's Expenses 6,282.79 367.00 8,000.00 8,000.00 74

TOTAL EXPENSES 2,992,207.25 741,053.00 3,560,000.00 3,378,000.00 75 Louisiana Board of Pharmacy FY 2018-2019 ~ Original Budget Worksheet

Summary

FY 16-17 FY 17-18 FY 17-18 FY 18-19 Actual (A) Q1 9/30/2017 Budget (A#1) Proposed Notes Income Statement

Total Revenue 3,228,078.78 456,119.00 3,210,000.00 3,221,000.00 76

Total Expenses 2,992,207.25 741,053.00 3,540,000.00 3,380,000.00 77

Net Ordinary Income 235,871.53 (284,934.00) (330,000.00) (159,000.00) 78

Other Income & Expenses 6003 Investment (36,327.01) 3,424.00 0.00 0.00 79

2350 Reserve Accounts 0.00 0.00 330,000.00 159,000.00 80

Net Income 199,544.52 (281,510.00) 0.00 0.00

FY 16-17 FY 17-18 FY 17-18 FY 18-19 Actual (A) Q1 9/30/2017 Budget (A#1) Proposed Fund Balance

Beginning Fund Balance 1,293,857.73 1,493,402.25 1,493,402.25 1,163,402.25

Total Income 3,191,751.77 459,543.00 3,210,000.00 3,221,000.00

Total Expenses 2,992,207.25 741,053.00 3,540,000.00 3,378,000.00

Ending Fund Balance 1,493,402.25 1,211,892.25 1,163,402.25 1,004,402.25

Reservations of Fund Balance 1,750,000.00 1,750,000.00 1,750,000.00 1,000,000.00

Unreserved Fund Balance (256,597.75) (538,107.75) (586,597.75) 4,402.25

FY 16-17 FY 17-18 FY 17-18 FY 18-18 Actual (A) Q1 9/30/2017 Budget (A#1) Proposed Notes on Reservation of Fund Balance Net Pension Liability 1,000,000.00 1,000,000.00 1,000,000.00 500,000.00 Other Post Employment BenefitsDRAFT500,000.00 500,000.00 500,000.00 250,000.00 Continuing Payroll Obligations 150,000.00 200,000.00 200,000.00 200,000.00 Land & Bldg Maintenance 100,000.00 50,000.00 50,000.00 50,000.00 TOTAL 1,750,000.00 1,750,000.00 1,750,000.00 1,000,000.00 Louisiana Board of Pharmacy FY 2018-2019 ~ Original Budget Worksheet

NOTES

Revenue

1 Estimate 250 new graduates and 350 reciprocities, for 600 new pharmacists, at $300 each 2 Estimate 350 reciprocity applications, at $150 each 3 Estimate 8,300 pharmacists to renew their licenses, at $100 each 4 Estimate 300 applications for pharmacy intern registration, at $10 each 5 Estimate 1,700 applications for technician candidate registration, at $25 each 6 Estimate 550 applications for technician certificate, at $100 each 7 Estimate 6,800 technicians to renew their certificates, at $50 each 8 Estimate 1,950 permits to renew at $125 each, plus 25 new permits at $150 each 9 Estimate 135 AMS registrations, at $150 each 10 Estimate 680 DME permits, at $125 each 11 Estimate 480 EDK permits, at $25 each 12 Using historical data for CDS license activity 13 Using historical data for reinstatement fee activity 14 Using historical data for penalty fees applied to renewal of lapsed credentials for people 15 Using historical data for penalty fees applied to renewal of lapsed credentials for places 16 Using historical data for duplicate credential requests, at $5 each 17 Using historical data, estimate 84 pharmacists to order wall certificates, at $75 each 18 Estimate 3 pharmacists to order silver certificates, at $100 each 19 With minimal requests for supplements, planning zero revenue 20 Using historical data for sales of official lists, at $150 each 21 Using historical data for sales of document copies 22 Using historical data for document certification, at $20 each 23 Anticipate renewal of agreement with U.S. CPSC for inspections, at $150 each 24 New line item previously included in Miscellaneous, at $10 per request 25 When Board assets are surplused back to the state, revenue recorded here 26 Using historical data for NSF incidents 27 Using historical data for handling and mailing fees 28 Using historical data, estimate 88 cases for violations and reinstatement plus formal hearings 29 Using historical data for fines 30 Using historical data for cost recoveries 31 Using historical data, estimate 20,800 PMP access privileges, at $25 each 32 Improved coding should reduce use of this category; returning to historical budget amount 33 Projected revenue is 0.3% more than FY 17-18 budget as amended DRAFT Louisiana Board of Pharmacy FY 2018-2019 ~ Original Budget Worksheet

NOTES

Expenses

34 Using historical data for equipment rental plus slight increase in rental rate for two office copiers 35 Using historical data for equipment maintenance agreements 36 Using historical data for telephone expenses 37 Using historical data for office printing 38 Using historical data for postage with additional amount for one board election in spring 2019 39 Using historical data for dues and subscriptions 40 Using historical data for service charges applied to credit cards used for online renewals 41 Using historical data for office meeting expenses 42 Using historical data for office supply expenses 43 Using historical data for utilities 44 Agency assessment from Dept. of Civil Service, related to number of employees 45 Agency assessment from Office of Risk Management; anticipate rate increase for FY 18-19 46 Using historical data for depreciation of fixed assets 47 Routine replacement of computer hardware at end-of-life 48 Using historical data for miscellaneous expenses 49 Includes performance adjustments for staff as allowed by Civil Service (range 2-4%) 50 Planned increase of temp labor (students) 51 Calculated value: 2% of salaries + temp labor 52 Calculated value: 12% of salaries 53 Calculated value: 40% of salaries 54 Actual obligation provided to agency at end of fiscal year; this entry is historical data 55 Using historical data for board member per diem payments 56 Using historical data, for accountant and legislative auditor 57 Using historical data for legal expenses 58 Annual maintenance fee for eLicense + special reports as well as network support services 59 Anticipate higher bid price for PMP 60 Using historical data for property management, after completion of renovation project 61 Traditional allowance for travel expenses for executive director 62 Traditional allowance for travel expenses for assistant executive director 63 Traditional allowance for travel expenses for general counsel 64 Using historical data for compliance officers' field travel 65 Using historical data for rental cars for compliance officers 66 Using historical data for fuel for rental cars for compliance officers 67 Traditional allowance for conference travel for compliance officers 68 For educational development of office staff 69 Using historical data for mileage expenses for entire staff 70 Using historical data for member expenses at board meetings 71 Using historical data for member expenses at committee meetings 72 Using historical data for member expenses at conferences 73 Using historical data for mileage expenses for all members, including president 74 Using historical data for the president's expenses 75 Projected expensesDRAFT are 5% lower than FY 17-18 budget as amended

Summary

76 Projected revenue is 0.2% less than FY 16-17 actual revenue 77 Projected expenses are 13% higher than FY 16-17 actual expenses 78 Projected loss is 48% lower than FY 17-18 budget as amended 79 Investment revenue is not budgeted 80 Anticipate using reserves to fund projected loss Louisiana Board of Pharmacy FY 2018-2019 Budget Proposal

Data Worksheet

Acct Name Operations

5321 Equipment Rentals 17,000 Copier #1 375/month 04,500 Copier #2 375/month 04,500 Postage + folder 650/month 07,800

5370 Telephone System 15,000 Annual Maintenance Fee 1,600/year 01,600 AT&T charges 400/month 04,800 State OTM charges 500/month 06,000 Administrative officers (2) 200/month 02,400

5305 Printing 17,000 Office products historical basis/year 15,000 NABP e-Newsletter 4 issues/year 01,000 Board member elections 2019 term expiration 400

5125 Civil Service Assessment 07,000 FY 16-17 actual 05,805 FY 17-18 actual 06,663

5230 Office Insurance (ORM) 12,000 FY 16-17 actual 10,595 FY 17-18 actual 11,546

5190 Dues & Subscriptions 11,000 FY 16-17 actual 10,595 FY 17-18 budget 10,000

5390 Utilities 10,000 Electric (est.) 09,000 Water (est.) 00,900 FY 16-17 actual 09,400

Acquisitions DRAFT

5105 Acquisitions 25,000 Planned rotations of computers, printers, software, and furniture

Personal Services

5350 Salaries 1,590,000 Includes performance adjustments of 2-4% based on ratings from 07-01-2017

5340 Retirement 636,000 FY 16-17 Rate – 37.2% FY 17-18 Rate – 37.9% FY 18-19 Rate – est. 40.0%

5220 Health Insurance (SEGBP) 191,000 includes current staff as well as retirees and widows; current experience is 12% of salaries.

Professional Services

5295 Information Systems 130,000 Iron Data Maintenance 80,000 Essential Solutions (support) 45,000 Medical assessments 05,000

5297 Property Management 30,000 Security 295/month 03,540 Interior Maintenance 250/month 03,000 Groundskeeping + Pest 420/month 05,040 Rodent management 250/year 250 Trash & Recycling 165/month 01,980 General Maintenance 165/month 02,000 A/C Unit Replacement 10,000/each 10,000

5600 Prescription Monitoring Program 100,000 Contract awarded after Public bid price was $378,000 over 5 years: public bid process; 13-14 78,000 current vendor (Appriss) 14-15 76,800 acquired successful 15-16 76,800 bidder (Optimum Technology) 16-17 73,200 DRAFT 17-18 73,200 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Application Review Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Reciprocity Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Violations Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Impairment Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Roster of Approved Addictionists

Richard P. Amar, MD La. License No. 049558 Talbott Recovery Center Issued: 12-08-2000 Expires: 04-30-2019 5448 Yorktowne Drive Status: Active and unrestricted Atlanta, GA 30349 Certification: ABPN No. 2041 Telephone (844) 225-3097 Issued: 10-12-2010 Expires: 10-12-2020

Roy D. Ary, Jr., MD La. License No. MD.09977R BioBehavioral Medicine, Inc. Issued: 07-29-1993 Expires: 08-31-2017 4933 Wabash Street Status: Active and unrestricted Metairie, LA 70001 Certification: ABAM No. 000870 Telephone (504) 780-2766 Issued: 03-12-2009 Expires: 12-31-2019

Navjyot S. Bedi, MD Ga. License No. 055658 Talbott Recovery Center Issued: 12-03-2004 Expires: 04-30-2019 5448 Yorktowne Drive Status: Active and unrestricted Atlanta, GA 30349 Certification: ABAM No. 002509 Telephone (844) 225-3097 Issued: 05-02-2009 Expires: 12-31-2019

Joan E. Brunson, MD La. License No. MD.017125 Edgefield Recovery Center Issued: 06-16-1983 Expires: 09-30-2017 10631 Hwy. 71 North Status: Active and unrestricted (D) Cheneyville, LA 71325 Certification: ABAM No. 000999 Telephone (888) 327-2673 Issued: 03-12-2008 Expires: 12-31-2018

José Calderón-Abbo, MD La. License No. MD.14816R The Mind-Body Center of Louisiana Issued: 10-22-2002 Expires: 01-31-2018 3439 Magazine Street Status: Active and unrestricted New Orleans, LA 70115 Certification: ABAM No. 000881 Telephone (504) 891-8808 Issued: 03-12-2009 Expires: 03-12-2019

Louis Cataldie, MD La. License No. MD.012613 3535 Brentwood Drive Issued: 06-13-1974 Expires: 08-31-2017 Baton Rouge, LA 70806 Status: Active and unrestricted (D) Telephone (225) Certification: ABAM No. 003000 Facsimile Issued: 05-02-2009 Expires: 05-02-2019

John R. Colaluca, DO DRAFT La. License No. DO.021805 Palmetto Recovery Center Issued: 07-01-1993 Expires: 09-30-2017 86 Palmetto Road Status: Active and unrestricted (D) Rayville, LA 71269 Certification: ABAM No. 000886 Telephone (318) 728-2970 Issued: 03-12-2009 Expires: 03-12-2019

Revised: 11-15-2017 Page 1 of 3

J. David Hammond, Jr., MD La. License No. MD.022970 Palmetto Recovery Center Issued: 07-01-1996 Expires: 07-31-2017 86 Palmetto Road Status: Active and unrestricted Rayville, LA 71269 Certification: ABAM No. 2014243 Telephone (318) 728-2970 Issued: 11-15-2014 Expires: 11-15-2024

Dean A. Hickman, MD La. License No. MD.020992 Ochsner Medical Center Issued: 08-06-1990 Expires: 01-31-2018 1514 Jefferson Highway, BH-4 Status: Active and unrestricted New Orleans, LA 70121 Certification: ABPN No. 1163 Telephone (504) 842-3842 Issued: 04-08-1997 Expires: 12-31-2018

Oksana V. Kershteyn, MD Ga. License No. 065470 Talbott Recovery Center Issued: 01-07-2011 Expires: 03-31-2018 5448 Yorktowne Drive Status: Active and unrestricted Atlanta, GA 30349 Certification: ABPN No. 64327 Telephone (844) 225-3097 Issued: 05-18-2012 Expires: 05-18-2022

Edward C. LaFleur, MD La. License No. MD.025580 Victory Addiction Recovery Center Issued: 09-01-2002 Expires: 03-31-2018 111 Liberty Avenue Status: Active and unrestricted Lafayette, LA 70508 Certification: ABAM No. 2014630 Telephone (888) 991-2237 Issued: 11-15-2014 Expires: 11-15-2024

Scott D. Mayers, MD La. License No. MD.202066 Victory Addiction Recovery Center Issued: 06-16-2008 Expires: 11-30-2017 111 Liberty Avenue Status: Active and unrestricted Lafayette, LA 70508 Certification: ABAM No. 2014362 Telephone (888) 991-2237 Issued: 11-15-2014 Expires: 11-15-2024

Jay L. Piland, Sr., MD La. License No. MD.022337 Palmetto Recovery Center Issued: 08-23-1995 Expires: 03-31-2018 86 Palmetto Road Status: Active and unrestricted (D) Rayville, LA 71269 Certification: ABAM No. 2010367 Telephone (318) 728-2970 Issued: 12-11-2010 Expires: 12-11-2020

Arwen L. Podesta, MD La. License No. MD.200907 4322 Canal Street , No. 9 Issued: 06-01-2006 Expires: 09-30-2018 New Orleans, LA 70119 Status: Active and unrestricted Telephone (504) 252-0026 Certification: ABPN No. 6208 Facsimile (504) 322-3856 Issued: 06-03-2011 Expires: 06-03-2021

Alphonse K. Roy, III, MD La. License No. MD.012078 BioBehavioral Medicine, Inc. Issued: 06-15-1972 Expires: 09-30-2017 4933 Wabash Street Status: Active and unrestricted (D) Metairie, Louisiana 70001 DRAFT Certification: ABAM No. 000088 Telephone (504) 780-2766 Issued: 1986 (Issues prior to 1998 do not expire)

Revised: 11-15-2017 Page 2 of 3

Kelly A. Scheinberg, MD Ga. License No. 067608 Talbott Recovery Center Issued: 03-29-2012 Expires: 05-31-2017 5448 Yorktowne Drive Status: Active and unrestricted Atlanta, GA 30349 Certification: ABPN No. 2323 Telephone (844) 225-3097 Issued: 09-29-2014 Expires: 09-29-2024

Ronald V. Taravella, MD La. License No. MD.016298 7777 Hennessy Boulevard, Suite 302 Issued: 08-16-1981 Expires: 08-31-2017 Baton Rouge, LA 70808 Status: Active and unrestricted (D) Telephone (225) 767-4668 Certification: ABPN No. 39750 Facsimile (225) 765-3430 Issued: 06-30-1994 (Issues prior to 1998 do not expire)

Jennifer R. Velander, MD La. License No. MD.300460 Ochsner Medical Center Issued: 11-04-2015 Expires: 11-30-2017 1514 Jefferson Hwy. Status: Active and unrestricted New Orleans, LA 70121 Certification: ABPN No. 002346 Telephone (504) 842-4025 Issued: 09-29-2014 Expires: 09-29-2024

Jay A. Weiss, MD La. License No. MD.12286R Palmetto Recovery Center Issued: 06-18-1997 Expires: 09-30-2017 86 Palmetto Road Status: Active and unrestricted Rayville, LA 71269 Certification: ABAM No. 000853 Telephone (318) 728-2970 Issued: 03-12-2009 Expires: 12-31-2019

Bob Winston, MD La. License No. MD.11569R 2020 W. Pinhook Rd., Ste 504 Issued: 12-07-1995 Expires: 04-30-2018 Lafayette, LA 70508 Status: Active and unrestricted Telephone (337) 593-0830 Certifications: ABPN Facsimile (337) 593-0122 Issued: 11-30-1987 (Issues prior to 1998 do not expire)

DRAFT

Revised: 11-15-2017 Page 3 of 3

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Reinstatement Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Tripartite Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Regulation Revision Committee

Legislative Proposal 2018-B ~ CDS License for 3PL Draft #1

1 HLS 18-

2 Regular Session, 2018

3 House Bill No. _____

4 By Representative ______

6 CONTROLLED SUBSTANCES: Adds third party logistics providers as entities required to

7 obtain a controlled dangerous substance license and sets the fee for that license.

9 AN ACT

11 To amend and reenact R.S. 40:961, relative to definitions, R.S. 40:972(B), relative to fees, and

12 R.S. 40:973(A)(1), relative to licensing requirements.

13 Be it enacted by the Legislature of Louisiana:

14 Section 1. R.S. 40:961 is hereby amended and reenacted to read as follows:

15 §961. Definitions

16 As used in this Part, the following terms shall have the meaning ascribed to them

17 in this Section unless the context clearly indicates otherwise:

18 * * *

19 (38.1) “Third-party logistics provider” means a person that provides or

20 coordinates warehousing, facilitation of delivery, or other logistic services for a legend 21 drug or legendDRAFT device in interstate and intrastate commerce on behalf of a manufacturer, 22 distributor, or dispenser of a legend drug or legend device but does not take ownership of

23 the legend drug or legend device nor have responsibility to direct the sale or disposition

24 of the legend drug or legend device.

CODING: Words in stricken type are proposed deletions from existing law; words underscored are proposed additions. Legislative Proposal 2018-B ~ CDS License for 3PL Draft #1

25 * * *

26 Section 2. R.S. 40:972(B) is hereby amended and reenacted to read as follows:

27 §972. Rules and regulations and fees

28 * * *

29 B. The fees collected by the Board of Pharmacy for registration and licensing

30 shall not exceed the following schedule:

31 * * *

32 (6) Wholesaler / distributor, including third party logistics provider $50

33 * * *

34 Section 3. R.S. 40:973(A)(1) is hereby amended and reenacted to read as follows:

35 §973. Licensing requirements

36 A. (1) Every person who conducts research with, manufacturers, distributes

37 (including third-party logistics providers), procures, possesses,

38 prescribes, or dispenses any controlled dangerous substance within this

39 state or who proposes to engage in the research, manufacture,

40 distribution (including third-party logistics providers), procurement,

41 possession, prescribing, or dispensing of any controlled dangerous

42 substance within this state, shall obtain a controlled substance license

43 issued by the Board of Pharmacy in accordance with the rules and

44 regulations promulgated by it prior to engaging in such activity. 45 DRAFT* * * 46

CODING: Words in stricken type are proposed deletions from existing law; words underscored are proposed additions. Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Executive Committee

1 Louisiana Board of Pharmacy Policies & Procedures 2 3 Title: Application for New Pharmacy Permit (in-state) Policy No. IV.B.6 4 5 Approved: Revised: 6 7 8 1. The statutory authority requiring pharmacies to be licensed by the Board prior to 9 dispensing medications to Louisiana residents is found at La. R.S. 37:1221.A, 10 and further amplified at La. R.S. 37:1222. 11 12 2. The regulatory authority for the regulation of pharmacies is found at LAC 46:LIII. 13 Chapters 13-31. 14 15 3. The Executive Director shall develop and maintain an application form to be used 16 by applicants for nonresident pharmacy permits. The form shall be uniquely 17 identified and bear the date of its creation or revision. The application form shall 18 collect sufficient information necessary to: 19 a. Establish the identity of the applicant; 20 b. Describe the direct and indirect ownership profile of the applicant; 21  Direct ownership refers to the natural person(s) or legal person(s) 22 [organizations] seeking and holding the permit. 23  Indirect ownership refers to the natural person(s) or legal person(s) 24 holding ownership interests in the direct owner or other indirect 25 owners. There may be more than one level of indirect owners; if so, 26 all levels of indirect owners must be declared in the application. 27 i. by collecting specific information for every natural person with any 28 direct or indirect ownership interest in the pharmacy, specifically: 29 (a) Full legal name, date of birth, and Social Security number; 30 (b) Mailing address and telephone number; 31 (c) Percentage of ownership or fraction thereof; 32 (d) Evidence of any professional license or other credential 33 issued by any state government agency (either legible copy 34 or website verification thereof), and further, whether or not 35 the credential has ever been sanctioned or disciplined by 36 any state licensing agency or by any local, state, or federal 37 government agency, or by any local, state, or federal court. 38 In the event of any such sanction or discipline, or in the 39 event an application for such credential has ever been 40 denied or refused by any jurisdiction, a copy of the board, 41 agency, or court decision document shall be provided. 42 This requirement shall not be applicable to a natural person 43 DRAFTholding no direct ownership, no first-level indirect ownership, 44 and less than 5% ownership in any indirect level ownership 45 beyond the first level. 46 ii. by collecting specific information for every legal person 47 (organization) with any direct or indirect ownership interest in the 48 pharmacy, specifically: 49 Louisiana Board of Pharmacy Policies & Procedures 50 51 Title: Application for New Pharmacy Permit (in-state) Policy No. IV.B.6 52 53 Approved: Revised: 54 55 56 3.b.ii (cont.) 57 (a) Full legal name and Federal Employment Identification 58 Number, as evidenced by a copy of the Internal Revenue 59 Service (IRS) letter assigning that number, or in the 60 alternative, a signed W-9 form; 61 (b) Mailing address and telephone number; 62 (c) Percentage of ownership or fraction thereof; and 63 (d) An accounting of 100% of the ownership thereof, and further, 64 where there are multiple levels of ownership, an 65 organizational chart clearly identifying the corporate 66 relationships. 67 Where the legal person is a publicly traded firm or an 68 institutional investor, the accounting of its ownership shall 69 identify any natural person holding 5% or more ownership 70 interest in that organization. 71 c. Describe the pharmacy’s location and credentials issued by other 72 agencies; 73 d. Identify the pharmacy owner’s registered agent for the service of process; 74 e. Identify the special professional services intended for Louisiana residents; 75 and 76 f. Identify the Owner’s Managing Officer and Pharmacist-in-Charge, and 77 further, assist in the determination of their fitness for practice in those 78 capacities. 79 80 4. The application form shall instruct the applicant to cause the following persons 81 identified in their application to submit to a criminal background check (CBC): 82 a. Owner’s Managing Officer; 83 b. Pharmacist-in-Charge; and 84 c. Any natural person holding 20% or more ownership interest at the direct or 85 first-level indirect level; provided, however, that this requirement may be 86 waived in the event that person has already submitted to such CBC for the 87 Board and that CBC report was received less than five years prior to the 88 date of the application for the permit. 89 90 5. The application package should also contain additional guidance information for 91 the applicantDRAFT as well as a summary checklist designed to ensure the submission 92 of all additional required documents. 93 94 95 96 97 Louisiana Board of Pharmacy Policies & Procedures 98 99 Title: Application for New Pharmacy Permit (in-state) Policy No. IV.B.6 100 101 Approved: Revised: 102 103 104 6. All applications shall be referred to the Credentials Division staff for processing. 105 a. In the event the staff determines there are deficiencies in the application 106 or supporting materials, the staff shall communicate with the applicant to 107 assist them in compiling a complete application. 108 b. In the event the staff determines there is information (e.g., prior 109 disciplinary or legal action) impacting qualifications or fitness for practice, 110 staff shall refer the completed application to an administrative officer, for a 111 determination as to whether a referral to a Board committee is warranted. 112 i. In the event the administrative officer determines no committee 113 referral is warranted, the administrative officer shall annotate the 114 application form and return it to licensing staff for final 115 administrative review and issuance of the permit. 116 ii. In the event the administrative officer determines a referral to a 117 Board committee is warranted, he shall assign a case number to 118 the application, schedule a hearing before the appropriate 119 committee, and notify the applicant of the hearing, ensuring 120 compliance with due process requirements. 121 c. In the event staff determines the applicant does not meet all of the 122 licensing criteria and the applicant wishes to appeal that staff 123 determination, staff shall direct the applicant to submit a written appeal to 124 the Executive Director. The Executive Director shall present the appeal 125 and relevant information from the applicant’s file to the Board President. 126 The Board President shall have the authority to review such appeals and 127 determine whether to grant such requests, either in part or in full. The 128 Executive Director shall notify the applicant and the licensing staff of the 129 President’s decision. 130 131 7. When the licensing staff has completed the processing of the application, the 132 staff may issue the permit if they have been delegated the authority to issue it, or 133 in the alternative, shall refer the application to the licensing manager, for final 134 review and issuance of the permit. 135 DRAFT 1 Louisiana Board of Pharmacy Policies & Procedures 2 3 Title: Application for New Nonresident Pharmacy Permit Policy No. IV.B.7 4 5 Approved: Revised: 6 7 8 1. The statutory authority requiring nonresident pharmacies (located outside the 9 state) to be licensed by the Board prior to dispensing medications to Louisiana 10 residents is found at La. R.S. 37:1221.B and C, and further amplified at La. R.S. 11 37:1222. 12 13 2. The regulatory authority for the regulation of nonresident pharmacies is found at 14 LAC 46:LIII.Chapter 23. 15 16 3. The Executive Director shall develop and maintain an application form to be used 17 by applicants for nonresident pharmacy permits. The form shall be uniquely 18 identified and bear the date of its creation or revision. The application form shall 19 collect sufficient information necessary to: 20 a. Establish the identity of the applicant; 21 b. Describe the direct and indirect ownership profile of the applicant; 22  Direct ownership refers to the natural person(s) or legal person(s) 23 [organizations] seeking and holding the permit. 24  Indirect ownership refers to the natural person(s) or legal person(s) 25 holding ownership interests in the direct owner or other indirect 26 owners. There may be more than one level of indirect owners; if so, 27 all levels of indirect owners must be declared in the application. 28 i. by collecting specific information for every natural person with any 29 direct or indirect ownership interest in the pharmacy, specifically: 30 (a) Full legal name, date of birth, and Social Security number; 31 (b) Mailing address and telephone number; 32 (c) Percentage of ownership or fraction thereof; 33 (d) Evidence of any professional license or other credential 34 issued by any state government agency (either legible copy 35 or website verification thereof), and further, whether or not 36 the credential has ever been sanctioned or disciplined by 37 any state licensing agency or by any local, state, or federal 38 government agency, or by any local, state, or federal court. 39 In the event of any such sanction or discipline, or in the 40 event an application for such credential has ever been 41 denied or refused by any jurisdiction, a copy of the board, 42 agency, or court decision document shall be provided. 43 DRAFTThis requirement shall not be applicable to a natural person 44 holding no direct ownership, no first-level indirect ownership, 45 and less than 5% ownership in any indirect level ownership 46 beyond the first level. 47 48 49 Louisiana Board of Pharmacy Policies & Procedures 50 51 Title: Application for New Nonresident Pharmacy Permit Policy No. IV.B.7 52 53 Approved: Revised: 54 55 56 3.b (cont.) 57 ii. by collecting specific information for every legal person 58 (organization) with any direct or indirect ownership interest in the 59 pharmacy, specifically: 60 (a) Full legal name and Federal Employment Identification 61 Number, as evidenced by a copy of the Internal Revenue 62 Service (IRS) letter assigning that number, or in the 63 alternative, a signed W-9 form; 64 (b) Mailing address and telephone number; 65 (c) Percentage of ownership or fraction thereof; and 66 (d) An accounting of 100% of the ownership thereof, and further, 67 where there are multiple levels of ownership, an 68 organizational chart clearly identifying the corporate 69 relationships. 70 Where the legal person is a publicly traded firm or an 71 institutional investor, the accounting of its ownership shall 72 identify any natural person holding 5% or more ownership 73 interest in that organization. 74 c. Describe the pharmacy’s location and credentials issued by other 75 agencies; 76 d. Identify the pharmacy owner’s registered agent for the service of process; 77 e. Identify the special professional services intended for Louisiana residents; 78 and 79 f. Identify the Owner’s Managing Officer and Pharmacist-in-Charge, and 80 further, assist in the determination of their fitness for practice in those 81 capacities. 82 83 4. The application form shall instruct the applicant to cause the following persons 84 identified in their application to submit to a criminal background check (CBC): 85 a. Owner’s Managing Officer; 86 b. Pharmacist-in-Charge; and 87 c. Any natural person holding 20% or more ownership interest at the direct or 88 first-level indirect level; provided, however, that this requirement may be 89 waived in the event that person has already submitted to such CBC for the 90 Board and that CBC report was received less than five years prior to the 91 date DRAFTof the application for the permit. 92 93 5. The application package should also contain additional guidance information for 94 the applicant as well as a summary checklist designed to ensure the submission 95 of all additional required documents. 96 97 Louisiana Board of Pharmacy Policies & Procedures 98 99 Title: Application for New Nonresident Pharmacy Permit Policy No. IV.B.7 100 101 Approved: Revised: 102 103 104 6. All applications shall be referred to the Credentials Division staff for processing. 105 a. In the event the staff determines there are deficiencies in the application 106 or supporting materials, the staff shall communicate with the applicant to 107 assist them in compiling a complete application. 108 b. In the event the staff determines there is information (e.g., prior 109 disciplinary or legal action) impacting qualifications or fitness for practice, 110 staff shall refer the completed application to an administrative officer, for a 111 determination as to whether a referral to a Board committee is warranted. 112 i. In the event the administrative officer determines no committee 113 referral is warranted, the administrative officer shall annotate the 114 application form and return it to licensing staff for final 115 administrative review and issuance of the permit. 116 ii. In the event the administrative officer determines a referral to a 117 Board committee is warranted, he shall assign a case number to 118 the application, schedule a hearing before the appropriate 119 committee, and notify the applicant of the hearing, ensuring 120 compliance with due process requirements. 121 c. In the event staff determines the applicant does not meet all of the 122 licensing criteria and the applicant wishes to appeal that staff 123 determination, staff shall direct the applicant to submit a written appeal to 124 the Executive Director. The Executive Director shall present the appeal 125 and relevant information from the applicant’s file to the Board President. 126 The Board President shall have the authority to review such appeals and 127 determine whether to grant such requests, either in part or in full. The 128 Executive Director shall notify the applicant and the licensing staff of the 129 President’s decision. 130 131 7. When the licensing staff has completed the processing of the application, the 132 staff may issue the permit if they have been delegated the authority to issue it, or 133 in the alternative, shall refer the application to the licensing manager, for final 134 review and DRAFTissuance of the permit. From: Nerissa Montgomery To: Malcolm J. Broussard Subject: Pharmacies for Revision List Date: Wednesday, November 01, 2017 8:06:50 AM

Hi Malcolm,

Here are two more pharmacies and one CDS-HOS that expressed interest in the revision.

Legacy Pharmacy – Pending PHY-IR Super 1 Pharmacy #645 – Pending PHY-RC The NeuroMedical Center Rehabilitation Hospital Pharmacy - CDS.032298-HOS

For the Board, Nerissa Montgomery Administrative Coordinator 3 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, LA 70809 Telephone: (225) 925-6483 Fax: (225) 925-6499 [email protected] www.pharmacy.la.gov

1 Louisiana Board of Pharmacy Policies & Procedures 2 3 Title: Special Entrance Rates for Salaries Policy No. II.A.6 4 5 Approved: 11-06-2013 Revised: 11-18-2015 6 7 8 1. The statutory authority for the Board to engage employees is RS 37:1182.B.6. 9 10 2. The regulatory authority for Board employees is LAC 46:LIII.107.F. 11 12 3. The authority of the Louisiana Department of State Civil Service relative to state 13 employees is derived from Article X of the Louisiana State Constitution. 14 15 4. The Civil Service Rules of Pay are found in Chapter 6 – Pay Plan. 16 17 5. Civil Service Rule 6.5.b.1 authorizes an appointing authority to institute Special 18 Entrance Rates (SER) for current employees, provided that the Civil Service 19 Commission has approved the rate during a regularly scheduled meeting. 20 21 6. The Board reviewed the current salary structure for its administrative and 22 professional personnel. They also reviewed responses to recent job 23 announcements as well as the current job market and general economic conditions. 24 They determined the appointing authority should have flexibility in the maximum hire 25 rate for certain of its classified employees. Rescind 26 a. For the following positions in the Administrative Services (AS) classification, the 27 appointing authority may use a SER in the first quartile of the pay grid for the 28 position. 29 i. Administrative Coordinator 1 (ASto 605) 30 ii. Administrative Coordinator 3 (AS 609) 31 iii. Licensing Analyst 2 (AS 611) 32 iv. Administrative Assistant (AS 609) 33 b. For the following positions in the Medical Services (MS) classification, the 34 appointing authority may use a SER in the third quartile of the pay grid for the 35 position. 36 i. Pharmacist Compliance Officer (MS 525) 37 ii. Pharmacist Chief Compliance Officer (MS 527) 38 iii. Pharmacist Chief Operations Officer (MS 528) 39 c. The following factors, when present, may justify consideration of a SER for a new 40 hire: 41 i. A qualified applicant with exceptional qualifications; or 42 ii.Request Prevailing salaries for comparable positions in the private sector; 43 d. In the event the appointing authority intends to offer a special entrance rate to a 44 new hire, he shall first obtain approval from the Board’s President. 45 46 7. Civil Service Rule 6.16.2.b authorizes an appointing authority to grant an employee 47 a pay increase of up to 10% of the employee’s base pay to reduce compress, 48 realign pay between comparable employees, or alleviate supervisor/subordinate 49 pay inversions caused by job and pay plan changes. 50 Louisiana Board of Pharmacy Policies & Procedures 51 52 Title: Special Entrance Rates for Salaries Policy No. II.A.6 53 54 Approved: 11-06-2013 Revised: 11-18-2015 55 56 57 58 a. Current employees with annual salaries below the level of a new employee’s 59 entrance rate shall be raised to the new employee’s rate, provided the increase is 60 no greater than 10% of the current employee’s salary. 61 b. This policy shall apply to all full-time classified employees with permanent status. 62 The employee must have a current overall Performance Evaluation System 63 (PES) rating of “Exception,” “Successful” or equivalent to be eligible for an 64 Optional Pay Adjustment. 65 c. Employees who are at range maximum are not eligible to receive a base 66 increase. 67 d. This policy shall become effective upon Civil Service Commission approval.

Rescind to

Request 1 Louisiana Board of Pharmacy Policies & Procedures 2 3 Title: Extraordinary Qualifications / Credentials Policy No. II.A.7 4 5 Approved: Revised: 6 7 8 1. The authority of the Louisiana Department of State Civil Service relative to state 9 employees is derived from Article X of the Louisiana State Constitution. 10 11 2. The statutory authority for the Board to engage employees is RS 37:1182.B.6. 12 13 3. The regulatory authority for Board to engage employees is LAC 46:LIII.107.F. 14 15 4. The Civil Service Rules of Pay are found in Chapter 6 – Pay Rules. 16 17 5. Civil Service Rule 6.5.g authorizes an appointing authority, at his own discretion, 18 to pay a new employee at a rate above the minimum. 19 20 6. If an applicant who is eligible for appointment possesses extraordinary or 21 superior qualifications / credentials above and beyond the minimum qualifications 22 or credentials, the appointing authority may, at his own discretion, pay the 23 employee at a rate above the minimum provided that: 24 a. such superior qualifications / credentials are verified and documented as 25 job related; 26 b. the rate does not exceed the midpoint of the range for the affected job; 27 c. the rate is implemented in accordance with written policies and 28 procedures established by the Dept. of State Civil Service; and 29 d. the appointment is probational, provisional, or a job appointment. 30 31 7. The employee may be paid upon hiring or at any time within one year of the hire 32 date. If paid after the hiring date, the pay change must be prospective. The 33 salaries of all current probational and permanent employees who occupy 34 positions in the same job title and who possess the same or equivalent 35 qualifications/credentials may be adjusted up to but not to exceed the amount of 36 the percent difference between the special hiring rate and the regular hiring rate 37 provided that the qualifications/credentials are also verified and documented as 38 job related and that the rate is implemented in accordance with written policies 39 and procedures established by the department; such policies shall be posted in a 40 manner which assures their availability to all employees. Such adjustments shall 41 only be made on the same date that the higher pay rate is given to the newly 42 hired employee. 43 DRAFT 44 8. If an employee with permanent status resigns and is then rehired into either the 45 same position or into the same job title or a job with a lower maximum at the 46 same agency, the employee shall not be eligible for an increase under this rule 47 unless there has been a break in state service of at least 30 days. If an employee 48 with permanent status resigns and is then rehired into a job with a lower 49 50 Louisiana Board of Pharmacy Policies & Procedures 51 52 Title: Extraordinary Qualifications / Credentials Policy No. II.A.7 53 54 Approved: Revised: 55 56 57 maximum at any other agency, the employee shall not be eligible for an increase 58 under this rule unless there has been a break in service of at least 30 days. 59 60 9. Requests for exceptions to this rule must be approved by the Dept. of State Civil 61 Service Commission.

DRAFT 1 Louisiana Board of Pharmacy Loss Prevention 2 3 Title: Workers’ Compensation Post-Accident Drug Testing Policy No. I.P 4 5 Approved: 11-18-2015 Revised: 6 7 8 1. Authority 9 a. Executive Order No. BJ 08-69 provides for the promulgation by 10 executive agencies of written policies mandating drug testing of 11 employees, appointees, prospective employees and prospective 12 appointees in accordance with La. R.S. 49:1001, et seq. 13 b. La. R.S. 39:1535(B)(12) provides that the Office of Risk Management 14 ("ORM") may promulgate rules and regulations to establish procedures 15 governing risks and injuries sustained where a participating or covered 16 entity of the State may be liable for damages. 17 c. La. R.S. 23: 1081 and Louisiana Administrative Code Title 40, Part I, 18 Chapter 15 allows an employer to test an employee for drugs and 19 alcohol when the employee receives a personal injury from an accident 20 arising out of and in the course of his employment. 21 22 2. Applicability 23 a. In addition to any drug testing policy adopted by an executive agency 24 pursuant to Executive Order No. BJ 08-69, this policy shall also apply to 25 all persons having an employment relationship with an executive 26 agency, whether classified, unclassified, student employees, interns, 27 full-time, part-time, or temporary (hereinafter employee(s)"), when the 28 employee's agency is provided workers' compensation coverage 29 through ORM. 30 31 3. Drug Testing 32 a. All employees who are entitled to assert a claim pursuant to the 33 workers' compensation laws of Louisiana shall be subject to, and shall 34 cooperate in, post-accident drug testing. With or without prior 35 notification, any employee in an accident that occurs during the course 36 and scope of employment shall be required to submit to drug and/or 37 alcohol testing as soon as practicable under La. R.S. 23: 1081, whether 38 or not a compensable injury is immediately claimed by the employee, 39 where an accident occurs under any circumstance, regardless of fault, 40 which necessitates, or should reasonably necessitate, medical attention 41 to the employee as determined by the employee, the employee's 42 supervisor(s),DRAFT or the department head, regardless of whether the 43 employee actually desires, agrees to, seeks, or receives medical 44 attention. 45 a. Any employee directly involved in an on-duty accident or incident, and 46 whose action or inaction may have been a causative factor of same, shall 47 be required to immediately submit to drug and alcohol testing if: 48 49 Louisiana Board of Pharmacy Loss Prevention 50 51 Title: Workers’ Compensation Post-Accident Drug Testing Policy No. I.P 52 53 Approved: 11-18-2015 Revised: 54 55 56 i. Reasonable Suspicion: Circumstances give rise to a reasonable 57 suspicion of the employee’s drug or alcohol use or impairment; or 58 ii. Fatality: The accident or incident resulted in a fatality; or 59 iii. Hazardous Materials Release: The accident or incident resulted in 60 or caused the release of hazardous waste as defined in La. R.S. 61 30:2173(2) or hazardous materials as defined in La. R.S. 62 32:1502(5). 63 b. Employees should be aware of the legal presumption of impairment under 64 La. R.S. 23:1081 if an employee refuses, after being so directed, to 65 submit to drug or alcohol testing as a result of an on-duty accident or 66 incident. As a consequence of such refusal, benefits under the workers’ 67 compensation laws of the State of Louisiana may be denied. 68 69 4. Drug and Alcohol Testing Procedures 70 a. Testing shall be performed as provided for in the LAC 40:I.Chapter 15, 71 or its successor. 72 b. Testing shall be performed at the most practical hospital, medical facility, 73 or laboratory. ORM, or the agency, reserves the right to require 74 employees to submit to additional testing, if warranted. 75 c. A representative of the agency shall transport the employee being 76 tested to and from the testing site. Under no circumstance should any 77 employee who is believed to be impaired or under the influence of any 78 drug or alcohol be permitted to operate a motor vehicle. 79 80 5. Violations 81 a. Employees found to test positive or failing to promptly submit to testing 82 under this policy may be subject to dismissal or denial of their Workers' 83 Compensation benefits pursuant to La. R.S. 23:1081. 84 b. Employees and supervisors may also be subject to discipline, up to and 85 including dismissal, in accordance with their agency's drug-free policy 86 for failing to cooperate with, or to apply, the post-accident drug testing 87 requirements outlined in this policy. 88 89 6. Questions 90 a. QuestionsDRAFT regarding this policy should be directed to the Office of Risk 91 Management. 92 93 94 95 96 97 Louisiana Board of Pharmacy Loss Prevention 98 99 Title: Workers’ Compensation Post-Accident Drug Testing Policy No. I.P 100 101 Approved: 11-18-2015 Revised: 102 103 104 Revision History 105 106 11-15-2017 Amended Item 3.a to remove the requirement for drug testing after 107 all accidents or incidents and replace it with a requirement for such 108 testing in the three named circumstances; also added a section 109 notifying employees of the legal presumption of impairment if the 110 employee refuses to submit to testing after being directed to do so.

DRAFT 1 Louisiana Board of Pharmacy Policies & Procedures 2 3 Title: Purchases Policy No. II.E.1 4 5 Approved: 08-06-2008 Revised: 6 7 8 1. The statutory authority for the Board to disburse funds is found at La. R.S. 9 37:1182.A(20): Make disbursements by check, voucher, or any other reasonable 10 means deemed appropriate by the board and authorized by the president and the 11 executive director. 12 13 2. The regulatory authority for the Board to designate its Appointing Authority is 14 found at LAC 46:LIII.103.F: The executive director shall carry out functions of the 15 board relative to its statutory requirements and other duties as defined by the 16 board. With the board’s approval, the executive director serves as the appointing 17 authority and may appoint additional employees for professional, clerical, and 18 special duties necessary to carry out the board’s functions and may establish 19 standards for the conduct of employees. 20 21 1 3. The Board delegates to the Appointing Authority the responsibility for the proper 22 management of the office and its assets. 23 24 2 4. With respect to single purchases of less than $1,000, the Appointing Authority 25 delegates to the Office Manager the responsibility for adherence to all 26 appropriate laws and rules governing such procedures. Single purchases of 27 more than $1,000 require prior approval of the Appointing Authority. The Office 28 Manager shall collect and maintain all required documentation for each purchase 29 together with the record of disbursement. 30 31 5. In lieu of a state-approved credit/debit card, board members and employees may 32 use personal credit cards for board-approved expenses and attach detailed 33 receipts to expense reports submitted for reimbursement. 34 35 3. The Board authorizes the Appointing Authority to make application for, receive, 36 and manage the utilization of one or more LaCarte cards. The Appointing 37 Authority names the Office Manager as the Agency Purchasing Card Program 38 Administrator. 39 40 a. LaCarte is a Visa card issued by the Bank of America for the State of 41 Louisiana. A card is issued to a specific employee of the Board, and the 42 card will be embossed with the State of Louisiana, Board of Pharmacy, 43 employeeDRAFT name, employee account number, and state tax-exempt 44 number. 45 b. The use of the card is restricted to purchases for official state use only, for 46 individual purchases up to $1,000. It shall not be used for personal use, to 47 access cash, for alcohol, or for fuel, travel or entertainment purposes. It 48 shall not be used for contracted services or for 1099-reportable vendors. 49 c. A cardholder is limited to a maximum of $1,000 for a single purchase, and 50 a maximum of $2,500 in transactions per cycle. Expenditures resulting in 51 a cumulative annual amount in excess of the budgeted amount for that 52 category requires prior approval of the Appointing Authority. 53 d. The Appointing Authority shall determine the appropriate merchant codes 54 for card utilization, and the Office Manager shall monitor adherence to 55 those parameters. 56 e. The Office Manager shall maintain the card accounts, ensure prompt 57 reconciliation of periodic statements, perform post audits of purchases to 58 monitor compliance with appropriate policies, and prepare all required 59 reports. 60 f. The Office Manager shall record the issuance of a card in the cardholder’s 61 personnel record, and shall cancel and collect the card when it is no 62 longer needed or upon the termination of the employee. 63 g. When the Office Manager determines that the card has been used 64 inappropriately, the Appointing Authority shall be notified to initiate the 65 appropriate disciplinary process. 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 DRAFT 93 94 95 96 97 Louisiana Board of Pharmacy Policies & Procedures 98 99 Title: Purchases Policy No. II.E.1 100 101 Approved: 08-06-2008 Revised: 102 103 104 Revision History 105 106 11-15-2017 Revised to add statutory and regulatory authorities, remove authority for a 107 state-approved purchasing card, and authorize members and employees 108 to use personal credit cards for board-approved expenses. 109 110 08-06-2008 Completely re-written to comply with requirements from Office of State 111 Purchasing in the Division of Administration. 112

DRAFT 1 Louisiana Board of Pharmacy Policies & Procedures 2 3 Title: Invoices/Receipts Policy No. II.E.2 4 5 Approved: 05-11-2005 Revised: 6 7 8 2. The Office Manager shall not process the payment of invoices and/or receipts 9 without the approval of the Appointing Authority (as evidenced by his signature or 10 initials) and the appropriate backup information as proof that the goods were 11 received and/or that the repairs were made, as required by the Legislative 12 Auditor. 13 14 1. Therefore, all All invoices, receipts, shipping notices, packing slips, and tickets 15 for merchandise must be submitted to the Office Manager no later than 24 hours 16 after receipt. 17 18 Delayed receipts often cause late payments of bills and/or expense checks. 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 DRAFT 44 45 46 47 48 49 Louisiana Board of Pharmacy Policies & Procedures 50 51 Title: Invoices/Receipts Policy No. II.E.2 52 53 Approved: 05-11-2005 Revised: 54 55 56 Revision History 57 58 11-15-2017 Added requirement for documentation of approval of invoices for 59 payment. 60

DRAFT September 21, 2017 Malcolm J. Broussard Executive Director Louisiana State Board of Pharmacy

Dear Mr. Broussard: The Accreditation Council for Continuing Medical Education (ACCME), Accreditation Council for Pharmacy Education (ACPE), and American Nurses Credentialing Center (ANCC) are pleased to announce a new credit mark. Interprofessional continuing education (IPCE) credits for learning and change identify continuing education (CE) activities designed by and for the healthcare team. We developed this credit in response to requests from educators and learners for a designation that recognizes the value of IPCE. National and international health leadership organizations have identified interprofessional education and team-based care as a critical component of healthcare improvement. There is a growing body of evidence demonstrating that participation in IPCE improves healthcare professionals’ performance and patient outcomes.

“This activity was planned by and for the healthcare team, and learners will receive (INSERT #) Interprofessional Continuing Education (IPCE) credits for learning and change.”

Key Points  IPCE credits for learning and change can only be awarded by CE providers that are jointly accredited by the ACCME, ACPE, and ANCC. Jointly accredited CE providers must meet rigorous standards for educational quality and independence.  The IPCE credit designation is only used for activities that have been planned by and for the healthcare team. IPCE is when members from two or more professions learn with, from, and about each other to enable effective collaboration and improve health outcomes (ACCME, ACPE, ANCC, 2015).

IPCE Credit September 21, 2017 Page 2 of 2

 IPCE credits identify team-based CE activities— they do not replace education or credits for individual professions. Activities that offer IPCE credits may also offer credits for individual professions.  The IPCE credit is intended to complement other healthcare credit and metric systems.

We encourage you to consider recognition of IPCE credits for learning and change for licensing requirements. Jointly accredited providers have made, and will continue to make, a substantial difference to healthcare teams and the patients they serve. We believe your recognition of IPCE credits would encourage health professionals to participate in education that effectively improves interprofessional collaborative practice and health outcomes. These resources provide more information about Joint Accreditation and IPCE credit:  Joint Accreditation Framework: The history, expectations, and criteria for Joint Accreditation  IPCE Credit and Joint Accreditation flyer: Brief summary of Joint Accreditation and IPCE credit  By the Team for the Team: Evolving Interprofessional Continuing EducationTM for Optimal Patient Care – Report from the 2016 Joint Accreditation Leadership Summit: Best practices, case examples, key recommendations, and data about the value of interprofessional continuing education These materials, as well as other information, are available at the Joint Accreditation website. We would be happy to answer any questions you may have and to meet with you to discuss the value of IPCE and how it can support our shared mission of protecting and improving the health of the public. Sincerely,

Graham McMahon, MD, MMSc Peter H. Vlasses, PharmD Kathy Chappell, PhD, RN, President and CEO Executive Director FNAP, FAAN ACCME ACPE Senior Vice President ANCC

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

M E M O R A N D U M

To: Executive Committee

From: Malcolm Broussard

Date: November 14, 2017

Re: Proposal to improve compliance and enforcement policies and procedures

During your last meeting on August 22, you reviewed this proposal for the adoption of inspection blueprint documents. Given the length of the documents, you requested we distribute them to the members for their review. We included those documents with the other Executive Committee documents in the Board meeting binder. During his committee report, Mr. Aron directed the members to those documents and asked them to review the blueprints and be prepared to consider their approval at their next Board meeting on November 15. As a gentle reminder of the proposal, I have reproduced that earlier memo here.

With the development of core modules of the Universal Inspection Form by NABP, through a collaborative process with over 40 state boards of pharmacy, we now have an opportunity to improve our compliance and enforcement policies and procedures. In particular, the core modules of the Universal Inspection Form are: • Module I – Basic pharmacy inspection; • Module II – Compounding of nonsterile preparations, based on USP Chapter <795>; and • Module III – Compounding of sterile preparations, based on USP Chapter <797>. Additional modules under development include nuclear pharmacy and other special pharmacy practices.

Using the inspection forms, I have developed blueprint documents for the three modules itemized above. These blueprint documents contain the numbered standards itemized on the inspection forms. The blueprints for the compounding practices are based on nationally developed criteria derived from the USP standards; therefore, unless Louisiana intends to vary from certain USP standards, there is no need to modify those blueprint documents. The blueprint for the basic pharmacy inspection contains room for additional standards specific to Louisiana.

When the Board has approved the blueprint documents, I propose the following actions: 1. Develop a resource page on the Board’s website for pharmacies. Some existing resources could be linked, e.g., forms and applications, guidance documents, etc. In addition, we can place links to the blueprint documents. Pharmacies will then know the standards by which they will be inspected. 2. Map the blueprint standards to specific federal and state laws and rules. This should assist the compliance officer preparing an investigative report serving as the basis for board action. 3. Construct a matrix describing ranges of sanctions (including field and administrative corrections as well as board actions) for noncompliance with blueprint standards, including aggravating and mitigating factors. This should include authority for staff-initiated consent agreements for minor or routine compliance issues. 4. Prepare committee policies and procedures for Board approval. 5. Analyze inspection reports to collect information on which standards elicit most frequent noncompliant inspections, and use that data for educational communications. Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Blueprint for Inspection of Pharmacies

Module I – Basic Pharmacy Services

Pharmacy Practice Profile 01.00 – 15.02 Page 02

General Operations and Licensure 16.00 – 29.03 Page 03

Personnel 30.00 – 33.00 Page 04

Facility and Security 34.00 – 46.00 Page 04

Product Receipt and Inventory 47.00 – 63.00 Page 05

Prescription Processing 64.00 – 74.02 Page 07

Patient Counseling and Communication 75.00 – 86.02 Page 10

Quality Assurance / Quality Improvement Program 87.00 – 94.00 Page 11 DRAFT

Revision History Page 14

Module I – Version 1.1 Page 1 of 14 Effective 08-30-2017

Pharmacy Practice Profile

01.00 Name, location, contact information, and key personnel

02.00 Is the Pharmacist-in-Charge (PIC) or pharmacy manager/director present for the inspection?

03.00 Are there any other businesses located at this address?

04.00 Does the pharmacy have any other websites?

05.00 Do any other websites link to the pharmacy website (such as a provider or other affiliate?

06.00 Does the pharmacy allow patients to enter/update profile and medical information through the website?

07.00 Are patients able to order or refill prescriptions through the website?

08.00 Are photographs allowed during the inspection (no PHI)?

09.00 List of additional personnel interviewed as part of the inspection.

10.00 List of personnel present at the time of the inspection.

11.00 Business licensure information for Louisiana and Federal (La. Board of Pharmacy, CDS, La. Board of Drug & Device Distributors, DEA, FDA, etc.)

12.00 Type(s) of practice; Facility Size; Volume of Dispensing & Distribution; Staffing Summary; Interstate Activity.

13.00 If the pharmacy mails or delivers filled prescriptions (patient-specific, labeled with patient name when it leaves the pharmacy), are any of the deliveries to a provider or facility for administration to the patient?

14.00 Does the pharmacy provide prescription products to a provider or facility for ‘office use’ (not pursuant to a prescription received prior to delivery, not patient-specific, and not labeled with the patient name)?

15.00 Does the pharmacy provide prescription products to providers or facilities (including other pharmacies) as a wholesale distributor (sold to the provider or facility for their use, administration, or providing/dispensing to patients)?DRAFT

15.01 If so, is the percentage of product distributed at wholesale to providers or facilities within this state less than 5%? Indicate actual percentage and whether percentage is based on a number of units, number of prescriptions, dollar volume of total sales or dollar volume of prescription sales.

Module I – Version 1.1 Page 2 of 14 Effective 08-30-2017

15.02 If so, is the percentage of products distributed at wholesale to providers or facilities in other states less than 5%? Indicate actual percentage and whether percentage is based on a number of units, number of prescriptions, dollar volume of total sales or dollar volume of prescription sales.

[Additional Louisiana standards]

General Operations and Licensure

16.00 Are pharmacy licenses, permits, and registrations posted in customers’ view and current?

17.00 Is the most recent board of pharmacy inspection report available for review?

18.00 Were any repeat deficiencies noted?

19.00 Has this pharmacy been inspected by any other state for which it holds a license? Any noted deficiencies?

20.00 Is the pharmacy operating under an exemption or restriction granted by the state in which the pharmacy is located or by any other state in which the pharmacy is licensed?

21.00 Has this pharmacy been inspected as part of the NABP Verified Pharmacy Program?

22.00 Is the pharmacy operating under a waiver or variance granted by the state in which the pharmacy is located or by any other state in which the pharmacy is licensed?

23.00 Does the pharmacy have any additional restrictions, limitations, or waivers with regards to any federal licenses or registrations (FDA, DEA, etc.)?

24.00 Has the pharmacy been inspected by the DEA?

25.00 Has the pharmacy been inspected by the FDA?

26.00 Does the pharmacy hold any accreditations or certifications? DRAFT 27.00 Has the pharmacy held any accreditations or certifications in the past that have been relinquished, rescinded, or suspended?

28.00 Does the pharmacy perform patient lab testing such as blood glucose tests, cholesterol tests, etc.?

Module I – Version 1.1 Page 3 of 14 Effective 08-30-2017

29.00 Does the pharmacy maintain all required records, including but not limited to prescription files and invoices on site?

29.01 Are written and verbal prescriptions (reduced to writing) kept on site for the entire retention period?

29.02 Are electronic prescriptions (e-scripts but not fax) kept on site for the entire retention period?

29.03 Are all dispensing records (refills, verifications, DUR overrides) kept on-site for the entire retention period?

[Additional Louisiana standards]

Personnel

30.00 Are all pharmacist, pharmacy intern, pharmacy technician, and pharmacy technician candidate credentials issued by the board current?

31.00 Is there a process for periodic verification of credential validity?

32.00 Are pharmacists or other personnel providing patient services that require additional training or certification appropriately trained and certified?

33.00 Does the pharmacy maintain the proper staffing ratios for pharmacy interns, pharmacy technicians, and pharmacy technician candidates?

[Additional Louisiana standards]

Facility and Security

34.00 Does the pharmacy have a working security/alarm system in place that is in compliance with the laws and regulations of the resident state?

35.00 Are Schedule II controlled substances secured in a locked cabinet or safe?

36.00 Are there contingency plans in the event the pharmacy cannot be secured?

37.00 Is theDRAFT pharmacy clean and sanitary, and is there appropriate space for the prescription volume?

38.00 Does the pharmacy have a private area for patient counseling and providing patient services?

39.00 Is temperature in the drug storage area monitored?

Module I – Version 1.1 Page 4 of 14 Effective 08-30-2017

39.01 Is the temperature in the drug storage area within the USP range for controlled room temperature (20°C to 25°C or 68°F to 72°F)?

40.00 Are the refrigerator and freezer restricted to drug products only (no food)?

41.00 The pharmacy has a process for how the refrigerator temperature is monitored for excursions 24/7.

41.01 Is the temperature in the refrigerator within the USP range (2°C to 8°C or 36°F to 46°F)?

42.00 The pharmacy has a process for how the freezer temperature is monitored for excursions 24/7.

42.01 Is the temperature in the freezer within the USP range (-25°C to -10°C or -13°F to 14°F)?

43.00 Are there contingency plans in the event of power outage or refrigerator/ freezer failure?

44.00 Are there contingency plans in the event of heating or air conditioning failure?

45.00 Is there a plan of action if there are any temperature or humidity excursions to determine if the integrity of the products has been compromised?

46.00 Does the pharmacy utilize any automated apparatuses for prescription processing/counting (such as robotics, Baker cells, etc.)?

[Additional Louisiana standards]

Product Receipt and Inventory

47.00 Does the pharmacy restrict ordering to only approved wholesale distributors or manufacturers?

47.01 If the pharmacy is not restricted to vendors approved by the corporate office, or the pharmacy can purchase from other sources, are the other sources verified? If so, how? DRAFT 47.02 Are all products received from authorized trading partners?

47.03 Does the pharmacy ensure transaction data (transaction history, transaction information, transaction statement) is received at the same time or before the product is received?

Module I – Version 1.1 Page 5 of 14 Effective 08-30-2017

47.04 Does the pharmacy have a procedure to verify product (suspect or illegitimate) including quarantine of product and reporting?

48.00 Does the pharmacy utilize paper DEA-222 forms to procure Schedule II substances? If so, who has power of attorney to sign the forms?

49.00 Does the pharmacy utilize CSOS (electronic Schedule II ordering) to procure Schedule II substances?

50.00 Is the receipt of Schedule II orders documented appropriately? Does the DEA-222 form indicate quantity received and date on each line of product received? Does the CSOS record indicate verification of receipt and staff performing verification?

51.00 Are invoices for controlled substances (Schedules I-V) that are received filed separately and are the invoices signed/initialed and dated upon receipt and every item checked in?

52.00 Are all orders received when the pharmacy is open?

53.00 Does the pharmacy purchase any compounded preparations from other entities for dispensing to patients?

54.00 Does the pharmacy have a system in place to track prescription drug products in order to detect diversion or theft?

54.01 Are incidents of diversion or resignation/termination of personnel for cause appropriately reported?

55.00 Does the pharmacy keep a perpetual inventory log of all Schedule II controlled substances (including APIs, if applicable)?

56.00 Is the Schedule II perpetual inventory log reconciled regularly?

57.00 Is the most recent complete controlled substance inventory available for review?

57.01 Does the pharmacy maintain other required inventories (such as change in PIC, theft/loss, etc.)?

58.00 Does the pharmacy stock and sell OTC pseudoephedrine (an/or ephedrine) products? DRAFT 58.01 Are these products mailed, sent, or delivered into other states?

59.00 Does the pharmacy stock and sell other OTC restricted products for which identification is required and a log kept of the sale?

59.01 Are these products mailed, sent, or delivered into other states?

Module I – Version 1.1 Page 6 of 14 Effective 08-30-2017

60.00 Are outdated, damaged, or recalled products segregated? How often does the pharmacy check for out-of-date products? Does it include OTC products?

60.01 If the pharmacy destroys products on site, are appropriate records kept of the destruction?

60.02 Does the pharmacy use a reverse distributor?

60.03 Does the pharmacy have a hazardous waste handling and collection system? How does the pharmacy handle empty bottles of chemotherapy medications or warfarin or hazardous drug compounding waste?

61.00 Does the pharmacy repackage bulk containers of prescription medications into smaller containers for ease of use? What expiration date is used on the repackaged container?

62.00 Does the pharmacy prepackage bulk containers of prescription medications into unit-of-use quantities? What expiration date is used on the prepackaged container?

63.00 Does the pharmacy return to stock prescription drugs that were filled but never picked up?

[Additional Louisiana standards]

Prescription Processing

64.00 Patient Profile: Is patient profile data organized and readily accessible to facilitate consultation with the prescriber, patient, or caregiver?

64.01 If the pharmacy dispenses veterinary prescriptions, does the information gathered and recorded include the species, and name of the animal/owner as required by resident state law?

65.00 Prescription: Are adequate processes in place to assure the integrity, legitimacy, and authenticity of prescription orders?

65.01 Is there a procedure to follow when a prescription is suspected of DRAFT(or actually is) fraudulent?

65.02 Are adequate processes in place for assuring that prescription medications are not prescribed or dispensed based on online medical consultations without there being a pre-existing prescriber- patient/client relationship?

Module I – Version 1.1 Page 7 of 14 Effective 08-30-2017

65.03 Does the pharmacy have electronic prescription capability?

66.00 Accuracy: Is the accuracy of the information entered into the computer system verified (patient information and prescription information?

67.00 DUR: Does staff conduct prospective DUR prior to the dispensing of a medication or product?

67.01 The DUR process includes:

67.01.01 Drug-drug interaction (prescription and OTC);

67.01.02 Drug-allergy interaction;

67.01.03 Therapeutic duplication;

67.01.04 Under- or over-utilization (including clinical abuse/misuse);

67.01.05 Disease state or condition contraindication;

67.01.06 Incorrect dosage or duration of therapy; and

67.01.07 Gender or age-related contraindications.

67.02 Does the pharmacy staff obtain additional information to use in the DUR process?

67.03 Does the pharmacy have adequate resources/references related to the type of pharmacy practice it operates?

67.04 Does the pharmacy report appropriate data to the state PMP, in this state and the other states in which the pharmacy is licensed?

67.05 Does the pharmacy access state PMP data for specific patients?

67.06 Are DUR overrides/bypasses documented? Indicate if documented via a password/biometric override or by computer logs.

67.07 Is the DUR process performed electronically by the computer system?

67.08 If the DUR is manual, is there a system to document: DRAFT• How manual DUR is performed; • Specific issues that were identified; and • Pharmacist that considered the identified issues and gage the order to proceed.

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67.09 If the pharmacy dispenses veterinary prescriptions, does it have a veterinary drug database integrated into the computer system for electronic DUR?

68.00 Are filled prescriptions verified for accuracy prior to dispensing?

69.00 Are filled prescriptions appropriately labeled?

70.00 Confidentiality: Is access to the pharmacy computer system limited to appropriate personnel?

70.01 Does the pharmacy appropriately destroy PHI including labeled prescription vials?

71.00 Mail/Delivery: If applicable, are packing materials designed to maintain the physical integrity, stability, and purity of prescription medications and compounded preparations in transport?

72.00 Off-Site Processes: Are any portions of the prescription processing (in the questions below) performed at a different location?

72.01 Is patient information (demographics and contact information) and profile information (allergies, disease states, etc.) entered into the computer at another location?

72.02 Are prescriptions received by another location (including written, telephone, fax, electronic)?

72.03 Is prescription information entered into the computer system at another location?

72.04 Is the accuracy of the prescription information entered into the computer verified at another location?

72.05 Is any part of the DUR process (including assessing and acting on DUR alerts and warnings) performed at another location?

72.06 Are any prescriptions dispensed or sold from this facility filled at another location?

72.07 If any of the above functions are performed at another location, is the other location under common ownership? DRAFT 72.08 If any of the above functions are performed at another location, is that location in a different state than this facility?

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72.09 If any of the above functions are performed at another location, are there policies and procedures for the function that include maintaining records of the person(s) performing the function and accountability?

72.10 Is the other pharmacy and any personnel at another location licensed in this state?

73.00 Off-Site Inventory: Does the pharmacy maintain any emergency kits in nursing homes, long-term care facilities, or other entities (such as hospice, emergency medical services, ambulances, correctional facilities, etc.)?

73.01 Do the emergency kits contain any compounded sterile preparations?

74.00 Off-Site Devices: Does the pharmacy maintain any automated medication dispensing devices outside the pharmacy such as Pyxis in a nursing home, or a secure mailbox device that patients access after hours, etc.?

74.01 If so, are the automated devices appropriately licensed, registered, or approved by the board of pharmacy?

74.02 Do the automated dispensing devices contain any compounded sterile preparations?

[Additional Louisiana standards]

Patient Counseling and Communication

75.00 Does the pharmacy provide counseling for all new prescriptions picked up at the pharmacy (proactively, no ‘offer’)?

75.01 Is an ‘offer’ to counsel made for all new prescriptions picked up at the pharmacy?

76.00 Does the pharmacist provide counseling for all refilled prescriptions picked up at the pharmacy (proactively, no ‘offer’)?

76.01 Is an ‘offer’ to counsel made for all refilled prescriptions picked up at the pharmacy? DRAFT 77.00 Does the pharmacist provide counseling for refilled prescriptions picked up at the pharmacy when there is a change in therapy or other issue determined by the pharmacist (proactively, no ‘offer)?

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77.01 Is an ‘offer’ to counsel made for all refilled prescriptions picked up at the pharmacy when there is a change in therapy or other issued determined by the pharmacist?

78.00 Is patient counseling provided for delivered prescriptions? How?

79.00 Is patient counseling provided for mailed prescriptions? How?

80.00 Are patient package inserts (PPIs) provided with every fill and refill of medications for which they are required (such as hormone products, inhalers, etc.)? How?

81.00 Are MedGuides provided with every fill and refill of medications for which they are required (such as NSAIDs, antidepressants, etc)? How?

82.00 Are REMS (Risk Evaluation Mitigation Strategy) implementation programs performed? Identify the programs and confirm procedures in place.

83.00 Is patient counseling, the offer to counsel, or the refusal of patient counseling documented? How?

84.00 Do patients have 24-hour access to a pharmacist? How?

85.00 Are processes in place to handle a drug recall?

86.00 Does the pharmacy accept prescription drugs back for destruction as part of a drug take-back program?

86.01 Does the take-back program include controlled substances?

86.02 Does the pharmacy have a modified DEA registration (Authorized Collector) for controlled substances take-back?

[Additional Louisiana standards]

Quality Assurance / Quality Improvement Program

87.00 Is there a documented continuous quality improvement (CQI) program for the purpose of detecting, documenting, assessing, and preventing quality- related events (QREs)?

87.01 DRAFTPolicies and procedures for the program are maintained in the pharmacy in an immediately retrievable form.

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87.02 “Quality Related Event” (QRE) is defined to mean any departure from the appropriate dispensing of a prescribed medication that is or is not corrected prior to the delivery and/or administration of the medication, including (but not limited to): 1. A variation from the prescriber’s prescription drug order such as incorrect drug, strength, form, or patient; or inadequate or incorrect packaging, labeling, or directions; 2. A failure to identify and manage over-utilization or under- utilization, therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of treatment, drug-allergy interactions, or clinical abuse/misuse; 3. Packaging or warnings that fail to meet recognized standards, the delivery of a medication to the wrong patient, or the failure to detect and appropriately manage a significant actual or potential problem with a patient’s drug therapy.

87.03 There is documentation of initial/ongoing (at least yearly) review and training of all pharmacy employees on the CQI program and processes.

88.00 Documentation of QREs starts as soon as possible, but no more than three days after determining their occurrence.

88.01 Documentation includes all the pertinent data about the prescription involved including personnel involved at each step.

88.02 Documentation includes documenting the type of QRE details and how/who discovered the QRE.

88.03 Documentation includes possible contributing factors such as day and time the QRE occurred, number of pharmacists and technicians on duty, prescription volume that day, equipment failure, or other factors affecting workflow at the time.

88.04 Documentation includes steps taken to remediate, including communications with the patient and the provider, and if the medication was ingested, and disposition of the patient.

89.00 QRE data collected is analyzed to assess causes and any contributing factors (root cause)? Who performs that analysis and often is the analysisDRAFT performed?

89.01 The pharmacy uses the findings of the analysis to formulate an appropriate response and develop pharmacy systems and workflow processes designed to prevent QREs and increase good outcomes for patients.

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89.02 For pharmacies utilizing a drug formulary, a periodic review of such formulary is undertaken to ensure that appropriate medications are being offered/selected in the best interest of the patients.

90.00 Quality Meetings are held at least annually by staff members of the pharmacy to consider the effects on quality of the pharmacy system due to staffing levels, workflow, and technological support.

90.01 The meeting reviews data showing evidence of the quality of care for patients and develops plans for improvements to increase good outcomes for patients.

90.02 Improvements or changes made are evaluated for performance to measure the effectiveness of the CQI program.

91.00 Reporting: Incidents of QREs are reported to a nationally recognized error reporting program, an outside peer review committee, or a patient safety organization.

91.01 Adverse events are reported to the appropriate entities such as the board of pharmacy, MedWatch, FDA, VAERS, etc?

91.02 Incidents involving malfunctioning or defective medical equipment or devices (blood glucose meters, DME, injection devices, etc.) are documented and reported to the manufacturer or distributor.

92.00 Quality Self-Audits are performed by the pharmacy at least quarterly (and upon change in PIC) to determine whether the occurrence of QREs has decreased and whether there has been compliance with preventative procedures, and to develop a plan for improved adherence with the CQI program in the future.

93.00 Customer Surveys are conducted at least yearly of patients who receive pharmaceutical products and services at the pharmacy. A statistically valid sampling technique may be used in lieu of surveying each patient. Each pharmacy should use the results of its customer survey to evaluate its own performance at a particular time and over a period of time.

94.00 Patient Complaints are documented, tracked, and investigated as appropriate and the information is used as part of the CQI program.

[Additional Louisiana standards] DRAFT

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Revision History

08-30-2017 Version 1.1 027.00 Added relinquished.

DRAFT

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Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Blueprint for Inspection of Pharmacies

Module II – Compounding Nonsterile Preparations

General Operations Information 01.00 – 18.03 Page 03

Component Selection and Use 19.00 – 24.05 Page 06

Beyond Use Dating (BUD) 25.00 – 30.00 Page 08

Environment 31.00 – 48.00 Page 08

Training 49.00 – 54.00 Page 10

Compounding Equipment 55.00 – 59.00 Page 11

Documentation 60.00 – 61.01.14 Page 11

Compounding Procedures 62.00 – 72.01 Page 13

Finished Preparation Release Checks and Tests 73.00 – 82.00 Page 14

Patient Counseling and Communication 83.00 – 86.00 Page 15

Revision History DRAFT Page 16

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United States Pharmacopeia (USP)

Categories of Compounded Nonsterile Preparations

SIMPLE Making a preparation that has a United States Pharmacopeia (USP) compounding monograph or that appears in a peer-reviewed journal article that contains specific quantities of all components, compounding procedure and equipment, and stability data for that formulation with appropriate BUDs; or reconstituting or manipulating commercial products that may require the addition of one or more ingredients as directed by the manufacturer. Examples include Captopril Oral Solution, Indomethacin Topical Gel, and Potassium Bromide Oral Solution, Veterinary.

MODERATE Making a preparation that requires special calculations or procedures (such as calibration of dosage unit mold cavities) to determine quantities of components per preparation or per individualized dosage units; or making a preparation for which stability data for that specific formulation are not available. Examples include Morphine Sulfate Suppositories, diphenhydramine hydrochloride troches, and mixing two or more manufactured cream products when the stability of the mixture is not known.

COMPLEX Making a preparation that requires special training, environment, facilities, equipment, and procedures to ensure appropriate therapeutic outcomes. Examples of possible complex preparation types include transdermal dosage forms, modified-release preparations, and some inserts and suppositories for systemic effects.

[Abstracted from 2016 USP Compounding Compendium, current with USP-39/NF-34 through First Supplement]

DRAFT

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General Operations Information

01.00 Does the pharmacy dispense nonsterile compounded preparations pursuant to a prescription?

01.01 Are patient profiles complete and DUR performed for each prescription?

01.02 Do the compounded prescriptions produce a significant difference from a commercially available drug that is justified by a documented medical need of the individual patient as determined by the prescribing practitioner?

01.03 Are nonsterile compounded prescriptions picked up at the pharmacy?

01.04 Are nonsterile compounded prescriptions delivered to patients in their homes or residential facilities?

01.05 Are nonsterile compounded prescriptions delivered to practitioner for administration to the patient in the office, clinic, or facility?

02.00 Does the pharmacy distribute nonsterile compounded preparations?

02.01 Does the pharmacy distribute nonsterile compounded preparations to practitioners for office use?

02.02 Does the pharmacy distribute nonsterile compounded preparation to hospitals, clinics, or surgery centers?

02.03 Does the pharmacy have a sales force that distributes samples containing active ingredients?

03.00 Does the pharmacy provide nonsterile compounded preparations to other pharmacies for dispensing?

03.01 If so, does the pharmacy have central fill contracts or agreements with these pharmacies for patient-specific preparations?

04.00 Does the pharmacy compound oral preparations (tablets, capsules, liquids, lozenges, etc.)? DRAFT 05.00 Does the pharmacy compound topical (creams, ointments, inserts, suppositories, patches, sprays including nasal sprays, etc.)?

06.00 Does the pharmacy compound vitamin or nutritional supplements?

07.00 Does the pharmacy compound investigational drugs?

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08.00 Does the pharmacy make a copy of an approved commercial product?

08.01 Products are verified as not available via FDA list and/or the manufacturer and documented.

08.02 FDA list and manufacturer information is monitored, and when item is taken off the list or becomes available, any remaining stock is quarantined for destruction and not dispensed or distributed.

09.00 Does the pharmacy perform compounding identified as simple? If so, indicate percentage of total compounding activity designated as such. This activity includes: 1. Making a preparation that has a USP compounding monograph or that appears in a peer-reviewed journal article that contains specific quantities of all components, compounding procedure and equipment, and stability data for that formulation with appropriate beyond-use dates (BUDs). 2. Reconstituting or manipulating commercial products that may require the addition of one or more ingredients as directed by the manufacturer.

10.00 Does the pharmacy perform compounding identified as moderate? If so, indicate percentage of total compounding activity designated as such. This activity includes: 1. Making a preparation that requires special calculations or procedures (such as calibration of dosage unit mold cavities) to determine quantities of components per preparation or per individualized dosage units. 2. Making a preparation for which stability data for that specific formula is not available.

11.00 Does the pharmacy perform compounding identified as complex? If so, indicate percentage of total compounding activity designated as such. This activity includes making a preparation that requires special training, environment, facilities, equipment, and procedures to ensure appropriate therapeutic outcomes.

12.00 Does the pharmacy perform compounding with hazardous drugs? If so, indicate percentage of total compounding activity designated as such.

12.01 Is the pharmacy aware of the more stringent requirements of the DRAFTproposed USP Chapter <800>?

12.02 Does the pharmacy have a hazardous waste handling and collection system? For example, empty bottles that contained chemotherapy medications or warfarin, hazardous drug compounding waste.

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12.03 Do patient/caregiver training programs or materials contain information and precautions regarding the handling and disposal of hazardous products such as chemotherapy medications?

13.00 Are Safety Data Sheets (SDS) [formerly known as Material Safety Data Sheets (MSDS)] available to personnel for drugs and chemicals used in the pharmacy (including those for compounding, if applicable)?

14.00 Does the pharmacy compound using any controlled substances? If so, indicate percentage of total compounding activity designated as such.

15.00 APIs: Does the pharmacy make any nonsterile compounded preparations using bulk powder Active Pharmaceutical Ingredients (APIs)?

15.01 Does the pharmacy purchase APIs directly from the manufacturer?

15.02 Does the pharmacy verify that the manufacture of the API is an FDA-registered facility? How?

15.03 Does the pharmacy use active ingredients that are not from an FDA-registered facility?

15.04 Does the pharmacy computer track on-hand quantities of APIs used for compounding?

16.00 Does the pharmacy perform any testing in-house (not sent to an outside lab)?

17.00 Does the pharmacy send samples to an outside lab to perform testing?

18.00 Quality Assurance/Quality Improvement: Does the pharmacy’s continuous quality improvement program include nonsterile compounding measures? • Quality Related Events (QREs) related to the preparation of compounded products; • Personnel testing and validation; • Equipment calibration, testing, and validation; • End product testing, such as potency, particulates, consistency, etc.; and • Patient or prescriber reports or complaints regarding nonsterile compounded preparations.

18.01 DRAFTDoes the facility QA program identify action limits or thresholds and the appropriate follow-up mechanisms when action limits or thresholds are exceeded including a recall system?

18.02 Does the recall system include communication with both the patient and the prescriber regarding the affected nonsterile compounded preparation?

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18.03 Are QREs involving nonsterile compounded preparations or all pharmacy recall campaigns reported to the Board of Pharmacy?

Component Selection and Use

19.00 All bulk drug substances (APIs) used are: (1) Compliant with the standards of an applicable USP or NF monograph, if one exists; or (2) A component of an FDA-approved human drug product; or (3) On the list of bulk drug substances for use in compounding developed by the FDA and issued through regulation. [Note: must comply with (1) or (2) above until the FDA list is issued]

19.01 Certificates of Analysis (COAs) obtained for all bulk APIs used for compounding.

19.02 USP- or NF-grade substances used, if available.

19.03 If compendial quality components are not available, chemically pure, analytical reagent grade or ACS [American Chemical Society]-certified components are used and are determined to be free from impurities.

19.04 APIs or other components have labeling indicating use for pharmaceutical compounding or manufacturing. Labels do not indicate “for research purposes only”, “not for drug use”, or are handwritten labels from other pharmacies.

19.05 If compounding for both humans and animals, APIs or other components that are labeled for veterinary use only are segregated or marked in such a way to prevent them from being used for human compounding.

19.06 All substances and components have a complete label including a batch control or lot number, and an expiration date.

19.07 For APIs without an expiration date assigned by the manufacturer or supplier, the pharmacy assigns a conservative expiration date. The expiration date assigned does not exceed three years for ingredients used for nonsterile compounding and does not exceed one year for ingredients used for sterile compounding. The DRAFTpharmacy may perform purity and quality testing to further ext4end their expiration date.

19.08 All APIs and components received without an expiration date are labeled with the date they were received.

19.09 If the pharmacy repackages APIs into smaller containers for ease

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of use, the expiration date assigned is conservative (typically, the lesser of one year or the actual expiration date from the original container). Product may be tested to extend the expiration date, but may not exceed the original package expiration date.

19.10 Bulk component containers are labeled with appropriate OSHA hazard communication labels and hazardous substances (including hormones) are segregated.

19.11 Components from foreign sources that are derived from ruminant animals (cow, sheep, goat) have documentation that the component is in compliance with federal laws governing processing, use, and importation – that the animals were free from disease, and that they were born, raised, and slaughtered in locations where bovine spongiform encephalopathy and scrapie are not known to exist.

20.00 Where water is an ingredient, purified or distilled water is used.

21.00 Ingredients used for dietary or nutritional supplements meet USP, Food Chemicals Codex (FCC), or NF standards, or the pharmacy has alternate means to determine if the ingredients meet food-grade quality.

22.00 No preparations are made or ingredients used that appear on the FDA’s list of drug products withdrawn or removed from the market for safety reasons. The facility has a copy of the list or other way to determine.

23.00 When manufactured products are used for compounding, all the other excipients in the product (in addition to the active ingredient) are considered relative to the use, effectiveness, and stability of the compounded preparation to be made.

24.00 For animal compounding, the compounding meets the same standards as compounding for human patients.

24.01 The pharmacist is knowledgeable or has references regarding the individual species’ limitations in physiology and metabolic capacity that can result in toxicity when certain drugs or excipients are used.

24.02 It is determined and documented if the animal is used for food (meat, milk, eggs, etc.) or that the animal is a pet.

24.03 DRAFTThe pharmacist is familiar with or has a reference regarding drug residues in the food chain and withdrawal times if compounding for food-producing animals.

24.04 The facility has a list of drugs and components not allowed when compounding for food-producing animals.

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24.05 The pharmacist is familiar with or has a reference regarding regulations for drug use in performance animals (e.g., race or show horses, racing dogs).

Beyond Use Dating (BUD)

25.00 BUDs are assigned from the day of preparation.

26.00 BUDs for nonaqueous formulations are not later than the remaining time until the earliest expiration date of any API and not later than six months.

27.00 BUDs for water-containing oral formulations are not later than 14 days when stored at controlled cold temperatures (refrigerated).

28.00 BUDs for water-containing topical/dermal and mucosal liquid and semisolid formulations are not later than 30 days.

29.00 BUDs are assigned based on dispensing in tight, light-resistant contains/overpacks.

30.00 Extended BUDs are supported by testing data.

Environment

31.00 The nonsterile compounding area is a controlled environment and separate from the general pharmacy.

32.00 There is sufficient space available for the type and amount of compounding performed and the space is orderly to prevent mix-ups between ingredients, containers, labels, in-process materials, and finished preparations.

33.00 Only one preparation is compounded at a time.

34.00 Procedures are implemented to prevent cross-contamination, especially when compounding with drugs such as hazardous drugs and known allergens like penicillin that require special precautions.

35.00 The compounding area is well-lit.

36.00 The pharmacyDRAFT performs hazardous nonsterile compounding in a ventilated cabinet such as a BSC, CAI, or CACI; however, CAI may not be used for hazardous drugs that may volatilize. {USP Chapter <800> will change hazardous drug compounding requirements.}

36.01 Ventilated cabinets (BSC, CAI, CACI) used for hazardous compounding are certified or tested periodically.

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36.02 Hood prefilters are checked and replaced regularly. {Recommended}

36.03 If the hoods or isolators are not located in a closed, controlled room environment, there is documentation from the manufacturer and site testing to verify proper functioning of equipment under dynamic conditions for the safety of personnel.

37.00 Appropriate protective attire (gowns, gloves, masks, etc.) is available including appropriate personal protective equipment (PPE) for hazardous drug compounding if hazardous drugs are used.

38.00 There is a sink in the compounding area with hot and cold potable water, soap or detergent, and air-driers or single-use towels.

39.00 There is adequate space to wash equipment and utensils including access to water for rinsing. {Purified water is recommended, but not required.}

40.00 The temperature of the compounding area is controlled by a thermostat and an air conditioning system is in place.

41.00 Temperature in the compounding area is maintained to provide controlled room temperature storage of 20° to 25°C (68° to 77°F), or more restrictive if warranted by specific drug product storage requirements.

41.01 Temperature monitoring is in place to detect any excursions (24/7) by continuous monitoring or retroactive detection using min/max. Temperature records are maintained.

41.02 Excursion action plan is in place, including evaluating excursion effects on drug product integrity.

41.03 Temperature monitoring is also performed in drug storage areas, if separate from the compounding areas.

42.00 Humidity in the compounding area is maintained to provide humidity in the ranges warranted by specific drug product storage requirements. If drug products require storage in a ‘dry place’, humidity is not to exceed 40%. Generally recommended range is 35-60%.

42.01 DRAFTHumidity monitoring in place to detect any excursions (24/7) by continuous monitoring or retroactive detection using min/max. Humidity records are maintained.

42.02 Excursion action plan in place including evaluating excursion effects on drug product integrity.

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42.03 Humidity monitoring is also performed in drug storage areas, if separate from the compounding areas.

43.00 The bulk component storage area is adequately arranged and maintained in a clean and sanitary condition.

44.00 All components, equipment, and containers are stored off the floor, and handled and stored to prevent contamination.

45.00 All components and packaging containers and closures are properly rotated to use oldest first.

46.00 Hazardous drugs are appropriately identified and marked, received, handled and stored by appropriately trained personnel (OSHA regulations and NIOSH Alerts).

47.00 Trash is disposed of in a safe, sanitary, and timely manner including hazardous waste.

48.00 Environmental testing is performed to detect contamination by drug residue in the pharmacy area or areas served by the same ventilation system. {Recommendation: drug residue may cause cross contamination to other products or expose staff. Not required but is recommended if compounding with hazardous materials or known allergens such as penicillin, not using a hood, or the compounding room is not segregated.}

Training

49.00 All personnel of reproductive capability who handle or compound hazardous drugs or chemicals have confirmed in writing that they understand the risks of handling hazardous drugs, including teratogenicity, carcinogenicity, and reproductive issues.

50.00 There is documentation that all personnel that perform compounding are appropriately trained including policies and procedures, documentation, hazardous drug handling, and compounding technique and are not allowed to compound or supervise compounding until training is successfully completed.

51.00 There is documentation that the training process for the preparation of compounds includes demonstration of the compounding procedure first, followedDRAFT by the trainee performing the procedure under supervision successfully before being allowed to perform compounding.

52.00 There is documentation that training includes the operation of any equipment that may be used when preparing compounded products; documentation includes operation and troubleshooting.

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53.00 There is documentation available showing employees performing nonsterile compounding are evaluated at least annually (including hazardous drug handling).

54.00 If the pharmacy uses relief personnel from outside agencies to perform nonsterile compounding there is documentation that training is verified.

Compounding Equipment

55.00 Appropriate equipment and utensils are available, clean, and in good working order. Automated, mechanical, or electronic equipment (including capsule machines, autoclaves, ovens, etc.) are periodically inspected and calibrated.

56.00 Scales, balances, or other equipment used for measurement is validated and calibrated at least annually. If scales are not validated and sealed by a state or local weights and measures agency, describe procedure used.

57.00 Powder hoods used for nonsterile compounding are certified or tested periodically to ensure proper function. Hood filters are checked regularly and replaced when necessary.

58.00 All equipment is cleaned promptly after each use. Equipment and utensils washing using potable water with a soap or detergent, and rinsed. {Recommendation: rinse with purified water.}

59.00 The pharmacy uses separate equipment and utensils to compounding allergenic, cytotoxic, or hazardous products, or has detailed procedures for meticulous cleaning of equipment and utensils immediately after use to prevent cross contamination or exposure.

Documentation

60.00 The pharmacy creates a Master Formulation Record the first time before compounding a new preparation.

60.01 Every formulation is evaluated for incompatibilities and the potential for being ineffective or toxic.

60.02 The Master Formulation Record contains: DRAFT 60.02.01 Official or assigned name, strength, and dosage form;

60.02.02 All necessary calculations;

60.02.03 Description of all ingredients and their quantities;

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60.02.04 Compatibility and stability information including references (when available);

60.02.05 Equipment used for the preparation;

60.02.06 Mixing instructions (order of mixing, temperatures, duration of mixing, and other pertinent factors);

60.02.07 Container used and packaging requirements;

60.02.08 Assigned BUD information;

60.02.09 Labeling information, including the name of and quantity or concentration of each active ingredient;

60.02.10 Description of the finished preparation;

60.02.11 Storage requirements; and

60.02.12 Quality control procedures and expected results (e.g., dose measurement of capsule in the dose calibrator).

61.00 The pharmacy creates a Compounding Record for each compound prepared.

61.01 The Compounding Record includes:

61.01.01 Official or assigned name, strength, and dosage of the preparation;

61.01.02 Master Formulation Record reference;

61.01.03 Sources, lot numbers, and expiration dates of all components;

61.01.04 Total quantity or number of dosage units compounded;

61.01.05 Person compounding the preparation;

61.01.06 Person performing the quality control procedures;

61.01.07 Person who approved the preparation; DRAFT 61.01.08 Date of compounding;

61.01.09 Assigned internal identification number or prescription number;

61.01.10 Description of the final preparation;

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61.01.11 Assigned BUD;

61.01.12 Duplicate label;

61.01.13 Results of quality control procedures (weight range of filled capsules, pH of aqueous liquids, etc.); and

61.01.14 Documentation of any quality control issues, and any adverse reactions or preparation problems reported by the patient or caregiver including investigation and recall, if appropriate.

Compounding Procedures

62.00 The Master Formulation Record and the Compounding Record has been reviewed by the compounder to ensure it is error free.

63.00 Compounding personnel ascertain that ingredients for compounded preparations are of the correct identity and appropriate quality including a unit-by-unit physical inspection of the components.

64.00 The containers and closures selected meet USP standards (from container supplier).

65.00 Container selection determined by physical and chemical properties of the preparation.

66.00 Compounding personnel maintain good hand hygiene and wear clean and appropriate clothing for the compounding being performed.

67.00 Personnel don appropriate protective garb when compounding includes hazardous compounding.

68.00 Routine compounding procedures for batch preparation completed and verified according to written procedures, including: calculations correct, weighing and measuring performed correctly, order of mixing correct, compounding techniques performed correctly.

69.00 Procedures for in-process checks followed. These checks indicate that appropriate procedures and packaging are followed for each step, includingDRAFT addressing pharmacist verification of steps performed by non- pharmacists that includes visual inspection of product, and documentation of the compounding accuracy is performed to ensure proper measurement, reconstitution, and component usage. {Recommendation: compounding accuracy checked by a person other than the compounder.}

70.00 If there are any deviations from the master formulation record, these

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deviations are recorded.

71.00 There is a plan for cleaning, e.g., after each preparation, daily tasks, monthly tasks, etc.

72.00 Personnel are appropriately garbed for protection when cleaning.

72.01 Compounding employees are using appropriate techniques.

Finished Preparation Release Checks and Tests

73.00 The finished preparation is observed to appear as expected in the Master Formulation Record and documented.

74.00 As appropriate, the final completed preparation is assessed for weight, mixing, clarity, color, consistency, pH, and strength, and is documented.

75.00 There are established written processes that describe test or examinations conducted on the compounded preparation e.g., degree of weight variation in capsules.

76.00 Preparations with extended BUDs that are not supported by testing data are sampled and tested for physical, chemical, and microbiological characteristics.

76.01 If any failed tests or discrepancies are observed, there is an investigation and appropriate corrective actions taken before dispensing to patient.

76.02 If products are being tested are dispensed or distributed before the test results are obtained, there is a recall procedure if the test results indicate an issue.

77.00 There are appropriate control procedures to monitor the output and to verify the performance of compounding processes and equipment that may be responsible for causing variability in the final compounded preparations, e.g., validation of equipment and personnel performance documentation.

78.00 Labels on immediate patient-specific containers include identifiers for the persons preparing the compound and performing the final verification, BUD,DRAFT and indication that this is a compounded preparation, special requirements for storage, and appropriate packaging and labeling of hazardous materials.

79.00 Batch preparations (in anticipation of prescriptions) are of an appropriate volume and batch preparations in stock are all within their BUD (not outdated).

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80.00 Labels on batch preparations include the name and quantity of all contents, date of preparation (or internal code indicating this information), preparer and verification pharmacist identifiers, stability (BUD), and any auxiliary labels indicated including appropriate packaging and labeling of hazardous materials. {Recommendation: include time of preparation with the date.}

81.00 Preparations are stored properly prior to dispensing based upon conditions upon which BUD was assigned.

82.00 Preparations are examined immediately after preparation and again immediately prior to dispensing for any signs of instability.

Patient Counseling and Communication

83.00 Patient/caregiver training programs or materials contain information and precautions regarding the handling and disposal of hazardous products such as chemotherapy medications.

84.00 The required printed drug information materials (drug information sheets, patient package inserts, MedGuides, etc.) are provided for the compounded preparations.

85.00 Patients are instructed on the signs of product instability or contamination (as appropriate) and how to report any changes in the physical characteristics of the preparation to the pharmacy.

86.00 Product recalls include documentation that both the patient and the physician/prescriber of the potentially contaminated compounded preparation are notified of the potential risk.

DRAFT

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Revision History

08-30-2017 Version 1.1 80.00 Adjusted labeling requirement for batches, to change the inclusion of the preparation time from a required element to a recommendation for best practice.

DRAFT

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Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Blueprint for Inspection of Pharmacies

Module III – Compounding Sterile Preparations

Introduction Page 02

General Operations Information 001.00 – 021.12 Page 07

Component Selection and Use 022.00 – 027.02 Page 11

Environment 028.00 – 056.04 Page 13

Cleaning and Disinfection 057.00 – 071.00 Page 18

Training 072.00 – 085.02 Page 19

Garbing 086.00 – 098.00 Page 21

Environmental Monitoring 099.00 – 109.00 Page 22

Compounding Equipment 110.00 – 114.02 Page 26

Compounding Procedures 115.00 – 138.00 Page 27

Finished PreparationDRAFT Release Checks and Tests 139.00 – 146.00 Page 31

Patient Counseling and Communication 147.00 – 150.00 Page 33

Revision History Page 34

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Introduction

United States Pharmacopeia (USP)

Chapter <797> Pharmaceutical Compounding - Sterile

The objective of USP Chapter <797> is to describe conditions and practices to prevent harm, including death, to patients that could result from: • Microbial contamination (nonsterility); • Excessive bacterial endotoxins; • Variability in the intended strength of correct ingredients that exceeds either monograph limits for official articles or 10% for nonofficial articles; • Unintended chemical and physical contaminants; and • Ingredients of inappropriate quality in compounded sterile preparations (CSPs).

Despite the extensive attention in the chapter to the provision, maintenance, and evaluation of air quality, the avoidance of direct or physical contact contamination is paramount. It is generally acknowledged that direct or physical contact of critical sties of CSPs with contaminants, especially microbial sources, poses the greatest probability of risk to patients. Therefore, compounding personnel must be meticulously conscientious in precluding contact contamination of CSPs both within and outside ISO Class 5 areas.

To achieve the above five conditions and practices, the chapter provides minimum practice and quality standards for CSPs of drugs and nutrients based on current scientific information and best sterile compounding practices. The use of technologies, techniques, materials, and procedures other than those described in the chapter is not prohibited so long as they have been proven to be equivalent or superior with statistical significance to those described therein. The standards in the chapter to not pertain to the clinical administration of CSPs in patients via application, implantation, infusion, inhalation, injection, insertion, instillation, and irrigation, which are the routes of administration. Four specific categories of CSPs are described in the chapter: low-risk level, medium-risk level, high-risk level, and immediate use.

The standards in the chapter are intended to apply to all persons who prepare CSPs and all places where CSPs are prepared (e.g., hospitals and other healthcare institutions, patient treatment clinics, pharmacies, physician practice facilities, and other locations and facilities in which CSPs are prepared, stored, and transported). Persons who perform sterile compounding include pharmacists, nurses, pharmacy technicians, and physicians. These terms recognize that most sterile compounding is performed by or under the supervision of pharmacists in pharmacies and also that the chapter applies to all healthcare personnel who prepare, store, and transport CSPs. For the purposes of the chapter, CSPsDRAFT include any of the following: 1. Compounded biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals, including but not limited to the following dosage forms that must be sterile when they are administered to patients: aqueous, bronchial and nasal inhalations, baths and soaks for live organs and tissues, injections (e.g., colloidal dispersions, emulsions, solutions, suspensions), irrigations for wounds and body cavities, ophthalmic drops and ointments, and tissue implants.

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2. Manufactured sterile products that are either prepared strictly according to the instructions appearing in manufacturers’ approved labeling (product package inserts) or prepared differently than published in such labeling. [Note: The FDA states that “Compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling.” However, the FDA-approved labeling (product package insert) rarely describes environmental quality (e.g., ISO Class air designation, exposure durations to non_ISO classified air, personnel garbing and gloving, and other aseptic precautions by which sterile products are to be prepared for administration). Beyond-use exposure and storage dates or times for sterile products that have been either opened or prepared for administration are not specified in all package inserts for all sterile products. Furthermore, when such durations are specified, they may refer to chemical stability and not necessarily to microbiological purity or safety.]

ISO Classification of Particulate Matter in Room Air (limits are in particles of 0.5 microns and larger per cubic meter [ISO] and cubic feet [FS 209E]*

Class Name Particle Count ISO Class U.S. FS 209E ISO, m3 FS 209E, ft3 3 Class 1 35.2 1 4 Class 10 352 10 5 Class 100 3,520 100 6 Class 1,000 35,200 1,000 7 Class 10,000 352,000 10,000 8 Class 100,000 3,520,000 100,000

*Adapted from former Federal Standard No. 209E, General Services Administration, Washington, DC 20407 (September 11, 1992) and International Standards Organization (ISO) 14644-1:1999, Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness.

Microbial Contamination Risk Levels of Compounded Sterile Preparations

Low Risk Level Preparations compounded under all of the following conditions are at a low risk of contamination: 1. The compounded sterile preparations (CSPs) are compounded with aseptic manipulations entirely within ISO Class 5 or better air quality using only sterile ingredients, products, components, and devices. 2. The compounding involves only transfer, measuring, and mixing manipulations using not moreDRAFT than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container or package (e.g., bag, vial) of sterile product or administration container/device to prepare the CSP. 3. Manipulations are limited to aseptically opening ampuls, penetrating disinfected stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other

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sterile products, and containers for storage and dispensing. 4. For a low risk level preparation, in the absence of passing a sterility test, the storage periods cannot exceed the following time periods: before administration, the CSPs are properly stored and are exposed for not more than 48 hours at controlled room temperature, for not more than 14 days at a cold temperature, and for 45 days in solid frozen state.

Examples of Low Risk Compounding 1. Single-volume transfers of sterile dosage forms from ampuls, bottles, bags, and vials using sterile syringes with sterile needles, other administration devices, and other sterile containers. The solution content of ampuls should be passed through a sterile filter to remove any particles. 2. Simple aseptic measuring and transferring with not more than three packages of manufactured sterile products, including infusion or diluents solution to compound admixtures and nutritional solutions.

Medium Risk Level When CSPs are compounded aseptically under Low Risk conditions and one or more of the following conditions exist, such CSPs are at a medium risk of contamination: 1. Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP that will be administered either to multiple patients or to one patient on multiple occasions. 2. The compounding process includes complex aseptic manipulations other than the single-volume transfer. 3. The compounding process requires unusually long duration, such as that required to complete dissolution or homogenous mixing. 4. For a medium risk preparation, in the absence of passing a sterility test, the storage periods cannot exceed the following time periods: before administration, the CSPs are properly stored and are exposed for not more than 30 hours at controlled room temperature, for not more than 9 days at a cold temperature, and for 45 days in solid frozen state.

Examples of Medium Risk Compounding 1. Compounding of total parenteral nutrition fluids using manual or automated devices during which there are multiple injection, detachments, and attachments of nutrient source products to the device or machine to deliver all nutritional components to the final sterile container. 2. Filling of reservoirs of injection and infusion devices with more than three sterile drug products and evacuation of air from those reservoirs before the filled device is dispensed. 3. Transfer of volumes from multiple ampuls or vials into one or more final sterile containers. DRAFT

High Risk Level CSPs compounded under any of the following conditions are either contaminated or at a high risk to become contaminated: 1. Nonsterile ingredients, including manufactured products not intended for sterile

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routes of administration (e.g., oral), are incorporated or a nonsterile device is employed before sterilization. 2. Any of the following are exposed to air quality worse than ISO Class 5 for more than 1 hour: • Sterile contents of commercially manufactured products; • CSPs that lack effective antimicrobial preservatives; and • Sterile surfaces of devices and containers for the preparation, transfer, sterilization, and packaging of CSPs. 3. Compounding personnel are improperly garbed and gloved. 4. Nonsterile water-containing preparations are stored for more than 6 hours before being sterilized. 5. It is assumed, and not verified by examination of labeling and documentation from suppliers or by direct determination, that the chemical purity and content strength of ingredients meet their original or compendial specifications in unopened or in opened packages of bulk ingredients.

Examples of High Risk Compounding 1. Dissolving nonsterile bulk drug and nutrient powders to make solutions that will be terminally sterilized. 2. Exposing the sterile ingredients and components used to prepare and package CSPs to room air quality worse than ISO Class 5 for more than 1 hour. 3. Measuring and mixing sterile ingredients in nonsterile devices before sterilization is performed. 4. Assuming, without appropriate evidence or direct determination, that packages of bulk ingredients contain at least 95% by weight of their active chemical moiety and have not been contaminated or adulterated between uses.

Immediate Use The immediate use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a CSP. Such situations may include cardiopulmonary resuscitation, emergency room treatment, preparation of diagnostic agents, or critical therapy where the preparation of the CSP under conditions described for Low Risk Level subjects the patient to additional risk due to delays in therapy. Immediate use CSPs are not intended for storage for anticipated needs or batch compounding. Preparations that are medium risk level and high risk level CPSs shall not be prepared as immediate use CSPs.

Immediate use CSPs are exempt from the requirements described for Low Risk Level only when all of the following criteria are met: 1. The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous products or diagnostic radiopharmaceuticalDRAFT products from the manufacturers’ original containers and not more than two entries into any one container or package (e.g., bag, vial) of sterile infusion solution or administration container/device. For example, antineoplastic agents shall not be prepared as immediate use CSPs because they are hazardous drugs. 2. Unless required for the preparation, the compounding procedure is a continuous process not to exceed 1 hour.

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3. During preparation, aseptic technique is followed and, if not immediately administered, the CSP is under continuous supervision to minimize the potential for contact with nonsterile surfaces, introduction of particulate matter or biological fluids, mix-ups with other CSPs, and direct contact of outside surfaces. 4. Administration begins not later than 1 hour following the start of the preparation of the CSP. 5. Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer, the CSP shall bear a label listing patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared the CSP, and the exact 1-hour BUD and time. 6. If administration has not begun within 1 hour following the start of preparing the CSP, the CSP shall be promptly, properly, and safely discarded.

Compounding in worse than ISO Class 5 conditions increases the likelihood of microbial contamination, and administration durations of microbially contaminated CSPs exceeding a few hours increase the potential for clinically significant microbial colonization and thus for patient harm, especially in critically ill or immunocompromised patients.

[Abstracted from 2016 USP Compounding Compendium, current with USP-39/NF-34 through First Supplement]

DRAFT

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General Operations Information

001.00 Does the pharmacy dispense sterile compounded preparations pursuant to a prescription?

001.01 Are patient profiles complete and DUR performed for each prescription?

001.02 Are sterile compounded prescriptions picked up at the pharmacy?

001.03 Are sterile compounded prescriptions delivered/mailed to patients in their homes or residential facilities?

001.04 Are sterile compounded prescriptions delivered/mailed to the practitioner for administration to the patient in the office, clinic, or facility?

002.00 Does the pharmacy distribute sterile compounded preparations?

002.01 Does the pharmacy distribute sterile compounded preparations to practitioners for office use?

002.02 Does the pharmacy distribute sterile compounded preparation to hospitals, clinics, or surgery centers?

002.03 Is the pharmacy registered with the FDA as an Outsourcing Facility?

002.04 Does the pharmacy have a sales force that distributes samples containing active ingredients?

003.00 Does the pharmacy provide sterile compounded preparations to other pharmacies for dispensing?

003.01 If so, does the pharmacy have central fill contracts or agreements with these pharmacies for patient-specific preparations?

004.00 Which of the following sterile compounds are prepared?

004.01 Allergen extracts

004.02 Parenteral solutions DRAFT 004.03 Parenteral suspensions

004.04 Preservative-free parenterals

004.05 Ophthalmic preparations

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004.06 Oral or nasal inhalation preparations (not topical sprays)

004.07 Baths and soaks for live organs and tissues

004.08 Irrigations for wounds and body cavities

004.09 Any other sterile preparations (implants, pellets, etc.)

005.00 Does the pharmacy compound investigational drugs?

006.00 Does the pharmacy only make essential copies of a commercially available drug product on the Drug Shortage List or for a clinically justified reason for individual patients?

006.01 Products are verified as appearing on the Drug Shortage List in effect under 506(E) of the Federal Act at the time of compounding, distribution, and dispensing.

006.02 The Drug Shortage List is monitored and when a drug product is no longer on the list, any remaining stock is quarantined and not available for distribution or dispensing.

007.00 Does the pharmacy perform low-risk compounding?

007.01 Are all low-risk compounds assigned BUDs within USP guidelines (48 hours at controlled room temperature, 14 days refrigerated, 45 days frozen)?

007.02 If extended BUDs are used, list products with extended BUDs and maximum BUD in notes.

007.03 If extended BUDs are used, is further testing being performed to justify the use of extended BUDs?

008.00 Does the pharmacy perform medium-risk compounding?

008.01 Are all medium-risk compounds assigned BUDs within USP guidelines (30 hours at controlled room temperature, 9 days refrigerated, 45 days frozen)?

008.02 If extended BUDs are used, list products with extended BUDs and maximum BUD in notes. DRAFT 008.03 If extended BUDs are used, is further testing being performed to justify the use of extended BUDs?

009.00 Does the pharmacy perform high-risk compounding?

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009.01 Are all high-risk compounds assigned BUDs within USP guidelines (24 hours at controlled room temperature, 3 days refrigerated, 45 days frozen)?

009.02 If extended BUDs are used, list products with extended BUDs and maximum BUD in notes.

009.03 If extended BUDs are used, is further testing being performed to justify the use of extended BUDs?

010.00 Does the pharmacy provide sterile compounded preparations to be administered via an implantable infusion pump?

011.00 Does the pharmacy perform compounding for immediate use?

012.00 Does the pharmacy perform compounding with hazardous drugs?

012.01 Is the pharmacy aware of the more stringent requirements of the proposed USP Chapter <800>?

012.02 Are hazardous drugs segregated and stored in a room that is negative pressure (at least 0.01” water column) to adjacent areas and with at least 12 ACPH?

012.03 Is hazardous drug waste quarantined in a designated area and disposed of in compliance with local, state, and federal regulations?

013.00 Are Safety Data Sheets (SDS) [formerly known as Material Safety Data Sheets (MSDS)] available to personnel for drugs and chemicals used in the pharmacy (including those for compounding, if applicable)?

014.00 Does the pharmacy perform compounding using blood products (or other biological materials), such as wound care, autologous eye drops, etc?

015.00 Does the pharmacy compound using any federally controlled substances I-V?

016.00 Does the pharmacy make any sterile compounded preparations using bulk powder Active Pharmaceutical Ingredients (APIs)?

016.01 Does the pharmacy purchase APIs directly from the manufacturer? DRAFT 016.02 Does the pharmacy verify that the source of the API is an FDA- registered facility?

016.03 Does the pharmacy use active ingredients that are not from an FDA-registered facility?

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017.00 Does the pharmacy use scales/balances for sterile compounding?

017.01 If so, what type of scale/balance is used?

017.02 If the scale/balance is electronic, does the pharmacy use the automatic calibration?

018.00 Does the pharmacy have a lyophilizer?

018.01 Where is the lyophilizer located?

018.02 Note the products lyophilized and the volume or percent of products per week produced using the lyophilizer.

018.03 Is the lyophilizer part of the viable air and surface sampling, media fill testing procedures, and cleaning schedules and procedures?

019.00 Does the pharmacy perform any testing in-house (not sent to an outside lab)?

020.00 Does the pharmacy send samples to an outside lab to perform testing?

021.00 Quality Assurance/Quality Improvement: Does the pharmacy’s continuous quality improvement program include sterile compounding measures? If so, review 021.01 – 021.12 below.

021.01 Does the CQI program include QREs related to the preparation of compounded products?

021.02 Does the CQI program include nonviable environmental monitoring and testing?

021.03 Does the CQI program include viable environmental testing?

021.04 Does the CQI program include personnel testing and validation?

021.05 Does the CQI program include equipment calibration, testing, and validation?

021.06 Does the CQI program include sterilization method testing and validation. DRAFT 021.07 Does the CQI program include end product testing (such as: potency, particulates, sterility, endotoxins, etc.)?

021.08 Does the CQI program include patient or prescriber reports or complaints regarding CSPs?

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021.09 Does the facility QA program identify action limits or thresholds and the appropriate follow-up mechanisms when action limits or thresholds are exceeded, including a recall system?

021.10 Does the recall system include communication with both the patient and prescriber regarding the potentially contaminated CSP administered and the potential risks?

021.11 Are QREs involving CSPs that may have been contaminated or are recalled reported to the appropriate agency such as the Board of Pharmacy and/or FDA?

021.12 Are all incidents (Colony-forming units [CFUs] detected by any personnel, environmental, or product testing, or any other checks or tests including endotoxin, purity, potency, etc.) remediated, appropriately investigated, cause determined, and processes implemented to prevent in the future?

Component Selection and Use

022.00 All bulk drug substances (APIs) used are: (1) Compliant with the standards of an applicable USP or NF monograph, if one exists; or (2) A component of an FDA-approved human drug product; or (3) On the list of bulk drug substances for use in compounding developed by the FDA and issued through regulation. [Note: must comply with (1) or (2) above until the FDA list is issued]

022.01 Certificates of Analysis (COAs) obtained for all bulk APIs used for compounding.

022.02 USP- or NF-grade substances used, if available.

022.03 If compendia quality components are not available, chemically pure, analytical reagent grade or ACS [American Chemical Society]-certified components are used and are determined to be free from impurities.

022.04 APIs or other components have labeling indicating use for pharmaceutical compounding or manufacturing. Labels do not indicate “for research purposes only”, “not for drug use”, or are DRAFThandwritten labels from other pharmacies.

022.05 If compounding for humans and animals, APIs or other components that are labeled for veterinary use only are segregated or marked in such a way to prevent them from being used for human compounding.

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022.06 All substances and components have a complete label including a batch control or lot number, and an expiration date.

022.07 For APIs without an expiration date assigned by the manufacturer or supplier, the pharmacy assigns a conservative expiration date. The expiration date assigned is not greater than one year, and is supported with data and/or testing.

022.08 All APIs are labeled with the date they were received.

022.09 If the pharmacy repackages the APIs into smaller containers for ease of use, the expiration date assigned is conservative (typically the lesser of one year or the actual expiration date from the original container). Product may be tested to extend the expiration date, but may not exceed the original package expiration.

022.10 Bulk component containers are labeled with appropriate OSHA hazard communication labels and hazardous substances are segregated.

022.11 Components from foreign sources that are derived from ruminant animals (cow, sheep, goat) have documentation that the component is in compliance with federal laws governing processing, use, and importation – that the animals were free from disease, and that they were born, raised, and slaughtered in locations where spongiform encephalopathy and scrapie are not known to exist.

023.00 No preparations for human use are made or ingredients used that appear on the FDA’s list of drug products withdrawn or removed from the market for safety reasons. The facility should have a copy of the list or other way to determine.

024.00 No preparations are compounded that present demonstrable difficulties for compounding as identified by the FDA.

025.00 When manufactured products are used for compounding, all the other excipients (in addition to the active ingredient) in the manufactured product are considered relative to the use, effectiveness, and stability of the compounded preparation to be made.

026.00 For animal compounding, does the compounding meet the same standardsDRAFT as compounding for human patients?

026.01 The pharmacist is knowledgeable or has references regarding the individual species’ limitations in physiology and metabolic capacity that can result in toxicity when certain drugs or excipients are used.

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026.02 It is determined and documented if the animal is used for food (meat, milk, eggs, etc.) or that the animal is a pet.

026.03 The pharmacist is familiar with or has a reference regarding drug residues in the food chain and withdrawal times if compounding for food-producing animals.

026.04 The facility has a list of drugs and components not allowed when compounding for food-producing animals.

026.05 The pharmacist is familiar with or has a reference regarding regulations for drug use in performance animals (e.g., race or show horses, racing dogs).

027.00 If the pharmacy compounds stock solutions or components (that are then used to compound a finished product) using APIs, these stock solutions are categorized as high-risk compounding.

027.01 The stock solutions are assigned a BUD based on the USP <797> high-risk compound BUD, or there is documentation of stability or testing to support an extended BUD.

027.02 Compounded preparations using the stock solution are classified as high-risk compounds with appropriate handling with regard to BUD and testing requirements.

Environment

028.00 If the facility performs both sterile and nonsterile compounding, the areas are separate and distinct.

029.00 If the facility performs compounding using blood products (or other biological material), this compounding area is separate and distinct from the general compounding areas.

029.01 Are components used in compounding with blood products restricted to the blood compounding area (not used in other compounding areas)?

030.00 Entry into the sterile compounding area is limited to task-critical employees [limited to only the pharmacist(s) and other trained and authorizedDRAFT pharmacy personnel].

031.00 The anteroom has a line of demarcation or other separation of the dirty to clean side.

031.01 Carts used to bring supplies from the storeroom are kept on the outside of the line of demarcation.

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031.02 Carts used in the clean/buffer room are kept on the clean side of the line of demarcation.

032.00 All surfaces of the sterile compounding area carts, shelves, stools, chairs and other items resistant to disinfectants, non-permeable, non-carpeted or upholstered, and low-particulate generating.

033.00 Walls are painted with epoxy-based paint or other impermeable surface, and are seamless or have sealed seams where panels meet and corners with no cracks.

034.00 The ceiling tiles are composed of a vinyl surface, with the tiles caulked and sealed, and the seams where the walls meet the ceiling are caulked and sealed.

035.00 The floor is overlaid with wide sheet flooring and seamless or with heat- welded seams, with coving to the sidewall, and a sealed seam where the coving meets the wall.

036.00 The clean/buffer room or anteroom does not have dust-collecting overhangs, such as ceiling utility pipes, ledges, pneumatic tube stations, sprinkler heads, emergency exit signs, etc.

037.00 The exposed surfaces of the light fixtures are smooth, mounted flush, and sealed.

038.00 A working sink, located on the clean side of the line of demarcation, is available that enables pharmacy personnel to wash hands and enter the sterile compounding area without contaminating his/her hands and is away from/not adjacent to any PECs.

039.00 There is no sink or drain in the clean/buffer room.

040.00 Hand drying is with non-linting paper towels or an electronic or HEPA- filtered hand dryer.

040.01 If using a hand dryer, particle count and smoke testing is performed when the dryer is in use (while someone is actively using the dryer to dry their hands) at certification, and the immediate area around the dryer is part of the viable air and surface testing program performed [not applicable if only using towels]. DRAFT 041.00 All air ducts controlling air flow into the sterile compounding clean/buffer room and anteroom are equipped with HEPA filters that maintains the clean/buffer room in an ISO Class 7 environment.

042.00 Incoming air ducts through HEPA filters are on or near the ceiling and air return ducts are low on the walls in the anteroom and clean/buffer room.

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043.00 If there are particle generating equipment/appliances in the clean/buffer room or anteroom (e.g., computers, printers, refrigerators, dishwashers, etc.), they are located by an air return so air flows over and out of the room taking particles with it, and this air flow has been confirmed by smoke testing while the equipment was in use.

044.00 Beverages including drinking water, chewing gum, candy or food items are prohibited from the clean/buffer room or the anteroom.

045.00 If compounding occurs using nonsterile ingredients, products, components, or devices (e.g., compounding with nonsterile APIs or using nonsterile vials and closures), the pharmacy has appropriate equipment to sterilize the finished product.

045.01 Pre-sterilization procedures for high-risk CSPs (such as weighing and mixing) are performed in no worse than ISO Class 8 environment.

046.00 Completely enclosed anteroom and clean/buffer room (with a door) are equipped with monitors or gauges to measure differential pressure.

046.01 Anteroom is at least 0.02” water column positive pressure to general pharmacy areas.

046.02 Clean/buffer room is at least 0.02” water column positive pressure to the anteroom.

046.03 Hazardous compounding room and storage area is at least 0.01” water column negative pressure to ISO Class 7 anteroom.

046.04 Pressures are read and recorded each shift, or a minimum of once daily, or in the alternative, are continuously recorded.

046.05 There is a plan in place to detect and react to pressure differentials outside limits.

047.00 If the clean/buffer room and anteroom are not fully enclosed (open or with plastic strips – no door that closes), the air flow is measured across the openings.

047.01 The air flow is at least 40 feet per minute across the entire opening.

047.02 DRAFTAirflow is read and recorded each shift (minimum of once daily) or continuously.

047.03 Plan in place to detect and react to airflow measurements outside of limits

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047.04 This area is used only for low- and medium-risk compounding. (High-risk not allowed.)

048.00 The temperature of the compounding area is controlled by a thermostat and an air conditioning system is in place.

048.01 Temperature in the compounding area is maintained to provide controlled room temperature of 20°C or cooler (68°F or cooler), or more restrictive if warranted by specific drug product storage requirements. Recommended temperature range for performing sterile compounding while garbed is between 64-72°F (18-22°C).

048.02 Temperature monitoring in place to detect any excursions (24/7) by continuous monitoring or retroactive detection using min/max. Temperature records are maintained.

048.03 Temperature monitoring is also performed in drug storage area (if separate from the compounding area). Temperature is maintained at controlled room temperature of 20° to 25° C (68° to 77° F) or as specified by FDA approved labeling for drug product storage.

048.04 Temperature in the refrigerator or cooler is maintained to provide controlled cold temperature of 2° to 8°C (36° to 46°F) or as specified by FDA approved labeling for drug product storage.

048.05 Temperature monitoring in place to detect any excursions (24/7) by continuous monitoring or retroactive detection using min/max. Temperature records are maintained.

048.06 Temperature in the freezer is maintained to provide controlled frozen temperature of -10° to 25°C (-13° to 14°F), or as specified by FDA approved labeling for drug product storage.

048.07 Temperature monitoring in place to detect any excursions (24/7) by continuous monitoring or retroactive detection using min/ax. Temperature records are maintained.

048.08 Action plan in place for temperature excursions including evaluating excursion effects on drug product integrity.

049.00 Humidity: If warranted by specific drug products, humidity in the compounding area is maintained to provide humidity within the specified rangesDRAFT. If drug products require storage in a “dry place”, humidity is not to exceed 40%. Generally recommended range is 35-60% for performing sterile compounding.

049.01 If applicable, humidity monitoring in place to detect any excursions (24/7) by continuous monitoring or retroactive detection using min/max. Humidity records are maintained.

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049.02 If applicable, excursion action plan in place including evaluating excursion effects on drug product integrity.

049.03 If applicable, humidity monitoring is also performed in drug storage areas (if separate from the compounding areas).

050.00 Blowers on ISO-5 primary engineering controls are operated continuously during compounding activity, including during interruptions of less than eight hours.

051.00 When the ISO-5 laminar air LAFW blower is turned off, and before other personnel enter to perform compounding activities, only one garbed person is allowed to enter the buffer area for the purpose of turning on the blower (for at least 30 minutes) and of sanitizing the work surfaces.

052.00 The doors into the anteroom from the general pharmacy area and from the anteroom into the clean/buffer room are prevented from both being open at the same time (by interlocking, training of personnel, or signage).

053.00 The inside and outside doors of a pass-through are prevented from both being open at the same time (by interlocking, training of personnel, or signage).

053.01 Pass-throughs are located between outside areas and the anteroom, or between the anteroom and the buffer room (and NOT between the outside areas directly into the buffer room) {Recommended}

054.00 The immediate area around the doorway or pass-through into the anteroom from the general area is free of particle-generating materials (such as corrugated cardboard, etc.) and is located in an area that limits particles (not next to an outside door or window, etc.) to limit potential contamination from being brought in through the entry. {Recommended}

055.00 For BSC or LAFW that is NOT located in an ISO-7 clean/buffer room, the BSC or LAFW has been certified to maintain ISO-5 during compounding activities.

055.01 Used only for low-risk compounded preparations with a 12-hour or less BUD assigned.

055.02 DRAFTAll garbing requirements adhered to.

055.03 Located in an area that is maintained under sanitary conditions and only traveled by persons engaging in the compounding of sterile preparations.

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055.04 Location does not contain any unsealed windows or doors that connect to the outdoors or areas of high traffic flow, and is not adjacent to construction sites, warehouses, or food preparation areas.

055.05 The sink is separated from the immediate area of the ISO-5 workbench (not adjacent) and an eyewash station.

056.00 For CAI/CACI that is NOT located in an ISO-7 clean/buffer room, the CAI/CACI has been certified to maintain ISO-5 under dynamic conditions including transferring of ingredients, components, and devices, and during preparation of compounded sterile preparations.

056.01 The pharmacy has documentation from the manufacturer that the CAI or CACI will meet this standard when located in worse then ISO-7 environments.

056.02 The CAI or CACI is located in an area that is maintained under sanitary conditions and only traveled by persons engaging in the compounding of sterile preparations.

056.03 There is a sink in the compounding area, not directly adjacent to the CAI or CACI, that enables pharmacy personnel to wash hands and an eyewash station.

056.04 For NIOSH hazardous compounding in a CACI that is NOT located in a clean/buffer room, the CACI is located in a physically separated area that maintains a negative pressure of 0.01” water column pressure to adjacent areas and a minimum of 12 air changes per hour (ACPH).

Cleaning and Disinfection

057.00 Are all personnel performing cleaning appropriately garbed?

058.00 Is the sterile compounding area equipped with appropriate non-shedding cleaning equipment and supplies?

059.00 If cleaning tools are reused, is there a procedure to rinse and sanitize the tools and an appropriate clean storage area and are buckets inverted to prevent moisture accumulation? DRAFT 060.00 Are reusable tools appropriately labeled to prevent them from being used inappropriately, e.g., a mop used for the floors cannot also be used for the ceilings and walls?

061.00 Are there formulas and instructions for mixing or diluting the cleaning and sanitizing agents prior to use and is the preparation of cleaning supplies

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documented?

062.00 Are cleaning and sanitizing agents appropriately labeled including expiration dates?

063.00 Are appropriate cleaning agents used that are effective for bacteria, viruses, fungi, and spores?

064.00 Is the ISO-5 primary engineering control cleaned at the beginning of each shift, between compounding activities, at least every 30 minutes while compounding and after spills or suspected surface contamination?

064.01 If heavily soiled, cleaning includes the appropriate agent.

065.00 Does sanitizing of the ISO-5 primary engineering control include sanitizing with sterile 70% isopropyl alcohol using a nonlinting wipe?

066.00 Does daily cleaning and sanitizing include counters and easily cleanable work surfaces?

067.00 Does daily cleaning include the floors starting from the clean/buffer room and working outwards? Floor cleaning does not occur during compounding.

068.00 If fatigue mats are used, are they cleaned daily and let dry on both sides?

069.00 Is a tacky mat used and if so, is there a procedure in place regarding replacement?

070.00 Are the ceilings, walls, all shelving, bins, carts, chairs, and the tops and sides of the primary engineering controls thoroughly cleaned monthly? This includes removing everything from shelves and bins before cleaning, cleaning the undersides of cart surfaces and stools, wheels, etc.

071.00 Is enough time allocated for cleaning activities, including contact/dwell times for the cleaning/disinfection agents?

Training

072.00 There is documentation that compounding personnel are appropriately trained including policies and procedures, documentation, hazardous drug handling,DRAFT and aseptic technique. Compounding personnel includes persons performing, supervising, and verifying compounding activities.

072.01 All personnel performing compounding are not allowed to compound until training and initial testing is successfully completed.

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072.02 All personnel that supervise compounding and/or perform verifications of other’s compounding are not allowed to supervise or verify compounding until training and initial testing is successfully completed.

073.00 All personnel of reproductive capacity who handle or compound hazardous drugs or chemicals have confirmed in writing that they understand the risks of handling hazardous drugs.

074.00 There is documentation that all personnel (including housekeeping or other outside personnel) that perform cleaning activities in the compounding areas including hazardous compounding areas are appropriately trained in garbing, cleaning, and disinfection.

075.00 There is documentation of training on the operation of any equipment that may be used when preparing compounded sterile preparations.

076.00 If the pharmacy uses relief personnel from outside agencies to perform sterile compounding, training and certifications are verified.

077.00 There is documentation that all compounding personnel (including those supervising or performing verifications) have passed an initial written exam, and subsequent annual written exams for the appropriate compounding risk levels and NIOSH hazardous drugs.

078.00 There is documentation that all compounding personnel have passed an initial and subsequent annual competency assessments of aseptic compounding skills using observational audit tools including handling NIOSH hazardous drugs.

079.00 There is documentation that new compounding personnel have passed an initial observed gowning procedure and three gloved fingertip sampling tests.

080.00 There is documentation that compounding personnel preparing low or medium risk-level products have passed an annual observed gowning procedures and gloved fingertip sampling test.

081.00 There is documentation that a media fill test procedure is performed for each compounding employee at least annually for individuals that prepare low or medium risk-level products. DRAFT 082.00 The media fill testing procedures include:

082.01 Media selection (including obtaining COAs or growth promotion certificates from suppliers);

082.02 Fill volume;

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082.03 Incubation time and temperature (30-35°C for a minimum of 7 days then 20-25°C for 7 days);

082.04 Inspection of filled units;

082.05 Documentation;

082.06 Interpretation of results; and

082.07 Action levels set with the corrective actions required.

083.00 High-Risk Sterile Compounding: There is documentation that compounding personnel have passed an observed gowning procedure and gloved fingertip sampling test every six months.

084.00 High-Risk Sterile Compounding: There is documentation that a media fill test procedure is performed for each compounding employee at least every six months for individuals that prepare high-risk level products.

085.00 Employees who have failed any testing are prohibited from compounding until training is performed/reviewed and subsequent testing is performed successfully.

085.01 Gloved fingertip tests that failed have the organisms identified down to the genus to determine the most likely source of the contamination. This data is used to develop plans to prevent contamination.

085.02 There is a plan to evaluate the sterile compounds prepared by an employee with failed gloved fingertip tests or media fills to detect potential contamination of the sterile preparations compounded.

Garbing

086.00 Personnel are prohibited from compounding, or entering the clean/buffer room or anteroom if they have a rash, sunburn, weeping sores, conjunctivitis, or an active respiratory infection.

087.00 Personnel are required to remove all personal outer garments such as hats, scarves, sweaters, vests, coats, or jackets and any makeup or cosmeticsDRAFT before entering compounding areas.

088.00 Personnel are required to remove all hand and wrist jewelry, and all visible jewelry or piercings, such as earrings, lip or eyebrow piercings, etc. before entering clean/buffer room.

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089.00 Personnel are prohibited from wearing artificial nails or extenders, and required to keep natural nails neat and trimmed.

090.00 Garbing with dedicated shoes or shoe covers that are donned as the line of demarcation is crossed (with the dedicated or covered shoe never touching the same side of the line of demarcation as the dirty shoe).

091.00 Garbing includes head and facial hair covers and masks. There is a mirror available to check that all hair is covered.

092.00 Hand cleaning is performed in the anteroom and includes removing debris from under the nails with a nail cleaner followed by a vigorous washing of the hands and forearms with soap for at least 30 seconds with hands and arms then dried with a non-linting disposable towel or a hand dryer.

093.00 The gown is non-shedding with sleeves that fit snugly around the wrists and enclosed at the neck.

094.00 All bare skin is covered on the arms and legs (no bare ankles, wrists, etc.).

095.00 Prior to donning sterile gloves, a waterless alcohol based surgical hand scrub with persistent activity is used and hands are allowed to dry.

096.00 Upon leaving the sterile preparation compounding area, gowns are taken off and disposed of, or if used for non-hazardous compounding they are left in the anteroom and not reused for longer than one shift.

097.00 Pharmacists or other personnel do NOT enter the anteroom and cross the line of demarcation without donning shoe covers or dedicated shoes.

098.00 Pharmacists or other personnel do NOT enter the clean/buffer room without fully washing and garbing (e.g., not wearing just a mask to check a technician’s work).

Environmental Monitoring

099.00 The most recent primary engineering control and room certification report is available.

099.01 All ISO Class 7 and 8 SECs (clean/buffer rooms and anterooms) DRAFThave been certified within the last six months.

099.02 All ISO Class 5 PECs (laminar airflow workbenches or areas, BSCs, CAIs, CACIs, and barrier isolators) have been certified within the last six months.

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099.03 Certification procedures shall be performed by a qualified individual at least every 6 months and whenever the device or room is moved or major work is done to the space.

099.04 Certification procedures such as those outlined in the Controlled Environmental Testing Association (CETA)’s “Certification Guide for Sterile Compounding Facilities” (CAG-003-2006) shall be noted on the report.

099.05 If the certification procedures used are not those outlined in “Certification Guide for Sterile Compounding Facilities” (CAG-003- 2006), the facility has performed a comparison and determined the procedures used are equivalent or better than the procedures outlined in “Certification Guide for Sterile Compounding Facilities” (CAG-003-2006).

099.06 The PIC or compounding supervisor is familiar with what testing is required and interpretation of results, ensures all testing is performed appropriately (under dynamic conditions where appropriate), has action levels identified, evaluates results to detect issues or trends, and action levels are further customized based on trended data of performance.

100.00 The certification report includes information about the equipment used for performing calibration test including: identification of the equipment used by model, serial number, last calibration date (or when next calibration is due).

100.01 The equipment used had not exceeded its calibration date at the time of certification.

101.00 The HEPA filtered air changes per hour (ACPH) were measured for the compounding rooms.

101.01 ISO Class 7 sterile compounding room is certified as having a minimum of 30 ACPE with at least 15 ACPH from outside air sources.

101.02 ISO Class 7 anteroom (required if connected to a NIOSH hazardous compounding clean/buffer room) is certified as having a minimum of 30 ACPH.

101.03 DRAFTISO Class 8 anteroom is certified as having the recommended minimum of 20 ACPH. {Recommended}

101.04 ISO Class 7 hazardous sterile compounding room is certified as having a minimum of 30 ACPH.

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101.05 If a CACI is used in a non-HEPA filtered room, the room is certified to maintain a minimum of 12 ACPH.

102.00 Air pattern analysis using smoke testing was performed under dynamic conditions (people working in the hoods and rooms). The smoke flow is described in the report for the various tests as turbulent, sluggish, smooth, etc.

102.01 Air pattern analysis was conducted at the critical area (direct compounding area inside the ISO Class 5 PEC) to demonstrate unidirectional airflow and sweeping action over and away from the product under dynamic conditions (personnel compounding or simulating compounding in PEC).

102.02 Air pattern analysis was conducted to confirm positive pressure (and negative pressure into hazardous compounding rooms) at all points around all openings, doorways, and pass-throughs.

102.03 Air pattern analysis was conducted around particle generating equipment while the equipment was in operation to confirm airflow.

103.00 Differential air pressure between rooms was measured.

103.01 The differential pressure measured was at least 0.02” water column positive from the clean/buffer room to the anteroom and between the anteroom and all adjacent spaces with the doors closed.

103.02 The differential pressure measured was at least 0.01” water column negative from the hazardous clean/buffer room to the anteroom with the doors closed.

104.00 Displacement airflow between rooms or areas were measured; required for a clean/buffer room without a door that closes to the anteroom – may be an open space or may have plastic strips in doorways.

104.01 Displacement airflow (for low and medium-risk non-hazardous rooms only) was measured at a minimum differential velocity of 40 feet per minute from the clean/buffer room to the anteroom.

105.00 Particle counts of particles 0.5 um and larger were measured under dynamic conditions.

105.01 DRAFTISO Class 5 areas and hoods are certified as having less than 3,520 particles per cubic meter of air (100 particles per cubic foot).

105.02 ISO Class 7 areas are certified as having less than 352,000 particles per cubic meter of air (10,000 particles per cubic foot).

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105.03 ISO Class 8 areas are certified as having less than 3,520,000 particles per cubic meter of air (100,000 particles per cubic foot).

106.00 HEPA filter tests were performed.

106.01 All room HEPA filters were leak tested and if leaks found, they were fixed.

106.02 All PEC HEPA filters were leak tested and if leaks found, they were fixed.

107.00 PECs with failed tests are not used for compounding until the conditions are corrected and verified by subsequent testing.

108.00 Viable air (every six months) and surface sampling (periodically) tests have been conducted.

108.01 Appropriate growth media used (containing tryptic soy agar medium with polysorbate and lecithin (TSApl) added to neutralize cleaning agents for surface sampling) with appropriate corresponding incubation time and temperature used.

108.02 Viable air sampling by active impaction using a volumetric air sampling device.

108.03 Air samples were taken in each ISO Class 5 PEC, and in each sterile compounding room and anteroom, and the samples are at least 400 liters in volume. {Recommendation for ISO Class 5 PEC is 1,000 liters.}

108.04 Surface samples performed on all direct compounding areas inside of each ISO Class 5 PEC, in each room, inside any pass-throughs, and on surfaces likely to be contaminated due to position relative to doorways, etc.

108.05 Viable air and surface samples did not exceed USP action levels (or internal action levels if more restrictive): Classification Air Sample Surface Sample ISO Class 5 > 1 CFU/m3 > 3 CFU/plate ISO Class 7 > 10 CFU/m3 > 5 CFU/plate ISO Class 8 > 100 CFU/m3 > 100 CFU/plate

108.06 DRAFTCFUs detected by any means (viable air or surface sampling, gloved fingertip testing, failed sterility tests, etc.) are analyzed to determine the organism down to the genus.

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108.07 If the number of CFUs detected in the rooms exceeds action levels, compounding ceases, immediate remediation and investigation into the cause conducted, and compounding not resumed until subsequent tests are performed successfully .

108.08 If the number of CFUs detected in the PECs exceeds action levels, begin immediate remediation, including recleaning, retraining and retesting, and conduct investigation into the causes.

108.09 If any highly pathogenic (i.e., mold, yeast, coagulase positive staphylococcus, or gram negative rods) were detected in the PECs (whether or not the number of CFUs exceeds action levels), begin immediate remediation including recleaning, retraining and retesting, and conduct investigation into the causes.

108.10 The testing report indicates growth promotion testing or documentation and sterility quality control testing of the media plates was performed.{Recommendation}

108.11 The testing results report includes media lot numbers and expiration dates and a signature of the laboratory analyst and/or reviewer. {Recommendation}

109.00 Facilities performing routine air or surface sampling with internal qualified personnel routinely verify sampling procedures.

Compounding Equipment

110.00 Appropriate equipment and utensils are available, clean, and in good working order. Automated, mechanical, or electronic equipment (autoclaves, ovens, etc.) are periodically inspected, and calibrated yearly or in accordance with the equipment manufacturer guidelines.

111.00 All environmental monitoring equipment and gauges (differential pressure gauges or probes, air flow and velocity measuring equipment for rooms not fully enclosed, etc.) are periodically inspected, and calibrated yearly or in accordance with the equipment manufacturer guidelines. Calibration is documented.

112.00 All temperature and humidity (where applicable) monitoring devices (thermometers, hygrometers, probes, etc.) are periodically inspected, and calibrateDRAFTd yearly or in accordance with equipment manufacturer guidelines. Calibration is documented.

113.00 PEC (hood) prefilters are checked and replaced regularly. {Recommended}

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114.00 Where Automated Compounding Devices (ACDs) are used for sterile compounding (such as repeater pumps), there is a policy and procedure for their use and calibration.

114.01 There is documentation of the ACD tubing being changed or discarded every 24 hours.

114.02 The ACD is used when performing media fill testing.

Compounding Procedures

115.00 Gloves and critical sites are sanitized with adequate frequency and with an approved disinfectant, such as sterile 70% isopropyl alcohol (IPA) spray and a non-linting wipe.

116.00 Objects that shed particles are prohibited in the clean/buffer room area, including pencils, cardboard cartons, paper towels, reading material, and cotton items, e.g., gauze pads.

117.00 Essential paper related products (syringe overwraps, work records contained in a protective plastic sleeve) are wiped down with sterile 70% IPA before being brought into the clean/buffer room area.

118.00 Supplies required for the scheduled operations of the shift are prepared and decontaminated by wiping or spraying the outer surface with sterile 70% IPA (or removing the outer wrap as the item is introduced into the aseptic work area) and brought into the clean/buffer room in a bin or on a movable cart.

119.00 Compounding employees are using appropriate aseptic technique.

120.00 Compounding personnel ascertain that ingredients for compounded sterile preparations are of the correct identity and appropriate quality by reading vendors’ labels, and a unit-by-unit physical inspection of the product before use.

121.00 All rubber stoppers of vials and bottles and the neck of ampoules are sanitized every time with sterile 70% IPA (and a wait of at least ten seconds to dry) prior to the introduction of a needle or spike for the removal of the product.

122.00 SingleDRAFT-dose vials exposed to ISO Class 5 or cleaner air are used within six hours of the initial puncture and any remaining contents discarded; if used in less than ISO Class 5 air, they are used within one hour of the initial puncture and any remaining contents discarded.

123.00 The remaining contents of opened single-dose ampoules (or vials where container closure system has been removed) are discarded immediately.

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124.00 Multiple-dose vials formulated for removal of portions on multiple occasions are used within 28 days (or the manufacturer’s specific BUD if less) after the initial entry or puncture and any remaining contents discarded.

125.00 The Compounding Record is complete with the following minimum data elements:

125.01 Official or assigned name, strength, and dosage of the preparation;

125.02 Names, lot numbers, and expiration dates of all components;

125.03 Total quantity or number of units compounded;

125.04 Person compounding the preparation;

125.05 Person performing the quality control procedures;

125.06 Person who approved the preparation;

125.07 Date of compounding;

125.08 Assigned internal identification number or prescription number;

125.09 Assigned BUD and reference if extended beyond USP guidelines;

125.10 Duplicate label;

125.11 Sterilization method (if applicable); and

125.12 Indication of the quality control procedures to perform (testing, filter integrity, etc.) and results of the testing, quality control issues, and investigation and recall, if applicable.

126.00 Procedure for in-process checks is followed. These checks indicate that appropriate procedures and packaging are followed for each step, including addressing pharmacist verification of steps performed by non- pharmacists and visual inspection of product. Documentation of the compounding accuracy is recommended to be performed by someone other than the compounder to ensure proper measurement, reconstitution, and component usage. DRAFT 127.00 Labels on batch preparations include the name and quantity of all contents, date, and time of preparation (or internal code indicating this information), preparer and verification pharmacist identifiers, stability (BUD), and any auxiliary labels indicated including appropriate packaging and labeling of hazardous materials.

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127.01 Labels on batch single-use containers are clearly marked as “Single Use Only.” {Recommended}

128.00 Labels on patient-specific containers, in addition to standard label requirements, also include names and quantity or concentration of active ingredients, BUD, total volume, route of administration, storage conditions and other information for safe use.

128.01 Labels on patient-specific single-use containers are clearly marked as “Single Use Only.” {Recommended}

129.00 Inspect several different finished products and look for any particulates. Do any of the finished products inspected show any evidence of particulates? If so, list the products including lot and expiration date and obtain photos if possible. Request the product be quarantined and notify Board office immediately.

130.00 Preparations without additional stability testing or supported by data are assigned BUDs within USP <797> guidelines: • Low Risk: 48 hrs room – 14 days refrigerated – 45 days frozen; • Medium Risk: 30 hrs room – 9 days refrigerated – 45 days frozen; • High Risk: 24 hrs room – 3 days refrigerated – 45 days frozen.

131.00 If extended BUDs are assigned, they are supported with stability documentation – preparation must exactly match the preparation tested by the facility including concentration of all active ingredients, excipients, etc.

132.00 If extended BUDs are assigned, has the facility has performed its own stability testing.

133.00 Compounded multiple-dose vials with extended BUDs assigned have additional instruction provided that indicates remainder must be discarded 28 days after first puncture or use.

134.00 Filter Sterilization in an ISO Class 5 environment and documentation includes:

134.01 If the compounded preparation contains large particles, a prefilter is placed upstream from the sterilizing filter.

134.02 The 0.2 micron sterile microporous membrane filter used to sterilize DRAFTcompounded sterile preparations is chemically and physically compatible with the compounded sterile preparation; and the filter is intended for human-use applications for sterilizing compounded sterile preparations (labeling does not indicate ‘research only’ or ‘laboratory use’ only);

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134.03 Is the appropriate capacity filter being used for the volume being filtered?

134.04 Filtering is completed rapidly without filter replacement; and

134.05 Confirmation of filter integrity (bubble testing) is performed and value documented for each filter used with each batch sterilized by filtration.

135.00 Steam Sterilization documentation includes:

135.01 The autoclave has been validated for the exposure time and mass of the items to be sterilized;

135.02 Ensures live steam contacts all ingredients and surfaces to be sterilized, effectiveness verified with biological indicators and temperature sensing devices;

135.03 Solutions are passed through a 1.2 micron or small filter into the final containers to remove particulates before sterilization;

135.04 Heated filtered air is evenly distributed throughout the chamber with a blower;

135.05 That the compounded sterile preparation will not be adversely affected by the steam and heat; and

135.06 The description of steam sterilization includes conditions and duration for specific compounded sterile preparations.

136.00 Dry Heat Sterilization documentation includes:

136.01 Dry heat is only used for those items that cannot be sterilized by steam or would be damaged by moisture;

136.02 Sufficient space is left between materials to allow for air circulation;

136.03 The description of dry heat sterilization includes conditions and duration for specific compounded sterile preparations;

136.04 That the effectiveness of dry heat sterilization is verified each time using appropriate biological indicators; and DRAFT 136.05 The oven is equipped with a system for controlling and recording temperature and exposure period.

137.00 Depyrogenation by Dry Heat documentation includes:

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137.01 Dry heat depyrogenation is used to render glassware and containers (such as vials) free from pyrogens as well as viable microbes;

137.02 The description of the cycle and duration for specific load items;

137.03 The effectiveness of the cycle is verified using endotoxin challenge vials (EVCs); and

137.04 Bacterial endotoxin testing is performed on the ECVs to verify the cycle is capable of achieving a three log reduction in endotoxins.

138.00 Other methods of sterilization are used with documented procedures and validation performed.

Finished Preparation Release Checks and Tests

139.00 Are products visually checked for particulates or other foreign matter against both a light and a dark colored background as a condition of release?

140.00 Are there checks for container, closure integrity, and any other apparent visual defects?

141.00 Is compounding accuracy documented by verification of steps?

142.00 Is verification of ingredient identity and quantity verified? Is there a reconciliation of components?

143.00 Are labels verified as being correct and is a copy of the label included in the record?

144.00 Sterility Testing complies with USP <71>. If testing is performed to a more stringent standard, describe in inspection notes.

144.01 Sterility testing includes both bacterial and fungal testing.

144.02 Sterility testing is performed on all compounded sterile preparations that have extended BUDs.

144.03 Sterility testing is performed for high-risk compounded sterile DRAFTpreparations prepared in batches of more than 25 identical containers.

144.04 Sterility testing is performed for compounded sterile preparations exposed longer than 12 hours at 2°C to 8°C or longer than 6 hours at warmer than 8°C before being sterilized.

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144.05 The appropriate quantities of units are sterility tested: • For parenterals:  For less than 100 units, test 10% or 4 units, whichever is greater;  For 100 to 500 units, test 10 units; and  For more than 500 units, test 2% or 20 units, whichever is less. • For large-volume parenterals:  2% of the units or 10 containers, whichever is less. • For non-parenterals (eye drops, inhalation, etc.):  For less than 200 units, test 5% or 2 containers, whichever is greater;  For 200 or more units, test 10 containers; or  If the product is packaged in unit doses, use the parenteral testing parameters above.

144.06 For products failing testing, product is quarantined, and an investigation is performed including microbial identification and action taken.

144.07 If items are dispensed or distributed prior to sterility testing completion, there is a written procedure requiring daily observation of the incubated media. If there is any evidence of microbial growth, there is an immediate recall and both the patient and the physician/prescriber for the patient to whom a potentially contaminated compounded sterile preparation was administered are notified of the potential risk.

145.00 Endotoxin Testing complies with USP <85>. If testing is performed to a more stringent standard, describe in inspection notes.

145.01 Is endotoxin testing performed for all high-risk level compounded sterile preparations for administration by injection prepared in groups of more than 25 single-dose packages, such as ampoules, bags, syringes, vials, etc.?

145.02 High-risk compounded sterile preparations prepared in multiple dose vials for administration to multiple patients.

145.03 High-risk compounded sterile preparations exposed longer than 12 hours at 2°C to 8°C (25°F to 46°F) or longer than 6 hours at warmer than 8°C (46°F) before they are sterilized. DRAFT 145.04 For products failing testing, product is quarantined, and an investigation is performed and action taken.

146.00 Potency Testing is performed. {Recommended}

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Patient Counseling and Communication

147.00 Do patient/caregiver training programs or materials contain information and precautions regarding the handling and disposal of hazardous products such as chemotherapy medications?

148.00 Are required printed drug information materials (drug information, PPI, MedGuides, etc.) provided for the compounded products?

149.00 Are patients instructed on the signs of product instability or contamination (as appropriate) and to report any changes in the physical characteristics of the product to the pharmacy?

150.00 Product recalls include documentation that both the patient AND the physician/prescriber of the potentially contaminated compounded sterile preparation was administered are notified of the potential risk.

DRAFT

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Revision History

08-30-2017 Version 1.1 006.00 Changed question relative preparation of copies of commercially approved products to limit it to certain circumstances.

006.03 Deleted item due to specific data requested in 006.00.

007.02 New question requests additional information relative to BUD in low-risk compounding.

007.03 New question requests additional information about testing for BUD in low-risk compounding.

008.02 New question requests additional information relative to BUD in medium-risk compounding.

008.03 New question requests additional information about testing for BUD in medium-risk compounding.

009.02 New question requests additional information relative to BUD in high-risk compounding.

009.03 New question requests additional information about testing for BUD in high-risk compounding.

010.01 Deleted item due to absence of parameter in USP chapter.

012.02 Observation: when USP chapter is final, will need to change pressure parameter from “0.01” to “0.03”.

016.00 Deleted reference to nonsterile preparations.

017.00 New question asking about use of scales or balances in compounding of sterile preparations.

DRAFT017.01 New question asking details about scales used.

017.02 New question asking about electronic scales.

021.00 Question about pharmacy’s continuous quality improvement (CQI) program relative to

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compounding of sterile preparations.

021.01 thru 021.12 Additional questions about different aspects of the pharmacy’s CQI program.

023.00 Added clarification “for human use”.

027.02 Deleted item; not covered in USP chapter.

027.03 Deleted item; not covered in USP chapter.

027.04 Deleted item; not covered in USP chapter.

038.01 Deleted recommendation re hand-free sink.

040.00 Observation: Future revision of USP 797 will removed heated hand dryer.

045.01 Clarification; requirement, not recommendation.

048.01 Clarification re temperature standards.

048.03 Clarification re temperature standards.

048.04 Clarification re temperature standards.

048.06 Clarification re temperature standards.

064.01 New item seeking additional detail.

065.00 Clarification – sanitizing vs cleaning.

067.00 Clarification re timing of floor cleaning.

071.00 Clarification re time for cleaning activities.

085.01 Clarification – deleted media fill tests.

099.04 Clarification; changed “standards” to “procedures.”

DRAFT099.05 Clarification allows for alternative procedures equivalent or superior to listed reference.

099.06 Adds additional person beyond PIC.

101.03 Clarification – recommendation, not requirement.

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108.00 Clarification of timing of samples.

108.06 Clarification – deleted media fills.

108.07 Clarification re CFUs on clean rooms.

108.08 New question relative to CFUs in PECs; distinct from 108.07.

108.09 Clarification re action plans on CFUs.

108.10 Clarification; recommendation, not requirement.

108.11 Clarification; recommendation, not requirement.

109.00 Clarification re sampling procedures.

112.00 Clarification re monitoring devices.

113.00 Deleted this item due to its relocation.

123.00 Clarification on single-dose containers.

128.00 Clarification on labeling of patient-specific containers.

134.02 Added example of inappropriate use of filters.

134.03 New item for additional data point re filters.

139.00 Clarification of visual checks prior to release.

140.00 Additional detail re visual checks prior to release.

144.00 Allows for alternative but superior standard for sterility testing.

144.03 Clarification of standard for sterility testing in DRAFThigh-risk compounding.

145.00 Allows for alternative but superior standard for endotoxin testing.

147.00 Item deleted; standards incorporated elsewhere in blueprint.

Module III – Version 1.1 Page 36 of 36 Effective 08-30-2017

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

M E M O R A N D U M

To: Executive Committee

From: Malcolm Broussard

Date: November 14, 2017

Re: Contract for Accounting Services

As you know, the Board has contracted with Kolder, Champagne, Slaven & Co., LLC, an accounting firm headquartered in Lafayette, La. since 1998. Since the beginning of the contract, the Board’s account has been managed by one of the partners in that firm, Mr. Russell Champagne, at the Breaux Bridge office.

We have been informed of a planned split in the firm, and Mr. Champagne will be retaining his current office location and staff at the Breaux Bridge location. Mr. Champagne has inquired whether we would like to stay with his office and staff, or in the alternative, transition to another location and staff within the original firm.

• If the Board wishes to remain with the original firm, we need do nothing. The contract is with the firm, and the firm would simply move our account to another location.

• If the Board wishes to remain with Mr. Champagne and his staff, then we need to terminate the existing contract and seek approval of a new contract for the remainder of the current fiscal year. The following suggested motions are designed to facilitate this option: Resolved, the Board authorizes the executive director to prepare, sign and deliver formal notice of its intent to terminate the existing contract with Kolder, Champagne, Slaven & Co., LLC effective December 18, 2017.

Resolved, the Board authorizes the executive director to prepare and sign a contract for professional accounting services with Russell F. Champagne, CPA, A Professional Corporation, effective December 18, 2017 for the remainder of Fiscal Year 2017-2018.

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

M E M O R A N D U M

To: Executive Committee

From: Malcolm Broussard

Date: November 14, 2017

Re: Pharmacy Technician Certification Examinations

As you may recall, the Board is in the process of updating its chapter of rules for pharmacy technicians; we have submitted the Board’s comprehensive report for the regulatory project to the Joint Legislative Oversight Committee on Health & Welfare. Assuming no intervention, the Board intends to publish the rule changes as a Final Rule in the December 2017 edition of the state register, with a delayed effective date of January 1, 2018.

One of the changes authorized is the ability for the Board to approve more than one pharmacy technician certification examination, by changing references to the test in the rule from “the board-approved test” to “a board-approved test.” You will recall the Board approves that (and all others) test annually, typically at the May meeting. The Board first approved the test administered by PTCB in January 2000.

The administrator of the Examination for Certification of Pharmacy Technicians (ExCPT) approached the Board in August 2009 seeking approval of their test as an alternative to the PTCB test. The Board provided guidance on how to obtain that approval, but it appears the petitioner elected not to follow that guidance. More recently, the new administrator of that test [National Healthcareer Association (NHA)] petitioned the Board for approval of the test, and the Board repeated its original guidance. NHA approached NABP, and NABP partnered with ACPE to perform a comprehensive comparison of the PTCB and ExCPT tests – not only to determine psychometric validity but also to compare the examination blueprints, to ensure both examinations were testing for the same competencies. The latter analysis is critical when different tests are used to qualify for the same license.

During a recent meeting of the Advisory Council for Uniform Standards for Pharmacy Technicians, the initial results of that comparison were revealed, demonstrating that the blueprints for both tests were substantially similar, with the primary difference that PTCB examines for competency in sterile compounding and ExCPT does not. However, PTCB recently announced that it would be revising their examination blueprint to de-emphasize sterile compounding. When that alteration is completed, the blueprints will be substantially equivalent.

We recommend the Board consider the approval of the ExCPT for pharmacy technicians as an alternative to the PTCB test, and further, to allow that approval to become effective when the rule change allowing such alternatives becomes effective, on January 1, 2018. The following suggested motion is designed to accomplish this recommendation: Resolved, the Board approves the Examination for Certification of Pharmacy Technicians (ExCPT) administered by the National Healthcareer Association (NHA) effective January 1, 2018, for the remainder of Fiscal Year 2017-2018. Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Report of Assistant Executive Director

PRESCRIPTION MONITORING PROGRAM (PMP)

BOARD MEETING – NOVEMBER 15, 2017

1 NUMBER OF ELIGIBLE PRESCRIPTION TRANSACTIONS REPORTED TO THE PMP

Total Reported: 114,536,023 (06/01/2008 through 09/30/2017) 14,000,000

12,000,000

10,000,000

8,000,000

6,000,000

4,000,000

2,000,000

0 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 RXs 6,019,931 11,154,837 12,124,061 12,584,423 12,989,950 13,032,083 13,020,364 12,403,123 12,241,613 8,965,638 2 PRESCRIBER & PHARMACIST SEARCHES – 2017

Total for 2017: 2,620,374

600,000 569,608 535,268

500,000 474,653 Prescribers Pharmacists 407,024 400,000 340,724

300,000 293,097

200,000

100,000

0 1st Quarter 2nd Quarter 3rd Quarter 4th Quarter

3 PRESCRIBER & PHARMACIST SEARCHES (01/01/2009 THROUGH 09/30/2017)

Overall Search Total: 12,999,277 2,000,000 Prescribers Pharmacists 1,800,000 1,740,249

1,579,529 1,600,000 1,447,593 1,400,000

1,200,000 1,166,655 1,066,781 1,040,845 969,726 1,000,000 842,139 800,000 650,514 600,000 496,270 460,522 382,204 400,000 368,376 235,985 153,783 212,754 200,000 74,277 111,075 0 2009 2010 2011 2012 2013 2014 2015 2016 2017 4 PMP User Statistics for 2017Q3 (07/01/2017 through 09/30/2017) PMP Role Title - Number of Providers Eligible Number of Providers Approved for Number of PMP Searches by Approved Providers Healthcare for PMP Access PMP Access During 2017Q2 Provider (as of 06/30/2017) (as of 06/30/2017) (Percentage of Total) Physician (MD, DO) 12,485 4,584 322,455 (33.02%) Nurse Practitioner (APRN) 2,745 1,392 53,453 (5.47%) Dentist (DDS) 2,120 565 1,692 (0.17%) Physician Assistant (PA) 728 305 12,831 (1.31%) Optometrist (OD) 345 12 0 Podiatrist (DPM) 153 34 96 (0.01%) Medical Psychologist (MP) 89 67 4,853 (0.496%) Prescriber's Delegate NA 1,505 174,228 (17.84%) Pharmacist (PST) 8,778 3,835 368,032* (37.68%) Pharmacist's Delegate NA 571 38,992 (3.99%) Totals 27,443 12,870 976,632

PMP User Statistics for 2017Q2 (04/01/2017 through 06/30/2017) PMP Role Title - Number of Providers Eligible Number of Providers Approved for Number of PMP Searches by Approved Providers Healthcare for PMP Access PMP Access During 2017Q2 Provider (as of 06/30/2017) (as of 06/30/2017) (Percentage of Total) Physician (MD, DO) 12,482 4,528 308,906 (35.26%) Nurse Practitioner (APRN) 2,595 1,326 48,838 (5.56%) Dentist (DDS) 2,119 557 1,770 (0.20%) Physician Assistant (PA) 721 287 11,913 (1.36%) Optometrist (OD) 338 13 0 Podiatrist (DPM) 151 34 118 (0.01%) Medical Psychologist (MP) 87 65 3,048 (0.34%) Prescriber's Delegate NA 1,284 160,675 (18.34%) Pharmacist (PST) 8,577 3,721 302,883 (34.57%) Pharmacist's Delegate NA 484 37,841 (4.31%) Totals 27,070 12,299 875,992 5 LAW ENFORCEMENT REQUESTS

Total Number of Law Enforcement Requests Processed: 8,703 01/01/2009 through 09/30/2017

1,400 1,230 1,224 1,200 1,150 1,011 1,000 889 Requests 845 843 831 800 Processed 680 600

400

200

0 2009 2010 2011 2012 2013 2014 2015 2016 2017 6 Requests for Full Exemption from PMP Reporting November 15, 2017

In accordance with L4.R.S:40.4.X-A.1006.C. The board may issue an exemption from the reporting requirement to a dispenser whose practice activities are inconsistent with the intent of the program. The board may rescind any previously issued exemption without the need for an informal or formal hearing.

Permit Permit Name Scope of Practice flEA City State

. Specialty Compounding Palm Beach 6870 NR allMedRxSpecialty Pharmacy Yes FL Pharmacy Gardens

7526 HOS Avoyelles Hospital Pharmacy In-Patient HOSPharmacy Yes Marksville LA

7534 IN BAARTPrograms Breaux Bridge Opioid Replacement Therapy Yes Breaux Bridge LA

6102 CH Beauregard Agape Clinic Charity Clinic No Deridder LA

. . Non-Drug Dispensing 7528 NR Cardinal Health Pharmacy Services No Cary NC Pharmacy

4741 NR Caremark Nonresident Pharmacy No Phoenix AZ

6592 NR CHDPharmacy Data Processing Pharmacy Yes Columbus OH Christus Coushatta Health Care Center 5460 HOS In-Patient Pharmacy Yes Coushatta LA Pharmacy

5667 CH CMAPExpress Pharmacy Charitable Pharmacy Yes Alexandria LA

5556 CH Community Health Worx Charitable Pharmacy No Alexandria LA

5242 NR CVSCaremark Nonresident Pharmacy No Orlando FL

6448 NR Dohmen LifeScience Services Retail Pharmacy Yes Chesterfield MO

7060 NR ESIMail Order Processing, Inc. Data Processing Pharmacy No Mason OH

4459 NR Express Scripts Data Processing Pharmacy No Albuquerque NM

4570 NR Express Scripts Data Processing Pharmacy No Troy NY

6987 NR Express Scripts Data Processing Pharmacy Yes Fairfield OH

6990 NR Express Scripts Data Processing Pharmacy No Temple Terrace FL

7052 NR Express Scripts Data Processing Pharmacy No Saint Louis MO

7053 NR Express Scripts Data Processing Pharmacy No Saint Louis MO

7058 NB Express Scripts Data Processing Pharmacy Yes Tempe AZ

6986 NR Express Scripts Data Processing Pharmacy Yes Dublin OH

6991 NR Express Scripts Data Processing Pharmacy Yes North Huntingdon PA

7529 NR Factor One Source Pharmacy Specialty Pharmacy Yes Cumberland MD

7442 lB FASTAccess Specialty Therapeutics Specialty Pharmacy Yes Metairie LA 7523 NB Fertility Pharmacy of America Fertility Pharmacy Yes Na5hville TN

7010 NR Gentry Health Services Specialty Pharmacy Yes Medina OH

5542 HOS Greenbrier Hospital In-Patient Hospital Pharmacy Yes Covington LA

7299 NB lmprimisRxTX Retail Pharmacy Yes Allen TX

7218 NR Lumicer Health Services MailOrder Pharmacy Yes Madison WI

7512 NR Marley Drug Mail Order Pharmacy Yes Winston Salem NC

7505 NR Matlock Specialty Pharmacy Specialty Pharmacy Yes Arlington TX

4745 NB Med 4 Home Pharmacy MailOrder Pharmacy Yes Kansas City MO

5918 HOS Northern Louisiana Medical Center In-Patient HOSPharmacy Yes Ruston LA

7527 HOS Oakdale Community Hospital In-Patient HOSPharmacy Yes Oakdale LA

6094 HOS Ochsner Medical Center - West Bank In-Patient HOSPharmacy Yes Terrytown LA

7111 NR OptiMed Specialty Pharmacy Specialty Pharmacy Yes Kalamazoo MI

4466 NB PharMerica LongTerm Care Pharmacy YES Indianapolis IN

7508 NB Prime Therapeutics Central Processing Pharmacy Yes Irving TX

5956 NB Ridgeway Pharmacy Specialty Pharmacy Yes Victor MT

2651 HOS RiverOaks Hospital In-Patient HOSPharmacy Yes River Ridge LA

5478 NB Rx.comCommunity Pharmacy Mail Order Pharmacy Yes Fort Worth TX

6738 NB SimfaRose Pharmacy Specialty Pharmacy YES Pembroke Pines FL

SlidellMemorial Hosp & Medical Ctr 1021 HOS In-Patient HOSPharmacy Yes Slidell LA Pharmacy

7483 NB Starcare Pharmacy Independent Retail Pharmacy Yes Prosper TX Thibodaux Regional Medical Center 1103 HOS In-Patient HOSPharmacy Yes Thibodaux LA Pharmacy

7520 NR U.S.PharmaMed, LLC MailOrder Pharmacy Yes Raleigh NC

6792 Ff05 University Hospital & Clinics In-Patient HOSPharmacy Yes Lafayette LA

7506 IR Vital Rxof Louisiana, LLC Specialty Pharmacy Yes LakeCharles LA

7521 NR Walgreens #1109-2 CallCenter No Muscle Schoals AL West Calcasieu Cameron Hospital 1196 HOS In-Patient HOSPharmacy Yes Sulphur LA Pharmacy

7525 HOS Winn Parish Medical Center Pharmacy In-Patient HOSPharmacy Yes Winnfield LA

6583 HOS Woman’s Hospital Pharmacy In-Patient HOSPharmacy YES Baton Rouge LA Staff Recommendation Approvethe proposed waiversconditioned upon executionof the standard ConsentAgreement:

EXEMPTIONTO PRESCRIPTION MONITORINGPROGRAM REPORTING REQUIREMENTS CONSENT AGREEMENT

WHEREAS, in order to facilitate the pharmacy’s request for an exemption to the reporting requirements to the Louisiana Board of Pharmacy’s Prescription Monitoring Program (PMP) as required by law, the Pharmacy indicated below agrees to the following terms:

(1) The Pharmacy shall not be authorized to dispense any controlled dangerous substances (CDS) or drugs of concern, with the exception of a hospital pharmacy permit’s inpatient dispensing, as identified by the Louisiana Board of Pharmacy (Board) by regulation. (2) Upon the first instance of receipt of evidence by the Board indicating the Pharmacy dispensed CDS or drugs of concern, the Pharmacy agrees to the followingsanction: The Pharmacy agrees to pay a fine of $5,000.00 and reimburse the Board $250.00 in administrative hearing costs, with total payment due the Board of $5,250.00, due by certified check or money order within 30 days of notice of this prohibited activity.

(3) Upon the second instance of receipt of evidence indicating the Pharmacy dispensed CDS or drugs of concern, the Pharmacy agrees to pay the above sanction, the termination of this exemption and the resumption of its reporting to the PMP. (4) The Pharmacy shall post a copy of this agreement adjacent or attached to its pharmacy permit.

By signing this Consent Agreement, Respondent agrees that the Board has jurisdiction in this matter and waives all rights to informal conference, to Notice of Hearing, to a formal Administrative Hearing, and to judicial review of this Consent Agreement. Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Report of General Counsel

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Report of Executive Director

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

November 15, 2017

Agenda Item 11-L: Report of Executive Director

1. Meeting Activity 2. Reports 3. Examinations 4. Operations 5. State Activities 6. Regional & National Activities 7. International Activities

1. Meeting Activity In addition to Board and committee meetings, I have also participated in or attended the following meetings since the last Board meeting. Oct. 3-4 NABP Executive Officers Forum @ NABP Oct. 4-5 NABP .Pharmacy Executive Board Meeting @ NABP Oct. 8-11 NABP-AACP District 6 Meeting @ San Antonio, TX Oct. 13 P-1 Orientation @ Xavier College of Pharmacy Oct. 22-25 MALTAGON Conference @ Charleston, SC Oct. 29-30 Advisory Committee for Uniform Standards for Pharmacy Technicians @ Washington, DC

2. Reports A. Internal Reports (posted in Boardroom Library) 1. Census – Compliance Division – Practitioner Recovery Program & Discipline 2. Census – Credentials Division – CDS & Pharmacy Programs 3. Credentials Division – Licensure Activity Report 4. Credentials Division – Application Activity Report 5. Credentials Division – Exceptions Report

B. External Reports 1. La. Div. of Administration – Boards & Commissions a. Monthly Report of Member Per Diem b. Quarterly Report of Member Expense Reimbursements c. Act 12 (2009) Annual Boards & Commissions Report 2. La. Div. of Administration – Property Assistance Agency a. Monthly Agency Fleet Mileage Report 3. La. Div. of Administration – Office of Group Benefits a. Non-Discrimination Testing Report 4. La. Div. of Administration – Office of Risk Management a. Monthly Loss Claims Report b. Monthly Report re Transitional Return to Work c. Quarterly Risk Exposure Report d. Quarterly Property Safety & Maintenance Inspections 5. La. Div. of Administration – Office of Statewide Reporting & Accounting Policy a. Quarterly Report of Accounts Receivable

Page 1 of 5 6. La. Dept. of Health – Bureau of Health Services Financing a. Monthly Report of Pharmacy Openings & Closures 7. La. Dept. of Justice – Office of the Attorney General a. Quarterly Report of Private Legal Fees Paid 8. La. Dept. of Revenue a. Quarterly Employer’s Return of State Withholding Tax 9. La. Dept. of Civil Service a. Payroll Comparison Report 10. La. Dept. of Treasury – Cash Management Review Board a. Quarterly Report of Agency Bank Accounts 11. La. State Employees Retirement System a. Monthly Report of Employer & Employee Contributions 12. La. Workforce Commission a. Quarterly Report of Employer’s Unemployment Tax 13. La. Legislative Auditor a. Act 12 (2009) Annual Boards & Commissions Report 14. La. House of Representatives a. Act 12 (2009) Annual Boards & Commissions Report 15. La. Senate a. Act 12 (2009) Annual Boards & Commissions Report 16. Joint Legislative Committee on the Budget a. Act 12 (2009) Annual Boards & Commissions Report 17. Legislative Fiscal Office a. Act 12 (2009) Annual Boards & Commissions Report 18. U.S. Dept. of Health & Human Services – Office of Public Health a. Quarterly Report to ESAR-VHP 19. U.S. Dept. of Labor – Bureau of Labor Statistics a. Monthly Survey of Current Employment Statistics 20. U. S. Dept. of Treasury – Internal Revenue Service a. Quarterly Employer’s Federal Tax Return

3. Examinations A. MPJE – the results for the second trimester of 2017 are available. Joe Fontenot and I performed the annual review of all the items in the Board’s database of test questions. Of the 1,883 items in the scored item pool, we removed 51, and of the 672 items in the pretest item pool, we removed 44. Of the 943 items in the pool of new items written earlier in the year by all the state writers, we accepted 155. We began the review with 2,555 items approved for Louisiana; we removed 95 and added 155, resulting in a total of 2,615 approved items.

B. NAPLEX – the results for the second trimester of 2017 are available.

C. PARE – our last administration of this test was in July 2014.

D. PTCB – the results for the second half of 2017 are not yet available.

4. Operations A. Credentials Division We opened the renewal cycle on July 1 for DME permits. Those credentials expire on August 31 unless renewed timely. We mailed reminder notices to 687 permit holders in late June. 86% of them renewed timely, and of that number, 80% renewed using the online option. On September 13, we mailed expiration notices to 80 permit holders. By October 20, that number had been reduced to 56. We opened the renewal cycle on November 1 for pharmacist licenses, pharmacy permits, and CDS licenses for pharmacies. We mailed reminder notices on October 31 to 8,874 pharmacists, 1,869 pharmacy permit holders, and 1,357 pharmacies with CDS licenses. We held back one notice for a pharmacist due to a defaulted student loan. In Page 2 of 5 addition, we held back notices for 124 pharmacy permit holders; of that number, 12 were due to the absence of a pharmacist-in-charge, 5 were due to the combination of the absence of a pharmacist-in-charge and no inspection within the prior two years, and 107 were due to the absence of an inspection within the prior two years.

B. Compliance Division Our 6 pharmacist compliance officers are responsible for inspecting all the pharmacies and other facilities holding controlled substances (CDS). The census reports available for this meeting reflect 1,463 pharmacies within the state, as well as approximately 470 various types of facilities and persons for CDS visits, including hospitals, animal control shelters, researchers, etc. In addition to their routine site visits, the compliance officers are also responsible for investigating complaints filed with the Board. We began the fiscal year with 147 cases pending from the prior fiscal year. We have entered 148 new cases and closed 120, leaving 175 cases still open for the fiscal year. Of the 120 cases closed this fiscal year, 57% were disposed of through staff activities and the balance through committee and Board action.

C. Administrative Division Two new employees started working for the Board since your last meeting: • Elena Rust is a licensing assistant for the CDS program; and • Jonesha Cushenberry is a licensing assistant for the Pharmacy program. As you recall, Pinell & Martinez, a CPA firm in Covington, was selected to perform the Board’s annual financial audit. They completed their work in late August and tendered their report to the Office of the Legislative Auditor. A copy of their report was posted in the Boardroom Library. The Legislative Auditor is currently engaged in their performance audit of the Board and the Prescription Monitoring Program. Finally, we have received word from our CPAs at Kolder, Champagne, Slaven & Company of a pending split in the firm. Mr. Champagne will be separating from the firm and forming a new CPA firm which will include Ms. Penny Scruggins and the rest of the staff at their Breaux Bridge office. We have suggested to the Executive Committee their consideration of a new contract with that new firm in lieu of continuing the current contract with the original firm. The committee will consider that recommendation at their meeting this week.

5. State Activities A. La. Dept. of Health – Bureau of Health Services Financing The department published a Final Rule in the September 2017 edition of the Louisiana Register relative to licensing standards for ambulatory surgical centers (ASC). Among the standards is a section on pharmaceutical services. ASCs are required to provide pharmaceutical services, either through a contracted provider or by in-house pharmacy licensed by the Board. ASCs are required to obtain a CDS license from the Board and a DEA registration. Other detailed standards for the pharmaceutical services are included in the rule.

B. La. State Board of Dentistry The agency published a Notice of Intent in the October 2017 edition of the Louisiana Register, amending their rules for three purposes: (1) require mandatory access and review of patient information in the Prescription Monitoring Program, consistent with the provisions of Act 76 of the 2017 Legislature; (2) provide a pathway to licensure for dentists and dental hygienists who fail the licensure examination three times; and (3) revised their continuing education requirements to include the opioid education requirement included within Act 76 of the 2017 Legislature.

C. La. State Board of Medical Examiners The agency published a Notice of Intent in the October 2017 edition of the

Page 3 of 5 Louisiana Register, amending their rule to add the mandatory access and review of patient information in the Prescription Monitoring Program, consistent with the provisions of Act 76 of the 2017 Legislature, for all of their licensees with prescriptive authority for opiate (physicians, podiatrists, and physician assistants). The agency also published a second Notice of Intent in the same edition of the state register, amending their rules for those physicians engaged in collaborative practice activities with advanced practice registered nurses, consistent with a similar rule amendment recently promulgated by the La. State Board of Nursing. Finally, we learned the Legislative Auditor has initiated a performance audit of the medical board.

6. Regional & National Activities A. National Association of Boards of Pharmacy (NABP) The annual meeting of this association is one of the three meetings for which certain of your travel expenses are eligible for reimbursement, subject to the limitations itemized in the Board’s travel policy as well as the state’s travel policy in PPM-49. For your planning purposes, the 2018 Annual Meeting is scheduled for May 5-8 at the Hyatt Regency Hotel in Denver, CO.

B. NABP-AACP District 6 The annual meeting of this association is one of the three meetings for which certain of your travel expenses are eligible for reimbursement, subject to the limitations itemized in the Board’s travel policy as well as the state’s travel policy in PPM-49. For your planning purposes, the 2018 meeting will be held October 14-17 at the Westin Crown Center in Kansas City, MO. Districts 7 and 8 will be joining District 6 for that meeting.

C. MALTAGON The annual meeting of this association is one of the three meetings for which certain of your travel expenses are eligible for reimbursement, subject to the limitations itemized in the Board’s travel policy as well as the state’s travel policy in PPM-49. For your planning purposes, the 2018 conference will be held October 11-14 at the Westin Crown Center in Kansas City, MO.

D. U.S. Congress The Restoring Board Immunity Act was introduced in July 2017 (H.R. 3446 in the House and S. 1649 in the Senate). The proposed legislation seeks to reform occupational licensing activities by states. Due to the 2015 decision by the U.S. Supreme Court in the North Carolina Dental Board case, there has been concern raised for the appropriate level of immunity held by members of such licensing boards. The legislation seeks to restore that immunity from antitrust activities, in return for the state’s decision to adopt one of two pathways identified in the legislation – active state supervision or judicial review. Copies of the House and Senate bills as well as summaries from different type of organizations were posted in the Boardroom Library.

E. U.S. Dept. of Labor The department awarded a $7.5 million grant to the National Conference of State Legislatures (NCSL) to study state occupational licensing activities, with two primary goals: (1) to identify licensing criteria to ensure that existing and new licensing requirements are not overly broad or burdensome and don’t create unnecessary barriers to labor market entry, and (2) to improve portability for selected occupational licenses across state lines. The NCSL has partnered with the National Governors Association (NGA) and the Council of State Governments (CSG) to administer the federal grant awarded by the U.S. Dept. of Labor. The coalition selected 11 states to form a peer learning consortium focused on occupational licensing policy. They will focus on learning best practices from each other and begin implementing actions to remove barriers to labor market entry and Page 4 of 5 improve portability and reciprocity. The coalition has selected 34 occupations for their study; several health care professions were selected including dental hygienists, radiologic technologists, respiratory therapists, and pharmacy technicians. A copy of the press release from the Dept. of Labor announcing the grant was posted in the Boardroom Library, as was the announcement from NCSL concerning the 11 sates selected for the study and list of occupations selected.

F. Federal Trade Commission (FTC) The new chairwoman of FTC established the Economic Liberty Task Force for the purpose of reviewing state-based occupational licensing. With the observation that nearly one-third of all occupations in the nation now require a license, up from 5% in the 1950s, and with a lack of portability of those licenses, a review is in order. The task force hosted its first roundtable on July 27 and its most recent on November 7. A copy of the FTC’s September 12, 2017 testimony before the Committee on Small Business of the U.S. House of Representatives on the issue of occupational licensure and competition was posted in the Boardroom Library.

7. International Activities A. International Pharmaceutical Federation (FIP) For your planning purposes, the 2018 congress will be held Sep. 2-6 in Glasgow, Scotland.

B. .Pharmacy .Pharmacy is a generic top level domain (gTLD) on the Internet. Although it is owned by NABP, the application to the Internet Corporation for Assigned Names & Numbers (ICANN) for the .Pharmacy domain was endorsed by several international organizations, including the World Health Organization (WHO), Interpol, the Pharmaceutical Group of the European Union (PGEU), the International Pharmaceutical Federation (FIP), and the National Association of Pharmacy Regulatory Authorities (NAPRA). .Pharmacy is different from most TLDs in that access to a website on .Pharmacy is restricted to applicants whose legitimacy has been verified by NABP or one of its international partners. The vision for .Pharmacy is to create an online pharmacy community where patients can go to safely order prescription drugs, knowing the sites have already been verified as legitimate pharmacies, licensed by the appropriate pharmacy regulatory authority. In addition to pharmacies, the plan is to create a presence for a number of related organizations, including professional membership organizations, colleges of pharmacy, boards of pharmacy, drug manufacturers, and consumer-oriented drug information organizations. .Pharmacy began accepting applications for website registrations in June 2015. By October 2017, there were 464 registered domains, 358 of which were held by pharmacy organizations representing approximately 45% of the physical pharmacy locations in the U.S. Although most of the domains are based in the U.S., 21 domains are based in Canada, 2 from the Netherlands, and one each from Germany, Japan, and the United Kingdom. More information, including a list of registered domains, is available at www.safe.pharmacy.

Respectfully submitted, Malcolm J Broussard Executive Director

Page 5 of 5 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Compliance Division Census Report

November 15, 2017

Practitioner Recovery Program • Probation Completion Report

09-05-2017 PHY.015750 David Allen Guillory

• Active Probation 41 Pharmacist 1 Pharmacy intern 6 Technician

• Active Suspension 39 Pharmacist 2 Pharmacy intern 16 Technician 4 Technician candidate

Disciplinary Restrictions • Probation Completion Report

10-30-2017 PST.018508 Anthony John Grzib, Jr. 11-04-2017 PTC.023974 Taquincion Diara Watson

• Active Probation 12 Pharmacist 1 Pharmacy intern 5 Technician 1 Technician candidate 6 Pharmacy permit 1 CDS-PHY license 1 DME permit

• Active Suspension 55 Pharmacist 1 Pharmacy intern 78 Technician 19 Technician candidate 12 Pharmacy permit 4 CDS-PHY license 81 CDS license for practitioners Louisiana Board of Pharmacy Credentials Division Pharmacy Program

06/30/08 06/30/09 06/30/10 06/30/11 06/30/12 06/30/13 06/30/14 06/30/15 06/30/16 06/30/17 11/07/17 PST.VI LA 0 0 0 12 10 9 9 13 16 18 20 NR000910151415162423 Total 0 0 0 21 20 24 23 28 32 42 43

PST-GVI LA 00006131312152626 NR0000035551010 Total 00006161817203636

PST-M LA 00035312100 NR 0 0 0 11 11 11 13 10 10 9 9 Total 14 16 14 14 12 11 9 9

PST-G LA 0 0 0 158 157 164 166 186 204 216 215 NR 0 0 0 30 35 32 31 31 35 30 30 Total 0 0 0 188 192 196 197 217 239 246 245

PST LA 4,612 4,750 4,860 4,654 4,933 4,981 5,140 5,408 5,304 5,372 5,495 NR 1,964 2,029 2,098 2,079 2,212 2,527 2,479 2,471 2,835 2,950 3,047 Total 6,576 6,779 6,958 6,733 7,145 7,508 7,619 7,879 8,139 8,322 8,542 PST 6,576 6,779 6,958 6,935 7,353 7,758 7,871 8,108 8,441 8,655 8,875

PNT LA 1,074 1,035 965 907 938 942 948 952 957 946 927 NR 67 84 153 137 128 128 127 143 127 145 150 Total 1,141 1,119 1,118 1,044 1,066 1,070 1,075 1,095 1,084 1,091 1,077

PNT-FPG Total 00050362434 PNT 1,141 1,119 1,118 1,049 1,066 1,073 1,081 1,097 1,088 1,094 1,081

CPT LA 4,780 4,733 5,363 5,720 5,509 5,751 6,463 6,584 6,815 6,418 6,778 NR 144 109 144 145 120 112 138 141 152 141 163 Total 4,924 4,842 5,507 5,865 5,629 5,863 6,601 6,725 6,967 6,559 6,941

CPT-M Total 00010121222 CPT 4,924 4,842 5,507 5,866 5,629 5,864 6,603 6,726 6,969 6,561 6,943

PTC LA 1,446 1,510 1,679 1,574 1,665 1,658 1,870 1,929 1,813 1,971 1,983 NR 23 32 35 35 39 37 37 52 48 54 62 PTC 1,469 1,542 1,714 1,609 1,704 1,695 1,907 1,981 1,861 2,052 2,045

PHY CH 11 12 14 12 12 12 12 12 12 11 11 HOS 167 167 165 151 154 158 164 163 160 163 162 HOX000191814118766 IN 37 37 27 14 10 12 12 11 11 12 12 INX 0 0 0 11 14 13 11 10 10 11 12 IR 588 592 587 570 568 558 583 588 576 577 583 IRX 0 0 0 21 19 17 10 10 7 6 6 NR 250 256 286 318 361 387 422 473 513 515 521 NRN00000099878 NRP00000012222 NU 16 16 16 15 15 15 15 14 15 14 14 PEN00000000000 PEX00000122222 SAT00000013666 RC 534 545 562 576 587 597 619 649 671 651 648 RPP 1 PHY 1,603 1,625 1,657 1,707 1,758 1,784 1,872 1,954 2,000 1,983 1,994

AMS AMS 255 306 361 55 64 349 92 456 113 104 116 AMS-X 0 0 0 301 302 289 359 356 367 335 371 AMS 255 306 361 356 366 638 451 812 480 439 487

EDK EDK 439 388 503 417 435 421 464 474 454 402 446 EDK-X 0 0 0 13 13 10 10 10 10 9 11 EDK 439 388 503 430 448 431 474 484 464 411 457

DME LA 223 160 209 336 345 346 325 NR 218 281 267 287 291 273 DME 378 490 603 622 637 598

CDTM 41 41 52 59 66 69 MAR 1,617 2,037 2,383 2,603 2,820 2,907 PMP 10,949 SWP 58 78 126 38 54 48 48 53 TM 49 TOTAL 21,405 22,865 24,254 24,635 24,766 36,507 Louisiana Board of Pharmacy Credentials Division CDS Program

06/30/09 06/30/10 06/30/11 06/30/12 06/30/13 06/30/14 06/30/15 06/30/16 06/30/17 11/07/17 Classification AMS Automated Medication Sys 000002629222831 AMX Automated Medication Sys - Exempt 000002100 2 APN APRN 607 758 889 1,015 1,103 1,479 1,954 2,296 2,343 2,782 DDS Dentist 2,267 2,363 2,027 2,048 1,902 2,123 2,133 2,134 1,929 2,134 DET Drug Detection / Canine 20 22 14 12 10 11 11 9 8 7 DEX Drug Detection / Canine - Exempt 1100 0 DIS Distributor 363 400 279 288 273 324 319 301 284 294 DPM Podiatrist 161 165 139 136 118 133 142 152 136 153 DVM Veterinarian 1,000 1,065 922 901 852 1,002 1,045 1,085 1,007 1,213 ETC Animal Euthanasia Tech - Cert 44 49 16 766551 3 ETL Animal Euthanasia Tech - Lead 0 0 12 20 21 23 23 22 24 24 HOS Hospital 405 438 280 267 263 272 271 289 278 304 HOX Hospital - Exempt 0 0 12 14 56655 5 LAB Laboratory 14 15 8678887 8 LAX Laboratory - Exempt 004555544 4 MD Physician 14,599 15,269 12,362 11,727 10,698 11,913 12,124 12,360 11,575 12,540 MFR Manufacturer 52 58 48 50 45 42 42 37 38 45 MP Medical Psychologist 50 58 65 67 69 78 82 86 84 88 OD Optometrist 269 278 275 287 279 309 316 326 297 346 PA Physician Assistant 232 272 294 326 344 449 487 610 667 733 PHX Pharmacy - Exempt 0 0 50 47 41 30 24 21 20 21 PHY Pharmacy 0 0 1,307 1,318 1,329 1,357 1,379 1,367 1,339 1,338 REP Sales Representative 66 88 29 20 70000 0 RES Researcher 119 156 109 110 98 113 113 108 100 108 ROF Registered Outsourcing Facility 0000008141315 SAC Substance Abuse Clinic 14 17 7999976 6 SAX Subst. Abuse Clinc - Exempt 0 0 0 0 0 0 100 0

Total 20,282 21,471 19,148 18,680 17,484 19,721 20,538 21,268 20,193 22,204

Total Credentials Under Management

Pharmacy 16,601 17,818 18,260 18,625 21,405 22,865 24,254 24,635 24,766 36,507 CDS 20,698 21,916 19,148 18,680 17,745 20,009 20,809 21,316 20,193 22,204 Total 37,299 39,734 37,408 37,305 39,150 42,874 45,063 45,951 44,959 58,711 Louisiana Board of Pharmacy Census Report

Type of Credential 6/30/1996 3/19/1997 6/30/1998 6/30/1999 6/30/2000 6/30/2001 6/30/2002 6/30/2003 6/30/2004 6/30/2005 6/30/2006 6/30/2007

Pharmacists In-state 3,660 4,143 4,247 4,269 4,830 3,887 4,386 4,435 4,486 4,532 4,460 4,522 Out-of-state 446 1,339 1,435 1,421 944 1,901 1,453 1,455 1,484 1,686 1,915 1,975 TOTAL 4,106 5,482 5,682 5,690 5,774 5,788 5,839 5,890 5,970 6,218 6,375 6,497

Pharmacy Interns In-state 980 1,079 Out-of-state 109 117 TOTAL 957 976 929 995 1,154 1,089 1,196

Pharmacy Technicians In-state 4,552 4,587 Out-of-state 163 152 TOTAL 3,216 3,453 3,505 4,114 4,455 4,715 4,739

Pharmacy Technician Candidates In-state 1,081 1,389 Out-of-state 32 32 TOTAL 2,896 2,372 1,336 1,069 1,074 1,113 1,421

Pharmacy Permits IR 634 636 609 621 585 584 576 573 633 729 681 620 RC 473 471 493 505 520 528 535 541 555 473 430 491 H 174 171 175 172 171 171 174 179 181 181 167 164 IN 45 38 39 19 17 18 19 27 36 35 36 NU 1010910 12141313131716 CH 4474 891112121212 PEN OS 152 168 175 216 223 262 313 353 339 200 226 240 PE 104 102 120 102 95 94 0 CO 12 12 12 12 12 13 13 0 TOTAL 1,608 1,612 1,639 1,668 1,663 1,717 1,771 1,818 1,760 1,644 1,568 1,579

Equipment Permits AMS 0 109 136 158 174 173 212 EDK 468 461 474 444 471 428 412 Louisiana Board of Pharmacy Census Report

Type of Credential 6/30/2008 6/30/2009 6/30/2010 6/30/2011 6/30/2012 6/30/2013 6/30/2014 6/30/2015 6/30/2016 6/30/2017 11/7/2017

Pharmacists In-state 4,612 4,750 4,860 5,000 5,095 5,170 5,329 5,596 5,540 5,632 5756 Out-of-state 1,964 2,029 2,098 2,179 2,258 2,588 2,542 2,512 2,901 3,023 3119 TOTAL 6,576 6,779 6,958 7,179 7,353 7,758 7,871 8,108 8,441 8,655 8875

Pharmacy Interns In-state 1,074 1,035 965 917 938 945 950 953 959 948 931 Out-of-state 67 84 153 137 128 128 131 144 129 146 150 TOTAL 1,141 1,119 1,118 1,054 1,066 1,073 1,081 1,097 1,088 1,094 1081

Pharmacy Technicians In-state 4,780 4,733 5,363 5,722 5,509 5,752 6,463 6,585 6,815 6,419 6779 Out-of-state 144 109 144 145 120 112 138 141 152 142 164 TOTAL 4,924 4,842 5,507 5,867 5,629 5,864 6,601 6,726 6,967 6,561 6943

Pharmacy Technician Candidates In-state 1,446 1,510 1,679 1,574 1,665 1,658 1,870 1,929 1,813 1,971 1983 Out-of-state 23 32 35 35 39 31 37 52 48 54 62 TOTAL 1,469 1,542 1,714 1,609 1,704 1,695 1,907 1,981 1,861 2,025 2045

Pharmacy Permits IR 588 592 587 591 587 575 583 598 583 583 589 RC 534 545 562 576 587 597 619 649 671 651 648 H 167 167 165 170 172 172 175 174 173 175 174 IN 37 37 27 25 24 25 23 21 21 23 24 NU 16 16 16 15 15 15 15 14 15 14 14 CH 11 12 14 12 12 12 12 12 12 11 11 PEN 1 2222 2 NR 250 256 286 318 361 387 432 484 523 524 531 RPP 1 TOTAL 1,603 1,625 1,657 1,707 1,758 1,784 1,861 1,954 2,000 1,983 1994

Equipment Permits AMS 255 306 361 356 366 638 451 812 480 439 487 EDK 439 388 503 430 448 431 474 484 464 411 457 DME 223 378 490 603 622 637 598 Special Activity CDTM 41 41 52 59 66 69 MAR 1,617 2,037 2,383 2,603 2,820 2907 PMP 10949 SWP 58 78 126 38 54 48 48 53 TM 49 Louisiana Board of Pharmacy CDS Program - Census Report

6/30/2009 6/30/2010 6/30/2011 6/30/2012 6/30/2013 6/30/2014 6/30/2015 6/30/2016 6/30/2017 11/7/2017 Classification AMS Automated Medication System 000002830222833 APN Advanced Practice Registered Nurse 607 758 889 1,015 1,103 1,479 1,954 2,296 2,343 2,782 DDS Dentist 2,267 2,363 2,027 2,048 1,902 2,123 2,133 2,134 1,929 2,134 DET Drug Detection Canine 20 22 14 12 10 11 12 9 8 7 DIS Distributor 363 400 279 288 273 324 319 301 284 294 DPM Podiatrist 161 165 139 136 118 133 142 152 136 153 DVM Veterinarian 1,000 1,065 922 901 852 1,002 1,045 1,085 1,007 1,213 ETC Animal Euthanasia Tech - Cert 44 49 28 27 27 29 28 27 25 27 HOS Hospital 405 438 292 281 268 278 277 294 283 309 LAB Analytical Laboratory 14 15 12 11 12 13 13 12 11 12 MD Physician 14,599 15,269 12,362 11,727 10,698 11,913 12,124 12,360 11,575 12,540 MFR Manufacturer 52 58 48 50 45 42 42 37 38 45 MP Medical Psychologist 50 58 65 67 69 78 82 86 84 88 OD Optometrist 269 278 275 287 279 309 316 326 297 346 PA Physician's Assistant 232 272 294 326 344 449 487 610 667 733 PHY Pharmacy 0 0 1357 1,365 1,370 1,387 1,403 1,388 1,359 1,359 RES Researcher 119 156 109 110 98 113 113 108 100 108 ROF Registered Outsourcing Facility 00000 08 141315 SAC Substance Abuse Clinic 14 17 7 9 9 9 10 7 6 6 TOTAL 20,202 21,916 19,119 18,660 17,477 20,009 20,809 21,268 20,193 22,204

Total Credentials Under Board Management

Pharmacy Program 16,601 17,818 18,260 18,625 21,405 22,865 24,254 24,635 24,766 36,507 CDS Program 20,698 21,916 19,119 18,660 17,477 20,009 20,809 21,316 20,193 22,204 TOTAL 37,299 39,734 37,379 37,285 38,882 42,874 45,063 45,951 44,959 58,711 New Credentials Issued FYE 2018 ~ 1st Quarter July 1, 2017 - September 30, 2017

Prefix Subcategory CredentialType Total AMS Automated Medication System 7 AMS X Automated Medication System - Exempt 13 Prefix Totals 20

CDS AMS CDS License - Automated Medication System 2 CDS AMX CDS License - Automated Medication System - Exempt 2 CDS APN CDS License - APRN 164 CDS DDS CDS License - Dentist 30 CDS DIS CDS License - Distributor 5 CDS DPM CDS License - Podiatrist 1 CDS DVM CDS License - Veterinarian 53 CDS HOS CDS License - Hospital 4 CDS LAB CDS License - Laboratory 1 CDS MD CDS License - Physician 192 CDS MFR CDS License - Manufacturer 4 CDS MP CDS License - Medical Psychologist 2 CDS OD CDS License - Optometrist 12 CDS PA CDS License - Physician Assistant 13 CDS PHY CDS License - Pharmacy 12 CDS RES CDS License - Researcher 3 Prefix Totals 500

CDTM Collaborative Drug Therapy Management (V) 2

CPT Certified Pharmacy Technician 151

DME Durable Medical Equipment (DME) Provider 19

EDK Emergency Drug Kit 45 EDK X Emergency Drug Kit - Exempt 2 Prefix Totals 47

MA Medication Administration (V) 96

PHY HOS Pharmacy - Hospital Inpatient 3 PHY IN Pharmacy - Institutional 1 PHY IR Pharmacy - Community ~ Independent 10 PHY NR Pharmacy - Nonresident 19 Prefix Totals 33

PIC Pharmacist-in-Charge (V) 9

PMP CDS PMP - CDS Credential (V) 903 PMP PHY PMP - PHY Dispenser Account (V) 86 PMP PST PMP - Pharmacist (V) 93 Prefix Totals 1082

PNT Pharmacy Intern 35 PNT FPG Pharmacy Intern - Foreign Pharmacy Graduate 2 Prefix Totals 37

PST Pharmacist 191

PTC Pharmacy Technician Candidate 364

SWP Special Work Permit 10

TM CPT Therapeutic Marijuana Designation - CPT 2 TM OMO Therapeutic Marijuana Designation - OMO 1 TM PST Therapeutic Marijuana Designation - PST 7 Prefix Totals 10

Grand Totals 2571 Pending Applications

PHARMACY CREDENTIALS Prefix Subcat. CredentialType 04/26/16 08/03/16 11/07/16 01/13/17 05/03/17 8/16/2017 11/7/2017 AMS Automated Medication System 5337111314 CPT Certified Pharmacy Technician 40 54 53 41 48 30 26 DME Durable Medical Equipment 16 27 23 23 18 23 20 EDK Emergency Drug Kit 73 PHY CH Pharmacy - Charitable PHY HOS Pharmacy - Hospital Inpatient 2367796 PHY IN Pharmacy - Institutional 1 1 PHY IR Pharmacy - Community ~ Independent 19 16 20 21 21 23 32 PHY NR Pharmacy - Nonresident 96 89 89 94 67 92 94 PHY NRN Pharmacy - Nonresident Nuclear 23 PHY NU Pharmacy - Nuclear PHY PEN Pharmacy - Penal PHY RC Pharmacy - Community ~ Chain 7 4 3 1 2 PHY RPP Pharmavy - Remote Processor 1 1 PHY SAT Pharmacy - Hospital Off-Site Satellite PHY TM Pharmacy - Therapeutic Marijuana 40 PIC Pharmacist-in-Charge 1111 PNT FPG Pharmacy Intern - Foreign Graduate 123341 PNT Pharmacy Intern 30 58 101 89 43 65 66 PST Pharmacist 254 419 294 272 282 374 316 PTC Pharmacy Technician Candidate 353 346 480 515 405 502 395 Subtotal 824 1021 1073 1077 907 1144 1018

CDS CREDENTIALS Prefix Subcat. CredentialType 04/26/16 08/03/16 11/07/16 01/13/17 05/03/17 8/16/2017 11/7/2017 CDS AMS CDS - Automated Medication System 2 CDS APN CDS - APRN 7677121213 CDS DDS CDS - Dentist 1 1 1 1 4 CDS DET CDS - Drug Detection / Canine 2233 CDS DIS CDS - Distributor 4 6 10 8 8 4 CDS DPM CDS - Podiatrist CDS DVM CDS - Veterinarian 1 2 2 CDS ETC CDS - Animal Euthanasia Tech, Certified CDS ETL CDS - Animal Euthanasia Tech, Lead 1 1 2 CDS HOS CDS - Hospital 7 7 11 14 18 14 CDS MD CDS - Physician 10 9 10 8 13 19 15 CDS MFR CDS - Manufacturer 11211 CDS MP CDS - Medical Psychologist 1 CDS OD CDS - Optometrist 22212 CDS PA CDS - Physician Assistant 3 4 13 6664 CDS PHY CDS - Pharmacy 23 20 23 25 26 23 30 CDS PHX CDS - Pharmacy - Exempt 1 CDS REP CDS - Sales Representative CDS RES CDS - Researcher 8 6 10 8877 CDS ROF CDS - Registered Outsourcing Facility 311114 CDS SAC CDS - Substance Abuse Clinic 2 1 CDS TM CDS - Therapeutic Marijuana 40 Subtotal 58 65 86 72 94 104 146

OTHER CREDENTIALS Prefix Subcat. CredentialType 04/26/16 08/03/16 11/07/16 01/13/17 05/03/17 8/16/2017 11/7/2017 CDTM Collaborative Drug Therapy Management LB Law Book MA Medication Administration 4 3 5 10 9 7 4 PMP PMP - CDS Credential 61 55 34 33 65 266 284 PMP PMP - MIS Credential PMP PMP - PHY Credential 86 PMP PMP - PST Credential 67557031 SWP Special Work Permit 48 62 71 52 31 11 10 TM CPT Therapeutic Marijuana Designation - CPT 3 TM OMO Therapeutic Marijuana Designation - OMO 6 TM PST Therapeutic Marijuana Designation - PST 18 Subtotal 119 127 115 100 175 287 412

TOTAL 1001 1213 1274 1249 1176 1535 1576 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

November 15, 2017

Agenda Item 11-L: Report of Executive Director

Section 2 – A – 5 ~ Exceptions Report

1. PIC at Multiple Pharmacies Board Policy I.A.4 permits the Executive Director to approve requests from pharmacists wishing to serve as the Pharmacist-in-Charge (PIC) of more than one pharmacy at the same time. The policy requires the concurrence of the President, as well as notice to the Board at its next meeting. As authorized by the President, the Executive Director has delegated this authority to the General Counsel and the Assistant Executive Director. • On August 24, 2017 Mr. Aron and Mr. Fontenot concurred to grant a request from Max Edwin Daughtry (PST.011764) for permanent dual PIC privileges at Specialty Hospital of Winnfield (PHY.005967-HOS) and Winn Parish Medical Center Pharmacy (PHY.Pending-HOS). PST Daughtry had prior permanent approval for dual PIC privileges but a change of ownership of Winn Parish Medical Center Pharmacy prompted a new request.

2. Special Work Permits for military-trained applicants and their spouses LAC Title 46: LIII §904 authorizes the Board to provide preferential licensing procedures for military-trained applicants and their spouses. As authorized by the President, the Executive Director has delegated this authority to the General Counsel and the Assistant Executive Director. • On August 24, 2017, Mr. Aron and Mr. Finalet concurred to grant a request of Stephanie Lynn Driggers. She has been issued SWP.00756 to practice for up to 120 days while her application to become a PST is in process. The SWP will expire on December 24, 2017.

3, Special Work Permits Board Policy I.A.7 permits the Executive Director to issue Special Work Permits to document the resurrection of expired non-renewable credentials and for other purposes as authorized by the Board. The policy requires the concurrence of the President, as well as notice to the Board at its next meeting. As authorized by the President, the Executive Director has delegated this authority to the General Counsel and the Assistant Executive Director. • On August 28, 2017, Mr. Aron and Mr. Finalet concurred to grant a request from Betty Louise Sanders. She had previously obtained PTC.018632 which expired on September 22, 2013. She is PTCB-certified and was issued a Special Work Permit for one year to earn 600 hours of practical experience. • On August 28, 2017, Mr. Aron and Mr. Finalet concurred to grant a request from Tranell Dyshea Moore. She had previously obtained PTC.021201 which expired on September 24, 2015. She is PTCB-certified and was issued a Special Work Permit for one year to earn 600 hours of practical experience. • On September 5, 2017, Mr. Aron and Mr. Finalet concurred to grant a request from Marcus Trumain Aaron. He had previously obtained PTC.013466 which expired on May 15, 2009. He is PTCB-certified and was issued a Special Work Permit for one year to earn 600 hours of practical experience. • On September 12, 2017, Mr. Aron and Mr. Finalet concurred to grant a request from Lerionne Tyshai Larkin. She had previously obtained PTC.022054 which expired on May 12, 2016. She is PTCB-certified and was issued a Special Work Permit for one year to earn 600 hours of practical experience. • On September 25, 2017, Mr. Aron and Mr. Finalet concurred to grant a request from Page 1 of 2 Tammy Nanette Vidrine. She had previously obtained PTC.018022 which expired on April 6, 2013. She is PTCB-certified and was issued a Special Work Permit for one year to earn 600 hours of practical experience. • On October 18, 2017, Mr. Aron and Mr. Finalet concurred to grant a request from Vicki Lee Rigmaiden. She had previously obtained PTC.016071 which expired on August 22, 2011. She passed the PTCB examination and was issued a Special Work Permit for one year to earn 600 hours of practical experience. • On October 19, 2017, Mr. Aron and Mr. Finalet concurred to grant a request from Chauna Demetrius Modica. She had previously obtained PNT.016071 which expired on May 9, 2015. She passed the NABPLEX and MPJE examinations and was issued a Special Work Permit for one year to earn her hours of practical experience. • On October 27, 2017, Mr. Aron and Mr. Finalet concurred to grant a request from Trianda Racquela Walker. She had previously obtained PTC.023788 which expired on September 27, 2017. She passed the PTCB examination and was issued a Special Work Permit for one year to earn 600 hours of practical experience. • On October 31, 2017, Mr. Aron and Mr. Finalet concurred to grant a request from Nancy Jane Taresh. She had previously obtained PTC.023738 which expired on September 14, 2017. She passed the PTCB examination and was issued a Special Work Permit for one year to earn 600 hours of practical experience. • On October 31, 2017, Mr. Aron and Mr. Finalet concurred to grant a request from Andria Yvette Robson-James. She had previously obtained PTC.021033 which expired on August 18, 2015. She passed the PTCB examination and was issued a Special Work Permit for one year to earn 600 hours of practical experience. • On October 31, 2017, Mr. Aron and Mr. Finalet concurred to grant a request from Jordan Anthony LeBlanc. He had previously obtained PTC.016950 which expired on May 1, 2012. He passed the PTCB examination and was issued a Special Work Permit for one year to earn 600 hours of practical experience. • On November 3, 2017, Mr. Aron and Mr. Finalet concurred to grant a request from Misty LaShaun Akins. She had previously obtained PTC.020469 which expired on March 10, 2015. She passed the PTCB examination and was issued a Special Work Permit for one year to earn 600 hours of practical experience. • On November 3, 2017, Mr. Aron and Mr. Finalet concurred to grant a request from Chenita Lashea’ Dorsey. She had previously obtained PTC.018545 which expired on December 31, 2013. She passed the PTCB examination and was issued a Special Work Permit for one year to earn 600 hours of practical experience.

Page 2 of 2 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Multistate Pharmacy Jurisprudence Examination (MPJE™)

May 1 – August 31, 2017

School Reports Interpretation of Scores Frequency Distribution of Scaled Scores Cumulative Record (since January 2000)

November 15, 2017

Multistate Pharmacy Jurisprudence Examination (MPJE™)

This computer adaptive competency assessment is administered by the National Association of Boards of Pharmacy (NABP). The examination blueprint is designed to assess the applicant’s competency in federal and state laws relative to pharmacy practice and is therefore specific for a given state. The examination is administered via an open window process; applicants may schedule the examination at a local testing center at any time following approval by the state board and receipt of an Authorization to Test (ATT) document from NABP. Individual scores are available to applicants via secure web posting approximately 7-10 days following the examination. Summary reports are provided to the state boards on a calendar trimester basis.

Table of Contents

Current Trimester Report for ULM School of Pharmacy 03

Cumulative Report (since January 2000) for ULM School of Pharmacy 07

Current Trimester Report for Xavier College of Pharmacy 12

Cumulative Report (since January 2000) for Xavier College of Pharmacy 16

MPJE-23-2017 Trimester 2

Multistate Pharmacy Jurisprudence Examination® (MPJE®) School Summary Report

University of Louisiana at Monroe

Test Window: May 1, 2017 - August 31, 2017

Page 1 of 4 This MPJE score report provides summary information for first-time examinees from ACPE-accredited schools/colleges and for all examinees, regardless of repeater status and/or the educational institution. Tables 1 and 2 contain school, state, and national pass rate information as well as total score means.

MPJE in-state: Examinees taking the MPJE for the same jurisdiction as respective pharmacy program MPJE out of state: Examinees testing in different jurisdiction than respective pharmacy program

Table 1 First-Time Candidates, ACPE-Accredited Programs Only

Total Scaled Standard Candidates Pass Rate % Score Mean Deviation

In-state 73 78.08% 76.67 2.79 Out of state 66 95.45% 80.65 4.19 State 259 78.38% 77.00 3.32 National 16575 84.89% 78.41 3.90

Table 2 All Candidates

Total Scaled Standard Candidates Pass Rate % Score Mean Deviation

In-state 80 76.25% 76.61 2.94 Out of state 67 95.52% 80.63 4.17 State 293 77.13% 76.83 3.40 National 18640 83.24% 78.16 3.93

Table 3 Total Scaled Score Min/Max

Table 3 contains information on the range of Min Max scaled scores achieved by FT ACPE (First-Time, ACPE-Accredited) candidates as well as the FT ACPE 57 100 pool of all candidates. It also shows the boundaries of the Scaled Score Range. All Candidates 57 100 Scaled Score Range 0 100

Candidates who did not answer enough questions to receive a score are reflected in pass rate data as a fail but are not included in mean scaled score data.

Page 2 of 4 The following tables and graphs are scaled score frequency distributions for MPJE candidates who tested in-state. Candidates who did not answer enough questions to receive a score are not reflected in the frequency distributions.

Table 4 & Graph 1 School Frequency Distribution of Scaled Scores

Based on First-Time Candidates from ACPE-Accredited Programs N = 73

Frequency 20

Scaled Score Interval

Page 3 of 4 Table 5 & Graph 2 National Frequency Distribution of Scaled Scores

Based on First-Time Candidates from ACPE-Accredited Programs N = 8347

4500

4000

3500

3000

2500

2000 Frequency

1500

1000

500

Scaled Score Interval

Page 4 of 4 Multistate Pharmacy Jurisprudence Examination (MPJE)

University of Louisiana at Monroe

2000 2001 2002 2003 Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 125 82 100 57 59 123 77 119

School Average Score: 83.27 82.76 80.84 81.37 80.17 80.41 78.57 80.04

State Average Score: 81.64 80.49 80.64 80.32 80.34 79.41 77.32 78.87

National Average Score: 82.24 81.75 82.25 81.51 90.78 79.85 79.92 79.33

School Pass Rate: 94.40 91.46 90.00 91.23 88.14 88.62 77.92 88.24

State Pass Rate: 89.89 86.25 87.84 90.00 92.00 85.98 72.88 84.67

National Pass Rate: 91.37 90.50 91.22 90.54 90.78 84.93 84.52 82.61

FIRST-TIME CANDIDATE GROUP

No. of Candidates 117 78 92 51 55 111 59 110

School Average Score: 83.67 83.14 80.89 81.78 80.22 80.58 79.31 80.22

State Average Score: 82.14 80.97 80.67 80.51 80.30 79.41 77.69 79.23

National Average Score: 82.55 82.05 82.59 81.86 82.08 80.19 80.34 79.76

School Pass Rate: 96.58 93.59 90.22 90.20 89.09 88.29 81.36 88.18

State Pass Rate: 92.59 87.32 88.06 89.77 91.49 86.32 75.00 86.55

National Pass Rate: 92.57 91.37 92.45 91.75 92.15 86.45 86.58 84.67 Multistate Pharmacy Jurisprudence Examination (MPJE)

University of Louisiana at Monroe

2004 2005 2006 2007 Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 62 110 59 146 68 111 50 151

School Average Score: 79.39 80.79 79.25 80.50 80.43 81.92 80.20 81.62

State Average Score: 78.58 80.03 80.50 80.03 80.01 81.34 80.15 81.47

National Average Score: 80.10 79.83 80.39 80.04 80.68 80.42 81.26 81.14

School Pass Rate: 91.94 91.82 89.83 87.67 88.24 92.79 90.00 92.05

State Pass Rate: 86.90 92.55 90.55 87.03 91.09 92.39 87.18 90.39

National Pass Rate: 85.63 84.75 86.57 85.69 87.25 87.82 89.38 89.78

FIRST-TIME CANDIDATE GROUP

No. of Candidates 52 104 55 132 60 102 43 140

School Average Score: 79.73 80.96 79.33 80.66 80.80 82.14 81.05 81.83

State Average Score: 79.04 80.11 80.71 80.29 80.24 81.52 80.59 81.84

National Average Score: 80.58 80.25 80.80 80.44 81.09 80.80 81.72 81.51

School Pass Rate: 92.31 92.31 89.09 87.12 91.67 94.12 95.35 93.57

State Pass Rate: 90.14 92.53 91.38 88.69 92.31 93.53 91.18 92.49

National Pass Rate: 88.16 86.87 88.51 87.51 89.41 89.34 91.43 91.24 Multistate Pharmacy Jurisprudence Examination (MPJE)

University of Louisiana at Monroe

2008 2009 2010 2011 Jan - Jun Jul - Dec Jan - AprMay - Aug Sep - Dec Jan - AprMay - Aug Sep - Dec Jan - AprMay - Aug Sep - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 61 137 42 120 36 38 104 35 5 71 12

Mean Scaled Score - School 81.26 81.99 80.95 82.58 80.75 81.47 82.14 81.89 82.60 82.73 83.83

Mean Scaled Score - State 81.33 81.34 79.57 81.69 80.35 81.37 80.88 81.64 81.01 80.41

Mean Scaled Score - National 81.59 81.27 80.29 82.39 80.25 80.45 82.51 80.57 80.27 82.23 80.46

School Pass Rate: 96.72 91.97 88.10 95.00 86.11 94.74 90.38 91.43 100.00 97.18 100.00

State Pass Rate: 91.75 91.05 81.03 94.52 85.92 90.00 92.64 95.79 89.91 90.99

National Pass Rate: 90.31 89.92 86.23 93.74 87.04 89.09 94.83 89.35 86.43 92.17 86.24

FIRST-TIME CANDIDATE GROUP

No. of Candidates 58 127 37 117 34 34 96 30 5 66 11

Mean Scaled Score - School 81.52 82.13 81.30 82.56 81.09 82.12 82.67 82.33 82.60 83.08 84.18

Mean Scaled Score - State 81.53 81.62 79.69 81.76 80.98 82.07 80.93 82.07 81.52 81.14

Mean Scaled Score - National 81.97 81.57 80.75 82.58 80.63 80.82 82.67 80.94 81.17 82.86 81.76

School Pass Rate: 96.55 91.34 89.19 94.87 88.24 97.06 93.75 93.33 100.00 100.00 100.00

State Pass Rate: 92.31 91.95 80.77 94.34 89.66 93.44 92.92 97.56 94.06 94.32

National Pass Rate: 91.82 91.16 88.45 94.30 88.68 90.64 95.50 90.79 92.24 96.05 94.00 Multistate Pharmacy Jurisprudence Examination (MPJE)

University of Louisiana at Monroe

2012 2013 2014 2015 Jan - Apr May - Aug Sep - Dec Jan - Apr May - Aug Sep - Dec Jan - Apr May - Aug Sep - Dec Jan - Apr May - Aug Sep - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 4 126 87 47 94 30 32 122 39 42 122 56 * testing in same/different state 72 / 54 11 / 34 11 / 36 40 / 54 2 / 28 5 / 27 62 / 60 6 / 33 13 / 29 68 / 54 13 / 43 Mean Scale Score - School * 82.25 82.44/82.70 80.09/79.85 81.45/84.03 82.50/82.59 80.50/82.79 79.40/81.41 81.44/83.32 78.50/81.42 76.85/81.90 81.44/84.13 79.85/83.12 * testing in same/different state Mean Scaled Score - State 81.18 80.91 79.62 81.33 80.82 80.43 80.36 80.18 80.13 79.81 80.56 80.05

Mean Scaled Score - National 80.41 82.43 80.55 80.92 82.50 80.52 81.04 82.52 81.08 81.32 82.40 80.91

School Pass Rate: * 100.00 97.22/90.74 90.91/85.29 100/97.22 95.00/98.15 100 / 92.86 100 / 85.19 95.16/96.67 83.33/87.88 76.92/93.10 94.12/98.15 84.62/95.35 * testing in same/different state State Pass Rate: 90.41 90.69 81.61 93.98 90.51 85.21 82.52 86.08 82.69 80.69 88.14 86.55

National Pass Rate: 84.54 92.76 86.85 87.18 92.98 87.01 87.62 93.28 88.50 88.20 93.04 87.78

FIRST-TIME CANDIDATE GROUP

No. of Candidates 4 124 70 44 93 28 29 119 33 38 120 49 * testing in same/different state 72 / 52 10 / 29 10 / 34 39 / 54 1 / 27 5 / 24 62 / 57 3 / 30 11 / 27 68 / 52 7 / 42 Mean Scaled Score - School * 82.25 82.44/83.02 80.62/79.90 81.80/84.26 82.77/82.59 82.00/83.19 79.40/82.29 81.44/83.58 78.00/81.97 76.91/82.04 81.44/84.40 78.71/83.14 * testing in same/different state Mean Scaled Score - State 81.75 81.03 80.21 81.90 81.03 81.08 81.05 80.62 81.13 80.63 80.62 80.81

Mean Scaled Score - National 81.44 82.75 81.26 81.78 82.76 81.22 81.82 82.80 81.79 82.14 82.66 81.60

School Pass Rate: * 100.00 97.22/92.31 89.66/90.00 100.00/97.0697.44/98.15 100 / 96.30 100 / 91.67 95.16/98.25 66.67/90.00 72.73/92.59 94.12/98.08 85.71/95.24 * testing in same/different state State Pass Rate: 93.22 91.03 85.71 97..22 91.88 87.29 85.88 89.29 84.96 83.61 88.77 91.06

National Pass Rate: 89.13 93.94 89.60 91.08 93.95 90.04 90.85 94.34 90.87 91.72 93.97 90.35 Multistate Pharmacy Jurisprudence Examination (MPJE)

University of Louisiana at Monroe

2016 2017 2018 2019 Jan - Apr May - Aug Sep - Dec Jan - Apr May - Aug Sep - Dec Jan - Apr May - Aug Sep - Dec Jan - Apr May - Aug Sep - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 80 143 66 45 147 * testing in same/different state 7 / 73 89 / 54 15 / 51 6 / 39 80 / 67 Mean Scale Score - School * 80.14/84.04 77.42/79.20 77.67/78.71 74.50/78.67 76.61/80.63 * testing in same/different state Mean Scaled Score - State 80.92 77.12 76.91 77.39 76.83

Mean Scaled Score - National 81.10 78.08 77.08 77.59 78.16

School Pass Rate: * 100 / 98.63 83.15/79.63 73.33/80.39 50.00/94.87 76.25/95.52 * testing in same/different state State Pass Rate: 90.23 77.93 75.14 75.57 77.13

National Pass Rate: 87.62 82.66 74.77 76.90 83.24

ACPE probation eff. 06-24-2017 FIRST-TIME CANDIDATE GROUP

No. of Candidates 76 133 48 40 139 * testing in same/different state 7 / 69 84 / 49 6 / 42 4 / 36 73 / 66 Mean Scaled Score - School * 80.14/84.23 77.31/79.41 78.83/79.07 74.75/78.67 76.67/80.65 * testing in same/different state Mean Scaled Score - State 81.58 77.10 77.33 78.28 77.00

Mean Scaled Score - National 81.84 78.24 77.61 78.31 78.41

School Pass Rate: * 100 / 98.55 82.14/77.55 66.67/83.33 50.00/94.44 78.08/95.45 * testing in same/different state State Pass Rate: 92.79 77.21 77.88 80.85 78.38

National Pass Rate: 90.71 83.77 78.24 82.10 84.89 MPJE-24-2017 Trimester 2

Multistate Pharmacy Jurisprudence Examination® (MPJE®) School Summary Report

Xavier University of Louisiana

Test Window: May 1, 2017 - August 31, 2017

MPJE in-state: Examinees taking the MPJE for the same jurisdiction as respective pharmacy program MPJE out of state: Examinees testing in different jurisdiction than respective pharmacy program

Table 1 First-Time Candidates, ACPE-Accredited Programs Only

Total Scaled Standard Candidates Pass Rate % Score Mean Deviation

In-state 86 75.58% 76.66 3.32 Out of state 78 70.51% 76.58 4.09 State 259 78.38% 77.00 3.32 National 16575 84.89% 78.41 3.90

Table 2 All Candidates

Total Scaled Standard Candidates Pass Rate % Score Mean Deviation

In-state 95 73.68% 76.36 3.63 Out of state 92 67.39% 76.23 3.94 State 293 77.13% 76.83 3.40 National 18640 83.24% 78.16 3.93

Table 3 Total Scaled Score Min/Max

Candidates who did not answer enough questions to receive a score are reflected in pass rate data as a fail but are not included in mean scaled score data.

Table 4 & Graph 1 School Frequency Distribution of Scaled Scores

Based on First-Time Candidates from ACPE-Accredited Programs N = 86

Frequency 20

Scaled Score Interval

Page 3 of 4 Table 5 & Graph 2 National Frequency Distribution of Scaled Scores

Based on First-Time Candidates from ACPE-Accredited Programs N = 8347

4500

4000

3500

3000

2500

2000 Frequency

1500

1000

500

Scaled Score Interval

Page 4 of 4 Multistate Pharmacy Jurisprudence Examination (MPJE)

Xavier College of Pharmacy

2000 2001 2002 2003 Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 25 94 53 126 43 122 71 158

School Average Score: 78.92 78.90 77.43 79.86 79.12 78.18 76.75 77.99

State Average Score: 81.64 80.49 80.64 80.32 80.34 79.41 77.32 78.87

National Average Score: 82.24 81.75 82.25 81.51 81.72 79.85 79.92 79.33

School Pass Rate: 80.00 80.85 69.81 88.10 81.40 77.05 67.61 75.95

State Pass Rate: 89.89 86.25 87.84 90.00 92.00 85.98 72.88 84.67

National Pass Rate: 91.37 90.50 91.22 90.54 90.78 84.93 84.52 82.61

FIRST-TIME CANDIDATE GROUP

No. of Candidates 23 86 38 107 38 102 53 122

School Average Score: 79.04 79.01 77.58 79.92 79.58 78.18 77.04 78.48

State Average Score: 82.14 80.97 80.67 80.51 80.30 79.41 77.69 79.23

National Average Score: 82.55 82.05 82.59 81.86 82.08 80.19 80.34 79.76

School Pass Rate: 78.26 80.23 71.05 86.92 86.84 78.43 71.70 78.69

State Pass Rate: 92.59 87.32 88.06 89.77 91.49 86.32 75.00 86.55

National Pass Rate: 92.57 91.37 92.45 91.75 92.15 86.45 86.58 84.67 Multistate Pharmacy Jurisprudence Examination (MPJE)

Xavier College of Pharmacy

2004 2005 2006 2007 Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 66 123 82 135 139 181 77 169

School Average Score: 77.36 78.64 78.06 78.96 79.04 79.82 78.47 79.76

State Average Score: 78.58 80.03 80.50 80.03 80.01 81.34 80.15 81.47

National Average Score: 80.10 79.83 80.39 80.04 80.68 80.42 81.26 81.14

School Pass Rate: 78.79 80.49 76.83 82.22 87.77 86.19 77.92 87.57

State Pass Rate: 86.90 92.55 90.55 87.03 91.09 92.39 87.18 90.39

National Pass Rate: 85.63 84.75 86.57 85.69 87.25 87.82 89.38 89.78

FIRST-TIME CANDIDATE GROUP

No. of Candidates 56 101 63 121 121 156 62 154

School Average Score: 77.73 79.19 78.57 79.36 79.14 80.27 79.47 80.03

State Average Score: 79.04 80.11 80.71 80.29 80.24 81.52 80.59 81.84

National Average Score: 80.58 80.25 80.80 80.44 81.09 80.80 81.72 81.51

School Pass Rate: 80.36 84.16 79.37 85.12 87.60 89.10 85.48 88.96

State Pass Rate: 90.14 92.53 91.38 88.69 92.31 93.53 91.18 92.49

National Pass Rate: 88.16 86.87 88.51 87.51 89.41 89.34 91.43 91.24 Multistate Pharmacy Jurisprudence Examination (MPJE)

Xavier College of Pharmacy

2008 2009 2010 2011 Jan - Jun Jul - Dec Jan - AprMay - Aug Sep - Dec Jan - AprMay - Aug Sep - Dec Jan - AprMay - Aug Sep - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 55 208 63 162 68 42 160 83 10 77 44

Mean Scaled Score - School 78.25 79.49 78.03 80.20 78.10 78.93 79.89 78.17 76.50 79.32 78.93

Mean Scaled Score - State 81.33 81.34 79.57 81.69 80.35 81.37 80.88 81.64 81.01 80.41

Mean Scaled Score - National 81.59 81.27 80.29 82.39 80.25 80.45 82.51 80.57 80.27 82.23 80.46

School Pass Rate: 80 83.17 74.60 88.27 77.94 80.95 88.75 78.31 70.00 81.82 81.82

State Pass Rate: 91.75 91.05 81.03 94.52 85.92 90.00 92.64 95.79 89.91 90.99

National Pass Rate: 90.31 89.92 86.23 93.74 87.04 89.08 94.83 89.35 86.43 92.17 86.24

FIRST-TIME CANDIDATE GROUP

No. of Candidates 45 181 44 150 47 32 157 61 7 67 29

Mean Scaled Score - School 79.02 79.71 78.55 80.35 78.79 79.66 79.95 78.48 78.14 79.84 80.14

Mean Scaled Score - State 81.53 81.62 79.69 81.76 80.98 82.07 80.93 82.07 81.52 81.14

Mean Scaled Score - National 81.97 81.57 80.75 82.58 80.63 80.82 82.67 80.94 81.17 82.86 81.76

School Pass Rate: 88.89 85.64 79.55 88.67 82.98 84.38 89.17 78.69 85.71 86.57 89.66

State Pass Rate: 92.31 91.95 80.77 94.34 89.66 93.44 92.92 97.56 94.06 94.32

National Pass Rate: 91.82 91.16 88.45 94.30 88.68 90.64 95.50 90.89 92.24 96.05 94.00 Multistate Pharmacy Jurisprudence Examination (MPJE)

Xavier College of Pharmacy

2012 2013 2014 2015 Jan - Apr May - Aug Sep - Dec Jan - Apr May - Aug Sep - Dec Jan - Apr May - Aug Sep - Dec Jan - Apr May - Aug Sep -Doc

TOTAL CANDIDATE GROUP

No. of Candidates 13 181 87 53 188 115 52 193 128 81 215 103 * testing in same/different state 94 / 87 23 / 65 6 / 47 95 / 93 46 / 69 12 / 40 82 / 111 43 / 85 26 / 55 105 / 110 33 / 70 Mean Scaled Score - School * 79.69 79.27/78.48 76.96/79.95 78.17/79.09 79.46/79.55 77.33/78.72 76 / 79.28 78.35/79.98 77.05/80.62 75.27/79.70 79.39/80.75 78.36/80.64 * testing in same/different state Mean Scaled Score - State 81.18 80.91 79.62 81.33 80.82 80.43 80.36 80.18 80.13 79.81 80.56 80.05

Mean Scaled Score - National 80.41 82.43 80.55 80.92 82.50 80.52 81.04 82.52 81.08 81.32 82.40 80.91

School Pass Rate: * 84.62 84.04/81.61 60.87/86.15 83.33/76.60 85.26/81.72 71.74/76.81 50 / 82.50 76.83/90.09 65.12/90.59 50.00/72.73 81.90/89.09 78.79/85.71 * testing in same/different state State Pass Rate: 90.41 90.69 81.61 93.98 90.51 85.21 82.52 86.08 82.69 80.69 88.14 86.55

National Pass Rate: 84.54 92.76 86.85 87.18 92.98 87.01 87.62 93.28 88.50 88.20 93.04 87.78

FIRST-TIME CANDIDATE GROUP

No. of Candidates 9 163 70 43 171 86 43 176 98 65 193 73 * testing in same/different state 87 / 76 11 / 54 3 / 40 89 / 82 31 / 55 8 / 35 76 / 100 24 / 74 14 / 51 94 / 99 14 / 59 Mean Scaled Score - School * 79.78 79.34/78.70 77.55/80.57 81.33/79.38 79.66/79.94 77.03/78.85 76.63/79.31 78.83/80.23 77.33/80.86 76.29/80.28 79.24/81.07 79.00/81.47 * testing in same/different state Mean Scaled Score - State 81.75 81.03 80.21 81.90 81.03 81.08 81.05 80.62 81.13 80.63 80.62 80.81

Mean Scaled Score - National 81.44 82.75 81.26 81.78 82.76 81.22 81.82 82.80 81.79 82.14 82.66 81.60

School Pass Rate: * 88.89 83.91/84.24 63.64/87.04 100 / 77.50 87.64/82.93 67.74/74.55 50 / 80 80.26/90.00 62.5 / 91.89 57.14/78.43 80.85/91.92 92.86/91.53 * testing in same/different state State Pass Rate: 93.22 91.03 85.71 97.22 91.88 87.29 85.88 89.29 84.96 83.61 88.77 91.06

National Pass Rate: 89.13 93.94 89.60 91.08 93.95 90.04 90.85 94.34 90.87 91.72 93.97 90.35 Multistate Pharmacy Jurisprudence Examination (MPJE)

Xavier College of Pharmacy

2016 2017 2018 2019 Jan - Apr May - Aug Sep - Dec Jan - Apr May - Aug Sep - Dec Jan - Apr May - Aug Sep - Dec Jan - Apr May - Aug Sep -Doc

TOTAL CANDIDATE GROUP

No. of Candidates 111 182 130 61 187 * testing in same/different state 13 / 98 92 / 90 51 / 79 18 / 43 95 / 92 Mean Scaled Score - School * 75.15/79.34 75.93/77.13 75.16/76.56 74.00/75.63 76.36/76.23 * testing in same/different state Mean Scaled Score - State 80.92 77.12 76.91 77.39 76.83

Mean Scaled Score - National 81.10 78.08 77.08 77.59 78.16

School Pass Rate: * 53.85/82.65 64.13/74.44 56.86/78.48 44.44/65.12 73.68/67.39 * testing in same/different state State Pass Rate: 90.23 77.93 75.14 75.57 77.13

National Pass Rate: 87.62 82.66 74.77 76.90 83.24

FIRST-TIME CANDIDATE GROUP

No. of Candidates 94 163 77 42 164 * testing in same/different state 10 / 84 83 / 80 16 / 61 6 / 36 86 / 78 Mean Scaled Score - School * 74.90/79.99 76.04/77.46 73.19/76.64 75.17/75.64 76.66/76.58 * testing in same/different state Mean Scaled Score - State 81.58 77.10 77.33 78.28 77.00

Mean Scaled Score - National 81.84 78.24 77.61 78.31 78.41

School Pass Rate: * 50.00/88.10 65.06/76.25 31.25/77.05 50.00/66.67 75.58/70.51 * testing in same/different state State Pass Rate: 92.79 77.21 77.88 80.85 78.38

National Pass Rate: 90.71 83.77 78.24 82.10 84.39 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

North American Pharmacist Licensure Examination (NAPLEX™)

May 1 – August 31, 2017

School Reports Interpretation of Scores Frequency Distribution of Scaled Scores Cumulative Record (since January 2000)

November 15, 2017

North American Pharmacist Licensure Examination (NAPLEX™)

This computer adaptive competency assessment is administered by the National Association of Boards of Pharmacy (NABP). The examination blueprint is designed to assess the applicant’s competency in basic pharmacy practice and is recognized by pharmacy regulatory authorities in all of the states and territories within the USA. The examination is administered via an open window process; applicants may schedule the examination at a local testing center at any time following approval by the state board and receipt of an Authorization to Test (ATT) document from NABP. Individual scores are available to applicants via secure web posting approximately 7-10 days following the examination. Summary reports are provided to the state boards on a calendar trimester basis.

Table of Contents

Current Trimester Report for ULM College of Pharmacy 03

Cumulative Report (since January 2000) for ULM College of Pharmacy 08

Current Trimester Report for Xavier College of Pharmacy 13

Cumulative Report (since January 2000) for Xavier College of Pharmacy 18

NAPLEX-23-2017 Trimester 2

North American Pharmacist Licensure Examination® (NAPLEX®) School Summary Report

University of Louisiana at Monroe

Test Window: May 1, 2017 - August 31, 2017

Page 1 of 5 This NAPLEX score report consists of two levels of scores: aggregated school scores and individual candidate scores. Beginning November 1, 2015, individual (unidentified) scores are reported in the NAPLEX Roster excel file. Summary information is provided separately for first-time examinees from ACPE-accredited schools/colleges and for all examinees, regardless of repeater status and/or the educational institution.

Tables 1 and 2 contain school, state, and national pass rate information as well as total score means and area score means for each of the two main NAPLEX content domains: Area 1 - Ensure Safe and Effective Pharmacotherapy and Health Outcomes (67%) Area 2 - Safe and Accurate Preparation, Compounding, Dispensing and Administration of Medications and Provision of Healthcare Products (33%)

Table 1 First-Time Candidates, ACPE-Accredited Programs Only

Total Scaled Standard Area 1 Scaled Standard Area 2 Scaled Standard Candidates Pass Rate % Score Mean Deviation Score Mean Deviation Score Mean Deviation

School 92 85.87% 91.55 15.90 12.14 1.11 12.49 1.25 State 193 84.46% 91.60 16.58 12.19 1.14 12.34 1.44 National 12545 90.22% 97.19 16.89 12.56 1.17 12.66 1.40

Table 2 All Candidates

Total Scaled Standard Area 1 Scaled Standard Area 2 Scaled Standard Candidates Pass Rate % Score Mean Deviation Score Mean Deviation Score Mean Deviation

School 95 84.21% 90.85 16.22 12.09 1.12 12.43 1.29 State 203 82.76% 90.83 17.05 12.15 1.15 12.29 1.46 National 13428 88.07% 95.88 17.65 12.48 1.21 12.59 1.44

Table 3 Total Scaled Score Min/Max

Table 3 contains information on the range of scaled Min Max scores achieved by FT ACPE (First-Time, ACPE- Accredited) candidates as well as the pool of all FT ACPE 24 141 candidates. It also shows the boundaries of the Scaled All Candidates 24 141 Score Range. Scaled Score Range 0 150

Page 2 of 5 Interpretation and Uses of Candidate Scores At the candidate level, two sets of scores are produced: an overall, composite score and area scores. Only overall scores are used to make pass/fail decisions. Area scores are intended to provide insight into performances in each of the content area domains independent of one another.

There are a total of two area scores, one per main competency area. Area scores are reported on a scale of [6,18], where a score of 6 is the lowest possible score and a score of 18 is the highest possible score. This reporting scale does not have a number-correct interpretation. In other words, a score of 6 does not mean that the candidate answered 6 questions correctly. Instead, area scores are computed from ability estimates that are created for sets of items that map to each of the two content areas.

Table 4 shows the mean area scores for candidates scoring within the designated ranges of NAPLEX total scores. Data in this table includes outcomes from all candidates testing between January 1, 2016 and December 31, 2016.

Comparison Information Total Scaled Score Range AREA 1 AREA 2 0 - 24 8 7 25 - 49 9 9 50 - 74 11 11 75 - 99 12 12 100 - 124 13 13 125 - 150 15 15

Page 3 of 5 The following tables and graphs are scaled score frequency distributions for NAPLEX candidates. Candidates who did not answer enough questions to receive a score are not reflected in the frequency distributions.

Table 5 & Graph 1 School Frequency Distribution of Scaled Scores

Based on First-Time Candidates N = 92

Cumulative Percent of Scaled Score Range Frequency the Upper Limit of the Interval [0,4] 0 0% [0,4] 0 [5,9] 0 0% [5,9] 0 [10,14] 0 0% [10,14] 0 [15,19] 0 0% [15,19] 0 [20,24] 0 0% [20,24] 0 [25,29] 0 0% [25,29] 0 [30,34] 0 0% [30,34] 0 [35,39] 0 0% [35,39] 0 [40,44] 0 0% [40,44] 0 [45,49] 0 0% [45,49] 0 [50,54] 0 0% [50,54] 0 [55,59] 2 2% [55,59] 2 [60,64] 4 7% [60,64] 4 [65,69] 2 9% [65,69] 2 [70,74] 5 14% [70,74] 5 [75,79] 6 21% [75,79] 6 [80,84] 14 36% [80,84] 14 [85,89] 12 49% [85,89] 12 [90,94] 11 61% [90,94] 11 [95,99] 6 67% [95,99] 6 [100,104] 11 79% [100,104]11 [105,109] 2 82% [105,109]2 [110,114] 8 90% [110,114]8 [115,119] 7 98% [115,119]7 [120,124] 1 99% [120,124]1 [125,129] 1 100% [125,129]1 [130,134] 0 100% [130,134]0 [135,139] 0 100% [135,139]0 [140,144] 0 100% [140,144]0 [145,150] 0 100% [145,150]0

8 Frequency 6

Scaled Score Interval

Page 4 of 5 Table 6 & Graph 2 National Frequency Distribution of Scaled Scores

Based on First-Time Candidates from ACPE-Accredited Programs N = 12545

Cumulative Percent of Scaled Score Range Frequency the Upper Limit of the Interval [0,4] 0 0% [0,4] 0 [5,9] 0 0% [5,9] 0 [10,14] 0 0% [10,14] 0 [15,19] 0 0% [15,19] 0 [20,24] 0 0% [20,24] 0 [25,29] 1 0% [25,29] 1 [30,34] 3 0% [30,34] 3 [35,39] 7 0% [35,39] 7 [40,44] 18 0% [40,44] 18 [45,49] 35 1% [45,49] 35 [50,54] 69 1% [50,54] 69 [55,59] 117 2% [55,59]117 [60,64] 208 4% [60,64]208 [65,69] 308 6% [65,69]308 [70,74] 461 10% [70,74]461 [75,79] 706 15% [75,79]706 [80,84] 885 22% [80,84]885 [85,89] 1115 31% [85,89]### [90,94] 1273 41% [90,94]### [95,99] 1361 52% [95,99]### [100,104] 1455 64% [100,104]### [105,109] 1363 75% [105,109]### [110,114] 1180 84% [110,114]### [115,119] 950 92% [115,119]950 [120,124] 582 96% [120,124]582 [125,129] 304 99% [125,129]304 [130,134] 125 100% [130,134]125 [135,139] 17 100% [135,139]17 [140,144] 2 100% [140,144]2 [145,150] 0 100% [145,150]0

1600

1400

1200

1000

800 Frequency 600

400

200

Scaled Score Interval

Page 5 of 5 North American Pharmacist Licensure Examination (NAPLEX)

University of Louisiana at Monroe

2000 2001 2002 2003 Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 76 47 18 40 30 10 13 62 27 10 70 24

School Average Score: 96.51 91.62 88.61 88.93 87.30 87.00 82.85 100.24 89.56 78.40 101.44 92.50

State Average Score: 96.75 88.52 86.05 84.66 93.82 82.05 75.50 101.46 87.48 77.50 99.40 87.33

National Average Score: 91.78 99.86 91.21 90.25 101.70 90.50 90.81 101.21 90.02 91.50 101.40 89.40

School Pass Rate: 96.05 82.98 88.89 85.00 90.00 90.00 84.62 85.48 77.78 60.00 95.71 87.50

State Pass Rate: 92.50 78.57 77.27 75.86 89.29 70.00 50.00 85.90 70.37 62.50 94.90 80.00

National Pass Rate: 82.95 92.05 83.04 81.07 94.38 83.69 81.52 93.76 81.73 82.77 93.84 79.55

FIRST-TIME CANDIDATE GROUP

No. of Candidates 71 33 9 37 20 6 13 61 20 2 64 16

School Average Score: 97.13 96.00 94.00 88.32 86.90 90.67 82.85 100.44 92.80 73.50 102.69 98.56

State Average Score: 97.49 93.61 87.77 88.78 95.92 85.93 81.89 103.71 91.15 74.00 100.41 92.38

National Average Score: 96.51 101.85 96.48 94.54 103.35 94.22 95.13 103.00 94.62 97.39 103.38 95.88

School Pass Rate: 95.77 96.97 100.00 83.78 85.00 100.00 84.62 85.25 75.00 50.00 96.88 100.00

State Pass Rate: 94.59 93.18 84.62 83.33 91.84 73.33 77.78 90.28 70.00 66.67 95.65 90.48

National Pass Rate: 91.44 95.44 91.39 87.91 96.75 90.10 89.27 96.74 88.52 91.47 96.54 89.64 North American Pharmacist Licensure Examination (NAPLEX)

University of Louisiana at Monroe

2004 2005 2006 2007 Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 3 64 18 9 72 17 2 60 10 3 90 23

School Average Score: 85.67 105.30 94.83 82.67 104.17 101.65 98.00 113.17 95.80 107.67 117.27 101.57

State Average Score: 81.33 103.47 96.71 95.00 101.77 92.50 86.67 111.87 96.07 88.00 117.29 94.73

National Average Score: 92.13 102.16 91.70 91.32 104.85 87.72 86.89 107.02 93.18 89.95 113.33 94.18

School Pass Rate: 100.00 96.88 94.44 88.89 90.28 94.12 100.00 93.33 80.00 100.00 95.56 78.26

State Pass Rate: 83.33 96.12 100.00 100.00 87.83 78.57 77.78 89.17 79.31 63.64 95.52 74.51

National Pass Rate: 83.22 95.11 84.79 82.88 89.15 71.73 68.82 90.52 77.07 71.38 94.47 78.76

FIRST-TIME CANDIDATE GROUP

No. of Candidates 2 58 17 5 70 11 2 58 4 3 89 19

School Average Score: 87.00 107.34 93.47 81.40 105.09 110.09 98.00 114.59 125.00 107.67 117.66 103.05

State Average Score: 84.00 105.61 99.73 101.50 103.64 98.94 93.33 112.95 95.41 103.40 118.18 95.00

National Average Score: 100.14 104.14 96.60 98.84 107.67 95.89 97.18 110.34 99.96 102.16 116.00 102.19

School Pass Rate: 100.00 100.00 94.12 80.00 91.43 100.00 100.00 94.83 100.00 100.00 95.51 78.95

State Pass Rate: 100.00 100.00 100.00 100.00 90.09 88.89 100.00 90.38 70.59 100.00 96.69 76.74

National Pass Rate: 95.07 97.38 92.22 91.31 92.86 82.12 81.12 94.49 84.74 84.09 97.23 88.12 North American Pharmacist Licensure Examination (NAPLEX)

University of Louisiana at Monroe

2008 2009 2010 2011 Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 11 98 12 6 91 8 3 67 6 2 91 9

Mean Scaled Score - School 94.73 106.39 93.83 97.83 113.84 77.25 98.00 99.97 93.17 67.50 97.40 87.22

Mean Scaled Score - State 93.70 103.31 95.41 94.80 108.26 84.32 83.15 94.22 80.13 99.66 85.27

Mean Scaled Score - National 96.76 112.08 96.61 93.72 112.51 93.62 84.75 101.11 84.90 83.97 103.27 88.08

School Pass Rate: 90.91 92.86 83.33 83.33 95.60 50.00 100.00 95.52 100.00 0.00 89.01 77.78

State Pass Rate: 90.00 90.34 82.76 80.00 92.64 63.16 61.54 83.24 65.00 90.81 73.17

National Pass Rate: 83.11 95.48 81.96 76.40 95.03 78.20 65.07 92.39 72.20 67.85 94.16 76.57

FIRST-TIME CANDIDATE GROUP

No. of Candidates 3 97 5 3 88 3 0 67 2 1 87 3

Mean Scaled Score - School 110.33 106.76 95.80 93.00 115.34 78.33 0.00 99.97 97.00 62.00 99.39 84.67

Mean Scaled Score - State 96.00 104.42 95.82 86.00 108.80 84.10 92.00 94.46 90.75 100.88 83.70

Mean Scaled Score - National 106.63 114.11 103.62 106.27 114.65 102.87 100.12 103.06 94.26 96.99 105.03 96.71

School Pass Rate: 100.00 93.81 80.00 66.67 96.59 33.33 0.00 95.52 100.00 0.00 93.10 66.67

State Pass Rate: 83.33 92.35 82.35 57.14 93.04 60.00 66.67 84.15 83.33 93.18 74.07

National Pass Rate: 92.24 97.44 90.66 90.76 97.50 89.51 88.38 95.31 86.71 87.50 96.57 89.24 North American Pharmacist Licensure Examination (NAPLEX)

University of Louisiana at Monroe

2012 2013 2014 2015 Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec S+O/N+D TOTAL CANDIDATE GROUP

No. of Candidates 6 80 17 3 40 7 1 68 11 4 79 9 / 3

Mean Scaled Score - School 75.33 97.14 85.41 92.00 100.45 88.43 101.00 95.10 82.27 82.00 94.93 83.89/89.67

Mean Scaled Score - State 81.25 98.42 86.95 77.25 98.66 86.88 73.85 96.45 80.88 82.15 95.51 85.60/73.62

Mean Scaled Score - National 83.15 102.81 88.15 80.17 102.78 87.03 80.22 101.71 89.22 83.84 100.46 88.25/73.84

School Pass Rate: 83.33 92.50 82.35 100.00 90.00 100.00 100.00 89.71 63.64 50.00 89.87 77.78/100

State Pass Rate: 68.75 93.82 76.19 55.56 92.95 81.82 53.85 90.75 70.59 69.23 88.24 76.00/46.15

National Pass Rate: 68.33 95.21 77.86 61.07 94.65 75.91 63.24 93.86 79.77 67.06 92.29 77.64/46.27

FIRST-TIME CANDIDATE GROUP

No. of Candidates 2 80 9 3 38 4 1 68 3 1 78 5 / 0

Mean Scaled Score - School 49.50 97.14 87.11 92.00 101.68 92.00 101.00 95.10 92.00 74.00 94.62 83.60 / 0

Mean Scaled Score - State 84.00 99.47 91.00 80.75 99.30 88.33 85.00 96.96 83.34 77.00 96.08 86.50 / 0

Mean Scaled Score - National 94.87 104.13 95.75 92.48 104.02 92.69 90.89 102.80 93.94 94.01 101.53 91.24 / 0

School Pass Rate: 50.00 92.50 77.78 100.00 92.11 100.00 100.00 89.71 66.67 0.00 89.74 80.00 / 0

State Pass Rate: 75.00 95.35 72.73 75.00 94.08 83.33 100.00 92.12 73.68 33.33 89.34 75.00 / 0

National Pass Rate: 87.69 97.19 90.14 85.14 96.57 84.46 83.15 95.61 85.36 84.96 93.86 81.88 / 0 North American Pharmacist Licensure Examination (NAPLEX)

University of Louisiana at Monroe

2016 2017 2018 2019 Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 4 94 18 11 95

Mean Scaled Score - School 60.25 87.35 83.76 87.45 90.85

Mean Scaled Score - State 66.88 89.27 77.06 80.50 90.83

Mean Scaled Score - National 74.52 84.81 81.48 79.33 95.88

School Pass Rate: 0.00 76.6 77.78 81.82 84.21

State Pass Rate: 22.22 77.61 54.72 70.59 82.76

National Pass Rate: 48.80 85.71 65.32 62.73 88.07

ACPE probation eff. 06-24-2017 FIRST-TIME CANDIDATE GROUP

No. of Candidates 1 91 4 2 92

Mean Scaled Score - School 31.00 87.62 79.67 72.50 91.55

Mean Scaled Score - State 47.33 89.71 71.05 87.50 91.6

Mean Scaled Score - National 78.95 95.9 83.02 86.04 97.19

School Pass Rate: 0.00 76.92 50.00 50.00 85.87

State Pass Rate: 0.00 78.07 38.10 75.00 84.46

National Pass Rate: 57.75 87.78 65.64 76.19 90.22 NAPLEX-24-2017 Trimester 2

North American Pharmacist Licensure Examination® (NAPLEX®) School Summary Report

Xavier University of Louisiana

Test Window: May 1, 2017 - August 31, 2017

Table 1 First-Time Candidates, ACPE-Accredited Programs Only

Total Scaled Standard Area 1 Scaled Standard Area 2 Scaled Standard Candidates Pass Rate % Score Mean Deviation Score Mean Deviation Score Mean Deviation

School 121 81.82% 90.57 17.97 12.17 1.19 12.22 1.63 State 193 84.46% 91.60 16.58 12.19 1.14 12.34 1.44 National 12545 90.22% 97.19 16.89 12.56 1.17 12.66 1.40

Table 2 All Candidates

Total Scaled Standard Area 1 Scaled Standard Area 2 Scaled Standard Candidates Pass Rate % Score Mean Deviation Score Mean Deviation Score Mean Deviation

School 127 80.31% 90.03 18.00 12.14 1.18 12.17 1.65 State 203 82.76% 90.83 17.05 12.15 1.15 12.29 1.46 National 13428 88.07% 95.88 17.65 12.48 1.21 12.59 1.44

Table 3 Total Scaled Score Min/Max

Comparison Information Total Scaled Score Range AREA 1 AREA 2 0 - 24 8 7 25 - 49 9 9 50 - 74 11 11 75 - 99 12 12 100 - 124 13 13 125 - 150 15 15

Table 5 & Graph 1 School Frequency Distribution of Scaled Scores

Based on First-Time Candidates N = 121

Cumulative Percent of Scaled Score Range Frequency the Upper Limit of the Interval [0,4] 0 0% [0,4] 0 [5,9] 0 0% [5,9] 0 [10,14] 0 0% [10,14] 0 [15,19] 0 0% [15,19] 0 [20,24] 0 0% [20,24] 0 [25,29] 0 0% [25,29] 0 [30,34] 0 0% [30,34] 0 [35,39] 1 1% [35,39] 1 [40,44] 1 2% [40,44] 1 [45,49] 1 2% [45,49] 1 [50,54] 1 3% [50,54] 1 [55,59] 2 5% [55,59] 2 [60,64] 4 8% [60,64] 4 [65,69] 5 12% [65,69] 5 [70,74] 7 18% [70,74] 7 [75,79] 10 26% [75,79] 10 [80,84] 11 36% [80,84] 11 [85,89] 9 43% [85,89] 9 [90,94] 18 58% [90,94] 18 [95,99] 11 67% [95,99] 11 [100,104] 16 80% [100,104]16 [105,109] 6 85% [105,109]6 [110,114] 7 91% [110,114]7 [115,119] 5 95% [115,119]5 [120,124] 5 99% [120,124]5 [125,129] 1 100% [125,129]1 [130,134] 0 100% [130,134]0 [135,139] 0 100% [135,139]0 [140,144] 0 100% [140,144]0 [145,150] 0 100% [145,150]0

Frequency 8

Scaled Score Interval

Page 4 of 5 Table 6 & Graph 2 National Frequency Distribution of Scaled Scores

Based on First-Time Candidates from ACPE-Accredited Programs N = 12545

Cumulative Percent of Scaled Score Range Frequency the Upper Limit of the Interval [0,4] 0 0% [0,4] 0 [5,9] 0 0% [5,9] 0 [10,14] 0 0% [10,14] 0 [15,19] 0 0% [15,19] 0 [20,24] 0 0% [20,24] 0 [25,29] 1 0% [25,29] 1 [30,34] 3 0% [30,34] 3 [35,39] 7 0% [35,39] 7 [40,44] 18 0% [40,44] 18 [45,49] 35 1% [45,49] 35 [50,54] 69 1% [50,54] 69 [55,59] 117 2% [55,59]117 [60,64] 208 4% [60,64]208 [65,69] 308 6% [65,69]308 [70,74] 461 10% [70,74]461 [75,79] 706 15% [75,79]706 [80,84] 885 22% [80,84]885 [85,89] 1115 31% [85,89]### [90,94] 1273 41% [90,94]### [95,99] 1361 52% [95,99]### [100,104] 1455 64% [100,104]### [105,109] 1363 75% [105,109]### [110,114] 1180 84% [110,114]### [115,119] 950 92% [115,119]950 [120,124] 582 96% [120,124]582 [125,129] 304 99% [125,129]304 [130,134] 125 100% [130,134]125 [135,139] 17 100% [135,139]17 [140,144] 2 100% [140,144]2 [145,150] 0 100% [145,150]0

1600

1400

1200

1000

800 Frequency 600

400

200

Scaled Score Interval

Page 5 of 5 North American Pharmacist Licensure Examination (NAPLEX)

Xavier College of Pharmacy

2000 2001 2002 2003 Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 10 80 43 28 85 40 22 69 48 19 90 40

School Average Score: 77.60 87.99 81.67 76.50 93.14 85.15 76.00 93.23 86.98 79.42 94.46 84.33

State Average Score: 96.75 88.52 86.05 84.66 93.82 82.05 75.50 101.46 87.48 77.50 99.40 87.33

National Average Score: 91.78 99.86 91.21 90.25 101.70 83.69 90.81 101.21 90.02 91.50 101.40 89.40

School Pass Rate: 60.00 77.50 62.79 57.14 85.88 82.50 54.55 79.71 85.42 68.42 90.00 75.00

State Pass Rate: 92.50 78.57 77.27 75.86 89.29 70.00 50.00 85.90 70.37 62.50 94.90 80.00

National Pass Rate: 82.95 92.05 83.04 81.07 94.38 83.69 81.52 93.76 81.73 82.77 93.84 79.55

FIRST-TIME CANDIDATE GROUP

No. of Candidates 1 77 23 10 74 29 8 63 40 8 83 26

School Average Score: 95.00 88.19 82.13 74.80 95.92 86.48 80.63 95.00 88.60 87.75 95.34 88.04

State Average Score: 97.49 93.61 87.77 88.78 95.92 85.93 81.89 103.71 91.15 74.00 100.41 92.38

National Average Score: 96.51 101.85 96.48 94.54 103.35 94.22 95.13 103.00 94.62 97.39 103.38 95.88

School Pass Rate: 100.00 77.92 65.22 50.00 90.54 82.76 75.00 84.13 90.00 87.50 90.36 80.77

State Pass Rate: 94.59 93.18 84.62 83.33 91.84 73.33 77.78 90.28 70.00 66.67 95.65 90.48

National Pass Rate: 91.44 95.44 91.39 87.91 96.75 90.10 89.27 96.74 88.52 91.47 96.54 89.64 North American Pharmacist Licensure Examination (NAPLEX)

Xavier College of Pharmacy

2004 2005 2006 2007 Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 10 82 19 6 95 30 20 94 48 17 81 56

School Average Score: 76.40 98.99 91.68 83.00 98.92 73.07 72.15 106.20 92.81 74.18 109.07 86.77

State Average Score: 81.33 103.47 96.71 95.00 101.77 92.50 86.67 111.87 96.07 88.00 117.29 94.73

National Average Score: 92.13 102.16 91.70 91.32 104.85 87.72 86.89 107.02 93.18 89.95 113.33 94.18

School Pass Rate: 70.00 96.34 84.21 83.33 86.32 56.67 50.00 82.98 77.08 52.94 83.95 64.29

State Pass Rate: 83.33 96.12 100.00 100.00 87.83 78.57 77.78 89.17 79.31 63.64 95.52 74.51

National Pass Rate: 83.22 95.11 84.79 82.88 89.15 71.73 68.82 90.52 77.07 71.38 94.47 78.76

FIRST-TIME CANDIDATE GROUP

No. of Candidates 2 79 10 3 90 19 5 87 31 3 68 46

School Average Score: 72.50 100.06 98.80 85.00 101.34 79.79 69.40 109.32 93.10 94.67 114.60 90.50

State Average Score: 84.00 105.61 99.73 101.50 103.64 98.94 93.33 112.95 95.41 103.40 118.18 95.00

National Average Score: 100.14 104.14 96.60 98.84 107.67 95.89 97.18 110.34 99.96 102.16 116.00 102.19

School Pass Rate: 50.00 98.73 100.00 66.67 88.89 68.42 40.00 86.21 77.42 100.00 92.65 71.74

State Pass Rate: 100.00 100.00 100.00 100.00 90.09 88.89 100.00 90.38 70.59 100.00 96.69 76.74

National Pass Rate: 95.07 97.38 92.22 91.31 92.86 82.12 81.12 94.49 84.74 84.09 97.23 88.12 North American Pharmacist Licensure Examination (NAPLEX)

Xavier College of Pharmacy

2008 2009 2010 2011 Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 22 138 55 18 138 28 19 148 52 25 124 45

Mean Scaled Score - School 81.36 96.77 89.82 80.33 97.59 86.96 73.63 89.73 77.15 76.00 99.13 85.04

Mean Scaled Score - State 93.70 103.31 95.41 94.80 108.26 84.32 83.15 94.22 80.13 99.66 85.27

Mean Scaled Score - National 96.76 112.08 96.61 93.72 112.51 93.62 84.75 101.11 84.90 83.97 103.27 88.08

School Pass Rate: 68.18 81.88 76.36 61.11 83.33 71.43 42.11 75.00 59.62 64.00 87.10 75.56

State Pass Rate: 90.00 90.34 82.76 80.00 92.64 63.16 61.54 83.24 65.00 90.81 73.17

National Pass Rate: 83.11 95.48 81.96 76.40 95.03 78.20 65.07 92.39 72.20 67.85 94.16 76.57

FIRST-TIME CANDIDATE GROUP

No. of Candidates 5 124 36 6 127 12 6 143 16 6 115 33

Mean Scaled Score - School 85.40 98.77 92.47 81.00 99.77 83.33 79.83 90.78 84.00 61.00 101.95 85.45

Mean Scaled Score - State 96.00 104.42 95.82 86.00 108.80 84.10 92.00 94.46 90.75 100.88 83.70

Mean Scaled Score - National 106.63 114.11 103.62 106.27 114.65 102.87 100.12 103.06 94.26 96.99 105.03 96.71

School Pass Rate: 80.00 84.68 80.56 50.00 86.61 66.67 50.00 76.92 75.00 16.67 92.17 81.82

State Pass Rate: 83.33 92.35 82.35 57.14 93.04 60.00 66.67 84.15 83.33 93.18 74.07

National Pass Rate: 92.24 97.44 90.66 90.76 97.50 89.51 88.38 95.31 86.71 87.50 96.57 89.24 North American Pharmacist Licensure Examination (NAPLEX)

Xavier College of Pharmacy

2012 2013 2014 2015 Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec S+O/N+D TOTAL CANDIDATE GROUP

No. of Candidates 13 120 21 10 136 43 18 138 27 15 141 22 / 9

Mean Scaled Score - School 76.69 95.13 83.24 68.67 95.13 81.47 70.72 96.29 80.41 72.13 96.03 86.73/59.78

Mean Scaled Score - State 81.25 98.42 86.95 77.25 98.66 86.88 73.85 96.45 80.88 82.15 95.51 85.60/73.62

Mean Scaled Score - National 83.15 102.81 88.15 80.17 102.78 87.03 80.22 101.71 89.22 83.84 100.46 88.25/73.84

School Pass Rate: 46.15 90.00 61.90 40.00 86.03 65.12 50.00 92.75 70.37 53.33 85.11 86.36/22.22

State Pass Rate: 68.75 93.82 76.19 55.56 92.95 81.82 53.85 90.75 70.59 69.23 88.24 76.00/46.15

National Pass Rate: 68.33 95.21 77.86 61.07 94.65 75.91 63.24 93.86 79.77 67.06 92.29 77.64/46.27

FIRST-TIME CANDIDATE GROUP

No. of Candidates 3 111 12 1 131 29 3 131 18 4 137 10 / 1

Mean Scaled Score - School 84.67 97.71 95.58 47.00 96.65 82.76 61.00 97.15 82.33 84.75 97.31 89.60/27.00

Mean Scaled Score - State 84.00 99.47 91.00 80.75 99.30 88.33 85.00 96.96 83.84 77.00 96.08 86.50/73.67

Mean Scaled Score - National 94.87 104.13 95.75 92.48 104.02 92.69 90.89 102.80 93.94 94.01 101.53 91.24/81.00

School Pass Rate: 66.67 93.69 91.67 0.00 89.31 68.97 66.67 93.89 72.22 75.00 87.59 80.00 / 0

State Pass Rate: 75.00 95.35 72.73 75.00 94.08 83.33 100.00 92.12 73.68 33.33 89.34 75.00/33.33

National Pass Rate: 87.69 97.19 90.14 85.14 96.57 84.46 83.15 95.61 85.36 84.96 93.86 81.88/58.74 North American Pharmacist Licensure Examination (NAPLEX)

Xavier College of Pharmacy

2016 2017 2018 2019 Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec

TOTAL CANDIDATE GROUP

No. of Candidates 16 123 43 25 127

Mean Scaled Score - School 61.87 89.84 75.2 77.68 90.03

Mean Scaled Score - State 66.88 89.27 77.06 80.50 90.83

Mean Scaled Score - National 74.52 94.81 81.48 79.33 95.88

School Pass Rate: 25.00 78.05 51.16 64.00 80.31

State Pass Rate: 22.22 77.61 54.72 70.59 82.76

National Pass Rate: 48.80 85.71 65.32 62.73 88.07

FIRST-TIME CANDIDATE GROUP

No. of Candidates 4 114 22 1 121

Mean Scaled Score - School 63.67 91.1 74.81 111.00 90.57

Mean Scaled Score - State 47.33 89.71 81.05 87.50 91.60

Mean Scaled Score - National 78.95 95.9 83.02 86.04 97.19

School Pass Rate: 25.00 80.7 50.00 100.00 81.82

State Pass Rate: 0.00 78.07 38.10 75.00 84.46

National Pass Rate: 57.75 87.78 65.64 76.19 90.22

Louisiana Board of Pharmacy

Financial Statements

June 30, 2017

Louisiana Board of Pharmacy Table of Contents

Independent Auditor’s Report ...... 1

Financial Statements

Statement of Net Position ...... 4

Statement of Revenues, Expenses, and Changes in Net Position ...... 5

Statement of Cash Flows ...... 6

Notes to Financial Statements ...... 7

Required Supplementary Information

Schedule of Employer’s Proportionate Share of Net Pension Liability ...... 23

Schedule of Employer’s Pension Contributions ...... 24

Schedule of Funding Progress for OPEB Plan...... 25

Other Supplementary Information

Schedule of Per Diem Paid to Board Members ...... 26

Reports Required by Government Auditing Standards

Independent Auditor’s Report on Internal Control over Financial Reporting and on Compliance and Other Matters Based on an Audit of Financial Statements Performed in Accordance with Government Auditing Standards ...... 27

Summary of Auditor’s Results and Schedule of Findings ...... 29

Summary Schedule of Prior Year Findings ...... 30

Supplementary Information as Required by the Louisiana Division of Administration

Annual Fiscal Report ...... 31

Independent Auditor’s Report

To the Board Members of Louisiana Board of Pharmacy Baton Rouge, Louisiana

We have audited the accompanying financial statements of the business-type activities of the Louisiana Board of Pharmacy, a component unit of the State of Louisiana, as of and for the year ended June 30, 2017, and the related notes to the financial statements, which collectively comprise the Louisiana Board of Pharmacy’s basic financial statements as listed in the table of contents.

Management’s Responsibility for the Financial Statements

Management is responsible for the preparation and fair presentation of these financial statements in accordance with accounting principles generally accepted in the United States of America; this includes the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of financial statements that are free from material misstatement, whether due to fraud or error.

Auditor’s Responsibility

Our responsibility is to express an opinion on these financial statements based on our audit. We conducted our audit in accordance with auditing standards generally accepted in the United States of America and the standards applicable to financial audits contained in Government Auditing Standards, issued by the Comptroller General of the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free from material misstatement.

An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements. The procedures selected depend on the auditor’s judgment, including the assessment of the risks of material misstatement of the financial statements, whether due to fraud or error. In making those risk assessments, the auditors consider internal control relevant to the Louisiana Board of Pharmacy’s preparation and fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Louisiana Board of Pharmacy’s internal control. Accordingly, we express no such opinion. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinions.

1 To the Board Members of Louisiana Board of Pharmacy Baton Rouge, Louisiana

Opinion

In our opinion, the financial statements referred to above present fairly, in all material respects, the respective financial position of the business-type activities of Louisiana Board of Pharmacy, as of June 30, 2017, and the respective changes in financial position and cash flows thereof for the year then ended in accordance with accounting principles generally accepted in the United States of America.

Other Matters

Required Supplementary Information Management has omitted the management's discussion and analysis information that accounting principles generally accepted in the United States of America require to be presented to supplement the basic financial statements. Such missing information, although not a part of the basic financial statements, is required by the Governmental Accounting Standards Board, who considers it be an essential part of financial reporting for placing the basic financial statements in an appropriate operational, economic, or historical context. Our opinion on the basic financial statements is not affected by this missing information.

Accounting principles generally accepted in the United States of America require that the schedule of employer’s proportionate share of net pension liability at page 23; and schedule of employer’s pension contributions at page 24; and schedule of funding progress for OPEB plan at page 25, be presented to supplement the basic financial statements. Such information, although not a part of the basic financial statements, is required by the Governmental Accounting Standards Board, who considers it to be an essential part of financial reporting for placing the basic financial statements in an appropriate operational, economic, or historical context. We have applied certain limited procedures to the required supplementary information in accordance with auditing standards generally accepted in the United States of America, which consisted of inquiries of management about the methods of preparing the information and comparing the information for consistency with management’s responses to our inquiries, the basic financial statements, and other knowledge we obtained during our audit of the basic financial statements. We do not express an opinion or provide any assurance on the information because the limited procedures do not provide us with sufficient evidence to express an opinion or provide any assurance.

Supplementary and Other Information Our audit was conducted for the purpose of forming an opinion on the financial statements of the Louisiana Board of Pharmacy. The accompanying schedule of per diem paid to board members at page 26 and the annual fiscal report at page 31 is presented for purposes of additional analysis and are not a required part of the financial statements.

The schedule of per diem paid to board members and annual fiscal report is the responsibility of management and was derived from and relate directly to the underlying accounting and other records used to prepare the basic financial statements. Such information has been subjected to the auditing procedures applied in the audit of the basic financial statements and certain additional procedures, including comparing and reconciling such information directly to the underlying accounting and other records used to prepare the financial statements or to the financial statements themselves, and other additional procedures in accordance with auditing standards generally accepted in the United States of America. In our opinion, the accompanying schedules are fairly stated, in all material respects, in relation to the basic financial statements as a whole.

2 To the Board Members of Louisiana Board of Pharmacy Baton Rouge, Louisiana

Other Reporting Required by Government Auditing Standards

In accordance with Government Auditing Standards, we have also issued our report dated August 29, 2017, on our consideration of the Louisiana Board of Pharmacy’s internal control over financial reporting and on our tests of its compliance with certain provisions of laws, regulations, contracts, and grant agreements and other matters. The purpose of that report is to describe the scope of our testing of internal control over financial reporting and compliance and the results of that testing, and not to provide an opinion on internal control over financial reporting or on compliance. That report is an integral part of an audit performed in accordance with Government Auditing Standards in considering the Louisiana Board of Pharmacy’s internal control over financial reporting and compliance.

Covington, Louisiana August 29, 2017

Financial Statements

Louisiana Board of Pharmacy Statement of Net Position June 30, 2017

ASSETS AND DEFERRED OUTFLOWS OF RESOURCES Current Assets Cash and cash equivalents$ 950,154 Accounts receivable 14,594 Accrued interest on investments 11,351 Prepaid expenses 6,600 982,699 Noncurrent Assets Investments 4,125,240 Capital assets, net 1,965,800 6,091,040 7,073,739 Deferred Outflows of Resources Deferred outflows related to pension plan 1,215,759 $ 8,289,498

LIABILITIES, DEFERRED INFLOWS OF RESOURCES, AND NET POSITION Current Liabilities Accounts payable $ 5,376 Accrued salaries and related expenses 45,146 Accrued compensated absences - current 56,822 107,344 Noncurrent Liabilities Accrued compensated absences 64,264 Pension liability 5,336,594 Other post-employment benefits 1,209,508 6,610,366 6,717,710 Deferred Inflows of Resources Deferred inflows related to pension plan 78,386

Net Position Net investment in capital assets 1,965,800 Unrestricted (472,398) 1,493,402 $ 8,289,498

See accompanying notes to financial statements. 4 Louisiana Board of Pharmacy Statement of Revenues, Expenses, and Changes in Net Position For the Year Ended June 30, 2017

Operating Revenues Licenses, permits, and fees$ 3,228,079

Operating Expenses Salaries and payroll taxes 1,359,284 Employee benefits 860,137 Office expenses 241,536 Software and computer services 195,547 Depreciation 60,721 Lease expense 15,170 Legal and professional services 99,394 Conventions and board meetings 78,745 Travel 81,674 2,992,208 Operating income 235,871

Non-Operating Revenues (Expenses) Net investment loss (36,327) (36,327) Change in net position 199,544 Net position, beginning of year 1,293,858 Net position, end of year $ 1,493,402

See accompanying notes to financial statements. 5 Louisiana Board of Pharmacy Statement of Cash Flows For the Year Ended June 30, 2017

Cash Flows From Operating Activities Receipts from licenses, permits, and fees$ 3,213,815 Payments to employees for services (2,120,988) Payments to suppliers for goods and services (545,114) (2,666,102) Net cash provided by operating activities 547,713

Cash Flows From Capital and Related Financing Activities Purchase of capital assets (2,423) Net cash used in capital and related financing activities (2,423)

Cash Flows From Investing Activities Purchase of securities (873,228) Investment income 52,198 Net cash used in investing activities (821,030)

Change in cash and cash equivalents (275,740) Cash and cash equivalents, beginning of year 1,225,894 Cash and cash equivalents, end of year $ 950,154

Reconciliation of operating income to net cash provided by operating activities: Operating income$ 235,871 Adjustments to reconcile operating income to net cash provided by operating activities: Depreciation 60,721 Decrease (increase) in: Accounts receivable (14,264) Prepaid expenses 23,300 Deferred outflows related to pensions (616,777) Increase (decrease) in: Accounts payable 279 Accrued salaries and related expenses 13,088 Accrued compensated absences 669 Pension liability 790,941 Other post-employment benefits obligation 37,479 Deferred inflows related to pensions 16,406 Net cash provided by operating activities$ 547,713

See accompanying notes to financial statements. 6 Louisiana Board of Pharmacy Notes to Financial Statements

1. History and Summary of Significant Accounting Policies

History and Nature of Operations The Louisiana Board of Pharmacy (the “Board”) is a component unit of the state of Louisiana created within the Louisiana Department of Health, as provided by Louisiana Revised Statute (R.S.) 37:1171, in 1888. The Board is charged with the authority and responsibility of regulating the profession and practice of pharmacy in the interest of the health, safety, and welfare of the citizens of the state of Louisiana.

The Board is composed of seventeen members, appointed by the governor, including two licensed pharmacists from each of the eight pharmacy districts and one representative of the consumers from the state at large. Operations of the Board are funded through self-generated revenues primarily derived from fees for the issuance of licenses, permits, and examinations. For the year ended June 30, 2017, the Board had twenty full-time employees and three part-time employees, administered 44,959 active credentials, and issued 6,795 new credentials.

Financial Reporting Entity GASB Codification Section 2100 has defined the governmental reporting entity to be the state of Louisiana. The Board is considered a component unit of the state of Louisiana because the state exercises oversight responsibility in that the governor appoints the Board members and public service is rendered within the state’s boundaries. The accompanying financial statements present information only as to the transactions of the Board as authorized by Louisiana statutes and administrative regulations.

Annually, the State of Louisiana issues a basic financial statement which includes the activity contained in the accompanying financial statement. The basic financial statement is issued by the Louisiana Division of Administration – Office of Statewide Reporting and Accounting Policy and audited by the Louisiana Legislative Auditor.

Basis of Accounting For financial reporting purposes, the Board is considered a special-purpose government engaged only in business-type activities. All activities of the Board are accounted for within a single proprietary (enterprise) fund.

Proprietary funds are accounted for using the "economic resources" measurement focus and the accrual basis of accounting. Accordingly, all assets and liabilities (whether current or noncurrent) are included on the Statement of Net Position. The Statement of Revenues, Expenses and Changes in Net Position presents increases (revenues) and decreases (expenses) in total net position. Under the accrual basis of accounting, revenues are recognized in the period in which they are earned while expenses are recognized in the period in which the liability is incurred.

Operating revenues and expenses generally result from providing services and producing and delivering goods in connection with a proprietary fund’s principal ongoing operations. The principal operating revenues are user charges and fees, while operating expenses consist of salaries, ordinary maintenance, assessments, indirect costs and depreciation. All revenues and expenses not meeting this definition are reported as non-operating revenues and expenses.

7 Louisiana Board of Pharmacy Notes to Financial Statements

Net Position The Board follows GASB No. 63, Financial Reporting of Deferred Outflows of Resources, Deferred Inflows of Resources, and Net Position. This standard provides guidance for reporting the financial statement elements of deferred outflows of resources and deferred inflows of resources. Deferred outflows represent the consumption of the government's resources that are applicable to a future reporting period. A deferred inflow represents the acquisition of resources that are applicable to a future reporting period.

Because deferred outflows and deferred inflows are, by definition, neither assets nor liabilities, the statement of net assets title is now referred to as the statement of net position. The statement of net position reports net position as the difference between all other elements in a statement of net position and should be displayed in three components—net investment in capital assets, restricted net position (distinguishing between major categories of restrictions), and unrestricted net position.

 Net Investment in Capital Assets - Consists of capital assets including restricted capital assets net of accumulated depreciation and reduced by the outstanding balances of any bonds, mortgages, notes, or other borrowings that are attributable to the acquisition, construction, or improvement of those assets

 Restricted - Consists of amounts with constraints placed on the use by (1) external groups such as creditors, grantors, contributors, or laws or regulations of other governments; or (2) law through constitutional provisions or enabling legislation

 Unrestricted - All other amounts that do not meet the definition of "restricted" or "net investment in capital assets"

Restricted net position represents unexpended revenue bond proceeds as well as certain other resources set aside for the purpose of improvements to capital assets and funding debt service payments in accordance with bond resolutions.

When both restricted and unrestricted resources are available for use, it is the Board’s policy to use restricted resources first, then unrestricted as needed.

Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

New Accounting Standard The Board has implemented GASB Statement No. 72, Fair Value Measurement and Application, which enhances transparency through new note disclosures as reflected in Note 4 Fair Value Measurement. This statement is effective for financial reporting periods beginning after June 15, 2015. GASB 72 addresses accounting and financial reporting issues related to fair value measurements by clarifying the definition of fair value, establishing general principles for measuring fair value, providing additional fair value application guidance, and enhancing fair value measurement disclosures. Adoption of the guidance did not have a significant impact on amounts reported or disclosed in the financial statements.

8 Louisiana Board of Pharmacy Notes to Financial Statements

Budget Practices The Board prepares its budget in accordance with the Louisiana Licensing Agency Budget Act, R.S. 39:1331-1342. The budget is prepared on a modified accrual basis of accounting. Although budget amounts lapse at year-end, the Board retains its unexpended net position to fund expenses of the succeeding year.

Cash and Cash Equivalents For the purpose of the statement of net position and statement of cash flows, cash and cash equivalents include all demand accounts and money market funds of the Board with an original maturity of 90 days or less. Under state law, the Board may deposit funds within a fiscal agent bank organized under the laws of the state of Louisiana, the laws of any other state in the Union, or the laws of the United States. The carrying amounts of cash deposits and money market accounts are reported in the statement of financial position at cost which approximates fair value because of the short maturities of those instruments.

Prepaid Expenses Payments to vendors for supplies and services include costs applicable to the next accounting period and are recorded as prepaid items.

Investments In accordance with R.S. 49:327(D), those funds determined by the Board to be in excess of immediate needs shall be available for investment. The Board’s investments, which consist solely of U.S. Treasury securities, are stated at fair value, as determined by quoted market prices, with realized and unrealized gains and losses included on the statement of revenues, expenses and, changes in net position. Dividend and interest income are accrued when earned.

Capital Assets Capital assets with a cost of $1,000 or more are reported at cost in the statement of net position. Repairs and maintenance are expensed as incurred. Depreciation is computed using the straight-line method over the estimated useful lives as follows:

Description Years

Building 40 Building improvements 10 - 20 Furniture and equipment 5 - 10 Software 5

Estimated useful life is management’s estimate of how long the asset is estimated to meet service demands.

Post-Employment Health Care and Life Insurance Benefits The Board provides certain continuing health care and life insurance benefits for its retired employees. The Board recognizes the expense of providing these retiree benefits in accordance with GASB Statement No. 45, Accounting and Financial Reporting by Employers for Postemployment Benefits Other Than Pensions.

9 Louisiana Board of Pharmacy Notes to Financial Statements

Compensated Absences Employees earn and accumulate annual and sick leave at various rates, depending on their years of service. Annual and sick leave that may be accumulated by each employee is unlimited. Upon termination, employees or their heirs are compensated for up to 300 hours of unused vacation leave at the employee’s hourly rate of pay at the time of termination. Upon retirement, unused vacation leave in excess of 300 hours plus unused sick leave are used to compute retirement benefits. The cost of current leave privileges are recognized as a current-year expense. The cost of leave not requiring current resources is recorded as a long-term obligation.

Pension Plan For purposes of measuring the net pension liability, deferred outflows of resources and deferred inflows of resources related to pensions, and pension expense, information about the fiduciary net position of the Louisiana State Employees’ Retirement System (“LASERS”) and additions to/deductions from the LASERS’ fiduciary net position have been determined on the same basis as they are reported by LASERS. For this purpose, benefit payments (including refunds of employee contributions) are recognized when due and payable in accordance with the benefit terms. Investments are reported at fair value.

2. Deposits with Financial Institutions

For reporting purposes, deposits with financial institutions include demand deposits and money market funds. Deposits in bank accounts are stated at cost, which approximates market. Under state law these deposits must be secured by federal deposit insurance or the pledge of securities owned by the fiscal agent bank. The market value of the pledged securities plus the federal deposit insurance must at all times equal the amount on deposit with the fiscal agent. These pledged securities are held in the name of the pledging fiscal agent bank in a holding custodial bank in the form of safekeeping receipts. The Board’s cash deposits at June 30, 2017 consisted of the following:

Money Cash Market Total Deposits per statement of net position (reconciled bank balance)$ 892,393 $ 57,761 $ 950,154

Deposits held by financial institution$ 900,927 $ 57,761 $ 958,688

Category 3 bank balances: a. Uninsured and uncollateralized$ - $ - $ - b. Uninsured and collateralized with securities held by the pledging institution - - - c. Uninsured and collateralized with securities held by the pledging institution's trust department or agent, but not in the Board's name 400,927 - 400,927 Total category 3 bank balances$ 400,927 $ - $ 400,927

10 Louisiana Board of Pharmacy Notes to Financial Statements

Custodial Deposit Risk In the case of deposits, this is the risk that in the event of a bank failure, the deposits may not be returned to the Board. As of June 30, 2017, $400,927 of the Board’s bank balance was exposed to custodial credit risk because the deposits were uninsured and collateralized with securities held by the pledging institution's trust department or agent but not in the Board’s name. The money market mutual funds are held in federated government reserves.

Money Market Accounts At June 30, 2017, the Board had $57,761 within money market accounts backed by securities issued by the U.S. government and provides daily liquidity. The accounts are not bank deposits and, therefore, are not subject to collateralization. The balance is reported at cost which approximates market.

3. Investments

Investments consists of the following at June 30, 2017:

Moody's Credit Cost Fair Value Interest Rates Quality Rating

U.S. treasury securities$ 4,153,863 $ 4,125,240 1.00% - 1.98% AAA

The following schedule summarizes the Board’s net investment income (loss) as reported on the statement of revenues, expenses, and changes in net position for the year ended June 30, 2017:

Interest income$ 52,198 Decrease in fair value (88,525) $ (36,327)

Credit Risk Credit risk is the risk that an issuer of an investment will not fulfill its obligation to the holder of the investment. This is measured by the assignment of a rating by a national recognized statistical rating organization. The Board limits this risks by holding all investments in U.S. treasury securities which has a Moody’s Investors Service Credit Quality Rating of AAA.

Concentration of Credit Risk Concentration of credit risk is the risk of loss attributed to the magnitude of the Board’s investment in a single issuer. The investment policy of the Board contains no limitations on the amount that can be invested in any one issuer beyond that stipulated by the State of Louisiana.

Interest Rate Risk Interest rate risk is the risk that changes in market interest rates will adversely affect the fair value of an investment. Generally, the longer the maturity of an investment - the greater the sensitivity of its fair value to changes in market interest rates is.

11 Louisiana Board of Pharmacy Notes to Financial Statements

Information about the sensitivity of the fair values of the Board’s investments to market interest rate fluctuations is provided by the following table that shows the distribution of the Board’s investments by maturity:

Less Than 1 to 2 2 to 5 More Than 1 Year Years Years 5 Years Total

U.S. Treasury securities$ - $ 98,842 $ 4,026,398 $ - $ 4,125,240

4. Fair Value Measurements

GASB Statement No. 72, Fair Value Measurements and Application, provides a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The three levels of the fair value hierarchy are described as follows:

 Level 1 inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Board has the ability to access.

 Level 2 inputs to the valuations methodology include: quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in inactive markets; inputs other than quoted prices that are observable for the asset or liability; inputs that are derived principally from or corroborated by observable market data by correlation or other means.

 Level 3 inputs to the valuation methodology are unobservable and significant to the fair value measurement. Unobservable inputs reflect the Board’s own assumptions about the inputs market participants would use in pricing the asset or liability (including assumptions about risk). Unobservable inputs are developed based on the best information available in the circumstances and may include the Board’s own data.

The Board uses appropriate valuation techniques based on the available inputs to measure the fair value of its investments. The asset's fair value measurement level with the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. When available, valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs.

The following table sets forth, by level, the Board’s assets at fair value as of June 30, 2017:

Level 1 Level 2 Level 3 Total Cash equivalents Money market accounts$ - $ 57,761 $ - $ 57,761 Investments U.S. treasury securities - 4,125,240 - 4,125,240 $ - $ 4,183,001 $ - $ 4,183,001

The Board used significant other observable inputs, particularly dealer market prices for comparable investments as of the valuation date (Level2). There have been no changes in the methods and assumptions used in the prior fiscal year.

12 Louisiana Board of Pharmacy Notes to Financial Statements

5. Capital Assets

A summary of changes in capital assets is as follows:

Balance at Balance at 06/30/16 Additions Deletions 06/30/17 Capital assets, not being depreciated Land$ 1,004,940 $ - $ - $ 1,004,940

Capital assets, being depreciated Building and improvements 1,057,861 - - 1,057,861 Furniture, fixtures, and equipment 379,734 2,423 - 382,157 Software 408,560 - - 408,560 1,846,155 2,423 - 1,848,578 2,851,095 2,423 - 2,853,518 Accumulated depreciation (826,997) (60,721) - (887,718) $ 2,024,098 $ (58,298) $ - $ 1,965,800

Depreciation expense for the year ended June 30, 2017 was $60,721.

6. Noncurrent Liabilities

The following is a summary of the long-term obligation transactions for the year ended June 30, 2017:

Balance at Payments and Balance at Due Within 06/30/16 Additions Reductions 06/30/17 One Year

Accrued compensated absences$ 120,417 $ 32,218 $ (31,549) $ 121,086 $ 56,822 Pension liability 4,545,653 1,892,532 (1,101,591) 5,336,594 - Other post-employment benefits 1,172,029 95,809 (58,330) 1,209,508 - $ 5,838,099 $ 2,020,559 $ (1,191,470) $ 6,667,188 $ 56,822

7. Pension Plan

The Board is a participating employer in a statewide, public employee retirement system, the Louisiana State Employees’ Retirement System (“LASERS”). LASERS has a separate board of trustees and administers a cost-sharing, multiple-employer defined benefit pension plan, including classes of employees with different benefits and contribution rates (“subplans”). Article X, Section 29(F) of the Louisiana Constitution of 1974 assigns the authority to establish and amend benefit provisions of all subplans administered by LASERS to the State Legislature. LASERS issues a public report that includes financial statements and required supplementary information, and a copy of the report may be obtained at www.lasersonline.org.

13 Louisiana Board of Pharmacy Notes to Financial Statements

Plan Descriptions/Benefits Provided LASERS administers a plan to provide retirement, disability, and survivor benefits to eligible state employees and their beneficiaries as defined in R.S. 11:411-414. The age and years of creditable service (“service”) required in order for a member to receive retirement benefits are established by R.S. 11:441 and vary depending on the member’s hire date, employer and job classification. Act 992 of the 2010 Regular Legislative Session closed existing sub-plans for members hired before January 1, 2011, and created new subplans for regular members, hazardous duty members, and judges.

The substantial majority of members may retire with full benefits at any age upon completing 30 years of service and at age 60 upon completing 5-10 years of service. Additionally, members may choose to retire with 20 years of service at any age, with an actuarially reduced benefit. Eligibility for retirement benefits and the computation of retirement benefits are provided for in R.S. 11:444. The basic annual retirement benefit for members is equal to a percentage (between 2.5% and 3.5%) of average compensation multiplied by the number of years of service, generally not to exceed 100% of average compensation. Average compensation is defined as the member’s average annual earned compensation for the highest 36 consecutive months of employment for members employed prior to July 1, 2006, or highest 60 consecutive months of employment for members employed after that date. A member leaving service before attaining minimum retirement but after completing certain minimum service requirements, generally 10 years, becomes eligible for a benefit provided the member lives to the minimum service retirement age and does not withdraw the accumulated contributions.

Eligibility requirements and benefit computations for disability benefits are provided for in R.S. 11:461. All members with 10 or more years of service or members aged 60 or older regardless of date of hire who become disabled may receive a maximum disability benefit equivalent to the regular retirement formula without reduction by reason of age. Hazardous duty personnel who become disabled in the line of duty will receive a disability benefit equal to 75% of final average compensation.

Provisions for survivor benefits are provided for in R.S. 11:471-478. Under these statutes, the deceased member who was in state service at the time of death must have a minimum of five years of service, at least two of which were earned immediately prior to death, or who has a minimum of 20 years of service regardless of when earned in order for a benefit to be paid to a minor or handicapped child. Benefits are payable to an unmarried child until age 18 or age 23 if the child remains a full-time student. The minimum service requirement is 10 years for a surviving spouse with no minor children, and benefits are to be paid for life to the spouse or qualified handicapped child.

LASERS has established a Deferred Retirement Option Plan (DROP). When members enter DROP, their status changes from active member to retiree even though they continue to work and draw their salary for a period up to three years. The election is irrevocable once participation begins. During participation, benefits otherwise payable are fixed and deposited in an individual DROP account. Upon leaving DROP, members must choose among available alternatives for the distribution of benefits that have accumulated in their DROP accounts.

Cost of Living Adjustments As fully described in Title 11 of the Louisiana Revised Statutes, LASERS allows for the payment of cost of living adjustments, or COLAs, that are funded through investment earnings when recommended by the board of trustees and approved by the Legislature. These ad hoc COLAs are not considered to be substantively automatic.

14 Louisiana Board of Pharmacy Notes to Financial Statements

Contributions Article X, Section 29(E)(2)(a) of the Louisiana Constitution of 1974 assigns the Legislature the authority to determine employee contributions. Employer contributions are actuarially determined using statutorily established methods on an annual basis and are constitutionally required to cover the employer’s portion of the normal cost and provide for the amortization of the unfunded accrued liability. Employer contributions are adopted by the Legislature annually upon recommendation of the Public Retirement Systems’ Actuarial Committee Employer contributions to LASERS for the fiscal year ended June 30, 2017 were $570,642, with active member contributions ranging from 7.5% to 8%, and employer contributions of 35.80%.

Pension Liabilities, Pension Expense, and Deferred Outflows of Resources and Deferred Inflows of Resources Related to Pensions At June 30, 2017, the Board reported a liability of $5,336,594 for its proportionate share of the LASERS net pension liability. The net pension liability for LASERS was measured as of June 30, 2016, and the total pension liability used to calculate the net pension liability was determined by an actuarial valuation as of that date. The Board’s proportion of the net pension liability was based on projections of the Board’s long-term share of contributions to the pension plan relative to the projected contributions of all participating employers, actuarially determined. As of June 30, 2016, the most recent measurement date, the Board’s proportion and the change in proportion from the prior measurement date was 0.06796%, or an increase of 0.00113%.

For the year ended June 30, 2017, the Board recognized a total pension expense of $663,902. The Board reported deferred outflows of resources and deferred inflows of resources related to pensions from the following sources:

Deferred Deferred Outflows of Inflows of Resources Resources

Differences between expected and actual experience$ 3,090 $ 49,495

Net difference between projected and actual earnings on pension plan investments 664,682 -

Changes in proportion and differences between Employer - - contributions and proportionate share of contributions 75,110 28,891

Employer contributions subsequent to the measurement date 472,877 - $ 1,215,759 $ 78,386

Deferred outflows of resources related to pensions resulting from the Board’s contributions subsequent to the measurement date will be recognized as a reduction of the LASERS net pension liability in the year ended June 30, 2018.

15 Louisiana Board of Pharmacy Notes to Financial Statements

Other amounts reported as deferred outflows of resources and deferred inflows of resources related to pensions will be recognized in pension expense as follows:

Period Ended: Amount

6/30/2018 $ 113,662 6/30/2019 113,971 6/30/2020 258,309 6/30/2021 158,554 $ 644,496

Actuarial Assumptions The total pension liability for LASERS in the June 30, 2016 actuarial valuation was determined using the following actuarial assumptions, applied to all periods included in the measurements:

Valuation date: June 30, 2016

Actuarial Cost Method: Entry age normal cost

Estimated remaining service life ("ERSL"): 3 years

Investment rate of return 7.75% per annum

Inflation rate 3.0% per annum

Salary increases, including inflation and merit increases: 4.0% to 13.0%, including inflation

Cost of living adjustments: Not substantively automatic

Mortality rate Non-disabled members: Mortality rates based on the RP-2000 Combined Healthy Mortality Table Disabled members: Mortality rates based on the RP-2000 Disabled Retiree Mortality Table

16 Louisiana Board of Pharmacy Notes to Financial Statements

The long-term expected rate of return was determined using a building-block method in which best- estimate ranges of expected future real rates of return (expected returns, net of pension plan investment expenses and inflation) are developed for each major asset class. These ranges are combined to produce the long-term expected rate of return by weighting the expected future real rates of return by the target asset allocation percentage and by adding expected inflation and an adjustment for the effect of rebalancing/diversification. The target allocation and best estimates of arithmetic/geometric real rates of return for each major asset class are summarized in the following table:

Expected Portfolio Real Asset Class Rate of Return

Cash -0.24% Domestic equity 4.31% International equity 5.48% Domestic fixed income 1.63% International fixed income 2.47% Alternative investments 7.42% Global tactical asset allocation 2.92% Total fund 5.30%

Discount Rate The discount rate used to measure the total pension liability was 7.75%. The projection of cash flows used to determine the discount rate assumed that employee contributions will be made at the current contribution rate and that employer contributions from participating employers will be made at contractually required rates, actuarially determined. Based on those assumptions, the pension plan’s fiduciary net position was projected to be available to make all projected future benefit payments of current active and inactive plan members. Therefore, the long-term expected rate of return on pension plan investments was applied to all periods of projected benefit payments to determine the total pension liability.

Sensitivity of the Proportionate Share of the Net Pension Liability to Changes in the Discount Rate The following presents the Board’s proportionate share of the net pension liability using the current discount rate as well as what the Board’s proportionate share of the net pension liability would be if it were calculated using a discount rate that is one percentage-point lower or one percentage-point higher than the current rate: Current 1.0% Decrease Discount Rate 1.0% Increase (6.75%) (7.75%) (8.75%) Employer's proportionate share of the net pension liability$ 6,556,500 $ 5,336,594 $ 4,300,057

Pension Plan Fiduciary Net Position Detailed information about LASERS fiduciary net position is available in the separately issued financial reports referenced above.

17 Louisiana Board of Pharmacy Notes to Financial Statements

Payables to the Pension Plan At June 30, 2017, the Board reported accrued retirement of $11,204 for the outstanding amount of employer contributions to the pension plan required for the year ended June 30, 2017. This amount is included as accrued salaries and related expenses on the statement of net position.

Notes to Required Supplementary Information Changes of Benefit Terms include a 1.5% COLA, effective July 1, 2014, provided by Act 102 of the 2014 Louisiana Regular Legislative Session.

8. Post-Employment Health Care and Life Insurance Benefits

Plan Description The Board’s employees may participate in the state of Louisiana’s Other Postemployment Benefit Plan (“OPEB Plan”), an agent multiple-employer defined benefit OPEB Plan that provides medical, prescription drug, and life insurance benefits to eligible active employees, retirees, and their beneficiaries.

The state administers the OPEB Plan through the Office of Group Benefits (“OGB”). R.S. 42:801-883 assigns the authority to establish and amend benefit provisions of the OPEB Plan. OGB offers several standard healthcare plans for both active and retired employees. OGB does not issue a publicly-available financial report of the OPEB Plan; however, it is included in the state of Louisiana's Comprehensive Annual Financial Report (CAFR). The CAFR may be obtained from the Office of Statewide Reporting and Accounting Policy's website at www.doa.la.gov/osrap.

Funding Policy The contribution requirements of OPEB Plan members and the Board are established and may be amended by R.S. 42:801-883. The OPEB Plan is currently funded on a pay-as-you-go basis through a combination of retiree and Board contributions. Employees do not contribute to their postemployment benefits costs until they become retirees and begin receiving those benefits. The retirees contribute to the cost of retiree healthcare based on a service schedule. Contribution amounts vary depending on what healthcare provider is selected from the OPEB Plan and if the member has Medicare coverage. For the year ended June 30, 2017, the Board contributed $58,330 for eight retirees and two surviving spouses.

Employer contributions are based on plan premiums and the employer contribution percentage. This percentage is based on the date of participation in an OGB plan (before or after January 1, 2002) and employee years of service at retirement. Employees who begin participation or rejoin the plan before January 1, 2002, pay approximately 25% of the cost of coverage (except single retirees under age 65 who pay approximately 25% of the active employee cost).

18 Louisiana Board of Pharmacy Notes to Financial Statements

For those beginning participation or rejoining on or after January 1, 2002, the percentage of premiums contributed by the employer and employee is based on the following schedule:

Employer Employee Service Percentage Percentage

Under 10 years 19% 81% 10-14 years 38% 62% 15-19 years 56% 44% 20+ years 75% 25%

In addition to healthcare benefits, retirees may elect to receive life insurance benefits. Basic and supplemental life insurance is available for the individual retiree and spouses of retirees subject to maximum values. Employers pay approximately 50% of monthly premiums. Participating retirees paid $0.54 each month for each $1,000 of life insurance and $0.98 each month for each $1,000 of spouse life insurance.

Annual OPEB Cost and Net OPEB Obligation The Board’s Annual Required Contribution (ARC) represents a level of funding that, if paid on an ongoing basis, is projected to cover the normal cost each year and to amortize any unfunded actuarial liabilities over a period not to exceed 30 years. The annual OPEB cost, the percentage of annual OPEB cost contributed to the plan, and the net OPEB obligation at the end of the year for the Board were as follows:

Annual required contribution (ARC)$ 94,880 Interest on net OPEB obligation 44,537 Adjustment to ARC (43,608) 95,809 Less contributions made (58,330) Increase in net OPEB obligation 37,479 Net OPEB Obligation, beginning of year 1,172,029 Net OPEB Obligation, end of year$ 1,209,508

The following table provides the Board’s annual OPEB cost, the percentage of annual OPEB cost contributed to the plan, and the net OPEB obligation for the last three fiscal years:

Percentage of Fiscal Year Annual Annual OPEB Net OPEB Ended OPEB Cost Cost Contributed Obligation

June 30, 2015$ 122,841 35.58%$ 1,096,000 June 30, 2016 127,327 40.29% 1,172,029 June 30, 2017 95,809 60.88% 1,209,508

19 Louisiana Board of Pharmacy Notes to Financial Statements

Funding Status and Funding Progress As of July 1, 2016 (the most recent actuarial valuation dated July 1, 2015, projected to July 1, 2016), the funded status of the plan was as follows:

Actuarial accrued liability (AAL)$ 1,267,803 Actuarial value of plan assets - Unfunded actuarial accrued liability (UAAL)$ 1,267,803

Funded ratio (actuarial value of plan assets - AAL) -

Covered payroll (annual payroll of active employees covered by the plan)$ 1,337,024

UAAL as a percentage of covered payroll 95%

Actuarial Methods and Assumptions The total OPEB obligation in the July 1, 2016 actuarial valuation was determined using the following actuarial assumptions, applied to all periods included in the measurements:

Valuation date July 1, 2016

Discount rate A 3.8% annual discount rate is assumed

Census data The census was provided by OGB as of January 2017.

Actuarial cost method Projected unit credit

Amortization method The unfunded actuarial accrued liability is amortized over the maximum acceptable period of 30 years on an open basis and calculated assuming a level percentage of projected payroll.

Non-claim expenses Based on the current amounts charged per retired employee and are $13.18 PEPM.

Mortality RP-2014 generational table using MP 2016 projection scale and applied on a gender-specific basis

20 Louisiana Board of Pharmacy Notes to Financial Statements

Actuarial valuations of an ongoing plan involve estimates of the value of reported amounts and assumptions about the probability of occurrence of events far into the future. Examples include assumptions about future employment, mortality, and healthcare cost trend. Amounts determined regarding the funded status of the plan and the annual required contributions are subject to continual revision as actual results are compared with past expectations and new estimates are made about the future.

The schedule of funding progress presented as required supplementary information following the notes to the financial statements presents multiyear trend information that shows whether the actuarial value of plan assets is increasing or decreasing over time relative to the actuarial accrued liabilities for benefits.

Projections of benefits for financial reporting purposes are based on the substantive plan (the plan as understood by the employer and plan members) and include the types of benefits provided at the time of each valuation and the historical pattern of sharing of benefit costs between the employer and the plan members to that point. The actuarial methods and assumptions used include techniques that are designed to reduce short-term volatility in actuarial accrued liabilities consistent with the long-term perspective of the calculations.

The actuarial assumptions included a 4.0 percent investment rate of return (net of administrative expenses). The UAAL is amortized over the maximum acceptable period of 30 years on an open basis. It is calculated using a level percentage of projected payroll. Other critical assumptions used in the actuarial valuation are the health care cost trend rate and participation assumptions. The health care cost trend assumption is used to project the cost of health care to future years. The valuation uses a health care cost trend rate assumption of 7.0% (6.0% post Medicare) in the year July 1, 2016 to June 30, 2017, grading down by 0.5% each year until an ultimate health care cost trend rate of 4.5% is reached. The participation assumption is the assumed percentage of future retirees that participate and enroll in the health plan. The participation breakouts are provided in the following table.

Years of Participation Services Percentage

<10 57% 10 - 14 72% 15 - 19 82% 20+ 100%

21 Louisiana Board of Pharmacy Notes to Financial Statements

9. Operating Leases

The following schedule summarizes the future minimum annual lease payments for office equipment required under the operating leases:

For the Year Ended June 30 Amount

2018$ 14,901 2019 10,822 2020 4,226 $ 29,949

The total payments for operating leases for office equipment during the fiscal year amounted to $15,218.

10. Risk Management

Losses arising from judgments, claims, and similar contingencies are paid through the state’s self- insurance fund operated by the Office of Risk Management, the agency responsible for the state’s risk management program, or by General Fund appropriation.

There is no pending litigation or claims against the Board at June 30, 2017, which if asserted, in the opinion of the Board’s legal advisors, would have at least a reasonable probability of an unfavorable outcome or for which resolution would materially affect the financial statements.

11. Subsequent Events

The Board’s management has evaluated subsequent events through August 29, 2017, which is the date the financial statements were available to be issued.

Required Supplementary Information

Louisiana Board of Pharmacy Schedule of Employer’s Proportionate Share of Net Pension Liability For the Year Ended June 30, 2017

Proportionate Share of the Net Pension Plan Fiduciary Net Liability as a Position as a Proportionate Share Percentage of its Percentage of the Proportion of the Net of the Net Pension Covered Employee Covered Employee Total Pension Fiscal Year* Pension Liability Liability Payroll Payroll Liability

2015 0.06584%$ 4,117,091 $ 1,193,177 345% 65.0% 2016 0.06683% 4,545,653 1,258,895 361% 62.7% 2017 0.06796% 5,336,594 1,310,804 407% 57.7%

*Amounts presented were determined as of the measurement date (previous fiscal year end).

This schedule is intended to show information for 10 years. Additional years will be displayed as they become available.

See independent auditor’s report. 23 Louisiana Board of Pharmacy Schedule of Employer’s Pension Contributions For the Year Ended June 30, 2017

Contributions in Contributions as a Relation to the Percentage of Statutorily Required Statutorily Required Contribution Covered Employee Covered Employee Fiscal Year* Contribution Contribution Deficiency (Excess) Payroll Payroll

2015$ 464,626 $ 464,626 $ - $ 1,258,895 36.9% 2016 455,545 455,545 - 1,230,204 37.0% 2017 469,268 469,268 - 1,310,804 35.8%

*Amounts presented were determined as of the end of the Board's fiscal year.

This schedule is intended to show information for 10 years. Additional years will be displayed as they become available.

See independent auditor’s report. 24 Louisiana Board of Pharmacy Schedule of Funding Progress for OPEB Plan For the Year Ended June 30, 2017

Actuarial UAAL as a Actuarial Accrued Unfunded AAL Funded Covered % of Covered Date of the Value of Assets Liability (AAL) (UAAL) Ratio Payroll Payroll Actuarial Valuation (a) (b) (b - a) (a / b) ( c ) [ (b - a) / c ]

July 1, 2014$ - $ 1,742,900 $ 1,742,900 0%$ 1,186,200 147% July 1, 2015 - 1,800,374 1,800,374 0% 1,255,700 143% July 1, 2016 - 1,267,803 1,267,803 0% 1,337,024 95%

See independent auditor’s report. 25

Other Supplementary Information

Louisiana Board of Pharmacy Schedule of Per Diem Paid to Board Members For the Year Ended June 30, 2017

Name Amount

Allen Cassidy $ 900 Blake Pitre 2,100 Brian Bond 2,700 Carl Aron 3,450 Chris Melancon 2,025 Clovis Burch 300 Deborah Simonson 225 Diane Milano 1,275 Don Resweber 1,350 Douglas Robichaux 1,725 Jacqueline Hall 1,050 Marty McKay 2,250 Pamela Reed 225 Raymond Strong 450 Rhonny Valentine 1,875 Richard Soileau 1,800 Richard Indovina, Jr. 2,025 Richard Mannino 450 Ronald Moore 525 Ryan Dartez 75 Morris Rabb 2,400 $ 29,175

The schedule of per diem paid to board members is presented in compliance with House Concurrent Resolution No. 54 of the 1979 Session of the Louisiana Legislature.

See independent auditor’s report 26

Reports Required by

Government Auditing Standards

To the Board Members of Louisiana Board of Pharmacy Baton Rouge, Louisiana

We have audited, in accordance with the auditing standards generally accepted in the United States of America and the standards applicable to financial audits contained in Government Auditing Standards issued by the Comptroller General of the United States, the financial statements of the business-type activities of the Louisiana Board of Pharmacy, as of and for the year ended June 30, 2017, and the related notes to the financial statements, which collectively comprise the Louisiana Board of Pharmacy’s basic financial statements, and have issued our report thereon dated August 29, 2017.

Internal Control Over Financial Reporting

In planning and performing our audit of the financial statements, we considered the Louisiana Board of Pharmacy’s internal control over financial reporting (“internal control”) to determine the audit procedures that are appropriate in the circumstances for the purpose of expressing our opinions on the financial statements, but not for the purpose of expressing an opinion on the effectiveness of the Louisiana Board of Pharmacy’s internal control. Accordingly, we do not express an opinion on the effectiveness of the Louisiana Board of Pharmacy’s internal control.

A deficiency in internal control exists when the design or operation of a control does not allow management or employees, in the normal course of performing their assigned functions, to prevent, or detect and correct, misstatements on a timely basis. A material weakness is a deficiency, or a combination of deficiencies, in internal control, such that there is a reasonable possibility that a material misstatement of the entity’s financial statements will not be prevented, or detected and corrected on a timely basis. A significant deficiency is a deficiency, or a combination of deficiencies, in internal control that is less severe than a material weakness, yet important enough to merit attention by those charged with governance.

Our consideration of internal control was for the limited purpose described in the first paragraph of this section and was not designed to identify all deficiencies in internal control that might be material weaknesses or significant deficiencies. Given these limitations, during our audit we did not identify any deficiencies in internal control that we consider to be material weaknesses. However, material weaknesses may exist that have not been identified.

27 To the Board Members Louisiana Board of Pharmacy Page 2

Compliance and Other Matters

As part of obtaining reasonable assurance about whether the Louisiana Board of Pharmacy’s financial statements are free from material misstatement, we performed tests of its compliance with certain provisions of laws, regulations, contracts, and grant agreements, noncompliance with which could have a direct and material effect on the determination of financial statement amounts. However, providing an opinion on compliance with those provisions was not an objective of our audit, and accordingly, we do not express such an opinion. The results of our tests disclosed no instances of noncompliance or other matters that are required to be reported under Government Auditing Standards.

Purpose of this Report

The purpose of this report is solely to describe the scope of our testing of internal control and compliance and the results of that testing, and not to provide an opinion on the effectiveness of the entity’s internal control or on compliance. This report is an integral part of an audit performed in accordance with Government Auditing Standards in considering the entity’s internal control and compliance. Accordingly, this communication is not suitable for any other purpose. Under Louisiana Revised Statute 24:513, this communication is distributed by the Louisiana Legislative Auditor as a public document.

Covington, Louisiana August 29, 2017

28 Louisiana Board of Pharmacy Summary of Auditor’s Results and Schedule of Findings For the Year Ended June 30, 2017

A. Summary of Auditor’s Results

Financial Statements a. Type of auditor's report issued: Unmodified b. Internal control over financial reporting:

Material weaknesses identified yes  no

Significant deficiencies identified that are not considered to be material weaknesses yes  none noted c. Noncompliance material to financial statements noted yes  no

B. Findings in Accordance with Government Auditing Standards

None noted.

A management letter was issued for the year ended June 30, 2017.

29 Louisiana Board of Pharmacy Summary Schedule of Prior Year Findings For the Year Ended June 30, 2017

A. Findings in Accordance with Government Auditing Standards

None noted.

Annual Fiscal Report

Louisiana Board of Pharmacy Annual Fiscal Report For the Year Ended June 30, 2017

The following annual fiscal report to the Office of the Governor, Division of Administration, Office of Statewide Reporting and Accounting Policy presents the financial position of the Louisiana Board of Pharmacy as of June 30, 2017, and the results of its operations (including cash flows) for the year then ended. The information is presented in the format requested by the Office of Statewide Reporting and Accounting Policy for consolidation into the Louisiana Comprehensive Annual Financial Report.

See independent auditor’s report. 31 ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

STATEMENT OF NET POSITION ASSETS CURRENT ASSETS: CASH AND CASH EQUIVALENTS 950,154.37 INVESTMENTS: OTHER INVESTMENTS 0.00 RESTRICTED INVESTMENTS - CURRENT 0.00 RECEIVABLES (NET): RECEIVABLES - EMPLOYER CONTRIBUTION RECEIVABLES - EMPLOYER CONTRIBUTION (GROSS) 0.00 RECEIVABLES - EMPLOYER CONTRIBUTION (ALLOWANCE FOR 0.00 UNCOLLECTIBLES) RECEIVABLES - TUITION AND FEES RECEIVABLES - TUITION AND FEES (GROSS) 0.00 RECEIVABLES - TUITION AND FEES (ALLOWANCE FOR 0.00 UNCOLLECTIBLES) RECEIVABLES - OTHER RECEIVABLES - OTHER (GROSS) 14,593.74 RECEIVABLES - OTHER (ALLOWANCE FOR UNCOLLECTIBLES) 0.00 PLEDGES RECEIVABLE (NET) - CURRENT 0.00 LEASES RECEIVABLE - CURRENT 0.00 DERIVATIVE INSTRUMENTS 0.00 DUE FROM OTHER FUNDS 0.00 DUE FROM FEDERAL GOVERNMENT 0.00 INVENTORIES 0.00 PREPAYMENTS 6,600.00 NOTES RECEIVABLE - CURRENT 0.00 OTHER CURRENT ASSETS 11,351.37 TOTAL CURRENT ASSETS $982,699.48

NONCURRENT ASSETS: RESTRICTED ASSETS: RESTRICTED CASH - NONCURRENT 0.00 RESTRICTED INVESTMENTS - NONCURRENT 0.00 RESTRICTED RECEIVABLES 0.00 RESTRICTED NOTES RECEIVABLE 0.00 OTHER RESTRICTED ASSETS 0.00 INVESTMENTS - NONCURRENT 4,125,239.71 RECEIVABLES (NET) - NONCURRENT: NON-CURRENT RECEIVABLES - EMPLOYER CONTRIBUTIONS 0.00 NON-CURRENT RECEIVABLES - TUITION AND FEES 0.00 NON-CURRENT RECEIVABLES - OTHER 0.00 NOTES RECEIVABLE - NONCURRENT 0.00 PLEDGES RECEIVABLE - NONCURRENT 0.00 LEASES RECEIVABLE - NONCURRENT 0.00 CAPITAL ASSETS: LAND 1,004,939.90 BUILDING & IMPROVEMENTS BUILDINGS AND IMPROVEMENTS (GROSS) 1,057,861.29 BUILDING & IMPROVEMENTS (ACCUMULATED DEPRECIATION) (198,481.40) MACHINERY & EQUIPMENT MACHINERY AND EQUIPMENT (GROSS) 790,716.81 MACHINERY & EQUIPMENT (ACCUMULATED DEPRECIATION) (689,236.91) INFRASTRUCTURE ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

INFRASTRUCTURE (GROSS) 0.00 INFRASTRUCTURE (ACCUMULATED DEPRECIATION) 0.00 INTANGIBLE ASSETS INTANGIBLE ASSETS (GROSS) 0.00 INTANGIBLE ASSETS (ACCUMULATED AMORTIZATION) 0.00 CONSTRUCTION IN PROGRESS 0.00 OTHER NONCURRENT ASSETS 0.00 TOTAL NONCURRENT ASSETS $6,091,039.40 TOTAL ASSETS $7,073,738.88

DEFERRED OUTFLOWS OF RESOURCES ACCUMULATED DECREASE IN FAIR VALUE OF HEDGING DERIVATIVES 0.00 DEFERRED AMOUNTS ON DEBT REFUNDING 0.00 ADJUSTMENT OF CAPITAL LEASE OBLIGATIONS 0.00 GRANTS PAID PRIOR TO MEETING TIME REQUIREMENTS 0.00 INTRA-ENTITY TRANSFER OF FUTURE REVENUES 0.00 LOSSES FROM SALE-LEASEBACK TRANSACTIONS 0.00 DIRECT LOAN ORIGINATION COSTS FOR MORTGAGE LOANS HELD FOR SALE 0.00 FEES PAID TO PERMANENT INVESTORS PRIOR TO SALE OF MORTGAGE 0.00 LOANS PENSION-RELATED DEFERRED OUTFLOWS OF RESOURCES 1,215,759.00 TOTAL DEFERRED OUTFLOWS OF RESOURCES $1,215,759.00

LIABILITIES CURRENT LIABILITIES: ACCOUNTS PAYABLE SALARIES, WAGES & RELATED BENEFITS 45,145.60 TRAVEL & TRAINING 0.00 OPERATING SERVICES 4,975.76 PROFESSIONAL SERVICES 0.00 SUPPLIES 0.00 GRANTS & PUBLIC ASSISTANCE 0.00 OTHER CHARGES 0.00 CAPITAL OUTLAY 0.00 ACCRUED INTEREST 0.00 DERIVATIVE INSTRUMENTS 0.00 DUE TO OTHER FUNDS 0.00 DUE TO FEDERAL GOVERNMENT 0.00 UNEARNED REVENUES 0.00 AMOUNTS HELD IN CUSTODY FOR OTHERS 400.00 OTHER CURRENT LIABILITIES 0.00 CURRENT PORTION OF LONG-TERM LIABILITIES: CONTRACTS PAYABLE 0.00 COMPENSATED ABSENCES PAYABLE 56,822.31 CAPITAL LEASE OBLIGATIONS 0.00 NOTES PAYABLE 0.00 BONDS PAYABLE 0.00 POLLUTION REMEDIATION OBLIGATIONS 0.00 ESTIMATED LIABILITY FOR CLAIMS 0.00 OTHER LONG-TERM LIABILITIES 0.00 TOTAL CURRENT LIABILITIES $107,343.67

NONCURRENT PORTION OF LONG-TERM LIABILITIES: CONTRACTS PAYABLE 0.00 ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

COMPENSATED ABSENCES PAYABLE 64,263.96 CAPITAL LEASE OBLIGATIONS 0.00 NOTES PAYABLE 0.00 BONDS PAYABLE 0.00 POLLUTION REMEDIATION OBLIGATIONS 0.00 ESTIMATED LIABILITY FOR CLAIMS 0.00 NET OPEB OBLIGATION 1,209,508.00 NET PENSION LIABILITY 5,336,594.00 OTHER LONG-TERM LIABILITIES 0.00 TOTAL LONG-TERM LIABILITIES $6,610,365.96 TOTAL LIABILITIES $6,717,709.63

DEFERRED INFLOWS OF RESOURCES ACCUMULATED INCREASE IN FAIR VALUE OF HEDGING DERIVATIVES 0.00 DEFERRED AMOUNTS ON DEBT REFUNDING 0.00 ADJUSTMENT OF CAPITAL LEASE OBLIGATIONS 0.00 GRANTS RECEIVED PRIOR TO MEETING TIME REQUIREMENTS 0.00 SALES/INTRA-ENTITY TRANSFER OF FUTURE REVENUES 0.00 GAINS FROM SALE-LEASEBACK TRANSACTIONS 0.00 POINTS RECEIVED ON LOAN ORIGINATION 0.00 LOAN ORIGINATION FEES RECEIVED FOR MORTGAGE LOANS HELD FOR SALE 0.00 PENSION-RELATED DEFERRED INFLOWS OF RESOURCES 78,386.00 TOTAL DEFERRED INFLOWS OF RESOURCES $78,386.00

NET POSITION: NET INVESTMENT IN CAPITAL ASSETS 1,965,799.69 RESTRICTED FOR: CAPITAL PROJECTS 0.00 UNEMPLOYMENT COMPENSATION 0.00 ENDOWMENTS - EXPENDABLE 0.00 ENDOWMENTS - NONEXPENDABLE 0.00 DEBT SERVICE 0.00 OTHER PURPOSES 0.00 UNRESTRICTED $(472,397.44) TOTAL NET POSITION $1,493,402.25 ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

STATEMENT OF REVENUES, EXPENSES, AND CHANGES IN NET POSITION

OPERATING REVENUES: SALES OF COMMODITIES & SERVICES 0.00 ASSESSMENTS 0.00 USE OF MONEY & PROPERTY 0.00 LICENSES, PERMITS & FEES 3,228,078.78 FEDERAL GRANTS & CONTRACTS 0.00 OTHER 0.00 TOTAL OPERATING REVENUES $3,228,078.78

OPERATING EXPENSES: COST OF SALES & SERVICES 682,889.77 ADMINISTRATIVE 2,248,596.50 DEPRECIATION 60,720.98 AMORTIZATION 0.00 UNEMPLOYMENT INSURANCE BENEFITS 0.00 TOTAL OPERATING EXPENSES $2,992,207.25

OPERATING INCOME (LOSS) $235,871.53

NONOPERATING REVENUES(EXPENSES) NON-OPERATING INTERGOVERNMENTAL REVENUES 0.00 NON-OPERATING INTERGOVERNMENTAL EXPENSES 0.00 GAIN ON SALE OF CAPITAL ASSETS 0.00 LOSS ON SALE OF CAPITAL ASSETS 0.00 FEDERAL GRANTS 0.00 INTEREST EXPENSE 0.00 OTHER NON-OPERATING REVENUES 52,197.81 OTHER NON-OPERATING EXPENSES (88,524.82) TOTAL NONOPERATING REVENUES (EXPENSES) $(36,327.01)

INCOME (LOSS) BEFORE CONTRIBUTIONS AND TRANSFERS $199,544.52

CAPITAL CONTRIBUTIONS 0.00 TRANSFERS IN 0.00 TRANSFERS OUT 0.00

CHANGE IN NET POSITION $199,544.52

NET POSITION - BEGINNING $1,292,796.72 NET POSITION - RESTATEMENT 1,061.01

ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

NET POSITION - ENDING $1,493,402.25 ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

STATEMENT OF CASH FLOWS

CASH FLOWS FROM OPERATING ACTIVITIES: RECEIPTS FROM CUSTOMERS 3,213,815.04 RECEIPTS FROM INTERFUND SERVICES PROVIDED 0.00 RECEIPTS FROM INTERFUND REIMBURSEMENTS 0.00 RECEIPTS OF PRINCIPAL/INTEREST FROM LOAN PROGRAMS 0.00 OTHER OPERATING RECEIPTS 0.00 PAYMENTS TO SUPPLIERS & SERVICE PROVIDERS (545,114.38) PAYMENTS FOR LOANS MADE UNDER LOAN PROGRAMS 0.00 PAYMENTS TO EMPLOYEES FOR SERVICES (2,120,987.72) PAYMENTS FOR INTERFUND SERVICES USED 0.00 PAYMENTS FOR SCHOLARSHIPS AND FELLOWSHIPS 0.00 OTHER OPERATING PAYMENTS 0.00 NET CASH PROVIDED (USED) BY OPERATING ACTIVITIES $547,712.94

CASH FLOWS FROM NONCAPITAL FINANCING ACTIVITIES: PROCEEDS FROM THE ISSUANCE OF NON-CAPITAL DEBT 0.00 RECEIPTS FROM OPERATING GRANTS 0.00 RECEIPTS FROM OTHER FUNDS 0.00 PAYMENTS FOR PRINCIPAL ON NON-CAPITAL DEBT 0.00 PAYMENTS FOR INTEREST ON NON-CAPITAL DEBT 0.00 PAYMENTS FOR GRANTS AND SUBSIDIES 0.00 PAYMENTS TO OTHER FUNDS 0.00 NET CASH PROVIDED (USED) BY NONCAPITAL FINANCING ACTIVITIES $0.00

CASH FLOWS FROM CAPITAL AND RELATED FINANCING ACTIVITIES: PROCEEDS FROM THE ISSUANCE OF CAPITAL DEBT 0.00 RECEIPTS FROM CAPITAL GRANTS 0.00 PROCEEDS FROM THE SALE OF CAPITAL ASSETS 0.00 PAYMENTS TO ACQUIRE, CONSTRUCT & IMPROVE CAPITAL ASSETS (2,422.99) PAYMENTS FOR PRINCIPAL ON CAPITAL DEBT 0.00 PAYMENTS FOR INTEREST ON CAPITAL DEBT 0.00

NET CASH PROVIDED (USED) BY CAPITAL AND RELATED FINANCING $(2,422.99) ACTIVITIES

CASH FLOWS FROM INVESTING ACTIVITIES: PURCHASES OF INVESTMENTS (873,225.86) PROCEEDS FROM THE SALE OF INVESTMENTS 0.00 INTEREST AND DIVIDENDS 52,196.34 NET CASH PROVIDED (USED) BY INVESTING ACTIVITIES $(821,029.52)

NET INCREASE/(DECREASE) IN CASH & CASH EQUIVALENTS $(275,739.57)

ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

CASH & CASH EQUIVALENTS AT BEGINNING OF YEAR 1,225,893.94 RESTATEMENT OF BEGINNING CASH AND CASH EQUIVALENTS 0.00

CASH & CASH EQUIVALENTS AT END OF YEAR $950,154.37

RECONCILIATION OF OPERATING INCOME (LOSS) TO NET CASH PROVIDED (USED) BY OPERATING ACTIVITIES:

OPERATING INCOME (LOSS) $235,871.53

ADJUSTMENTS TO RECONCILE OPERATING INCOME (LOSS) TO NET CASH PROVIDED (USED) BY OPERATING ACTIVITIES: DEPRECIATION/AMORTIZATION 60,720.98 PROVISION FOR UNCOLLECTIBLE ACCOUNTS 0.00 NONEMPLOYER CONTRIBUTING ENTITY REVENUE 0.00 OTHER 0.00 (INCREASE)/DECREASE IN ACCOUNTS RECEIVABLE (14,263.74) (INCREASE)/DECREASE IN DUE FROM OTHER FUNDS 0.00 (INCREASE)/DECREASE IN PREPAYMENTS 23,300.00 (INCREASE)/DECREASE IN INVENTORIES 0.00 (INCREASE)/DECREASE IN OTHER ASSETS 0.00 (INCREASE)/DECREASE IN DEFERRED OUTFLOWS RELATED TO PENSIONS (616,777.00) INCREASE/(DECREASE) IN ACCOUNTS PAYABLE & ACCRUALS 278.89 INCREASE/(DECREASE) IN COMPENSATED ABSENCES 669.07 INCREASE/(DECREASE) IN DUE TO OTHER FUNDS 0.00 INCREASE/(DECREASE) IN UNEARNED REVENUES 0.00 INCREASE/(DECREASE) IN NET OPEB OBLIGATION 37,479.00 INCREASE/(DECREASE) IN NET PENSION LIABILITY 790,941.00 INCREASE/(DECREASE) IN OTHER LIABILITIES 13,087.21 INCREASE/(DECREASE) IN DEFERRED INFLOWS RELATED TO PENSIONS 16,406.00

NET CASH PROVIDED (USED) BY OPERATING ACTIVITIES $547,712.94 ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

STATEMENT OF CASH FLOWS NONCASH INVESTING, CAPITAL, AND FINANCING ACTIVITIES

Description Amount BORROWING UNDER CAPITAL LEASE(S) 0.00 GAIN ON DISPOSAL OF CAPITAL ASSETS 0.00 LOSS ON DISPOSAL OF CAPITAL ASSETS 0.00 CONTRIBUTIONS OF CAPITAL ASSETS 0.00

OTHER (specify below): 0.00 ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

DEPOSITS WITH FINANCIAL INSTITUTIONS (BANK BALANCES)

Uninsured and Collateralized with Uninsured and Securities Held by the Collateralized with Pledging Institution's Trust Uninsured and Securities Held by the Dept.or Agency but not in Total Deposits Uncollateralized Pledging Institution the Agency's Name (Bank Balance) (Bank Balance) (Bank Balance) (Bank Balance) Cash 892,393.00 0.00 0.00 400,927.00

Non-Negotiable Certificates of 0.00 0.00 0.00 0.00 Deposits Money Market Demand Accounts* 57,761.00 0.00 0.00 0.00 Total $950,154.00 $0.00 $0.00 $400,927.00

Do NOT include any cash or CD's on deposit with the State Treasurer *DOES NOT Include Money Market Mutual Funds ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

INVESTMENTS

Fair Market Value Valuation Credit Interest Type of Investment Value Hierarchy Techniques Custodial Credit Risk Risk Rate Risk US Government Obligations $4,125,240.00 Level 2 - Significant Other Dealer market prices Not Applicable 1 to 5 years (including Fannie Mae & Freddie Observable Inputs Mac) > 12 Months to Maturity at Purchase Date

Totals $4,125,240.00

Investments should be listed according to their investment type, FMV hierarchy if applicable, and risk disclosures as applicable Note: Investment types may be used multiple times depending on their FMV hierarchy and applicable risk disclosures. See the cash & investment note section of the instructions for details on completing this note. ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

CHANGES IN VALUATION TECHNIQUES

Type of Investment Current Year Valuation Technique Prior Year Valuation Technique Reason For Change US Government Obligations (including Fannie Level 2 Level 1 To correct entry error from Mae & Freddie Mac) > 12 Months to Maturity previous year at Purchase Date

GASB Statement No. 72 requires governments to use valuation techniques in assessing the fair value of investments. Per the standard, these valuation techniques should be applied consistently across accounting periods. However, when a government determines that another measurement is more representative of fair value, a change of valuation technique is permitted and disclosure is required. ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

DUES AND TRANSFERS

Account Type Amounts due from Other Funds Intercompany (Fund) Amount

Total $0.00

Account Type Amounts due to Other Funds Intercompany (Fund) Amount

Total $0.00

Account Type Transfers In Intercompany (Fund) Amount

Total $0.00

Account Type Transfers Out Intercompany (Fund) Amount

Total $0.00 ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

SCHEDULE OF CAPITAL ASSETS (INCLUDES CAPITAL LEASES)

Restated Beginning Prior Period Beginning Balance Adjustments Balance Additions Deletions Ending Balance Capital assets not depreciated: Land 1,004,939.90 0.00 $1,004,939.90 0.00 0.00 $1,004,939.90 Construction in progress 0.00 0.00 $0.00 0.00 0.00 $0.00 Total capital assets not depreciated $1,004,939.90 $0.00 $1,004,939.90 $0.00 $0.00 $1,004,939.90 Other capital assets: Buildings 1,057,861.29 0.00 $1,057,861.29 0.00 0.00 $1,057,861.29 Accumulated depreciation (137,780.42) (0.53) $(137,780.95) (60,700.45) 0.00 $(198,481.40) Total Buildings $920,080.87 $(0.53) $920,080.34 $(60,700.45) $0.00 $859,379.89 Machinery & Equipment 379,733.82 408,560.00 $788,293.82 2,422.99 0.00 $790,716.81 Accumulated depreciation (294,680.81) (394,535.57) $(689,216.38) (20.53) 0.00 $(689,236.91) Total Machinery & Equipment $85,053.01 $14,024.43 $99,077.44 $2,402.46 $0.00 $101,479.90 Infrastructure 0.00 0.00 $0.00 0.00 0.00 $0.00 Accumulated depreciation 0.00 0.00 $0.00 0.00 0.00 $0.00 Total Infrastructure $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 Intangibles 408,560.00 (408,560.00) $0.00 0.00 0.00 $0.00 Accumulated Amortization (394,535.57) 394,535.57 $0.00 0.00 0.00 $0.00 Total Intangibles $14,024.43 $(14,024.43) $0.00 $0.00 $0.00 $0.00 Total other capital assets $1,019,158.31 $(0.53) $1,019,157.78 $(58,297.99) $0.00 $960,859.79

Depreciation Total: $(60,720.98) ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

PENSIONS

Employer Contributions to the System: Pension Plan between the Covered-Employee Payroll Measurement Date and the during the Entity's Current Employer's Fiscal Year-end Fiscal Year LASERS 472,877.00 1,310,803.74 TRSL 0.00 0.00 LSERS 0.00 0.00 DARS 0.00 0.00 LCCRRF 0.00 0.00 ROVERS 0.00 0.00

ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

Other Postemployment Benefits (OPEB) - Office of Group Benefits (OGB)

ARC 94,880.00 Interest on NOO 44,537.00 ARC adjustment (43,608.00) Annual OPEB expense $95,809.00 Contributions (Employer payments to OGB for retirees' CY insurance premiums) (58,330.00) Increase in Net OPEB Obligation $37,479.00 NOO, beginning of year 1,172,029.00 NOO, ending of year $1,209,508.00

ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

OPERATING LEASES

Buildings Equipment Land Total 2017 0.00 15,218.00 0.00 $15,218.00 2018 0.00 14,901.00 0.00 $14,901.00 2019 0.00 10,822.00 0.00 $10,822.00 2020 0.00 4,226.00 0.00 $4,226.00 2021 0.00 0.00 0.00 $0.00 2022 0.00 0.00 0.00 $0.00 2023 0.00 0.00 0.00 $0.00 2024 0.00 0.00 0.00 $0.00 2025 0.00 0.00 0.00 $0.00 2026 0.00 0.00 0.00 $0.00 2027 0.00 0.00 0.00 $0.00 2028 0.00 0.00 0.00 $0.00 2029 0.00 0.00 0.00 $0.00 2030 0.00 0.00 0.00 $0.00 2031 0.00 0.00 0.00 $0.00 2032 0.00 0.00 0.00 $0.00 2033 0.00 0.00 0.00 $0.00 2034 0.00 0.00 0.00 $0.00 2035 0.00 0.00 0.00 $0.00 2036 0.00 0.00 0.00 $0.00 2037 0.00 0.00 0.00 $0.00 2038 0.00 0.00 0.00 $0.00 2039 0.00 0.00 0.00 $0.00 2040 0.00 0.00 0.00 $0.00 2041 0.00 0.00 0.00 $0.00 2042 0.00 0.00 0.00 $0.00 Total $0.00 $45,167.00 $0.00 $45,167.00

ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

CAPITAL LEASES

Buildings Equipment Land Total 2017 0.00 0.00 0.00 $0.00 2018 0.00 0.00 0.00 $0.00 2019 0.00 0.00 0.00 $0.00 2020 0.00 0.00 0.00 $0.00 2021 0.00 0.00 0.00 $0.00 2022 0.00 0.00 0.00 $0.00 2023 0.00 0.00 0.00 $0.00 2024 0.00 0.00 0.00 $0.00 2025 0.00 0.00 0.00 $0.00 2026 0.00 0.00 0.00 $0.00 2027 0.00 0.00 0.00 $0.00 2028 0.00 0.00 0.00 $0.00 2029 0.00 0.00 0.00 $0.00 2030 0.00 0.00 0.00 $0.00 2031 0.00 0.00 0.00 $0.00 2032 0.00 0.00 0.00 $0.00 2033 0.00 0.00 0.00 $0.00 2034 0.00 0.00 0.00 $0.00 2035 0.00 0.00 0.00 $0.00 2036 0.00 0.00 0.00 $0.00 2037 0.00 0.00 0.00 $0.00 2038 0.00 0.00 0.00 $0.00 2039 0.00 0.00 0.00 $0.00 2040 0.00 0.00 0.00 $0.00 2041 0.00 0.00 0.00 $0.00 2042 0.00 0.00 0.00 $0.00 Total $0.00 $0.00 $0.00 $0.00 Less amounts representing executory costs 0.00 0.00 0.00 $0.00 Net minimum lease payments $0.00 $0.00 $0.00 $0.00 Less amounts representing interest 0.00 0.00 0.00 $0.00 Present value of net minimum lease payments $0.00 $0.00 $0.00 $0.00

Gross Amount of Leased Asset (Historical Cost) 0.00 0.00 0.00 $0.00

ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

LESSOR LEASES

Cost 0.00 0.00 0.00 $0.00 Accumulated Depreciation 0.00 0.00 Carrying Value $0.00 $0.00 ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

LONG-TERM DEBT

Restated Beginning Prior Period Beginning Ending Due within Balance Adjustments Balance Additions Deletions Balance one year Bonds Payable: Bond Series:

0.00 0.00 0.00 0.00 0.00 0.00 0.00

Unamortized bond premiums and 0.00 0.00 $0.00 0.00 0.00 $0.00 0.00 discounts Total bonds payable $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00

Other Liabilities: Compensated absences payable 120,417.20 0.00 $120,417.20 669.07 0.00 $121,086.27 Capital lease obligations 0.00 0.00 $0.00 0.00 0.00 $0.00 Notes payable 0.00 0.00 $0.00 0.00 0.00 $0.00 Contracts payable 0.00 0.00 $0.00 0.00 0.00 $0.00 Pollution remediation obligation 0.00 0.00 $0.00 0.00 0.00 $0.00 Net OPEB obligation 1,172,029.00 0.00 $1,172,029.00 37,479.00 0.00 $1,209,508.00 Claims and litigation 0.00 0.00 $0.00 0.00 0.00 $0.00 Federal disallowed costs 0.00 0.00 $0.00 0.00 0.00 $0.00 Other long-term liabilities 4,545,448.82 0.00 $4,545,448.82 0.00 (4,545,448.82) $0.00 Total other liabilities $5,837,895.02 $0.00 $5,837,895.02 $38,148.07 $(4,545,448.82) $1,330,594.27 ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

SCHEDULE OF BONDS PAYABLE AMORTIZATION

Fiscal Year Ending: Principal Interest 2018 0.00 0.00 2019 0.00 0.00 2020 0.00 0.00 2021 0.00 0.00 2022 0.00 0.00 2023 0.00 0.00 2024 0.00 0.00 2025 0.00 0.00 2026 0.00 0.00 2027 0.00 0.00 2028 0.00 0.00 2029 0.00 0.00 2030 0.00 0.00 2031 0.00 0.00 2032 0.00 0.00 2033 0.00 0.00 2034 0.00 0.00 2035 0.00 0.00 2036 0.00 0.00 2037 0.00 0.00 2038 0.00 0.00 2039 0.00 0.00 2040 0.00 0.00 2041 0.00 0.00 2042 0.00 0.00 2043 0.00 0.00 2044 0.00 0.00 2045 0.00 0.00 2046 0.00 0.00 2047 0.00 0.00 2048 0.00 0.00 2049 0.00 0.00 2050 0.00 0.00 2051 0.00 0.00 2052 0.00 0.00 Premiums and Discounts $0.00

Total $0.00 $0.00

ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

SCHEDULE OF NOTES PAYABLE AMORTIZATION

Total $0.00 $0.00

ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

CONTINGENCIES AND COMMITMENTS

Description of Litigation Date of Action Amount

ANNUAL FISCAL REPORT (AFR) FOR 2017

AGENCY: 7-15-12 - Louisiana Board of Pharmacy PREPARED BY: Malcolm Broussard PHONE NUMBER: 225-925-6481 EMAIL ADDRESS: [email protected] SUBMITTAL DATE: 08/29/2017 04:29 PM

FUND BALANCE/NET POSITION RESTATEMENT

Account Name/Description Restatement Amount DEFERRED OUTFLOWS OF RESOURCES - PENSION-RELATED DEFERRED OUTFLOWS OF RESOURCES 143.08 Description: Auditor adjustment DEFERRED INFLOWS OF RESOURCES - PENSION-RELATED DEFERRED INFLOWS OF RESOURCES 1,122.11 Description: Auditor adjustment NONCURRENT LIABILITIES - NET PENSION LIABILITY Description: (204.18) Auditor adjustment

Total $1,061.01 I

115TH CONGRESS 1ST SESSION H. R. 3446

To help States combat abuse of occupational licensing laws by economic incumbents, to promote competition, to encourage innovation, to protect consumers, and to facilitate the restoration of antitrust immunity to State occupational boards, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

JULY 27, 2017 Mr. ISSA introduced the following bill; which was referred to the Committee on the Judiciary

A BILL To help States combat abuse of occupational licensing laws by economic incumbents, to promote competition, to encourage innovation, to protect consumers, and to facilitate the restoration of antitrust immunity to State occupational boards, and for other purposes.

1 Be it enacted by the Senate and House of Representa- 2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE. 4 This Act may be cited as the ‘‘Restoring Board Im- 5 munity Act of 2017’’ or the ‘‘RBI Act’’.

6 SEC. 2. STATEMENT OF FINDINGS AND PURPOSE. 7 Congress finds the following:

VerDate Sep 11 2014 03:58 Aug 08, 2017 Jkt 069200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3446.IH H3446 SSpencer on DSKBBV9HB2PROD with BILLS 2 1 (1) The prevalence of occupational licensing has 2 increased dramatically in recent decades, in part be- 3 cause private interests have sought licensing in order 4 to limit competition. 5 (2) Occupational licensing often limits opportu- 6 nities for workers, frustrates entrepreneurs seeking 7 to introduce new business models, and raises prices 8 paid by consumers. 9 (3) Licensing should be imposed only to combat 10 real, substantial threats to public health, safety, or 11 welfare and only where other less restrictive regu- 12 latory alternatives are insufficient to protect con- 13 sumers and serve the public interest. 14 (4) Regulators should consider a range of less 15 restrictive alternatives before enacting an occupa- 16 tional licensing regime, which may include inspec- 17 tions, bonding or insurance requirements, registra- 18 tion, and voluntary certification. 19 (5) Voluntary certification provides a particu- 20 larly significant alternative to licensure, as it allows 21 market participants to signal to consumers the at- 22 tainment of personal qualifications without limiting 23 entry into the marketplace. 24 (6) The failure of State governments to adopt 25 less restrictive alternatives to licensing, and less bur-

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12 SEC. 3. DEFINITIONS. 13 In this Act:

14 (1) CERTIFICATION.—The term ‘‘certification’’ 15 means a voluntary program under which— 16 (A) a private organization (in the case of 17 private certification) or the government of a 18 State (in the case of government certification) 19 authorizes an individual who meets certain per- 20 sonal qualifications to use ‘‘certified’’ as a des- 21 ignated title with respect to the performance of 22 a lawful occupation; and 23 (B) a non-certified individual may perform 24 the lawful occupation for compensation but may 25 not use the title ‘‘certified’’.

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1 (2) GOOD FAITH.—The term ‘‘good faith’’, with 2 respect to performance— 3 (A) means diligent performance that is di- 4 rected towards achieving the policies set forth 5 in this Act; 6 (B) does not include performance that is— 7 (i) designed to subvert or evade the 8 policies set forth in this Act; or 9 (ii) carried out in a manner that has 10 the systematic effect of subverting or evad- 11 ing the policies set forth in this Act; and 12 (C) refers to an objective, rather than sub- 13 jective, standard.

14 (3) LAWFUL OCCUPATION.—The term ‘‘lawful 15 occupation’’ means a course of conduct, pursuit, or 16 profession that includes the sale of goods or services 17 that are not themselves illegal to sell irrespective of 18 whether the individual selling the goods or services 19 is subject to occupational licensing laws.

20 (4) LEAST RESTRICTIVE REGULATION.—The 21 term ‘‘least restrictive regulation’’ means, from least 22 to most restrictive: 23 (A) One or more of the following, each of 24 which shall be considered equally restrictive: 25 (i) Market competition.

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17 (5) LESS RESTRICTIVE ALTERNATIVES TO OC-

18 CUPATIONAL LICENSING.—The term ‘‘less restrictive 19 alternatives to occupational licensing’’— 20 (A) means regulations that achieve the 21 public health or safety goals asserted by the 22 government to justify licensing while imposing a 23 less onerous restriction on entry into the mar- 24 ketplace; and

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3 (6) MEMBER, OFFICER, OR EMPLOYEE.—The 4 term ‘‘member, officer, or employee’’, with respect to 5 an occupational licensing board, means an individual 6 appointed by a State to the board.

7 (7) OCCUPATIONAL LICENSE.—The term ‘‘occu- 8 pational license’’ means a nontransferable authoriza- 9 tion under law for an individual to perform a lawful 10 occupation for compensation based on meeting per- 11 sonal qualifications established by the State govern- 12 ment.

13 (8) OCCUPATIONAL LICENSING BOARD.—The 14 term ‘‘occupational licensing board’’ or ‘‘board’’ 15 means an entity established under State law— 16 (A) the express purpose of which is to reg- 17 ulate the personal qualifications required to en- 18 gage in or practice a particular lawful occupa- 19 tion; 20 (B) that has authority conferred by State 21 law to interpret or enforce the occupational li- 22 censing laws of the State; and

23 (C) not less than 2⁄3 of the members of 24 which are appointed by an elected official of the 25 State.

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1 (9) OCCUPATIONAL LICENSING LAW.—The term 2 ‘‘occupational licensing law’’— 3 (A) means a State statute that allows an 4 individual to work in a lawful occupation and 5 use an occupational title; and 6 (B) does not include a business license, fa- 7 cility license, building permit, or zoning and 8 land use regulation, except to the extent that 9 the law regulates an individual’s personal quali- 10 fications to engage in or practice a lawful occu- 11 pation.

12 (10) OCCUPATIONAL REGULATION.—The term 13 ‘‘occupational regulation’’— 14 (A) means a statute, rule, practice, policy, 15 or other law that substantially burdens an indi- 16 vidual’s ability to work in a lawful occupation; 17 (B) includes a regulation requiring reg- 18 istration, certification, or an occupational li- 19 cense; and 20 (C) does not include a business license, fa- 21 cility license, building permit, or zoning and 22 land use regulation except to the extent that 23 such a requirement or restriction substantially 24 burdens an individual’s ability to work in a law- 25 ful occupation.

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1 (11) PERSONAL QUALIFICATIONS.—The term 2 ‘‘personal qualifications’’ means criteria related to 3 an individual’s personal background and characteris- 4 tics, including completion of an approved educational 5 program, satisfactory performance on an examina- 6 tion, work experience, other evidence of attainment 7 of requisite skills or knowledge, moral standing, 8 criminal history, and completion of continuing edu- 9 cation.

10 (12) REGISTRATION.—The term ‘‘registration’’ 11 means a requirement that an individual give notice 12 to the government of a State that may include— 13 (A) the individual’s name and address; 14 (B) the individual’s agent for service of 15 process; 16 (C) the location of the activity to be per- 17 formed; and 18 (D) a description of the service the indi- 19 vidual provides.

20 (13) SPECIALTY OCCUPATIONAL LICENSE FOR

21 MEDICAL REIMBURSEMENT.—The term ‘‘specialty 22 occupational license for medical reimbursement’’ 23 means a nontransferable authorization in law for an 24 individual to qualify for payment or reimbursement 25 from a government agency for the non-exclusive pro-

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3 (14) STATE.—The term ‘‘State’’ means— 4 (A) each of the several States; and 5 (B) the District of Columbia.

6 SEC. 4. ANTITRUST IMMUNITY.

7 (a) IN GENERAL.—Subject to subsection (b), the 8 Sherman Act (15 U.S.C. 1 et seq.) shall not apply to any 9 action of an occupational licensing board of a State, or 10 any action of a member, officer, or employee of the board 11 acting in the official capacity of that member, officer, or 12 employee, if— 13 (1) the requirements under section 5 of this Act 14 are satisfied; or 15 (2) the requirements under section 6 of this Act 16 are satisfied.

17 (b) REQUIREMENT OF GOOD FAITH.—The immunity 18 provided under subsection (a) shall not apply to any action 19 of an occupational licensing board of a State, or any action 20 of a member, officer, or employee of the board acting in 21 the official capacity of that member, officer, or employee, 22 unless the State acts in good faith to perform the applica- 23 ble requirements under section 5 or 6.

24 (c) EXISTING ENTITIES OR PROCEDURES.—The fact 25 that a State governmental entity or procedure was estab-

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7 (d) SAVINGS CLAUSE.—The immunity provided 8 under subsection (a) shall not apply to an action unrelated 9 to regulating the personal qualifications required to en- 10 gage in or practice a lawful occupation, such as rules of 11 an occupational licensing board governing minimum prices 12 or residency requirements.

13 SEC. 5. ACTIVE SUPERVISION.

14 (a) IN GENERAL.—The immunity under section 4(a) 15 shall apply to any action of an occupational licensing 16 board of a State, or any action of a member, officer, or 17 employee of that board acting in the official capacity of 18 that member, officer, or employee, if— 19 (1) the actions of the occupational licensing 20 board or member, officer, or employee are author- 21 ized by a non-frivolous interpretation of the occupa- 22 tional licensing laws of the State; 23 (2) the State adopts a policy of using less re- 24 strictive alternatives to occupational licensing to ad- 25 dress real, substantial threats to public health, safe-

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8 (b) POLICY.—The State shall adopt a policy pro- 9 viding that— 10 (1) occupational licensing laws should be con- 11 strued and applied to— 12 (A) protect public health, safety, and wel- 13 fare; and 14 (B) increase economic opportunity, pro- 15 mote competition, and encourage innovation; 16 (2) regulators should displace competition 17 through occupational licensing laws only if less re- 18 strictive alternatives to occupational licensing will 19 not suffice to protect consumers from real, substan- 20 tial threats to public health, safety, or welfare; and 21 (3) an occupational licensing law should be en- 22 forced against an individual only to the extent the 23 individual sells goods or services that are included 24 explicitly in the statute or regulation that defines 25 the occupation’s scope of practice.

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1 (c) ACTIVE SUPERVISION.—

2 (1) IN GENERAL.—The legislation enacted 3 under subsection (a)(3) shall satisfy each of the re- 4 quirements under this subsection.

5 (2) DAY-TO-DAY SUPERVISION.—

6 (A) ESTABLISHMENT OF OFFICE OF SU-

7 PERVISION OF OCCUPATIONAL BOARDS.—The 8 State shall establish an Office of Supervision of 9 Occupational Boards (referred to in this sub- 10 section as the ‘‘Office’’) to review the actions of 11 occupational licensing boards to ensure compli- 12 ance with the policy adopted under subsection 13 (b).

14 (B) DUTIES.—The Office shall— 15 (i) review and explicitly approve or re- 16 ject in writing any occupational regulation 17 proposed by a board before the board may 18 adopt or implement the occupational regu- 19 lation; 20 (ii) play a substantial role in the de- 21 velopment of a board’s rules and policies to 22 ensure they benefit consumers and do not 23 serve the private interests of providers of 24 goods and services regulated by the board;

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3 (3) INTERNAL REVIEW.—

4 (A) COMPLAINT.—The State shall estab- 5 lish a mechanism under which a person who is 6 a resident of or has a license to operate a busi- 7 ness in the State may file a complaint with the 8 Office about an occupational regulation of an 9 occupational licensing board in the State that 10 the person believes is inconsistent with the pol- 11 icy adopted under subsection (b).

12 (B) OFFICE RESPONSE.—Not later than 13 90 days after the date on which a person files 14 a complaint under subparagraph (A), the Office 15 shall— 16 (i) investigate the complaint; 17 (ii) identify remedies and instruct the 18 board to take action, where appropriate; 19 and 20 (iii) respond in writing to the com- 21 plainant.

22 (C) REVIEW.—The State shall establish a 23 mechanism for review of a determination made 24 by the Office under subparagraph (B), under 25 which a complainant may appeal the determina-

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9 (4) RIGHT TO RAISE DEFENSE.—

10 (A) IN GENERAL.—The State shall author- 11 ize an individual to assert as a defense, in any 12 administrative or judicial proceeding to enforce 13 an occupational regulation, that the regulation 14 does not comply with the policy adopted under 15 subsection (b).

16 (B) PROCEDURES.—In a proceeding de- 17 scribed in subparagraph (A)— 18 (i) an individual who asserts a defense 19 under this paragraph has the initial bur- 20 den of proof that the occupational regula- 21 tion being enforced substantially burdens 22 the individual’s ability to engage in a law- 23 ful occupation; 24 (ii) if an individual meets the burden 25 of proof under clause (i), the State shall be

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8 (5) PERIODIC ADVISORY REVIEW.—

9 (A) IN GENERAL.—The State shall estab- 10 lish a mechanism for periodic non-binding re- 11 view of existing occupational regulations, and 12 non-binding review of new proposed occupa- 13 tional regulations, to ensure that the occupa- 14 tional regulations comply with the policy adopt- 15 ed under subsection (b).

16 (B) SCOPE OF REVIEW.—The entity con- 17 ducting the review under subparagraph (A)— 18 (i) shall publish an annual written re- 19 port encompassing approximately 20 per- 20 cent of the occupations subject to occupa- 21 tional regulations within the State, such 22 that the entity will review all occupational 23 regulations within the State during each 5- 24 year period; and

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8 (C) REQUIREMENTS FOR ANALYSIS.—In 9 conducting the review required under subpara- 10 graph (A), the entity shall— 11 (i) determine whether the law or other 12 regulation satisfies the policy adopted 13 under subsection (b) of using the least re- 14 strictive regulation necessary to protect 15 consumers from real, substantial threats to 16 public health, safety, or welfare; 17 (ii) evaluate the effects of the law or 18 other regulation on opportunities for work- 19 ers, consumer choices and costs, general 20 unemployment, market competition, gov- 21 ernmental costs, and other effects; 22 (iii) compare the law or other regula- 23 tion to whether and how other States regu- 24 late the applicable occupation; and

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14 SEC. 6. JUDICIAL REVIEW.

15 (a) IN GENERAL.—The immunity under section 4(a) 16 shall apply to any action of an occupational licensing 17 board of a State, or any action of a member, officer, or 18 employee of that board acting in the official capacity of 19 that member, officer, or employee, if— 20 (1) the actions of the occupational licensing 21 board or member, officer, or employee are author- 22 ized by a non-frivolous interpretation of the occupa- 23 tional licensing laws of the State; 24 (2) the State adopts a policy of using less re- 25 strictive alternatives to occupational licensing to ad-

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6 (b) JUDICIAL REVIEW LEGISLATION.—Legislation 7 enacted by a State under subsection (a)(3)— 8 (1) shall— 9 (A) prohibit the State and any occupa- 10 tional licensing board from imposing an occupa- 11 tional licensing law unless the State— 12 (i) identifies an important government 13 interest in protecting against real, substan- 14 tial threats to public health, safety, or wel- 15 fare; and 16 (ii) demonstrates that the occupa- 17 tional licensing law is substantially related 18 to achievement of the important govern- 19 ment interest described in clause (i), in 20 light of the availability of less restrictive 21 alternatives to occupational licensing; 22 (B) provide an affirmative defense against 23 enforcement of any occupational licensing law 24 of the State under which the State shall be re-

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21 (c) RULE OF CONSTRUCTION.—Nothing in sub- 22 section (b) shall be construed to require legislation enacted 23 by a State under subsection (a)(3) to provide a right to

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The Problem

The Supreme Court’s recent decision in North Carolina State Board of Dental Examiners v. FTC has cast doubt regarding the antitrust liability of numerous state licensing boards. This uncertainty presents an opportunity to reform occupational regulation in the states. • In North Carolina State Board of Dental Examiners,1 the Supreme Court held that self-interested licensing boards may be subject to liability under the antitrust laws. The decision created significant uncertainty regarding the legality of numerous other state licensing boards’ regulation of occupational entry.

• Some states have responded by establishing a layer of bureaucratic oversight that merely monitors licensing board actions for consistency with state licensing laws. In any given case, this response may—or may not—satisfy the Supreme Court’s standard. In all cases, this response is a missed opportunity for reform, as establishing an additional layer of bureaucracy does not address the broader problems of over-reliance on licensure as an approach to occupational regulation. Nor does it address the problem of overly aggressive enforcement of licensing requirements.

• There is also legitimate concern that the decision eliminated a measure of state sovereignty. This concern was outlined by the dissenting opinion and has only been heightened due to uncertainty about the antitrust liability of licensing boards that has followed the decision.2

The Solution

Create a limited antitrust exemption for state licensing boards, conditioned on whether a state adopts occupational regulation reforms tracking one of two frameworks:

Framework # 1: Active Supervision and Periodic Review3

 Establish a State Office of Supervision of Occupational Boards, tasked with day- to-day board supervision of licensing authorities, including the duty to ensure that boards confine license enforcement to the sale of goods and services

1 135 S. Ct. 1101 (2015). 2 135 S. Ct. 1101, at 1125 (Alito, J., dissenting). 3 This framework is modeled on the provisions of the ALLOW Act, S.3158, introduced in 2016 by Senator Lee and cosponsor Senator Sasse, and referred to the Homeland Security and Governmental Affairs Committee. expressly included in any statutory definition of an occupation’s scope of practice.4  Create a state mechanism for periodic review of existing occupational regulations every five years, sunrise review of proposed new occupational regulations under a “least restrictive alternative” standard of review, and for publication of annual reports detailing review findings, analysis, and non-binding recommendations to legislators and regulators.5  Create a statutory affirmative defense that may be raised in actions to enforce occupation regulations. If a defendant establishes that the regulation in question “substantially burdens [his or her] ability to engage in a lawful occupation,” the burden of proof shifts to the state to establish that the regulation meets the requirements of intermediate scrutiny.6

Framework #2: Judicial Review

 Create a cause of action under state law that provides for judicial review of licensing laws under an intermediate scrutiny standard.7  Create a statutory affirmative defense that places the burden of proof in license enforcement actions on the state to establish that the licensing law in question meets the requirements of intermediate scrutiny.8  Award attorney fees and costs in successful challenges of licensing laws.9

This approach would address the concerns of both the majority and the dissent in North Carolina State Board of Dental Examiners by tying pro-competitive reforms to the restoration of state regulatory flexibility under federal antitrust law. By offering two paths—one that is process-oriented and one grounded in substantive rights—the bill appeals to a wider range of possible state-level partners committed to simultaneously addressing the legal uncertainty surrounding licensing boards and the need to lower barriers to work, enhance economic opportunity, and expand consumer choice.

4 Discussion draft, Sec. 5(c)(2). 5 Id., Sec. 5(c)(5). 6 Id., Sec. 5(c)(4). 7 Id., Sec. 6(b)(1)(C). 8 Id., Sec. 6(b)(1)(B). 9 Id., Sec. 6(b)(1)(D). Senate Bill Promises Antitrust Immunity to Boards That Reform Licensure in Latest State Action Defense Development

CLIENT ALERT | August 14, 2017

Jan P. Levine | [email protected] Melissa Hatch O’Donnell | [email protected]

Senators Mike Lee (R-UT), Ted Cruz (R-TX) and Ben Sasse (R-NE) recently introduced a bill that would extend a limited state action immunity to state licensure boards only if states implement reforms that reduce occupational licensing restrictions. In a panel discussion on August 9, Acting FTC Chairman Maureen K. Ohlhausen stated the goals of the bill are consistent with the FTC’s aim to curb overbroad occupational licensing and are a signal of growing public awareness of the costs of these licensing regimes. She is aware, however, of some state-level concerns about the bill’s mechanics.

The FTC, many academics and others have focused public attention on the high costs of excessive occupational licensing. According to the FTC, between 25 and 30 percent of jobs in the United States — including interior designers, florists and hair braiders — require a license. These licensing requirements, some argue, protect the interests of

THIS PUBLICATION MAY CONTAIN ATTORNEY ADVERTISING The material in this publication was created as of the date set forth above and is based on laws, court decisions, administrative rulings and congressional materials that existed at that time, and should not be construed as legal advice or legal opinions on specific facts. The information in this publication is not intended to create, and the transmission and receipt of it does not constitute, a lawyer-client relationship. Please send address corrections to [email protected]. © 2017 Pepper Hamilton LLP. All Rights Reserved. incumbents while reducing competition and hampering workers’ ability to enter a new field or move about the country. Further, licensing requirements in some fields often do not serve a clear public benefit: Consumers are well-equipped to judge an interior designer’s skills for themselves, and the cost of a “less than attractive” throw pillow, for example, is low.

The bill, titled the Restoring Board Immunity Act, seeks to curb occupational licensing by offering states that engage in reform an enticing prize: immunity for state occupational licensing boards to private antitrust suits challenging licensing requirements. While Chairman Ohlhausen and others laud the bill’s objectives, its critics consider the bill an archetypal federal overreach and prefer that licensing requirements be evaluated under the traditional state action doctrine as the Supreme Court has articulated it in a pair of recent cases: North Carolina Board of Dental Examiners and Phoebe Putney.

This client alert analyzes the bill and follows up on Pepper’s prior client alerts1 regarding state action antitrust immunity.

Background Currently, to enjoy state action immunity to the antitrust laws, a “nonsovereign actor controlled by active market participants” must satisfy a two-pronged test: “first that the challenged restraint . . . be one clearly articulated and affirmatively expressed as state policy, and second that the policy . . . be actively supervised by the State.” N.C. State Bd. of Dental Exam’rs v. FTC, 135 S. Ct. 1101, 1110 (2015) (internal quotations omitted). In 2013, the Supreme Court addressed the first prong of this immunity in FTC v. Phoebe Putney Health System, Inc., 568 U.S. 216 (2013). The Court held that state action immunity applies only when the state legislature has “clearly articulated and affirmatively expressed” a policy displacing competition and a state’s grant of general corporate powers is not enough to meet the “clear articulation” standard. Id. at 220.

In Board of Dental Examiners, the Supreme Court addressed the second prong of the state action immunity test. First, the Court held that the North Carolina Board of Dental Examiners — which was almost entirely composed of “market participants” (i.e., active dentists) — was subject to the “active supervision” requirement, rejecting the board’s position that, because North Carolina had dubbed it a “state agency,” it should be automatically exempt. Further, the Court held that the board’s actions were not immune because it was not subject to “active supervision” by the state when it issued cease-and- desist letters to nondentist teeth whiteners. Bd. of Dental Exam’rs, 135 S. Ct. at 1110. The Court observed that “the question is whether the State’s review mechanisms provide ‘realistic assurance’ that a nonsovereign actor’s anticompetitive conduct ‘promotes state policy, rather than merely the party’s individual interests.’” Id. at 116.

In Teladoc, Judge Robert Pitman of the U.S. District Court for the Western District of Texas picked up where Board of Dental Examiners left off, probing what “active supervision” requires. See Teladoc, Inc. v. Tex. Med. Bd., No. 1-15-CV-343, 2015 U.S. Dist. LEXIS 166754 (W.D. Tex. Dec. 14, 2015). In that case, Teladoc claimed that members of the Texas Medical Board (TMB) had stifled competition from telemedicine providers by adopting rules requiring that a physician conduct an in-person examination before treating a patient. The TMB moved to dismiss, arguing that it enjoyed state action immunity from the antitrust claim. Judge Pitman disagreed, holding that the supervision mechanisms cited by the TMB — potential judicial review and review by the Texas legislature — did not satisfy the active supervision requirement as articulated in Board of Dental Examiners. Id. at *29.

Cementing the perception that licensing board practices that previously would not have been challenged can entail serious antitrust exposure, the FTC brought an agency action in May against the Louisiana Real Estate Appraisers Board. The FTC’s complaint alleges that the board has unreasonably restrained price competition for real estate appraisal services by adopting a regulation that lenders’ agents must pay appraisers at a rate determined by one of three methods, rather than a rate decided via bona fide negotiation and operation of the free market. On June 30, the FTC also sent a letter to an assistant attorney general in North Carolina, expressing concern that a proposed bill that prescribes a single method for determining customary and appraisal fees would disrupt the free market and increase prices for consumers.

The Senate Bill The Senate bill’s proponents recognize that these judicial developments have created uncertainty about whether the state action immunity will shield state licensure boards. The bill addresses this uneasiness by offering antitrust protection for licensure boards, but only if they adopt occupational regulation reforms that track one of two frameworks. Both frameworks aim to reduce overreliance on licensure as an approach to occupational regulation and overly aggressive enforcement of licensing requirements. Under both frameworks, all board actions must be authorized by a “non-frivolous” interpretation of the state’s occupational licensing laws, and the state must adopt a policy of using occupational licensing only when less restrictive approaches, such as certifications, are insufficient to protect consumers.

Under the first framework, a state must (1) establish an officer tasked with day-to-day supervision of licensing authorities, which must ensure that the boards do not engage in overbroad enforcement; (2) establish an administrative complaint process that will review board action upon receipt of a complaint; (3) create a mechanism for periodic review of occupational regulations; and (4) create an affirmative defense that may be raised in actions to enforce occupational regulations, which can shift the burden of proof to the state to establish that the regulation satisfies intermediate scrutiny.

Under the second framework, the state must (1) create a cause of action providing for judicial review of licensing laws under the intermediate scrutiny standard; (2) create an affirmative defense that places the burden of proof in license enforcement actions on the state to establish that the licensing law in question satisfies intermediate scrutiny; and (3) award attorneys’ fees and costs in successful challenges of licensing laws.

Board members in states that implement reforms under one of the two frameworks would be immune from private antitrust actions and claims to damages challenging occupational license requirements. Other kinds of anticompetitive conduct — e.g., price fixing — would not be immune. Also, anticompetitive conduct could still be challenged under section 5 of the FTC Act.

In her panel discussion, Chairman Ohlhausen stated that the bill’s objectives were in line with the FTC’s recent efforts and that introduction of the bill is a signal of growing public awareness that overly aggressive licensing rules are hurting consumers and workers. She did not commit to supporting the bill in its current form, however, stating that she was “sensitive to” state concerns. Other panelists — Sarah Oxenham Allen, the assistant attorney general of Virginia, in particular — argued that the bill places too great of a burden on states and disregards principles of sovereignty.

This is yet another state action development, and we will keep you posted on this bill. Endnote 1 Access our prior client alerts here: “Texas Medical Board Loses Bid for State Action Immunity” (Jan. 5, 2016 available at http://www.pepperlaw.com/publications/ texas-medical-board-loses-bid-for-state-action-immunity-2016-01-05/); “The State Action Doctrine: Active Supervision Reigns Supreme” (Feb. 26, 2015 available at http://www.pepperlaw.com/publications/the-state-action-doctrine- active-supervision-reigns-supreme-2015-02-26/); “State Action Doctrine at the Supreme Court: Take Two” (March 19, 2014); “Supreme Court Limits State Action Immunity in FTC v. Phoebe Putney Health System, Inc.” (Feb. 22, 2013 available at http://www.pepperlaw.com/publications/supreme-court-limits-state-action-immunity- in-ftc-v-phoebe-putney-health-system-inc-2013-02-22/).

Jan Levine is a partner in Pepper Hamilton’s Health Sciences Department, a team of 110 attorneys who collaborate across disciplines to solve complex legal challenges confronting clients throughout the health sciences spectrum. Melissa Hatch O’Donnell is an associate in the Health Sciences Department.

Please note: As of January 20, 2017, information in some news releases may be out of date or not reflect current policies.

US LABOR DEPARTMENT AWARDS $7.5M TO FUND RESEARCH FOR IMPROVING GEOGRAPHIC MOBILITY FOR WORKERS IN LICENSED OCCUPATIONS

WASHINGTON – Over one-fifth of the current U.S. workforce is made up of workers in licensed occupations – jobs that require a government license. Current licensing systems, however, can become inefficient, resulting in barriers for workers trying to enter a profession, restricted worker mobility and ultimately impaired economic growth.

With this in mind, the U.S. Department of Labor today announced an award of $7.5 million to the National Conference of State Legislatures, or NCSL, for a project geared towards improving geographic mobility for workers in licensed occupations. NCSL will direct a coalition of 10 states working to achieve two primary goals:

Identify licensing criteria to ensure that existing and new licensing requirements are not overly broad or burdensome and don’t create unnecessary barriers to labor market entry Improve portability for selected occupational licenses across state lines

The project will also produce research and technical assistance materials available to all states in addressing similar issues.

“When licensing systems are inefficient, everyone is affected. Worker mobility is restricted, costs for consumers go up, and businesses have a harder time finding the employees they need,” said Labor Secretary Thomas E. Perez. “Taking steps to promote occupational licensing reform will help all workers gain access to good jobs.”

NCSL, in partnership with the National Governors Associations Center for Best Practices and the Council of State Governments, will work collaboratively across organizations and sectors in this multi-state project. Each state in the coalition will receive technical assistance, develop an action plan that identifies strategies to reduce barriers to labor market entry and improve licensure portability, and work toward implementation of the action plan.

Guidance on research, expertise in technical assistance and help with dissemination of project outputs will be provided by a group of national experts representing the selected occupations and target populations to be served by the project.

The partners will conduct five research projects: (1) a policy literature scan to identify relevant studies and reports and compile the results into a summary analysis; (2) a research effort to collect comprehensive information on licensure requirements for selected occupations across all states; (3) a review of existing research on barriers to entering the labor market for impacted populations; (4) analysis of sunrise/sunset provisions related to occupational licensing; and (5) research on specific topics related to states’ action plans.

ETA News Release: 01/12/2017 Contact Name: Joe Versen Email: [email protected] Phone Number: (202) 693-4696 Release Number: 17-0049-NAT

https://www.dol.gov/newsroom/releases/eta/eta20170112-0 1/1

For Immediate Release Sept. 20, 2017

Contact: Mick Bullock, NCSL 202-624-3557 or [email protected]

Elena Waskey, NGA 202-624-7787 or [email protected]

Kelley Arnold, CSG 859-244-8258 or [email protected]

11 States Chosen for Occupational Licensing Policy Study Aimed at Examining Potential Solutions and Reducing Barriers

Chicago – Eleven states will be participating in a peer learning consortium focused on occupational licensing policy according to project partners The National Conference of State Legislatures (NCSL), National Governors Association Center for Best Practices (NGA Center), and the Council of State Governments (CSG).

As a member of the consortium, these 11 states will become familiar with occupational licensing policy in their own state, learn about occupational licensing best practices in other states, and begin implementing actions to remove barriers to labor market entry and improve portability and reciprocity.

NCSL President, Sen. Deb Peters (R-S.D.) said, “This collaborative effort among elected officials and state and national experts will produce the playbook for policymakers in every state to address some of the barriers that are hindering the full potential of the American workforce and American worker.”

The following states were selected through a competitive application process and are members of the learning consortium: Arkansas Colorado Connecticut Delaware Illinois Indiana Kentucky Maryland Nevada Utah Wisconsin

“We shouldn’t make it unnecessarily difficult for those who already have the necessary skills to obtain jobs,” said NGA Chair Nevada Gov. Brian Sandoval. “I’m glad Nevada is part of this group of states that will work to reduce unnecessary burdens and help strengthen the nation’s workforce.”

Over the next three years, the states will engage with one another in a structured, peer learning consortium in which they will be able to share ideas and solutions to complex occupational licensing issues. Learning consortium states will benefit from a variety of resources and tools to help states identify strategies to reduce labor market barriers and improve the portability of occupational licenses.

CSG Vice-Chair, Rep. Helene Keeley (Del.) said, “At a time when states are striving to make themselves more attractive to working families, we must continue to tear down barriers that might prevent people from locating and working here. We need to provide them with the ability to seek and gain employment. In many cases, that involves helping skilled workers transfer their licenses from one state to another. By joining this CSG consortium, we hope to learn more about some of the best practices in other states that can help Delaware streamline and improve its processes to make the First State more inviting and user- friendly.”

NCSL, the NGA Center and CSG will provide targeted, state-specific technical assistance and support for the development and implementation of a personalized state action plan for each state. The Partners will also convene three multi-state learning consortium meetings where state teams can hear and learn from other states on occupational licensing successes and lessons. Each state will also benefit from up to three in-state meetings to help states implement their action plans. Consortium states will also receive targeted, state-specific technical assistance and support.

In January, the partners were awarded $7.5 million from the U.S. Department of Labor’s Employment and Training Administration to help states look at reducing barriers to the labor market and improve the portability and reciprocity of occupations across state lines. In addition to work with the consortium states, the partners will be providing research on the current state of the national occupational licensing landscape.

The consortium states will focus on some of the populations most burdened by occupational licensing including skilled immigrants, people with criminal records, active duty military, veterans and their spouses, and unemployed and dislocated workers. Each state will work to identify areas of their occupational licensing policy that may be creating extra barriers to entry for these populations and will examine potential solutions to reduce related barriers.

### LIST OF TARGET OCCUPATIONS

Barbers Pharmacy Technicians

Bus Driver (City/Transit) Physical Therapy Assistants

Bus Drivers, School or Special Client Pipefitters and Steamfitters

Construction Managers Plumbers

Construction and Building Inspectors Preschool Teachers, Except Special Education

Dental Hygienists Private Detectives and Investigators

Electricians Radiologic Technologists

Emergency Medical Technicians and Real Estate Appraisers Paramedics

Hairdressers, Hairstylists and Real Estate Sales Agents Cosmetologists

Heating, Air Conditioning, and Refrigeration Respiratory Therapists Mechanics and Installers

Heavy and Tractor-Trailer Truck Drivers Security and Fire Alarm Systems Installers

Insurance Sales Agents Security Guards

Licensed Practical and Licensed Vocational Skin care Specialists Nurses

Manicurists and Pedicurists Teacher Assistants

Massage Therapists Veterinary Technologists and Technicians

Nursing Assistants Vocational Education Teachers, Postsecondary

Occupational Therapy Assistants Water and Wastewater Treatment Plant and System Operators

PREPARED STATEMENT OF THE FEDERAL TRADE COMMISSION ON COMPETITION AND OCCUPATIONAL LICENSURE BEFORE THE JUDICIARY COMMITTEE SUBCOMMITTEE ON REGULATORY REFORM, COMMERCIAL AND ANTITRUST LAW UNITED STATES HOUSE OF REPRESENTATIVES WASHINGTON, D.C. SEPTEMBER 12, 2017

I. Introduction Chairman Marino, Ranking Member Cicilline, and Members of the Subcommittee, thank you for the opportunity to appear before you today. I am Maureen K. Ohlhausen, Acting

Chairman of the Federal Trade Commission (“FTC” or “Commission”), and I am pleased to join you to discuss competition perspectives on occupational licensing. This has long been an area of significant interest for the Commission and, as demonstrated by H.R. 3446 – the ‘‘Restoring

Board Immunity Act of 2017’’ (‘‘RBI Act’’) – it is of interest to Congress as well.1

The FTC recognizes that occupational licensing can offer important benefits. Licensing can protect consumers from actual health and safety risks and support other valuable public policy goals. But that does not mean all licensing is warranted, or that restrictions on an occupation always yield more benefits than harms. Licensing restrictions may impede competition and hamper entry into professional and services markets, yet offer few, if any, significant consumer benefits. Such regulations may lead to higher prices, lower quality, and reduced consumer access to services and goods. In the long term, these unnecessary restrictions can cause lasting damage to competition and the competitive process. They tend to render markets less responsive to consumer demand, and they dampen incentives for innovation in products, services, and business models. These restrictions also create barriers to entry and mobility for workers seeking to meet consumer demand for services. In the end, excessive occupational licensing means consumers lose the benefits of competition, workers are denied full economic opportunity, and our whole economy suffers.

1 This written statement presents the views of the Federal Trade Commission. Oral testimony and responses to questions reflect my views and do not necessarily reflect the views of the Commission or any individual Commissioner. Page 2 of 22

This testimony describes the FTC’s approach to evaluating the potential competitive effects of occupational licensing and related regulations, and how we use a combination of research, education, advocacy, and enforcement tools to promote competition among service providers. Typically, we have examined particular restrictions that may unduly limit competition in specific licensed occupations. Furthermore, when appropriate, the Commission has taken enforcement action to stop regulatory boards from exceeding their authority to suppress or eliminate competition. The Commission and its staff have not tended to focus on whether, as a general matter, certain occupations, trades, and professions should or should not be licensed or otherwise regulated.2 Recently, however, I convened the FTC Economic Liberty Task Force,3 which has begun to examine a range of broader licensing issues.

Occupational regulation can be especially problematic when regulatory authority is delegated to a board controlled by active market participants – members who work in, and may derive much or all of their income from, the very occupation they regulate. There may be good reasons to include board members with this type of expertise. However, when financially- interested members control or dominate a board, there is a risk that the board’s decisions will serve the private economic interests of its members, not the policies of the state or the well-being of its citizens. As the Supreme Court has observed, acknowledging the risk of self-dealing does not require an assumption that board members will act in bad faith. Rather, self-dealing arises

2 Some Commission and staff advocacy comments have questioned whether, for a certain service or occupation, licensure is a necessary or justified form of regulation. See, e.g., FTC Staff Comment to the Hon. O.H. Harris Concerning Texas S.B. 454 to License Interior Designers (1989), https://www.ftc.gov/sites/default/files/documents/advocacy_documents/ftc-staff-comment-hon.o.h.harris- concerning-texas-s.b.454-license-interior-designers/v890045.pdf. In addition, in the past, Commission staff have studied the general conditions under which licensure or some other form of occupational regulation may or may not be warranted. See generally, e.g., CAROLYN COX & SUSAN FOSTER, BUREAU OF ECON., FED. TRADE COMM’N, THE COSTS AND BENEFITS OF OCCUPATIONAL REGULATION (1990), http://www.ramblemuse.com/articles/cox_foster.pdf. 3 Fed. Trade Comm’n, Economic Liberty, https://www.ftc.gov/policy/advocacy/economic-liberty. Page 3 of 22 from inherent biases associated with “singularly strong private interests,” and “an assessment of the structural risk of market participants’ confusing their own interests with the State’s policy goals.”4

The FTC and its staff address these concerns primarily in two ways. First, as part of the

FTC’s competition advocacy program, we often respond to calls for public comment and invitations from legislators and regulators, who ask FTC staff to identify and analyze specific restrictions that may harm competition without offering countervailing consumer benefits.

Typically, we urge policymakers to integrate competition concerns into their decision-making process. Specifically, we ask that they consider whether: (1) any licensing regulations are likely to have a significant adverse effect on competition; (2) those restrictions are targeted to address actual risks of consumer harm; and (3) the restrictions are narrowly tailored to minimize burdens on competition, or whether less restrictive alternatives are available.5

Second, the Commission has used its enforcement authority to challenge anticompetitive conduct by regulatory boards whose members are active market participants. These enforcement actions have included challenges to agreements among competitors that restrain truthful and non- deceptive advertising, price competition, and contracting or other commercial practices. We have also challenged direct efforts to prohibit competition from new rivals where there is no legitimate justification for doing so. The Commission can only bring these actions when the challenged conduct harms competition and consumers, violates the federal antitrust laws, and falls outside of the scope of protected “state action.” Under the state action doctrine, which was first articulated by the Supreme Court in 1943, principles of federalism limit the application of the federal

4 N.C. State Bd. Dental Examiners v. FTC, 135 S. Ct. 1101, 1114 (2015). 5 License to Compete: Occupational Licensing and the State Action Doctrine, Hearing Before the S. Comm. on the Judiciary, Subcomm. on Antitrust, Competition Pol’y and Consumer Rights, 114th Cong., 2 (Feb. 2, 2016), https://www.ftc.gov/system/files/documents/public_statements/912743/160202occupationallicensing.pdf. Page 4 of 22 antitrust laws when restraints on competition are imposed or approved by the states themselves.6

A state acting as a sovereign may impose occupational licensing or other regulations that displace competition in favor of other goals and values. But as the Supreme Court has cautioned,

“The national policy in favor of competition cannot be thwarted by casting . . . a gauzy cloak of state involvement over what is essentially . . . [private anticompetitive conduct].”7 As one of two federal agencies charged with enforcing U.S. antitrust laws, the Commission is committed to ensuring that the state action doctrine remains true to its foundations.

The discussion below will cover several aspects of the Commission’s occupational licensing work.

 First, it provides a brief overview of the FTC’s interest and experience in

competition issues related to occupational licensing and competitor-controlled

regulatory boards;

 Second, it outlines general competition concerns in this area, touching on

some of the issues implicated by H.R. 3446; and

 Third, it provides additional details of the FTC’s work relating to the potential

competitive harm of excessive regulation of the occupations, including FTC

research, competition advocacy, and law enforcement.

II. Interest and Experience of the FTC

Competition is at the core of America’s economy and vigorous competition among sellers in an open marketplace can provide consumers the benefits of lower prices, higher quality products and services, and greater innovation. To advance that national policy, the FTC Act

6 Parker v. Brown, 317 U.S. 341 (1943). 7 Cal. Retail Liquor Dealers Ass’n v. Midcal Aluminum, Inc., 445 U.S. 97, 106 (1980). Page 5 of 22 grants the Commission broad enforcement authority with regard to both competition and consumer protection matters in most sectors of the economy.8 In addition, Section 6 of the FTC

Act provides, among other things, a general authority to investigate and report on market developments “in the public interest,” as well as authority to make recommendations based on those investigations.9 This distinct charge supports the FTC’s research, education, and competition advocacy efforts.

To fulfill these statutory mandates, the Commission seeks to identify private, public, and quasi-public restrictions that may unreasonably impede competition. In the context of occupational licensing, the Commission and its staff have for over thirty years conducted various economic and policy studies,10 as well as focused inquiries into regulations applying to particular occupations and their practitioners, such as nurses,11 eye doctors and vendors of optical goods,12 lawyers and other providers of legal services,13 dental hygienists,14 and the real estate brokers,15

8 The FTC’s authority reaches “[u]nfair methods of competition” and “unfair or deceptive acts or practices” that are “in or affecting commerce.” 15 U.S.C. § 45(a)(1) (2013). With some exceptions, the FTC’s authority ranges broadly over “commerce” without restriction to particular segments of the economy. Id. at § 45(a)(2). 9 15 U.S.C. § 46 (2006). 10 See, e.g., COX & FOSTER, supra note 2, at 4-12. 11 DANIEL J. GILMAN & TARA ISA KOSLOV, FED. TRADE COMM’N STAFF, POLICY PERSPECTIVES: COMPETITION AND THE REGULATION OF ADVANCED PRACTICE NURSES, (2014), http://www.ftc.gov/system/files/documents/reports/policy-perspectives-competition-regulation-advanced-practice- nurses/140307aprnpolicypaper.pdf. 12 FED. TRADE COMM’N, COMPETITION IN THE SALE OF RX CONTACT LENSES: AN FTC STUDY (2005), http://www.ftc.gov/sites/default/files/documents/reports/strength-competition-sale-rx-contact-lenses-ftc- study/050214contactlensrpt.pdf; RONALD S. BOND ET AL., FED. TRADE COMM’N, STAFF REPORT ON THE EFFECTS OF RESTRICTIONS ON ADVERTISING AND COMMERCIAL PRACTICE IN THE PROFESSIONS: THE CASE OF OPTOMETRY (1980), http://www.ftc.gov/sites/default/files/documents/reports/effects-restrictions-advertising-and-commercial- practice-professions-case-optometry/198009optometry.pdf. 13 JACOBS ET AL., CLEVELAND REGIONAL OFFICE & BUREAU OF ECONOMICS, FED. TRADE COMM’N, IMPROVING CONSUMER ACCESS TO LEGAL SERVICES: THE CASE FOR REMOVING RESTRICTIONS ON TRUTHFUL ADVERTISING (1984). 14 J. NELLIE LIANG & JONATHAN OGUR, RESTRICTIONS ON DENTAL AUXILIARIES: AN ECONOMIC POLICY ANALYSIS, FED. TRADE COMM’N, BUREAU OF ECON. STAFF REPORT (1987). Page 6 of 22 among others.16 More recently, the Economic Liberty Task Force held a July 2017 public roundtable to explore issues relating to streamlining occupational license portability across state lines.17 Based on this research, the larger body of economic literature, and its own investigations, the Commission has addressed potentially anticompetitive restrictions on certain occupations through competition advocacy, enforcement tools, and various forms of education and outreach.

III. Competition Issues Raised by Licensing and Other Occupational Regulations

Licensing laws and regulations establish conditions for entry into an occupation and define the occupation’s metes and bounds or “scope of practice.”18 Licensing has become an increasingly dominant form of occupational regulation, with studies suggesting that 25-30% of the U.S. workforce is employed in occupations that require a license.19 Licensing is generally the most stringent form of occupational regulation.20 Unlicensed practice, or the provision of services outside one’s scope of practice, may be prohibited by statute or regulation and may be subject to civil or criminal penalties.21

For some occupations, licensing laws and regulations may be an appropriate policy response to consumer protection or safety concerns. Licensing can help to prevent consumer

15 FED. TRADE COMM’N & U.S. DEP’T JUSTICE, COMPETITION IN THE REAL ESTATE BROKERAGE INDUSTRY (2007), http://www.ftc.gov/sites/default/files/documents/reports/competition-real-estate-brokerage-industry-report-federal- trade-commission-and-u.s.department-justice/v050015.pdf. 16 COX & FOSTER, supra note 2, (considering occupational regulation generally, as well as certain particular occupations). 17 Fed. Trade Comm’n, Streamlining Licensing Across State Lines, Initiatives to Enhance Occupational License Portability, https://www.ftc.gov/news-events/events-calendar/2017/07/streamlining-licensing-across-state-lines- initiatives-enhance . 18 U.S. DEP’T TREASURY, COUNCIL OF ECONOMIC ADVISORS & DEP’T LABOR, OCCUPATIONAL LICENSING: A FRAMEWORK FOR POLICY MAKERS, n. 6 and accompanying text (2015). 19 See id.; Morris M. Kleiner & Alan B. Krueger, Analyzing the Extent and Influence of Occupational Licensing on the Labor Market, 31 J. LAB. ECON. 173 (2013); Morris M. Kleiner & Alan B. Krueger, The Prevalence and Effects of Occupational Licensing, 48 BRIT J. INDUS. REL. 2 (2010). 20 See COX & FOSTER, supra note 2, at ch. V (regarding alternatives to licensing). 21 George J. Stigler, The Theory of Economic Regulation, 2 BELL J. ECON. & MGMT. SCI. 3, 13 (1971). Page 7 of 22 fraud and mitigate the effects of certain types of market failure – for example, those associated with persistent information asymmetries between professionals and consumers.22 Licensing regulations may serve an especially important function in health care, where consumers might face serious risks if they were treated by unqualified individuals, and patients might find it difficult (if not impossible) to assess quality of care at the time of delivery.

At the same time, licensing inherently constrains competition, albeit to varying degrees.23

When a law or regulation establishes required entry conditions for an occupation, only individuals who satisfy those conditions are legally permitted to provide the services associated with that occupation, which tends to reduce the number of market participants. This reduction in supply, and the resulting loss of competition, can lead to higher prices, reduced non-price competition on terms such as convenience or quality, or other distortions in services or labor markets.24 Licensing is estimated to result in 10-15% higher wages for licensed workers relative to unlicensed workers, after adjusting for differences in education, training, and experience,25 and numerous studies have shown that licensing leads to higher prices for consumers.26 In addition, although licensing may be designed to provide consumers with minimum quality

22 For example, consumers may not have reliable access to, or sufficient ability to understand, relevant information relating to the quality of the services they are consuming or the risks they may face and conflicts of interest may arise when professionals serve as both diagnosticians and treatment providers. See, e.g., COX & FOSTER, supra note 2, at 4-12. 23 See Stigler, supra note 21, at 13-17. 24 Regarding licensure generally, see Morris M. Kleiner, Occupational Licensing, 14 J. ECON. PERSP. 189, 192 (2000) (“The most generally held view on the economics of occupational licensing is that it restricts the supply of labor to the occupation and thereby drives up the price of labor as well as of services rendered.”); see also COX & FOSTER, supra note 2, at 21-36. 25 Morris M. Kleiner & Alan B. Krueger, The Prevalence and Effects of Occupational Licensing, 48 British J. Industrial Relations 676 (2010); see also Morris M. Kleiner & Alan B. Krueger, Analyzing the Extent and Influence of Occupational Licensing on the Labor Market, 31 J. LABOR ECON. S-173, S-191 (2013); COX & FOSTER, supra note 2, at 28-31 (reviewing studies of effects of licensing on the prices of dental, legal, and optometric services). 26 U.S. DEP’T TREASURY, COUNCIL OF ECONOMIC ADVISORS & DEP’T LABOR, supra note 18, at 14. Page 8 of 22 assurances, licensing provisions do not always increase service quality.27 Licensing costs and burdens may also discourage innovation and entrepreneurship. In some cases, these regulatory barriers to entry may severely impede the flow of labor or services to where they are most in demand, potentially reducing consumer access to valued services.28 Based on standard economic models, one 2011 study estimates that license-related restrictions have resulted in as many as

2.85 million fewer jobs nationwide, with an annual cost to consumers of up to $203 billion.29

As noted above, the FTC and its staff have not tended to focus on the broader question of whether individual occupations should be subject to licensure as a form of regulation; and we have not closely studied or determined whether the U.S. economy is characterized by excessive occupational licensing. We have begun, however, to extend some of our prior inquiries into the potential costs and benefits of licensure and other occupational regulations30 and to consider the kinds of evidence that could illuminate broader questions about the economic impact of licensing. For example, we announced yesterday that the Economic Liberty Task Force will hold a public roundtable on November 7, 2017, to examine recent and ongoing empirical research into the effects of occupational licensure on competition, consumers, and the workforce.31 But the

FTC has never attempted to design regulatory institutions or tell various jurisdictions and

27 See, e.g., Morris M. Kleiner & Robert T. Kurdle, Does Regulation Affect Economic Outcomes: The Case of Dentistry, 43 J. LAW & ECON. 547, 570 (2000) (“Overall, our results show that licensing does not improve dental health outcomes as measured by our sample of dental recruits. Moreover, treatment quality does not appear to improve significantly on the basis of the reduced cost of malpractice insurance or a lower complaint rate against dentists, where regulation is more stringent.”); see also COX & FOSTER, supra note 2, at 21-29. 28 For example, FTC staff comments on nursing regulations have focused on primary care provider shortages and the abilities of advanced practice nurses and others to meet the needs of underserved populations. See generally POLICY PERSPECTIVES: COMPETITION AND THE REGULATION OF ADVANCED PRACTICE NURSES, supra note 11, at 2, 20-26. 29 Morris M. Kleiner, Alan B. Krueger & Alex Mas, A Proposal to Encourage States to Rationalize Occupational Licensing Practices: A Proposal to the Brookings Institution Hamilton Project, Apr. 2, 2011. 30 See COX & FOSTER, supra note 2. 31 FTC Press Release, “FTC Announces Second Economic Liberty Public Roundtable,” Sept. 11, 2017, https://www.ftc.gov/news-events/press-releases/2017/09/ftc-announces-second-economic-liberty-public-roundtable. Page 9 of 22 licensing authorities how best to administer their licensing laws. Rather, we have recognized that specific licensure regulations can have good, bad, or mixed competitive effects, depending on the circumstances. Therefore, we typically focus on case-by-case competition analysis of particular restrictions, and we have urged legislators and regulators to do the same.

IV. FTC Advocacy Efforts

A central goal of the FTC’s competition advocacy program is to encourage federal, state, and local policymakers, as well as private, self-regulatory authorities, to integrate competition concerns into their decision-making process. By doing so, we hope they can avoid standards likely to interfere unnecessarily with the proper functioning of a competitive marketplace.32 Even well intentioned laws and regulations may impose undue burdens on competition, in ways that ultimately harm consumers. Moreover, public restraints on competition may sometimes prove particularly harmful and durable, but may not always be actionable under the federal antitrust laws. Competition advocacy – in the form of comments, testimony, workshops, reports, and amicus briefs – encourages federal and state policy makers to consider how existing and proposed regulations are likely to affect competition and consumers, as well as other important policy goals.

A. Framework for Analysis

To address these concerns while preserving the potential benefits of occupational licensing, the Commission and its staff have developed a framework that we recommend to

32 For a general discussion of the FTC’s “policy research and development” mission and the role of the advocacy program, see, e.g., WILLIAM E. KOVACIC, THE FEDERAL TRADE COMMISSION AT 100: INTO OUR 2ND CENTURY 92- 109; 121-24 (2009), http://www.ftc.gov/ftc/workshops/ftc100/docs/ftc100rpt.pdf. See also James C. Cooper, Paul A. Pautler, & Todd J. Zywicki, Theory and Practice of Competition Advocacy at the FTC, 72 ANTITRUST L.J. 1091 (2005); Maureen K. Ohlhausen, Identifying Challenging, and Assigning Political Responsibility for State Regulation Restricting Competition, 2 COMPETITION POL’Y INT’L 151, 156-7 (2006) (competition advocacy “beyond enforcement” of the antitrust laws), https://www.competitionpolicyinternational.com/file/view/6289; Tara Isa Koslov, Competition Advocacy at the Federal Trade Commission: Recent Developments Build on Past Success, 8 CPI ANTITRUST CHRON. 1 (2012), https://www.competitionpolicyinternational.com/file/view/6732. Page 10 of 22 policymakers evaluating licensing regulations. We note that various elements of the proposed

RBI Act are consistent with this framework and share similar procompetitive goals. Specifically, the FTC’s framework encourages policymakers to ask the following questions:

 Are there significant and non-speculative consumer health and safety issues,

or other legitimate public policy purposes, that warrant licensing?

 Are any of the specific conditions or restrictions imposed under licensing

likely to have a significant adverse effect on competition and consumers?

 If so, do the specific restrictions address the concerns at issue and protect

against demonstrable harms or risks? For example, are there good grounds for

claims that they reduce the risk of consumer harm from poor-quality services?

Will the regulation yield other demonstrated or likely consumer benefits?

 Are the regulations narrowly tailored to serve the state’s policy priorities

without unduly restricting competition?33

 Are less restrictive alternatives available that would still serve legitimate

public policy goals, but would be less harmful to competition?34

When consumer benefits are slight or highly speculative, a licensing regime may be generally undesirable. Similarly, policymakers may wish to avoid specific requirements that impede competition with no offsetting benefits. Further inquiry is important even when regulations serve well-founded consumer protection concerns; it is important to balance

33 For a more complete exposition of this framework, see POLICY PERSPECTIVES: COMPETITION AND THE REGULATION OF ADVANCED PRACTICE NURSES, supra note 11, at 16-17. 34 Other mechanisms may help consumers identify quality and value, without necessarily creating the same entry barriers as licensing. These approaches may include both private initiatives (e.g., consumer reviews and ratings, voluntary private certification or accreditation) as well as public ones (e.g., government registration or certification). Page 11 of 22 consumer benefits and costs, and alternative protections can sometimes accomplish as much or more, while doing less harm.

B. Specific Advocacy Efforts

Since the late 1970s, the Commission and its staff have submitted hundreds of comments35 and amicus curiae briefs36 to state and self-regulatory entities on competition policy and antitrust law issues relating to occupations such as real estate brokers,37 electricians,38 accountants,39 lawyers,40 dentists41 and dental hygienists,42 nurses,43 eye doctors and opticians,44

35 Many of these advocacy comments can be found at http://www.ftc.gov/policy/advocacy/advocacy-filings. 36 See, e.g., Brief of the Federal Trade Commission as Amicus Curiae Supporting Arguments to Vacate Opinion 39 of the Committee on Attorney Advertising Appointed by the Supreme Court of New Jersey, 190 N.J. 250 (N.J. 2007), http://www.ftc.gov/policy/advocacy/amicus-briefs/2007/05/re-petition-review-committee-attorney- advertising-opinion-39. For access to the FTC’s other recent amicus briefs, see http://www.ftc.gov/policy/advocacy/amicus-briefs. 37 FTC and Department of Justice Comment to Governor Jennifer M. Granholm Concerning Michigan H.B. 4416 to Impose Certain Minimum Service Requirements on Real Estate Brokers (2007), http://www.ftc.gov/sites/default/files/documents/advocacy_documents/ftc-and-department-justice-comment- governor-jennifer-m.grahholm-concerning-michigan-h.b.4416-impose-certain-minimum-service-requirements-real- estate-brokers/v050021.pdf. 38 FTC Staff Comment to the Hon. Glen Repp Concerning Texas H.B. 252 to Establish a System to Voluntarily License Electricians and Electrical Contractors (1989), http://www.ftc.gov/sites/default/files/documents/advocacy_documents/ftc-staff-comment-hon.glen-repp-concerning- texas-h.b.252-establish-system-voluntarily-license-electricians-and-electrical-contractors/v890034.pdf. 39 FTC Staff Comment to the Honorable Jean Silver Concerning Washington Administrative Code 4-25-710 to Require Additional Academic Credits for Certified Public Accountants (CPAs) (1996), http://www.ftc.gov/sites/default/files/documents/advocacy_documents/ftc-staff-comment-honorable-jean-silver- concerning-washington-administrative-code-4-25-710-require/v960006.pdf. 40 FTC Staff Letter to the Supreme Court of Tennessee, Concerning Proposed Amendments to the Tennessee Rules of Professional Conduct Relating to Attorney Advertising (2013), http://www.ftc.gov/sites/default/files/documents/advocacy_documents/ftc-staff-letter-supreme-court-tennessee- concerning-proposed-amendments-tennessee-rules-professional/130125tennesseadvertisingletter.pdf. 41 FTC Staff Letter to NC Representative Stephen LaRoque Concerning NC House Bill 698 and the Regulation of Dental Service Organizations and the Business Organization of Dental Practices (2012), http://www.ftc.gov/sites/default/files/documents/advocacy_documents/ftc-staff-letter-nc-representative-stephen- laroque-concerning-nc-house-bill-698-and-regulation/1205ncdental.pdf. 42 FTC Staff Comment Before the Maine Board of Dental Examiners Concerning Proposed Rules to Allow Independent Practice Dental Hygienists to Take X-Rays in Underserved Areas (2011), http://www.ftc.gov/sites/default/files/documents/advocacy_documents/ftc-staff-comment-maine-board-dental- examiners-concerning-proposed-rules-allow-independent-practice/111125mainedental.pdf. Page 12 of 22 and veterinarians.45 These advocacy efforts have focused on various restrictions on price competition, contracts or commercial practices, entry by competitors or potential competitors, and truthful and non-misleading advertising.

For example, a series of FTC staff competition advocacy comments have addressed various physician supervision requirements that some states impose on advanced practice registered nurses (APRNs).46 FTC staff has not questioned state interests in establishing licensing requirements for APRNs or other health professionals in the interest of patient safety.

Rather, staff has questioned the competitive effects of additional restrictions on APRN licenses, such as mandatory supervision arrangements with individual physicians, which are sometimes cast as “collaborative practice agreement” requirements. Physician supervision requirements may raise competition concerns because they give one group of health care professionals the ability to restrict access to the market by another, potentially competing or collaborating group of health care professionals. Based on substantial evidence and experience, expert bodies have concluded that ARPNs are safe and effective as independent providers of many health care services within

43 FTC Staff Comment to the Dep’t of Veterans Affairs: Proposed Rule Regarding Advanced Practice Registered Nurses (2016), https://www.ftc.gov/system/files/documents/advocacy_documents/comment-staff-ftc-office-policy- planning-bureau-competition-bureau-economics-department- veterans/v160013_staff_comment_department_of_veterans_affairs.pdf. 44 FTC Staff Comment Before the North Carolina State Board of Opticians Concerning Proposed Regulations for Optical Goods and Optical Goods Businesses (Jan. 2011), http://www.ftc.gov/os/2011/01/1101ncopticiansletter.pdf; Letter from Maureen K. Ohlhausen et al. to Arkansas State Representative Doug Matayo (Oct. 4, 2004), http://www.ftc.gov/os/2004/10/041008matayocomment.pdf. Cf. FTC Staff Comment Before the Connecticut Board of Examiners for Opticians (Mar. 27, 2002), http://www.ftc.gov/be.v020007.htm. 45 FTC Staff Comment Before the Virginia Board of Veterinary Medicine Concerning Regulations to Remove Restrictions on Advertising and Non-Veterinarian Relationships (1996), http://www.ftc.gov/sites/default/files/documents/advocacy_documents/ftc-staff-comment-virginia-board-veterinary- medicine-concerning-regulations-remove-restrictions/p864641.pdf. 46 Many of the individual advocacy comments regarding nursing restrictions, along with the research and analyses underlying those comments, are described in detail in POLICY PERSPECTIVES: COMPETITION AND THE REGULATION OF ADVANCED PRACTICE NURSES, supra note 11. Page 13 of 22 the scope of their training, licensure, certification, and practice.47 Therefore, we have suggested that fixed, mandatory physician supervision requirements may be excessive or unjustified.

In some situations, we have engaged in competition advocacy where no plausible public benefit is even offered on behalf of licensing restrictions. For example, in 2011, the Commission filed an amicus brief in St. Joseph Abbey v. Castille,48 clarifying the meaning and intent of the

Commission’s “Funeral Rule.”49 The plaintiffs, monks at St. Joseph Abbey who had built and sold simple wooden caskets consistent with their religious values, had challenged Louisiana statutes that required persons engaged solely in the manufacture and sale of caskets within the state to fulfill all licensing requirements applicable to funeral directors and establishments. Those requirements included, for example, a layout parlor for 30 people, a display room for six caskets, an arrangement room, the employment of a full-time, state-licensed funeral director, and, even though the Abbey did not handle or intend to handle human remains, installation of “embalming facilities for the sanitation, disinfection, and preparation of a human body.”50 The U.S. Court of

Appeals for the Fifth Circuit found that “no rational relationship exists between public health and

47 See, e.g., INST. OF MED., NAT’L ACAD. OF SCIENCES, THE FUTURE OF NURSING: LEADING CHANGE, ADVANCING HEALTH, 98-99 (2011); NAT’L GOVERNORS ASS’N, THE ROLE OF NURSE PRACTITIONERS IN MEETING INCREASING DEMAND FOR PRIMARY CARE, 7-8 (2012), http://www.nga.org/files/live/sites/NGA/files/pdf/1212NursePractitionersPaper.pdf (study funded by U.S. Dep’t Health & Human Servs., reviewing literature pertinent to NP safety and concluding “None of the studies in the NGA’s literature review raise concerns about the quality of care offered by NPs. Most studies showed that NP- provided care is comparable to physician-provided care on several process and outcome measures.”). 48 Brief for the Federal Trade Commission as Amicus Curiae Supporting Neither Party, St. Joseph Abbey v. Castille, 712 F.3d 215 (5th Cir. 2013), cert. denied, 134 S. Ct. 423 (2013) (“FTC Brief Amicus Curiae, St. Joseph Abbey v. Castille”). 49 47 Fed. Reg. 42260 (1982). 50 See FTC Brief Amicus Curiae, St. Joseph Abbey v. Castille at 12, quoting La. Rev. Stat. Ann. § 37:842(D)(3).

Page 14 of 22 safety and restricting intrastate casket sales to funeral directors. Rather, this purported rationale for the challenged law elides the realities of Louisiana's regulation of caskets and burials.”51

As noted earlier, the response of regulated industries to new and disruptive forms of competition is another area of concern. In some cases, regulators have acted to protect incumbent service providers currently subject to regulation. For example, in the taxi and related transportation business, innovative smartphone applications have provided consumers with new ways to arrange for transportation and, in some cases, have enabled new transportation services.

Although some jurisdictions have adapted to these innovations, others have pursued regulatory approaches that would impede the development of new services, often without putting forth evidence of a legitimate consumer protection justification. We have urged these jurisdictions to consider carefully the adverse consequences of limiting competition, and to question the basis for restrictions advocated by incumbent industry participants.52

V. FTC Enforcement Efforts

Although the FTC typically relies on competition advocacy to discourage potentially anticompetitive occupational licensing laws and regulations, the Commission sometimes invokes its enforcement authority to challenge anticompetitive conduct by regulatory boards that falls outside of the scope of protected state action.53 These enforcement actions have included

51 St. Joseph Abbey v. Castille, 712 F.3d at 226 (affirming the district court decision that the challenged regulations, and their enforcement by the state board, were unconstitutional). 52 See, e.g., FTC Staff Comment to the Honorable Brendan Reilly Concerning Chicago Proposed Ordinance O2014- 1367 Regarding Transportation Network Providers (2014), http://www.ftc.gov/system/files/documents/advocacy_documents/ftc-staff-comment-honorable-brendan-reilly- concerning-chicago-proposed-ordinance-o2014-1367/140421chicagoridesharing.pdf. Regarding new methods of retail sales of automobiles, see, e.g., FTC Staff Comment Before the Missouri House of Representatives Regarding House Bill 1124, Which Would Expand the Current Prohibition on Direct-to-Consumer Sales by Manufacturers of Automobiles (2014), http://www.ftc.gov/policy/policy-actions/advocacy-filings/2014/05/ftc-staff-comment- missouri-house-representatives-0. 53 The Supreme Court has recently admonished that reliance on the state action doctrine is “disfavored.” N.C. State Bd. of Dental Exam’rs v. FTC, 135 S. Ct. 1101, 1110 (2015) (quoting FTC v. Phoebe Putney Health Sys., Inc., 133 Page 15 of 22 challenges to agreements among competitors that restrained advertising and solicitation, price competition, and contract or commercial practices, as well as direct efforts to prohibit competition from new rivals, without any cognizable justification.54

For example, in 2003, the Commission sued the South Carolina Board of Dentistry, charging that the Board had illegally restricted the ability of dental hygienists to provide basic preventive dental services in schools.55 To address concerns that many schoolchildren, particularly those in low-income families, were not receiving any preventive dental care, the state legislature had eliminated a statutory requirement that a dentist examine each child before a hygienist could perform basic preventive care in schools. The Board then re-imposed the dentist examination requirement as an “emergency regulation.” Our complaint alleged that the Board’s action unreasonably restrained competition in the provision of preventive dental care services, depriving thousands of economically disadvantaged schoolchildren of needed dental care, and

S. Ct. 1003, 1010 (2013), FTC v. Ticor Title Ins. Co., 504 U.S. 621, 636 (1992)) (“[G]iven the fundamental national values of free enterprise and economic competition that are embodied in the federal antitrust laws, ‘state action immunity is disfavored, much as are repeals by implication.’”); Phoebe Putney Health Sys., 133 S. Ct. at 1016 (“federalism and state sovereignty are poorly served by a rule of construction that would allow ‘essential national policies’ embodied in the antitrust laws to be displaced by state delegations of authority ‘intended to achieve more limited ends.’”). Prior Commission testimony provides additional details on the history and scope of the state action exemption. See License to Compete, supra note 5; see also FED. TRADE COMM’N OFF. POL’Y PLAN., REPORT OF THE STATE ACTION TASK FORCE (2003), https://www.ftc.gov/sites/default/files/documents/advocacy_documents/report- state-action-task-force/stateactionreport.pdf. 54 The Commission also has advocated against attempts to exempt certain licensed health care professions from antitrust scrutiny for the purpose of permitting blatantly anticompetitive conduct. See FTC Staff Comment Before the Connecticut General Assembly Labor and Employees Committee Regarding Connecticut House Bill 6431 Concerning Joint Negotiations by Competing Physicians in Cooperative Health Care Arrangements, 3 (2013), http://www.ftc.gov/sites/default/files/documents/advocacy_documents/ftc-staff-comment-connecticut-general- assembly-labor-and-employees-committee-regarding-connecticut/130605conncoopcomment.pdf. 55 In re South Carolina State Bd. of Dentistry, Complaint (2003) (Dkt. No. 9311), http://www.fic.gov/os/2003/09/socodentistcomp.pdf. See also In re South Carolina State Bd. of Dentistry, Opinion and Order of the Commission (2004) (Dkt. No. 9311), http://www.fic.gov/os/adjpro/d9311/04072Scommissionopinion.pdf. Page 16 of 22 that its harmful effects on competition and consumers were unjustified. The Board ultimately entered into a consent agreement settling the charges.56

Similarly, in 2010, the Commission challenged the North Carolina Board of Dental

Examiners for issuing a series of cease-and-desist letters that successfully expelled low-cost nondentist providers of teeth-whitening services.57 As discussed in the next section, the FTC’s challenge led to the Supreme Court’s much-discussed opinion on the application of the state action doctrine to state boards dominated by active market participants. It is also worth noting that lower courts addressed competition issues underlying the FTC’s challenge to the board’s conduct: the U.S. Court of Appeals for the Fourth Circuit affirmed, among other things, the

FTC’s conclusion that the Board’s behavior was likely to cause significant competitive harm.58

Some of the Commission’s most important enforcement actions challenging restrictions on the dissemination of truthful advertising of professional services have been in the health care area.59 For example, some boards of optometry60 and dentistry61 have sought to suppress information that could be useful to consumers of their services.

When the FTC takes enforcement actions, it is mindful of state regulatory authority. The state action doctrine is highly protective of direct exercises of sovereign state authority; it provides considerable leeway to the states as to the delegation of that authority and, in particular, to the makeup and conduct of licensing boards. Intervention under the federal antitrust laws

56 In re South Carolina State Bd. of Dentistry, Decision and Order (2007) (Dkt. No. 93 I I), http://www.fic.gov/os/adjpro/d93111070911decision.pdf). 57 N.C. State Bd. of Dental Exam’rs, 135 S. Ct. at 1108-9. 58 N.C. State Bd. of Dental Exam’rs v. FTC, 717 F. 3d 359, 374 (4th Cir. 2013) (FTC’s finding “supported by substantial evidence.”). 59 For an example outside the health care area, see, e.g., Rhode Island Bd. of Accountancy, 107 F.T.C. 293 (1986) (consent order). 60 See, e.g., In the Matter of Massachusetts Bd. of Registration in Optometry, 110 F.T.C. 549 (1988). 61 Louisiana State Bd. of Dentistry, 106 F.T.C. 65 (1985) (consent order). Page 17 of 22 requires conduct that is anticompetitive under the antitrust laws, demonstrably harmful to consumers, and in excess of any clearly delegated authority and/or unsupervised by the state.

Notably, many of these FTC enforcement matters have been aided or reinforced by state legislatures or attorneys general.62 For example, the Texas state legislature and governor, apparently sharing concerns that motivated an FTC investigation, recently overrode rules imposed by the Texas Medical Board that effectively prevented most telemedicine in the state.63

As a result, the Commission closed its investigation of the Texas Medical Board’s alleged anticompetitive conduct.64 As the Commission said in its closing statement:

The Commission commends the State of Texas for directly exercising its sovereign authority to override the TMB’s rules and to reform its regulatory authority for the benefit of Texas consumers. As the Commission first noted in a 2004 report, when properly used, telemedicine has considerable promise to broaden access, lower costs, and improve health quality. The Commission hopes that by expanding the availability of telemedicine and telehealth alternatives, the new law will lead to many benefits for Texans, including increased competition among providers, more innovation in the delivery of care, increased access to healthcare services, reduced travel costs, and greater convenience.65

VI. North Carolina Board of Dental Examiners and the Future of the State Action Doctrine

As recounted in the Supreme Court’s North Carolina Board of Dental Examiners decision, states may regulate a particular occupation or profession by setting standards for

62 See, e.g., text accompanying notes 55-56 (regarding South Carolina State Bd. of Dentistry and conflict between Board and S.C. legislature); Brief of Amici Curiae State of Illinois et al., in Support of Petitioner, FTC v. Phoebe Putney Health Sys., Inc., 133 S. Ct. 1003, 1010 (2013) (No. 11-1160) (amici brief filed by 20 states in support of the FTC). 63 See S.B. No. 1107, 85th Legislative Session, Sec. 2 (striking Tex. Occ. Code Ann. § 111.004(5) and Sec. 3 (Tex. Occ. Code. Ann. §§ 111.005(a)(3), (b), 111.007, 111.007(b). 64 Statement of the Federal Trade Commission On the Commission Vote To Close the Investigation of the Texas Medical Board’s Conduct (Jun. 21, 2017), https://www.ftc.gov/system/files/documents/public_statements/1225993/1510180_texas_medical_board_statement_ of_the_commission_6-21-17.pdf. 65 Id. (citing FED. TRADE COMM’N & U.S. DEP’T OF JUSTICE, IMPROVING HEALTH CARE: A DOSE OF COMPETITION 23 (2004)). Page 18 of 22 licensing individuals to practice that occupation or profession and creating a board to administer those licensing standards. States often require that licensing boards include practicing members of the occupation or profession being regulated, and neither the Supreme Court nor the FTC has sought to dictate how such boards must be constituted.

The Court has, however, opined on the political accountability of boards controlled by market participants. In N.C. Dental, the Supreme Court held that a licensing board on which a controlling number of decision-makers are active market participants in the occupation the board regulates must satisfy both prongs of the test the Supreme Court articulated in California Retail

Liquor Dealers Association v. Midcal Aluminum.66 The Court held that board actions must be made pursuant to a clearly articulated and affirmatively expressed state policy to displace competition, and their conduct must be actively supervised by the state.67 The active supervision requirement ensures that any anticompetitive acts undertaken by private actors are in fact approved by the state as part of its regulatory policy. The mere possibility of supervision is not enough; state officials must have and exercise the power to review the anticompetitive acts of the private parties and to reject or modify those that conflict with state policy.68

The FTC and its staff are well aware that, in the wake of the N.C. Dental decision, many stakeholders have been grappling with questions of state authority and the independence of state regulatory boards. Indeed, we understand that these questions have helped to motivate introduction of the RBI Act. On the one hand, some stakeholders have voiced concerns that post-

66 See Midcal, supra note 7. 67 N.C. State Bd. of Dental Exam’rs, 135 S. Ct. at 1113-4; Midcal, supra note 7, at 105-6. 22 See, e.g., Decision and Order, Va. Bd. of Funeral Directors & Embalmers, 138 F.T.C. 645 (2004); R.I. Bd. of Accountancy, 107 F.T.C. 293 (1986). See also United States v. Tex. State Bd. of Public Accountancy, 464 F. Supp. 400, 402− 03 (W.D. Tex. 1978) (a competitive bidding case), aff’d as modified, 592 F.2d 919 (5th Cir. 1979), cert. denied, 444 U.S. 925 (1979). 68 Patrick v. Burget, 486 U.S. 94, 100−01 (1988). Page 19 of 22

N.C. Dental antitrust lawsuits that might be filed against state regulatory boards and their members could undermine state authority and the practical functioning of such boards.

Relatedly, some have expressed concerns about the possible exposure of individual board members – including part-time and/or voluntary board members – to money damages from private antitrust litigation (a concern that would not apply to FTC enforcement).

But there are also concerns on the other side, especially if reaction to N.C. Dental were to lead to attempts to further insulate state boards from federal antitrust scrutiny. As noted above, states can exercise their sovereign authority or delegate that authority to lesser state actors or independent boards,69 even if a board consists exclusively of self-interested private parties who may be engaged in conduct that otherwise would violate the antitrust laws. The state need only clearly articulate its delegation of authority to regulate in an anticompetitive manner, and then actively and adequately supervise the exercise of that delegated authority. Some are concerned, however, that responses to N.C. Dental’s clarification of when active supervision is needed might be cursory and pro forma or, in some cases, lead to the worst of both worlds. First, costly and burdensome oversight mechanisms intended to satisfy the active supervision requirement might impede commerce and the proper functioning of state licensing boards, without furthering competition or other state policy goals. Second, these approaches, if successful, would achieve the goal of insulating blatantly anticompetitive conduct by private actors.

Although the Commission believes that worries about undue antitrust enforcement are premature and unlikely to be borne out in future litigation, both sets of concerns about the long- term impact of N.C. Dental are understandable. The RBI Act seeks to balance these concerns,

69 State boards of occupational regulation are sometimes called “independent” boards, to the extent that they include members who are active market participants and others who work substantially outside state government, or to the extent the boards appear otherwise independent of a state’s executive branch of government. Page 20 of 22

providing additional assurance and stability to state policymakers, “independent” state boards,

and board members, while guarding against occupational licensing initiatives that, either

intentionally or unintentionally, might undermine “our national policy in favor of competition”

and thereby harm consumer welfare.70 In light of the Commission’s longstanding interest in

mitigating the anticompetitive effects of excessive occupational licensing, the Commission

supports the goals of the legislation. At the same time, we note that a substantial body of case

law regarding the state action doctrine has already struck a careful balance between the antitrust

laws and state sovereignty, and careful thought must be given to the details and potential

unintended consequences of any initiatives that would alter this balance.

VII. Conclusion

Occupational licensing can serve important goals and, when used appropriately, protect

consumers from harm. But, as is illustrated by the Commission’s history of advocacy and

enforcement, excessive occupational licensing can leave consumers and workers worse off, by

impeding competition without offering meaningful protection from legitimate health and safety

risks. Even when some form of licensing is warranted, specific regulations can have significant

adverse effects on competition and consumers. Such regulations should be analyzed for their

impact on competition and, when it seems likely that anticompetitive effects will outweigh any

consumer benefits, the proponents of any restrictions should bear the burden of justifying why

they are needed. We also urge states to be cautious when delegating authority to enforce

potentially anticompetitive regulations to self-interested boards whose members represent the

very occupation to be regulated.

70 See H.R. 3446, 115th Cong. § 2 (2017) (statement of findings and purpose). Page 21 of 22

Thank you for the opportunity to share the Commission’s views and to discuss our efforts to promote competition and protect consumers.

Page 22 of 22

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Agenda Item 12

Review of Louisiana Attorney General Opinion No. 17-0076 re Pharmacy Benefit Managers

Mr. Randal Johnson Louisiana Independent Pharmacies Association

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Agenda Item 13

Discussion of Letter to Attorney General & Dept. of Insurance re Pharmacy Benefit Managers

Mr. Mannino

Dear

It has come to the attention of the Louisiana Board of Pharmacy that Louisiana Law (R.S 22:1060.6) is routinely be violated by numerous PBMs/Insurance companies.

This statute addresses the issue of “clawbacks” Louisiana citizens are forced to pay for their prescriptions. (copy of R.S. 22:1060.6 attached).

Violations of this law have been verbally reported to board members from pharmacists in the state of Louisiana. These pharmacists have not produced written proof of these violations (but are willing to do so) because of the fear of reprisals from the PBMs/Insurance companies (some reprisals available to PBMs/Insurance Companies listed attachment A).

The board would like to know the following,

1) Is enforcement of R.S. 22:1060.6 within your authority? If not, whose authority is it?

2) What protection from reprisals would you give to every pharmacy and pharmacist that gives proof of violations of R.S. 22:1060.6?

We look forward to getting this information as soon as possible.

Respectfully,

Attachment A

Some of the reprisals available to the PBMs/Insurance companies a) excessive and unreasonable audits b) unreasonable recoupments c) unreasonable, undefined and discriminative reimbursements d) invoking unreasonable non-discloser agreements e) forcing their patients to use providers that are owned by the PBM f) refusal to provide complete contract details to all parties involved g) failure to provide full definition of all language in contracts h) forcing the patients to use providers other than the patient's preference; paying providers in different manners (i.e. paying "true ups" so as to hide the true amounts paid to a provider) i) charging unreasonable "DIR" fees or other fees based on expectations that are unreasonable or impossible for the provider to achieve (for example, taking back money because a patient refuses to take a medication, unable to take a medication or the physician will not order a medication).

2016 Regular Session ACT No. 527 ENROLLED SENATE BILL NO. 131

BY SENATOR JOHNS AND REPRESENTATIVES BAGLEY, HENSGENS, HOFFMANN, HORTON, LEBAS, POPE AND WILLMOTT N ACT

1 To enact R.S. 22:1060.6, relative to the prescription drug cost; to provide for pharmacist

2 communication with patients; to provide for an effective date; and to provide for

3 related matters.

4 Be it enacted by the Legislature of Louisiana:

5 Section 1. R.S. 22:1060.6 is hereby enacted to read as follows:

6 §1060.6. Limitation; patient payment

7 A. An individual shall not be required to make a payment for

8 pharmacists' services in an amount greater than the pharmacist or pharmacy 10 providing the pharmacists' services may retain from all payment sources. 11 B. The provision established in Subsection A of this Section shall become 12 effective on January

1, 2017.

13 Section 2. This Act shall become effective on August 1, 2016; if vetoed by the

14 governor and subsequently approved by the legislature, this Act shall become

effective on 15 August 1, 2016, or on the day following such approval by the

legislature, whichever is later.

PRESIDENT OF THE SENATE

SPEAKER OF THE HOUSE OF REPRESENTATIVES

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Agenda Item 14

Request for Waiver of Licensure Renewal Fee for Military Spouse

Lt. Col. Charlton Meginley

From: MEGINLEY, CHARLTON J Lt Col USAF AFLOA AFLOA/CSDC To: Malcolm J. Broussard Subject: RE: Military Spouse Licensing Date: Wednesday, September 06, 2017 4:06:41 PM

That's great! Thank you!

-----Original Message----- From: Malcolm J. Broussard [mailto:[email protected]] Sent: Wednesday, September 06, 2017 3:43 PM To: MEGINLEY, CHARLTON J Lt Col USAF AFLOA AFLOA/CSDC Subject: [Non-DoD Source] RE: Military Spouse Licensing

Lt Col Meginley,

The board's president has directed this topic be placed on the agenda of the board's next meeting, now scheduled for Nov. 15, 2017, for their consideration and direction to staff.

Malcolm J Broussard Executive Director Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, LA 70809-1700 USA ~ GMT-6 Telephone +1.225.925.6481 Telecopier +1.225.923.5669 [email protected]

-----Original Message----- From: MEGINLEY, CHARLTON J Lt Col USAF AFLOA AFLOA/CSDC [mailto:[email protected]] Sent: Tuesday, September 05, 2017 1:38 PM To: Malcolm J. Broussard Subject: FW: Military Spouse Licensing

Mr. Broussard,

Good afternoon. I'm Lt Col Charlton Meginley and I posed this question below many months ago to Senator Luneau. For a little background, my wife has been a pharmacist for nearly 20 yrs. For the last 14, she has been a military spouse, licensed not only in Louisiana (her home state), but Florida, Illinois, Texas, and Arizona (we were stationed in CA and Germany as well, but she was able to work at military facilities). As you can imagine, it is a terrible burden on her to have get licensed virtually every time we move. With the exception of a six week period in 2006, my wife has not been a pharmacist in Louisiana since 2003.

Both Florida and Illinois are states where because she is a military spouse, she doesn't have to pay the annual fee because she is no longer in that state. She is considered on active status, as long as she is a military spouse.

While LA's annual license fee isn't that great, to pay that fee, in addition to Texas' fee (where we are now stationed), in addition to any of the CE fees for the other states, you can see where the cost of my military service does become a burden on her. If the BoP is willing to address this matter with the legislature, it would be greatly appreciated. I can be reached at 985-290-2265 if you have any questions.

Thank you. Lt Col Meginley

Lt Col Charlton J. Meginley Chief Senior Defense Counsel, Central Circuit 550 D Street East, Ste 3, Building 399 Randolph AFB, TX 78150 (210) 565-0777; DSN 665-0777

CONFIDENTIALITY NOTICE: This electronic transmission contains confidential information intended only for the person(s) named in the distribution above. It may contain attorney work-product or information protected under the attorney-client privilege, both of which are protected from disclosure under the Freedom of Information Act, 5 U.S.C. § 552. Confidential information is also protected by the Privacy Act, 5 U.S.C. § 552a, or other applicable laws. If you receive this transmission in error, please notify the sender and delete copies of this message.

-----Original Message----- From: Luneau, Sen. (District Office) [mailto:[email protected]] Sent: Monday, August 14, 2017 10:01 AM To: MEGINLEY, CHARLTON J Lt Col USAF AFLOA AFLOA/CSDC Subject: [Non-DoD Source] RE: Military Spouse Licensing

Hi Lt. Col Meginley, The following text came directly from the Executive Director Louisiana Board of Pharmacy:

Ms. Baptiste-McNeal,

The Board's licensure fees and the exemptions to those fees are set by the legislature. In particular, R.S. 37:1208 allows the Board to waive license renewal fees for pharmacists and technicians in active duty military service. There is no statutory provision to waive fees for spouses of active duty military licensees.

Pursuant to Act 276 of the 2012 Legislature, the Board promulgated a rule establishing preferential licensing procedures for military-trained applicants and their spouses. That rule gives priority to applications from such applicants for their initial licenses. Neither the rule nor the law which authorized the rule (R.S. 37:3651) addresses license renewal fees.

I'm not aware of any previous requests for waivers of licensure fees for military spouses. I will bring this matter to the Board's attention to get their direction. We will also survey other state boards of pharmacy to determine the extent to which other states may offer such waivers.

Thanks, Malcolm

Malcolm J Broussard Executive Director Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, LA 70809-1700 USA ~ GMT-6 Telephone +1.225.925.6481 Telecopier +1.225.923.5669 [email protected]

Vanessa Baptiste-McNeal Legislative Assistant Senator W. Jay Luneau, District 29 711 Washington Street ~ Alexandria, LA 71301 (318) 484-2288 office ~ (318) 484-2287 fax [email protected]

-----Original Message----- From: Schanck, Maureen [mailto:[email protected]] Sent: Monday, August 07, 2017 2:01 PM To: Malcolm J. Broussard Cc: Russell, Scotti; Lewalski, Eileen; Halvorson, Melissa Subject: RE: Military Spouse Licensing Hi Malcolm, Please see the attached NABPLAW search completed by our student. She noticed that most states don't grant a fee exemption for military spouses. Texas waives the application fee for military spouses, but does require a renewal fee to be paid. Please let us know if you need anything else. Thanks, Maureen

[Interim communications redacted]

-----Original Message----- From: Malcolm J. Broussard [mailto:[email protected]] Sent: Monday, July 31, 2017 10:32 AM To: Russell, Scotti Subject: FW: Military Spouse Licensing Hello Scotti, I don't recall the Survey of Pharmacy Law addressing fee exemptions for military pharmacists or their spouses. We have exempted military pharmacists from renewal requirements for several years, but we now have a request for waivers for a military spouse. The military pharmacist has suggested most states are now offering such waivers and that Louisiana is behind the times on this issue. Is this an issue where NABP already has some data you can share? If not, is this a question that can be surveyed in a weekly secretary's mailbag? Thanks for whatever you can share. Malcolm

-----Original Message----- From: Malcolm J. Broussard Sent: Monday, July 31, 2017 12:27 PM To: 'Luneau, Sen. (District Office)' Subject: RE: Military Spouse Licensing Ms. Baptiste-McNeal, The Board's licensure fees and the exemptions to those fees are set by the legislature. In particular, R.S. 37:1208 allows the Board to waive license renewal fees for pharmacists and technicians in active duty military service. There is no statutory provision to waive fees for spouses of active duty military licensees. Pursuant to Act 276 of the 2012 Legislature, the Board promulgated a rule establishing preferential licensing procedures for military-trained applicants and their spouses. That rule gives priority to applications from such applicants for their initial licenses. Neither the rule nor the law which authorized the rule (R.S. 37:3651) addresses license renewal fees. I'm not aware of any previous requests for waivers of licensure fees for military spouses. I will bring this matter to the Board's attention to get their direction. We will also survey other state boards of pharmacy to determine the extent to which other states may offer such waivers. Malcolm J Broussard Executive Director Louisiana Board of Pharmacy

-----Original Message----- From: Luneau, Sen. (District Office) [mailto:[email protected]] Sent: Wednesday, July 26, 2017 3:21 PM To: Malcolm J. Broussard Subject: FW: Military Spouse Licensing Hi Mr. Broussard, Our Office has been contacted by Lt Col Meginley via email (see below) in reference to his wife's Louisiana Pharmacy License. He is active duty military and is currently living in another state. He is seeking information on behalf of his wife who holds a Louisiana Pharmacy License. Mrs. Meginley has not worked in Louisiana for many years; however, does pay the renewal fees for her license. He wants to know why does his wife have to pay a licensing fee instead of being granted a military spouse exemption on her license? According to Lt Col Meginley, other states have offered the exemption. Please contact me with any questions. Please update us with any actions in this matter. Thanks in advance, Vanessa Baptiste-McNeal Legislative Assistant Senator W. Jay Luneau, District 29

-----Original Message----- From: MEGINLEY, CHARLTON J Lt Col USAF AFLOA AFLOA/CSDC Sent: Friday, January 06, 2017 8:49 AM To: '[email protected]' Subject: Military Spouse Licensing Senator Luneau, Good morning. My name is Charlton Meginley and I am active duty Airman. I've been in the Air Force for the last 14 years serving as a Judge Advocate. I'm from Alexandria and went to NLU for undergrad, LSU for law school. My wife, Therese, is from Slidell and went to pharmacy school at NLU. We've been married for 17 years. As you can imagine, being in the military has presented various challenges for my family, but one of the biggest issues has been employment for my wife. As a medical professional, every time we move, she has to take another exam and get licensed in another state. To date, she is/has been licensed in Arizona, Florida, Illinois, Texas, and or course, Louisiana, her home state. Despite the fact she not practiced pharmacy in Louisiana in over 10 years, she still has to pay to keep her Louisiana license up to date. Louisiana is very different, as most states now grant a military spouse exemption to payment of licenses as long as you are not practicing in Louisiana. For instance, my wife is allowed to keep her Illinois license active (without payment of fees) as long as I am active duty; Florida as well. I would like you to please look into this issue. The fee is only $100. However, it really is the principle of the matter. Louisiana has not kept up with taking care of military spouses (those who are professionals) like other states, so this would be small step in rectifying it. Here is a link for Florida that talks about Licensing for military spouses: http://www.flhealthsource.gov/valor#MilitarySpouses Please let me know if you have any questions. My cell phone is 985-290-2265. Respectfully, Charlton Meginley Lt Col Charlton J. Meginley Chief Senior Defense Counsel, Central Circuit 550 D Street East, Ste 3, Building 399 Randolph AFB, TX 78150 (210) 565-0777; DSN 665-0777

Legislative Proposal 2018-D ~ Renewal Fee Waiver for Military Spouse Draft #1

1 HLS 18-

2 Regular Session, 2018

3 House Bill No. _____

4 By Representative

6 BOARD OF PHARMACY: Authorizes the board to waive the renewal fee for a military spouse.

8 AN ACT

10 To enact R.S. 37:1208.1, relative to the waiver of renewal fee for military spouse.

12 Be it enacted by the Legislature of Louisiana:

13 Section 1. R.S. 37:1208.1 is hereby enacted to read as follows:

14 §1208.1. Waiver of renewal fee for military spouse

15 Upon written request of any licensed pharmacist or certified technician who is the

16 spouse of a person serving in active duty in the military service of the United States, the

17 board may waive the requirement of the fee for the renewal of pharmacist license or 18 technician certificDRAFTate, in accordance with rules promulgated by the board.

Agenda Item 15

Petition for Additional Testing Opportunity by Applicant for Pharmacist Licensure

NAPLEX® North American Pharmacist Licensure Examination® MPJE® Multistate Pharmacy Jurisprudence Examination®

2017 Candidate Registration Bulletin

Please read the NAPLEX/MPJE Candidate Registration Bulletin thoroughly to ensure that you understand all the policies and procedures for taking your examination. This bulletin contains information for all registrations and scheduling of NAPLEX and MPJE appointments beginning January 1, 2017.1 Table of Contents

Essential Information...... 1 Before the Examination...... 1 Examination Day...... 1 After the Examination...... 2 If You Miss the Examination Appointment...... 2 NAPLEX/MPJE Registration...... 3 Welcome to the NAPLEX and MPJE ...... 3 NAPLEX and MPJE Registration Fees ...... 3 Online Examination Registration Through Your NABP e-Profile...... 3 Creating a New e-Profile in Order to Complete the Online Examination Registration...... 3 Completing the Online Examination Registration Form...... 4 Additional Registration Options...... 5 Testing Accommodations...... 7 Authorizing Use of Previous Accommodation Request...... 8 Testing Accommodations – Colorado, Florida, Maine, Oregon, and Utah Candidates...... 8 Scheduling With Testing Accommodations...... 9 Your Examination Appointment...... 10 Testing Centers...... 10 Jurisdictions Requiring MPJE...... 10 Eligibility Requirements...... 10 Authorization to Test...... 11 Scheduling Your Examination Appointment...... 11 NAPLEX/MPJE Administration...... 13 On the Day of the Examination...... 13 Identification Requirements...... 14 Name Matching Guidelines...... 14 Acceptable Forms of Primary Identification...... 15 Acceptable Forms of Secondary Identification...... 15 Unacceptable Forms of Identification...... 16 Temporary IDs...... 16 Legal Name Changes...... 16 Test Center Restrictions...... 17 Security Measures...... 18 Misconduct...... 18 Atypical Testing Circumstances ...... 20 NAPLEX and MPJE Score Withholding, Cancellation, or Invalidation...... 20 Inclement Weather ...... 20 Technical Difficulties...... 21

i Table of Contents (cont.)

NAPLEX...... 22 What Is the NAPLEX?...... 22 The NAPLEX Test Design ...... 22 NAPLEX Competency Statements...... 23 NAPLEX Sample Questions...... 24 Pre-NAPLEX...... 26 Registration Requirements ...... 26 Examination Questions and Scores...... 26 Preparation...... 27 Retaking the Pre-NAPLEX...... 27 Software and Computer Requirements...... 27 MPJE...... 28 What Is the MPJE? ...... 28 The MPJE Test Design ...... 28 MPJE Competency Statements ...... 29 MPJE Sample Questions...... 32 NAPLEX/MPJE Score Results...... 34 NAPLEX Score Results ...... 34 MPJE Score Results...... 34 NAPLEX and MPJE Score Review...... 35 Score Holds/Psychometric Review Process...... 35 Retake Policy...... 35 Waiting Periods...... 36 NAPLEX Score Transfer...... 37 NAPLEX Score Transfer Program ...... 37 Score Transfer Process ...... 37 NAPLEX Score Transfer Fee ...... 38 Participating Score Transfer Jurisdictions ...... 38 NAPLEX/MPJE Contacts...... 39 Contacts for Your Questions ...... 39 Candidate Comments ...... 39 Report Exam Misconduct or Irregularities ...... 39 Appendices...... 40 Appendix A...... 40 Appendix B...... 42 Appendix C...... 43

ii NAPLEX/MPJE Score Results

NAPLEX Score Results The NAPLEX is the means by which boards of pharmacy assess the competence of candidates for licensure. Any other use of individual NAPLEX scores is inappropriate and is not condoned by NABP. By applying to take the NAPLEX, you authorize NABP to release your test scores to your designated board of pharmacy. NABP will forward your NAPLEX score to the board(s) of pharmacy from which you are seeking licensure, as well as to any state that you have requested receive your scores by score transfer, unless NABP has withheld, invalidated, or canceled your NAPLEX score, as described in the Bulletin. The minimum acceptable passing score on the NAPLEX scale is 75. The passing score reported is not a percentage value. As of November 1, 2016, there no longer is a requirement to answer a minimum number of test questions in order to receive a test score. If a candidate does not complete the examination, all unanswered questions on the NAPLEX will be scored as incorrect. It is in the best interest of the candidate to complete the examination to achieve an optimum score. NABP uses a mathematically based weighted scoring model to calculate an ability measure for each examinee. The ability measures is transformed to a reporting scaled score that ranges from 0 to 150. Scaled scores do not represent the raw number of correct answers and should not be interpreted as such. The NAPLEX passing standard has been established by a panel of pharmacy experts, and the ability level that defines the passing standard is the same for all NAPLEX administrations.Specific questions about scoring should be emailed to [email protected]. Official score reports for candidates who receive a failing score on the NAPLEX will include a section which indicates their relative performance in each of the two major competency area. Because of the secure nature of the NAPLEX, no review of the test questions is allowed. Candidates may receive scores or an official score report for the NAPLEX directly from their boards of pharmacy.

MPJE Score Results The MPJE is the means by which boards of pharmacy assess pharmacist licensure candidates’ knowledge of pharmacy jurisprudence. Any other use of individual MPJE scores is inappropriate and is not condoned by NABP. By applying to take the MPJE, you authorize NABP to release your test scores to the designated boards of pharmacy. NABP will forward your MPJE score to the board of pharmacy from which you are seeking licensure unless NABP has withheld, invalidated, or canceled your MPJE score, as described in this Bulletin. By applying to take the MPJE, you authorize NABP to release your test scores to the designated boards of pharmacy. To receive an MPJE test score, you must have completed at least 107 questions on the examination. Candidates completing fewer than 107 questions will not have their scores reported. Candidates who complete at least 107 questions, but fewer than 120 questions, will have a penalty applied and their scores adjusted to reflect the number of questions that remained unanswered. Therefore, it is in the candidate’s best interest to

34 NAPLEX/MPJE Score Results

answer all questions presented. The minimum acceptable passing score on the MPJE scale is 75. The passing score reported is not a percentage value. NABP uses a mathematically based weighted scoring model to calculate an ability measure for each candidate. These ability measures are transformed to a reporting scale that ranges from 0 to 100. Scaled scores do not represent the raw number of correct answers and should not be interpreted as such. The score is calculated by first determining the candidate’s ability level on the MPJE and then determining whether the score has met the MPJE passing standard. The passing standard has been established by a panel of pharmacy experts and is the same for all candidates for licensure. Candidates will receive a score or an official score report for the MPJE directly from their boards of pharmacy. Because the MPJE is unique to the state or jurisdiction in which you seek licensure, it is not possible to transfer your MPJE score to another state. ! Note: Only the individual boards of pharmacy have the authority to issue a license to practice pharmacy. The posting by NABP of a passing score on an examination does not constitute a license to practice pharmacy. Boards will not accept examination scores posted online by NABP for purposes of score transfer or obtaining licensure. Online score reports are for candidate use only.

NAPLEX and MPJE Score Review On occasion, a candidate may believe that the score reported is not accurate. It is extremely unlikely that a score will be changed through the review process. However, should a candidate request to have a NAPLEX or MPJE score reviewed, they must do so within 60 days of the date that scores are released to the respective board of pharmacy. The request must be submitted in writing and be accompanied by the score review fee. In your written request you must include your name, NABP e-Profile number, address, and phone number. You will be informed in writing of the score review results within two to four weeks. The fee for the NAPLEX or MPJE score review is $100 per examination. The fee must be submitted in the form of a money order, bank draft, or a certified check payable to the National Association of Boards of Pharmacy or NABP. The rescore process includes a manual inspection of the examinee’s test session, which includes but is not limited to the following: answer patterns, time spent to respond to items, performance on scored versus non- scored items, and performance on various item formats. Upon verification that the exam was delivered as intended and that no technical anomaly occurred during the test session, the candidate’s score is recomputed via an independent scoring tool. The rescore process does not include the review of item content.

Score Holds/Psychometric Review Process On occasion, a candidate’s score will be placed on hold for further evaluation. Test scores may be subject to a hold as part of NABP’s routine quality control and assurances processes. Tests are evaluated to ensure compliance with delivery and scoring models. Test scores may also be held as a result of an incident reported at the testing center or an observed difference in a candidate’s performance on two or more examination attempts, or if a candidate’s score is unusually low. In the event of a score hold, NABP will notify the respective board of pharmacy and the candidate within seven business days. Should you receive notification of a score hold, there will be explicit instructions regarding the action that you need to take in order to respond to NABP’s inquiries. All inquiries regarding score holds should be addressed to [email protected].

Retake Policy Candidates will be limited to five attempts (if permitted by the board of pharmacy) to pass the NAPLEX and MPJE.

35 NAPLEX/MPJE Score Results

MPJE candidates will have five opportunities (if approved by the board) per jurisdiction or state to pass the exam. For example, a candidate may attempt to pass the MPJE in State A five times and will also have five attempts for State B. Some exceptions may apply, as NABP member boards retain the authority to determine the number of attempts per candidate in their jurisdiction. If you have any questions, or require more information about the five-attempt limit, please contact NABP Customer Service, Monday through Friday, 9 am to 5 pm Central Time, at 847/391-4406, or by email at [email protected]. ? See page 20 for more information on score cancellations.

Waiting Periods NAPLEX As of November 1, 2016, the NAPLEX waiting period is 45 days between a failed attempt on the NAPLEX and the next scheduled appointment to test. Some jurisdictions have a waiting period stated in rules or regulations that exceeds the NAPLEX 45-day waiting period. Candidates shall be required to comply with the jurisdiction’s stated waiting period in such cases. To retake the NAPLEX, candidates must complete the online registration and submit the fees. Eligibility must be reconfirmed by a board of pharmacy and candidates must adhere to the 45-day waiting period.The waiting period policy includes a provision that there shall be no more than three attempts to pass the NAPLEX in a 12-month period. If a candidate fails the NAPLEX three times in a 12-month period, the candidate shall be subject to eligibility approval by the board of pharmacy (or designated authority) and will not receive an authorization to test until the 12-month time frame has passed.

MPJE For the MPJE the waiting period is 30 days between attempts. Candidates who miss a scheduled testing appointment without following the cancellation procedure forfeit testing fees and may have to wait up to five business days after the scheduled appointment to pay a resitting fee and receive a new ATT (see “Resitting After a Missed/Canceled Appointment, page 6).

36 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

Announcements

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Facsimile 225.925.6499 www.pharmacy.la.gov ~ E-mail: [email protected]

November 15, 2017

Agenda Item 16: Announcements

Nov. 23 Thanksgiving Day – Board office closed Nov. 24 Acadian Day – Board office closed Nov. 28-30 NABP Forum for Compliance Officers & General Counsel – Mount Prospect, IL

Dec. 2 New Orleans Pharmacy Museum Annual Rx Gala – New Orleans, LA Dec. 3-7 ASHP MidYear Meeting – Orlando, FL Dec. 6-7 Violations Committee Preliminary Hearing Dec. 25 Christmas Day – Board office closed Dec. 26 State Holiday – Board office closed

Jan. 1 New Year’s Day – Board office closed Jan. 2 State Holiday – Board office closed Jan. 10 Louisiana Pharmacy Congress Prescription Monitoring Program Advisory Council Jan. 25-28 FARB Annual Forum – Coronado, CA

Tentative Board Meeting Dates for Calendar Year 2018

Feb. 20-22 May 22-24 Aug. 14-16 Nov. 13-15