Louisiana Board of 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Board Meeting

Public Meeting Binder

February 24, 2021

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. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Table of Contents ~ Public Meeting Binder

0 – A. Table of Contents 002 0 – B. Acronyms 004 0 – C. Agenda 009 1. Call to Order 2. Quorum Call 3. Call for Additional Agenda Items & Adoption of Agenda 4. Consideration of Draft Minutes from Previous Meetings ~ November 18, 2020 012 5. Report on Action Items 047 6. Confirmation of Acts 7. Opportunity for Public Comment 8 Special Orders of the Day 9. Committee Reports A. Finance 066 (1) Review of Interim Report for Fiscal Year 2020-2021 067 B. Application Review 074 C. Reciprocity 075 (1) List of Licensed by Reciprocity 076 D. Violations 077 (1) Consideration of Proposed Voluntary Consent Agreements (2) Reconsideration of Previous Decision from Administrative Hearing E. Impairment 078 F. Reinstatement 079 (1) List of Credential Reinstatements 080 G. Tripartite 090 H. Regulation Revision 091 (1) Consideration of Comments & Testimony from November 25, 2020 Public Hearing re Regulatory Project 2020-4 ~ Pharmacy Benefit Managers 092 (2) Consideration of Regulatory Proposal 2021-A ~ Collaborative Practice (Draft #1 - coded) and (Draft #1 – clean) 236 / 244 (3) Consideration of Legislative Proposal 2021-C ~ Collaborative Practice (Draft #1) 246 (4) Consideration of Legislative Proposal 2021-D ~ Limited Prescriptive Authority (Draft #2) 249 Preliminary Public Comments re Legislative Proposal 253 (5) Consideration of Proposed Report to 2021 Legislature re Senate Resolution 39 of 2nd Extraordinary Session of 2020 Legislature 255 (6) Consideration of Legislative Proposal 2021-A ~ CDS Schedule Update (Draft #3) 263 (7) Consideration of Legislative Proposal 2021-B ~ Renewal Fees (Draft #1) 266 (8) Consideration of Legislative Proposal 2021-E ~ PMP Audit Trail for Louisiana Medicaid (Draft #1) 268 (9) Consideration of Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the Louisiana Board of Pharmacy and the U.S. Food & Drug Administration 270 (10) Consideration of Regulatory Proposal 2021-B ~ Transfer of Marijuana Recommendations (Draft #1) 283 (11) Consideration of Proposed PPM.I.D.28 ~ COVID-19 Public Health Emergency: Guidance for Licensees re PREP Act Declaration by HHS (Draft #2) and (Draft #3) 284 / 291 (12) Consideration of Proposed PPM.I.A.34 ~ Allowance for Virtual Competency Demonstration for Certification in Basic Cardiopulmonary Resuscitation (Draft #1) 299 I. Executive 300 (1) Consideration of Interim Policies (PPM.I.D.1 – 27) 301 (2) Consideration of Proposed Revision of PPM.I.B.2 ~ Governance (Draft #1) 303 (3) Consideration of Proposed Revision of PPM.III.B.06 ~ Application for New Resident Pharmacy Permit (Draft #1) 306 (4) Consideration of Request for Approval of Pharmacy Technician Training Program – Sullivan College of Pharmacy & Health Sciences [Louisville, KY] 310 (5) Consideration of Proposal for Website from Covalent Logic 314 10. Staff Reports J. Assistant Executive Director – Mr. Fontenot 320 (1) Quarterly Report from Prescription Monitoring Program (PMP) 321 (2) Consideration of Requests for Waivers from PMP Reporting Rule 338 K. General Counsel – Mr. Finalet 342 (1) Consideration of Proposed Voluntary Consent Agreements & Surrenders L. Executive Director – Mr. Broussard 343 (1) Narrative Report 344 (2) Internal Reports  Credentials Div. – Census Report 350  Credentials Div. – Licensure Activity Report 362  Credentials Div. – Pending Application Report 363  Credentials Div. – Exceptions Report 364  Compliance Div. – Census Report 366  Compliance Div. – Complaint Investigation Policy Monitor 367 (3) Examination Reports  Pharmacists – MPJE 368  Pharmacists – NAPLEX 390  Technicians – ExCPT 414  Technicians – PTCB 417 11. New Agenda Items Added During Meeting 426 12. Announcements 427 13. Adjourn 429 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) ACHC Accreditation Commission for Health Care 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 ASPEN American Society of Parenteral & Enteral Nutrition ASPL American Society for Pharmacy Law ATT authorization to test 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 U.S. Centers for Disease Control and Prevention CDER U.S. Center for Drug Evaluation and Research (FDA) 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 U.S. Centers for Medicare and Medicaid Services CPD continuing professional development CPhA Canadian Pharmacists Association CPPA Center for Pharmacy Practice Accreditation CPSC U.S. Consumer Product Safety Commission

Revised 2018-0101 DEA U.S. Drug Enforcement Administration DEQ La. Department of Environmental Quality DME durable medical equipment DMEPOS durable medical equipment, prosthetics, orthotics, and supplies DNV Det Norske Veritas (Norwegian accreditation organization) DOA La. Div. of Administration DOA – FPC La. Div. of Administration – Facility Planning & Control DOA – ORM La. Div. of Administration – Office of Risk Management DOA – OSR La. Div. of Administration – Office of State Register DOA – OSRAP La. Div. of Administration – Office of Statewide Reporting & Accounting Policy DOE La. Dept. of Education DPSC La. Dept. of Public Safety & Corrections DSCS La. Dept. of State Civil Service DSM disease state management EDK emergency drug kit ELTP Electronic Licensure Transfer Program (NABP) EPA U.S. 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 U.S. Food & Drug Administration FEIS Fiscal & Economic Impact Statement 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 U.S. Federal Trade Commission GOHSEP Governor’s Office of Homeland Security & Emergency Preparedness GPhA Generic Pharmaceutical Association GPO U.S. Government Publishing 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 IRS U.S. Internal Revenue Service

Revised 2018-0101 ISMP Institute for Safe Medication Practices JCPP Joint Commission of Pharmacy Practitioners JLCB Joint Legislative Committee on the Budget LAC Louisiana Administrative Code LAMP Louisiana Academy of Medical Psychologists LANP Louisiana Association of Nurse Practitioners LAPA Louisiana Academy of Physician Assistants LASERS La. State Employees Retirement System LASIE Louisiana Association of Self-Insured Employers LBDDD La. Board of Drug & Device Distributors LBP La. Board of Pharmacy LDA Louisiana Dental Association LDAF La. Dept. of Agriculture & Forestry LDH La. Dept. of Health LDI La. Dept. of Insurance LDR La. Dept. of Revenue LFO Legislative Fiscal Office LHA Louisiana Hospital Association LIPA Louisiana Independent Association LLA La. Legislative Auditor LPA Louisiana Pharmacists Association LPC Louisiana Pharmacy Congress LPTA Louisiana Physical Therapy Association LPTB Louisiana Physical Therapy Board LSA Louisiana Sheriffs’ Association LSBD La. State Board of Dentistry LSBME La. State Board of Medical Examiners LSBN La. State Board of Nursing LSBOE La. State Board of Optometry Examiners LSBPNE La. State Board of Practical Nurse Examiners LSBVM La. State Board of Veterinary Medicine 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 NADDI National Association of Drug Diversion Investigators NAMSDL National Alliance for Model State Drug Laws NAPLEX North American Licensure Examination (NABP) NAPRA National Association of Pharmacy Regulatory Authorities () 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

Revised 2018-0101 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 OPEB other post employment benefits OSHA Occupational Safety and Health Administration PBM pharmacy benefit management PCAB Pharmacy Compounding Accreditation Board PCCA Professional Compounding Centers of America 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) PTAC Pharmacy Technician Accreditation Commission PTCB Pharmacy Technician Certification Board PTCE Pharmacy Technician Certification Examination PTEC Pharmacy Technician Educators Council PTTP pharmacy technician training program RFID/EPC Radio Frequency Identification / Electronic Product Code RS Louisiana Revised Statutes SAMSHA U.S. Substance Abuse & Mental Health Services Administration SEGBP State Employees Group Benefit Program 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 Pharmacopeia / United States Pharmacopeial Convention USP DI U.S. Pharmacopeia Dispensing Information USP-NF U.S. Pharmacopeia – National Formulary

Revised 2018-0101 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 2018-0101 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

NOTICE IS HEREBY GIVEN that a meeting of the Board has been ordered and will be conducted by videoconference at 9:00 a.m. on Wednesday, February 24, 2021. The meeting website is www.zoom.us; in the upper right corner of their homepage select the link for Join a Meeting. Enter the meeting identification number 825 9145 3494 and the meeting password (passcode) 123862. The meeting has been called 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 02-18-2021

1. Call to Order 2. Quorum Call 3. Call for Additional Agenda Items & Adoption of Agenda 4. Consideration of Draft Minutes from Previous Meeting – November 18, 2020 5. Report on Action Items 6. Confirmation of Acts 7. Opportunity for Public Comment 8. Special Orders of the Day 9. Committee Reports A. Finance – Mr. Resweber (1) Review of Interim Report for Fiscal Year 2020-2021 B. Application Review – Mr. Robichaux C. Reciprocity – Mr. Cassidy D. Violations – Mr. Indovina (1) Consideration of Proposed Voluntary Consent Agreements (a) Case No. 19-0379 ~ PST.014219 – Angela Waldron Allums (b) Case No. 20-0349 ~ PHY.008099 - Melior, Inc. d/b/a Lil Daves [Plaquemine, LA] + (c) Case No. 20-0344 ~ PST.016278 – David Keith Chauvin, Jr. (d) Case No. 20-0300 ~ PHY.007878 – LP1 Pharm, LLC d/b/a Landry’s Pharmacy 1 [Gonzales, LA] + (e) Case No. 20-0348 ~ PST.018760 – Darvis Keon Harvey + (f) Case No. 20-0301 ~ PHY.007731 – RD Pharma, LLC d/b/a Ralph’s Drugstores [Gonzales, LA] (g) Case No. 20-0329 ~ PHY.006506 – Sofie, Co. d/b/a Sofie [Dallas, TX] (h) Case No. 20-0353 ~ PST.016625 – Kristian Raymond Hahn (i) Case No. 20-0195 ~ PHY.007596 – Central Drug Store, Inc. d/b/a Central Pharmacy [Baton Rouge, LA] + (j) Case No. 20-0196 ~ PST.010511 – John Michael Anding

NOTE: Pursuant to the Open Meetings Law at 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. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq.

Board Meeting February 24, 2021 Page 2 of 3

9. Committee Reports D. Violations – Mr. Indovina (cont.) (2) Reconsideration of Previous Decision from Administrative Hearing (a) Case No. 19-0207 ~ CPT.011002 – Markella Ann Wyre E. Impairment – Ms. Hall F. Reinstatement – Mr. Valentine G. Tripartite – Dr. Strong H. Regulation Revision – Mr. McKay (1) Consideration of Comments & Testimony from November 25, 2020 Public Hearing re Regulatory Project 2020-4 ~ Pharmacy Benefit Managers (2) Consideration of Regulatory Proposal 2021-A ~ Collaborative Practice (Draft #1 - coded) (Draft #1 – clean) (3) Consideration of Legislative Proposal 2021-C ~ Collaborative Practice (Draft #1) (4) Consideration of Legislative Proposal 2021-D ~ Limited Prescriptive Authority (Draft #2) (5) Consideration of Proposed Report to 2021 Legislature re Senate Resolution 39 of 2nd Extraordinary Session of 2020 Legislature (6) Consideration of Legislative Proposal 2021-A ~ CDS Schedule Update (Draft #3) (7) Consideration of Legislative Proposal 2021-B ~ Renewal Fees (Draft #1) (8) Consideration of Legislative Proposal 2021-E ~ PMP Audit Trail for La. Medicaid (Draft #1) (9) Consideration of Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the Louisiana Board of Pharmacy and the U.S. Food and Drug Administration (10) Consideration of Regulatory Proposal 2021-B ~ Transfer of Marijuana Recommendations (Draft #1) (11) Consideration of Proposed PPM.I.D.28 ~ COVID-19 Public Health Emergency: Guidance for Licensees re PREP Act Declaration by HHS (Draft #2) (Draft #3) (12) Consideration of Proposed PPM.I.A.34 ~ Allowance for Virtual Competency Demonstration for Certification in Basic Cardiopulmonary Resuscitation (Draft #1) I. Executive Committee – Mr. Aron (1) Consideration of Request for Approval – Pharmacy Technician Training Program at Sullivan College of Pharmacy & Health Sciences [Louisville, KY] (2) Consideration of Interim Policies (3) Consideration of Committee Recommendations

NOTE: Pursuant to the Open Meetings Law at 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. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq.

Board Meeting February 24, 2021 Page 3 of 3

10. Staff Reports J. Assistant Executive Director – Mr. Fontenot (1) Quarterly Report of Prescription Monitoring Program (PMP) (2) Consideration of Requests for Waivers from PMP Reporting Requirement K. General Counsel – Mr. Finalet (1) Consideration of Proposed Voluntary Consent Agreements & Surrenders (a) Case No. 20-0352 ~ PHY.007065 – Mula Family Pharmacy, LLC d/b/a Mula’s Family Pharmacy & Gifts [Abbeville, LA] (b) Case No. 20-0391 ~ PST.013345 – Gerlando Joseph Messina (c) Case No. 20-0387 ~ PST.018873 – Enrique Javier Hernandez (d) Case No. 21-0004 ~ PST.022036 – Douglas Charles Klein (e) Case No. 21-0002 ~ PST.021473 – Clarke Allan Kueltzo (f) Case No. 20-0367 ~ CPT.013169 – Alicia Mary Fields-Carr (g) Case No. 20-0389 ~ CPT.008207 – Raschunda Shimeka Roshell (h) Case No. 21-0003 ~ PST.019049 – Margaret Diane Henderson (i) Case No. 20-0384 ~ PST.021687 – Rachael Jordan Flores (j) Case No. 20-0388 ~ PST.022486 – Austin Ryder Lucht (k) Case No. 21-0061 ~ PTC.029215 – Christopher Rainard Tomlin L. Executive Director – Mr. Broussard 11. New Agenda Items Added During Meeting 12. Announcements 13. Adjourn

Notes: 1. The public meeting binder will be posted on the Board’s website 24 hours prior to the beginning of the meeting. 2. Interested parties may submit public statements or comments on agenda items via email; communications addressed to [email protected] will be provided to the members.

NOTE: Pursuant to the Open Meetings Law at 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. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq.

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Consideration of Minutes from Previous Meetings

1 Louisiana Board of Pharmacy 2 3388 Brentwood Drive 3 Baton Rouge, Louisiana 70809-1700 4 Telephone 225.925.6496 ~ E-mail: [email protected] 5 6 7 8 9 10 11 12 13 14 15

16 Minutes 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 Administrative Hearing Wednesday, November 18, 2020 at 8:30 a.m. 33 34 & 35 36 Regular Board Meeting Wednesday, November 18, 2020 at 10:00 a.m. 37 38 39 40 Location: Embassy Suites Hotel 41 DRAFT4914 Constitution Avenue 42 Baton Rouge, Louisiana 70808 43 44

Page 1 of 34 45 Table of Contents 46 47 Agenda Item No. Description Page No. 48 49 Administrative Hearing 50 A. Call to Order 03 51 B. Invocation & Pledge of Allegiance 03 52 C. Amendment to Board Roster 03 53 D. Quorum Call 03 54 E. Call for Additional Agenda Items & Adoption of Agenda 04 55 F. Opportunity for Public Comment 05 56 * Appearances 05 57 G. Formal Hearing 06 58 H. New Agenda Items Added During Meeting 08 59 I. Adjourn 08 60 61 Board Meeting 62 1. Call to Order 08 63 2. Quorum Call 09 64 3. Call for Additional Agenda Items & Adoption of Agenda 10 65 4. Consideration of Draft Minutes from Previous Meeting 10 66 5. Report on Action Items 13 67 6. Confirmation of Acts 11 68 7. Opportunity for Public Comment 11 69 8. Special Orders of the Day 11 70 A. Presentation of Pharmacist Gold Certificate 11 71 B. Presentation of Distinguished Service Awards 12 72 C. Annual Election of Board Officers 12 73 9. Committee Reports 13 74 A. Finance 13 75 B. Application Review 14 76 C. Reciprocity 15 77 D. Violations 15 78 E. Impairment 18 79 F. Reinstatement 20 80 G. Tripartite 22 81 H. Regulation Revision 22 82 I. Executive 22 83 10. Staff Reports 84 J. Assistant Executive Director 26 85 K. General Counsel 28 86 L. Executive Director 31 87 11. New DRAFTAgenda Items Added During Meeting 33 88 12. Announcements 33 89 13. Adjourn 33 90 91 Page 2 of 34

92 The Louisiana Board of Pharmacy convened an administrative hearing on Wednesday, 93 November 18, 2020 at the Embassy Suites Hotel located at 4914 Constitution Avenue 94 in Baton Rouge, Louisiana 70808. The hearing was held pursuant to public notice, 95 each member received notice, each respondent received notice (unless specifically 96 stated otherwise in the official transcript), and public notice was properly posted. 97 98 A. Call to Order 99 In the absence of the Board President, First Vice President Marty McKay called the 100 hearing to order at 8:35 a.m. 101 102 B. Invocation & Pledge 103 Mr. Kevin LaGrange delivered the invocation then Dr. Raymond Strong led the group in 104 the Pledge of Allegiance. 105 106 C. Amendment to Board Roster 107 Mr. McKay informed the members and guests that Gov. Edwards had appointed a new 108 member to the Board since the previous Board meeting. Mr. Troy Menard is a 109 pharmacist who resides in the Covington area. He was appointed to complete the 110 remainder of the unexpired term of a previous member; his term will expire on June 30, 111 2025. Mr. McKay welcomed Mr. Menard to the Board. 112 113 D. Quorum Call 114 Mr. McKay called upon Secretary Richard Indovina to call the roll of members to 115 establish a quorum. 116 117 Members Present: 118 Mr. Allen W. Cassidy, Jr. 119 Mr. David A. Darce 120 Ms. JacquelineDRAFT L. Hall 121 Mr. Richard M. Indovina, Jr. 122 Mr. Kevin LaGrange 123 Mr. Robert C. LeBas Late arrival Page 3 of 34

124 Mr. Richard Mannino Late arrival 125 Mr. Marty R. McKay 126 Mr. J. Troy Menard 127 Mr. Anthony G. Mercante 128 Mr. Blake P. Pitre 129 Mr. Don L. Resweber 130 Dr. Raymond J. Strong 131 132 Member Absent: 133 Mr. Carl W. Aron 134 Dr. J Robert Cloud 135 Mr. Douglas E. Robichaux 136 Mr. Rhonny K. Valentine 137 138 Staff Present: 139 Mr. Malcolm J. Broussard, Executive Director 140 Mr. Carlos M. Finalet, III, General Counsel 141 Mr. M. Joseph Fontenot, Assistant Executive Director 142 Mr. Benjamin S. Whaley, Chief Compliance Officer 143 Ms. Kelley L. Villeneuve, Office Manager 144 145 After doing so, Mr. Indovina certified Mr. Aron, Dr. Cloud, Mr. LeBas, Mr. Mannino, Mr. 146 Robichaux, and Mr. Valentine were absent; however, the remaining 11 members were 147 present, constituting a quorum for the conduct of official business. It was noted that Mr. 148 LeBas arrived shortly thereafter at approximately 8:40 a.m. and Mr. Mannino arrived at 149 approximately 8:50 a.m. 150 151 E. Call for Additional Agenda Items & Adoption of Agenda 152 Mr. McKay asked ifDRAFT there were any additional agenda items, and none were requested. 153 With no objection, the Board adopted the posted agenda dated November 4, 2020. 154 155 Page 4 of 34

156 F. Opportunity for Public Comment 157 Mr. McKay reminded the members and guests the Open Meetings Law requires all 158 public bodies to provide an opportunity for public comment at all meetings and prior to 159 the vote on each agenda item. He solicited general comments on non-agenda items 160 from the guests present but none were offered. 161 162 Appearances 163 Mr. McKay indicated he would serve as the Hearing Officer. Mr. Carlos Finalet 164 served as the Prosecuting Attorney and Mr. Malcolm Broussard served as the Hearing 165 Clerk. 166 Mr. McKay informed the members the single case on the agenda originated with 167 the Violations Committee, and the members of that committee in attendance at their 168 December 2019 meeting were recused from the hearing. In particular, Dr. Cloud, Ms. 169 Hall, Mr. Indovina, Mr. Robichaux, and Mr. Valentine were excused. He reminded the 170 other members they should recuse themselves should the need arise. 171 Without objection, Mr. McKay waived the reading of the posted agenda and 172 instead directed the insertion thereof into these minutes. The posted agenda is re- 173 created here. 174 175 A G E N D A 176 NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official. 177 Revised 11-04-2020 178 179 A. Call to Order 180 181 B. Invocation & Pledge of Allegiance 182 183 C. Amendment to Board Roster 184 185 D. Quorum Call 186 DRAFT 187 E. Call for Additional Agenda Items & Adoption of Agenda 188 189 F. Opportunity for Public Comment

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190 191 * Appearances 192 193 G. Formal Hearing 194 195 1. Case No. 19-0207 ~ CPT.011002 – Markella Ann Wyre 196 197 H. New Agenda Items Added During Meeting 198 199 I. Adjourn 200 201 G. Formal Hearings 202 With Mr. McKay’s approval, Mr. Finalet began the hearing by calling the case listed on 203 the agenda. 204 205 Markella Ann Wyre (CPT.011002) Mr. Finalet appeared for the Board. The 206 respondent, Markella Ann Wyre, did not appear and was not represented by 207 counsel. Mr. Finalet informed the members he had checked the vicinity of the 208 meeting room to confirm the respondent’s absence. Mr. McKay ruled the hearing 209 would proceed as noticed in the form of a default proceeding. Mr. Finalet offered 210 an opening statement, presented no witnesses and five exhibits and then 211 proffered proposed Findings of Fact, Conclusions of Law, and Board Order. Mr. 212 Finalet tendered the matter to the hearing panel for its consideration. Mr. Darce 213 moved to enter into executive session for the purpose of deliberating the 214 disciplinary matter and discussing the respondent’s professional competency and 215 fitness for practice. There were no member questions or public comments. The 216 motion for executive session was adopted after a unanimous roll call vote in the 217 affirmative. 218 219 It was noted the hearing panel entered into executive session at 8:51 a.m. and then 220 reconvened at 9:30DRAFT a.m. Mr. McKay returned the hearing panel to open session; he 221 reported no decision was made during the executive session and questioned the 222 members as to their disposition of the case. 223 Page 6 of 34

224 Mr. Cassidy then moved, 225 Resolved, that the hearing panel, having heard the testimony and 226 considered the evidence, accept the Findings of Fact as proposed by the 227 Prosecuting Attorney, adopt them as our own, and then enter them into 228 the hearing record. 229 There were no member questions or public comments. The motion was adopted 230 after a unanimous roll call vote in the affirmative. Mr. Cassidy then moved, 231 Resolved, that the hearing panel accept the Conclusions of Law as 232 proposed by the Prosecuting Attorney, adopt them as our own, and then 233 enter them into the hearing record. 234 There were no member questions or public comments. The motion was adopted 235 after a unanimous vote in the affirmative. Mr. Cassidy then moved, 236 Resolved, that the hearing panel enter the following order at this time: 237 It is ordered, adjudged, and decreed that Louisiana Pharmacy 238 Technician Certificate No. 11002, held by Markella Ann Wyre, shall 239 be, and is hereby suspended for an indefinite period of time 240 effective on the entry of this order, and further, the respondent shall 241 pay the following assessments: 242 (1) A fine of $500; 243 (2) The administrative hearing fee of $250; and 244 (3) The investigative and hearing costs, including the costs of the 245 prosecuting attorney and the official recorder; and 246 It is further ordered, the acceptance of any future application for the 247 reinstatement of the certificate or any application for any other 248 credential issued by the Board shall be conditioned upon the 249 satisfaction of the following terms: 250 (1) Respondent shall have paid all assessments levied herein; 251 (2) Respondent shall have no pending legal or disciplinary matters 252 DRAFTagainst her in any jurisdiction; and 253 (3) Respondent shall have received a favorable recommendation 254 for her return to the practice of pharmacy without posing a threat 255 to the public’s health, safety, or welfare pursuant to a medical Page 7 of 34

256 evaluation from an addition medicine specialist approved by the 257 Board at her own expense. 258 Prior to the vote, Mr. Mannino questioned the need for a medical evaluation and 259 offered an amendment to remove the requirement for a medical evaluation 260 relative to any future reinstatement application. There were no member 261 questions or public comments on the proposed amendment. The motion for the 262 amendment was adopted after a unanimous vote in the affirmative. As to the 263 amended motion for the order, there were no further member questions or public 264 comments. The amended motion for the order was adopted after a unanimous 265 vote in the affirmative. 266 267 Mr. Finalet indicated completion of the single case scheduled for that day. 268 269 H. New Agenda Items Added During Meeting 270 There were no new agenda items added during the meeting. 271 272 I. Adjourn 273 Having completed the tasks itemized on the posted agenda, with no further business 274 pending before the Board and without objection, Mr. McKay adjourned the hearing at 275 9:35 a.m. 276 277 278 * * * * * * * 279 280 The Louisiana Board of Pharmacy convened a regular meeting on Wednesday, 281 November 18, 2020 at the Embassy Suites Hotel located at 4914 Constitution Avenue 282 in Baton Rouge, Louisiana 70808. The meeting was held pursuant to public notice, 283 each member received notice, and public notice was properly posted. 284 DRAFT 285 1. Call to Order 286 Mr. Marty McKay, First Vice President, called the meeting to order at 10:10 a.m. 287 Page 8 of 34

288 2. Quorum Call 289 Mr. McKay called upon the Secretary, Mr. Indovina, to call the roll of members to 290 establish a quorum. 291 292 Members Present: 293 Mr. Allen W. Cassidy, Jr. 294 Mr. David A. Darce 295 Ms. Jacqueline L. Hall 296 Mr. Richard M. Indovina, Jr. 297 Mr. Kevin LaGrange 298 Mr. Robert C. LeBas 299 Mr. Richard Mannino 300 Mr. Marty R. McKay 301 Mr. J. Troy Menard 302 Mr. Anthony G. Mercante 303 Mr. Blake P. Pitre 304 Mr. Don L. Resweber 305 Dr. Raymond J. Strong 306 307 Member Absent: 308 Mr. Carl W. Aron 309 Dr. J Robert Cloud 310 Mr. Douglas E. Robichaux 311 Mr. Rhonny K. Valentine 312 313 Staff Present: 314 Mr. Malcolm J. Broussard, Executive Director 315 Mr. Carlos M. Finalet, III, General Counsel 316 Mr. M. JosephDRAFT Fontenot, Assistant Executive Director 317 Mr. Benjamin S. Whaley, Chief Compliance Officer 318 Ms. Kelley L. Villeneuve, Office Manager 319 Page 9 of 34

320 Guests: 321 Mr. Richard Soileau 322 Ms Donna Soileau 323 Ms. Michele P. Alderman 324 Dr. Caitlin Bertrand – Genoa Pharmacy 325 Ms. Jessica Elliott – La. Retailers Association 326 Ms. Brandi Armand – La. Retailers Association 327 Ms. Juanita Pitre 328 Ms. Cathy McKay 329 Ms. Shelly Dupre – National Association of Chain Drug Stores (NACDS) 330 331 Mr. Indovina certified Mr. Aron, Dr. Cloud, Mr. Robichaux and Mr. Valentine were 332 absent; however, the remaining 13 members were present, constituting a quorum for 333 the conduct of official business. 334 335 3. Call for Additional Agenda Items & Adoption of Agenda 336 Mr. McKay asked if there were any additional agenda items to be added. Mr. Mannino 337 moved to add a discussion of USP Chapter 800 to the agenda. He noted the Board had 338 previously voted to implement enforcement of those federal standards on January 1, 339 2021. Since this was the last Board meeting prior to that implementation date and since 340 the current public health emergency had interrupted some pharmacies activities to 341 prepare for that implementation, he suggested the urgency for reconsideration of that 342 previous decision. There were no further member or public comments. The motion to 343 add the new agenda item was adopted after a unanimous roll call vote in the affirmative. 344 Mr. McKay indicated he would call for that discussion at Agenda Item 11. There were 345 no further requests to amend the agenda. Without objection, the members adopted the 346 amended agenda dated November 16, 2020. Mr. McKay requested authority to re- 347 order the agenda as may become necessary and there were no objections to that 348 request. DRAFT 349 350 4. Consideration of Draft Minutes from Previous Meeting 351 Mr. McKay reminded the members they had received the draft minutes from the Regular Page 10 of 34

352 Board Meeting on August 13 held by videoconference. With no objections, he waived 353 the reading of the draft minutes. With no requests for amendment or any objection to 354 their approval, Mr. McKay declared the minutes were approved as presented. Mr. 355 McKay reminded the members to sign the Minute Book. 356 357 6. Confirmation of Acts 358 Pursuant to Mr. McKay’s declaration that the officers, committees, and executive 359 director had attended to the business of the Board since their last physical meeting in 360 accordance with policies and procedures previously approved by the Board, Mr. Pitre 361 moved, 362 Resolved, that the actions taken and decisions made by the Board 363 officers, members and committees, and executive director in the general 364 conduct and transactions of Board business since February 5, 2020 are 365 approved, adopted, and ratified by the entire Board. 366 There were no member questions or public comments. The motion was adopted after a 367 unanimous vote in the affirmative. 368 369 7. Opportunity for Public Comment 370 Mr. McKay reminded the members and guests the Open Meetings Law requires all 371 public bodies to provide an opportunity for public comment at all meetings and for each 372 agenda item upon which a vote is to be taken. He solicited general comments on non- 373 agenda items from the guests present; none were offered. 374 375 * Statement of Purpose 376 Mr. McKay reminded the members of the purpose and mission of the Board of 377 Pharmacy by reciting the relevant portion of the Louisiana Pharmacy Practice Act. He 378 urged the members to keep their legislative mandate in mind as they considered all the 379 matters before them. 380 DRAFT 381 8. Special Orders of the Day 382 A. Presentation of Pharmacist Gold Certificate 383 In recognition of her achievement of 50 years of licensure as a Page 11 of 34

384 pharmacist, Mr. McKay presented a Pharmacist Gold Certificate to Ms. 385 Michele Alderman who was licensed by the Board in August 1969. Ms. 386 Alderman also served a six-year term as a member of the Board from 2004 387 to 2010. The members and guests congratulated her with a standing 388 ovation. 389 390 B. Presentation of Distinguished Service Awards 391 Mr. McKay called upon Mr. Broussard to present the awards. Mr. 392 Broussard explained the awards were being presented to board members 393 who had completed their terms of service to the Board in June 2020. Five 394 members completed their terms and three of them were present to receive 395 their awards; the awards for the other two members will be presented at a 396 future meeting. 397  Mr. Richard “Andy” Soileau served two terms, from July 2008 to June 398 2020; 399  Ms. Jackie Hall began her service in August 2002 and was re- 400 appointed to another six-year term concluding in 2026; and 401  Mr. Marty McKay began his service in January 2000 and was re- 402 appointed to another six-year term concluding in 2026. 403 404 C. Annual Election of Board Officers 405 Mr. McKay reminded the members and guests of the annual election of 406 officers usually conducted at the final meeting of the calendar year. He 407 indicated he would conduct elections for each of the five officer positions in 408 rank order, with the newly-elected officer assuming their position 409 immediately. Mr. Don Resweber nominated the entire slate of current officers 410 in their same positions as well as Mr. Valentine for the office of Third Vice 411 President. Mr. Mannino nominated Mr. LaGrange for the office of Third Vice 412 President.DRAFT After confirming no additional nominations, Mr. McKay indicated 413 he would conduct the election first for the only contested position, that of 414 Third Vice President. Following a roll call vote, Mr. Valentine was elected by 415 a majority of the members present and voting. Dr. Strong moved to re-elect, Page 12 of 34

416 by acclamation, the current slate of officers in their same positions. With no 417 member or public comments offered, the motion was adopted after a 418 unanimous vote in the affirmative. The following members were elected or 419 re-elected to officer positions: 420  Mr. Carl Aron – President 421  Mr. Marty McKay – First Vice President 422  Ms. Jacqueline Hall – Second Vice President 423  Mr. Rhonny Valentine – Third Vice President 424  Mr. Richard Indovina – Secretary 425 Mr. McKay congratulated all of the officers. 426 427 5. Report on Action Items 428 Mr. McKay called on Mr. Broussard for the report. Mr. Broussard directed the members 429 to a copy of the report in their meeting binder. There were no questions from the 430 members or guests. 431 432 9. Committee Reports 433 A. Finance Committee 434 Mr. McKay indicated he would present the committee report on behalf of 435 the committee chair, Mr. Pitre. He reviewed the Interim Report for Fiscal 436 Year 2020-2021, noting it was informational and did not require Board action. 437 There were no member questions or public comments. He then directed the 438 members to the Proposed Budget for Fiscal Year 2021-2022 in their meeting 439 binder. He reported the committee reviewed the budget developed by staff, 440 did not make any changes and voted to recommend its approval. He also 441 reported the committee requested staff to investigate the feasibility of 442 implementing a credit card convenience fee for online transactions, noting the 443 cost to the Board for that service is approximately $60,000 per year. Mr. Pitre 444 then moved,DRAFT 445 Resolved, to approve and adopt the Proposed Budget for Fiscal Year 446 2021-2022. 447 Prior to the vote, Mr. Indovina questioned the revenue line items relative to Page 13 of 34

448 credential renewals, noting the budget appeared to reflect a return to pre- 449 pandemic levels. Mr. Broussard confirmed the legislative resolution as well 450 as the Board’s emergency rule limit the waivers of credential renewal fees for 451 existing businesses in the current fiscal year, and further, there was no 452 direction from the legislature for such waivers for the fiscal year covered by 453 the proposed budget. He reminded the members in the event of any future 454 legislative direction to extend such waivers the Board routinely reviews 455 budget amendments during the first Board meeting of the new fiscal year, 456 typically in August. There were no further member questions or public 457 comments. The motion was adopted after a unanimous vote in the 458 affirmative. 459 Finally, Mr. McKay expressed his appreciation to the other committee 460 members for their ongoing efforts. 461 462 B. Application Review Committee 463 In the absence of Mr. Robichaux, the committee chair, Mr. McKay called 464 upon the ranking member, Mr. Indovina, to deliver the committee report. Mr. 465 Indovina reported the committee met the previous day to consider one 466 referral from staff, an applicant for a telepharmacy dispensing site permit 467 which had requested a waiver from the Board’s rule relative to the 15-mile 468 exclusion zone around the intended location of the dispensing site. Following 469 the committee’s interview and deliberations, Mr. Indovina reported the 470 committee voted to recommend the approval of the request for the waiver 471 and the issuance of the permit. He then moved, 472 Resolved, to approve the request from Genoa Pharmacy for a waiver 473 from the 15-mile exclusion zone in the Board’s rules for telepharmacy 474 dispensing site and to authorize staff to issue the telepharmacy 475 dispensing site permit, but to limit the telepharmacy dispensing to 476 patientsDRAFT of the Acadiana Crowley Mental Health Clinic in Crowley, 477 Louisiana, within which the telepharmacy dispensing site will be located. 478 Mr. McKay responded to questions from members; there were no public 479 comments. The motion was adopted after a unanimous vote in the Page 14 of 34

480 affirmative. 481 482 C. Reciprocity Committee 483 Mr. McKay called upon Mr. Cassidy for the committee report. He reported 484 the staff had evaluated 77 applications for pharmacist licensure by reciprocity 485 since the last Board meeting and that none of them contained information 486 that warranted a committee level review. In conformance with policies and 487 procedures previously approved by the Board, the staff approved the 488 applications and issued the credentials. Mr. Cassidy then directed the 489 members to a list of the new pharmacists licensed by reciprocity in their 490 meeting binder. 491 Finally, he closed his report with appreciation to the other committee 492 members for their ongoing efforts. 493 494 D. Violations Committee 495 Mr. McKay called upon Mr. Indovina for the committee report. Mr. 496 Indovina reported the committee met on October 21 to consider the 22 cases 497 on their docket. As committee chair, he authorized continuances of four of 498 the cases prior to the committee meeting. Following their interviews and 499 deliberations, the committee took no action against two of the respondents 500 and issued non-disciplinary Letters of Noncompliance to four of the 501 respondents. The committee authorized the automatic reinstatement of a 502 suspended pharmacist license back to probationary status contingent upon 503 the successful completion of an anger management course, and further, 504 ordered an emergency summary suspension of the license of a pharmacist 505 who had violated his probationary terms. The committee then offered 506 proposed voluntary consent agreements to the remaining 10 respondents. 507 Mr. Indovina reported eight of the respondents had accepted their proposed 508 agreements;DRAFT the two respondents who had not accepted their proposed 509 agreements were scheduled for a future administrative hearing. Mr. Indovina 510 then presented the following agreements to the members for their 511 consideration. Page 15 of 34

512 513 Louisiana CVS Pharmacy, LLC d/b/a CVS Pharmacy No. 4068 514 [Haughton, LA] (PHY.005771): Mr. Indovina moved to approve the 515 proposed voluntary consent agreement. There were no member questions or 516 public comments. The motion was adopted after a unanimous vote in the 517 affirmative. The Board assessed a fine of $10,000 plus administrative and 518 investigative costs. 519 520 Louisiana CVS Pharmacy, LLC d/b/a CVS Pharmacy No. 16801 [Monroe, 521 LA] (PHY.007241): Mr. Indovina moved to approve the proposed voluntary 522 consent agreement. He answered a question from one member. There were 523 no further member questions or public comments. The motion was adopted 524 after a unanimous vote in the affirmative. The Board assessed a fine of 525 $2,500 plus administrative and investigative costs. 526 527 Louisiana CVS Pharmacy, LLC d/b/a CVS Pharmacy No. 5521 [West 528 Monroe, LA] (PHY.005777): Mr. Indovina moved to approve the proposed 529 voluntary consent agreement. There were no member questions or public 530 comments. The motion was adopted after a unanimous vote in the 531 affirmative. The Board assessed a fine of $2,500 plus administrative and 532 investigative costs. 533 534 Walgreen La. Co., Inc. d/b/a Walgreen Pharmacy No. 6190 [Hammond, 535 LA] (PHY.004710): Mr. Indovina moved to approve the proposed voluntary 536 consent agreement. There were no member questions or public comments. 537 The motion was adopted after a unanimous vote in the affirmative. The 538 Board assessed a fine of $2,500 plus administrative and investigative costs. 539 540 Josie AnnDRAFT Foster (PTC.026539): Mr. Indovina moved to approve the 541 proposed voluntary consent agreement. There were no member questions or 542 public comments. The motion was adopted after a unanimous vote in the 543 affirmative. The Board issued a Letter of Reprimand; and further, assessed Page 16 of 34

544 administrative costs. 545 546 Hajira Ebady (PST.020956): Mr. Indovina moved to approve the proposed 547 voluntary consent agreement. Mr. Finalet replied to a question from one 548 member. There were no further member questions or public comments. The 549 motion was adopted after a unanimous vote in the affirmative. The Board 550 issued a Letter of Reprimand; and further, assessed a fine of $1,000 plus 551 administrative costs. 552 553 Institutional Pharmacies of Louisiana, LLC d/b/a Institutional 554 Pharmacies of Louisiana [Scott, LA] (PHY.005169): Mr. Indovina moved to 555 approve the proposed voluntary consent agreement. There were no member 556 questions or public comments. The motion was adopted after a unanimous 557 vote in the affirmative. The Board assessed a fine of $45,000 plus 558 administrative and investigative costs. 559 560 Barry John Dupre (PST.014468): Mr. Indovina moved to approve the 561 proposed voluntary consent agreement. There were no member questions or 562 public comments. The motion was adopted after a unanimous vote in the 563 affirmative. The Board suspended the license for one year and stayed the 564 execution of the suspension, then placed the license on probation for one 565 year effective November 18, 2020 subject to certain terms enumerated within 566 the voluntary consent agreement; and further, assessed administrative costs. 567 568 Mr. Indovina directed the members to the complaint investigation policy 569 monitor report in their meeting binder. He informed the members there were 570 182 open cases at the beginning of the fiscal year, 146 new cases added 571 since then and 149 cases closed, leaving 179 open cases as of November 6. 572 Of the 149DRAFT case closures, he reported the average number of days to 573 complete the investigation was 43, and that 3 of those 179 cases (2%) had 574 exceeded the policy benchmark of 180 days. He reminded the members the 575 most common reason for an investigation to exceed the 180-day threshold Page 17 of 34

576 was a collaborative investigation with other state or federal agencies and that 577 another reason for a nonresident case would be a nonresident case on 578 appeal. 579 Mr. Indovina reported the committee’s next meeting was scheduled for 580 December 15 to consider the 19 cases on that docket. He closed his report 581 with appreciation to the other committee members for their ongoing work. 582 583 E. Impairment Committee 584 Mr. McKay called upon Ms. Hall for the committee report. Ms. Hall 585 reported the committee met the previous day to consider nine referrals from 586 the staff – four requests for reinstatement, three requests for modification of 587 previous orders, one application for a new pharmacy technician candidate 588 registration and one case for informal conference. Following their interviews 589 of the applicants and subsequent deliberations, the applicant for a new 590 pharmacy technician candidate registration withdrew her application in lieu of 591 a denial of that application. Ms. Hall then presented the following 592 recommendations to the members for their consideration. 593 594 Johana Berenice Doucet (CPT.011781): Ms. Hall moved to approve the 595 proposed voluntary consent agreement. There were no member questions or 596 public comments. The motion was adopted after a unanimous vote in the 597 affirmative. The Board granted the request for reinstatement of the 598 previously lapsed certificate, suspended the certificate for five years and 599 stayed the execution of the suspension, then placed the certificate on 600 probation for five years effective November 18, 2020 subject to certain terms 601 enumerated within the voluntary consent agreement. 602 603 Kimiko Tiesha Austin (CPT.005676): Ms. Hall moved to approve the 604 proposedDRAFT voluntary consent agreement. There were no member questions or 605 public comments. The motion was adopted after a unanimous vote in the 606 affirmative. The Board granted the request for reinstatement of the 607 previously lapsed certificate, suspended the certificate for ten years and Page 18 of 34

608 stayed the execution of the suspension, then placed the certificate on 609 probation for ten years effective November 18, 2020 subject to certain terms 610 enumerated within the voluntary consent agreement. 611 612 Lisa Kay Moreau (PST.014955): Ms. Hall moved to approve the proposed 613 voluntary consent agreement. There were no member questions or public 614 comments. The motion was adopted after a unanimous vote in the 615 affirmative. The Board granted the request for release from the previously 616 executed no-practice agreement, suspended the license for five years and 617 stayed the execution of the suspension, then placed the license on probation 618 for five years effective November 18, 2020 subject to certain terms 619 enumerated within the voluntary consent agreement. 620 621 Amber Mone Loup (PST.018248): Ms. Hall moved to approve the proposed 622 voluntary consent agreement. There were no member questions or public 623 comments. The motion was adopted after a unanimous vote in the 624 affirmative. The Board granted the request for reinstatement of the 625 previously suspended license, converted the duration of the suspensive 626 period from an indefinite term to a term of five years and stayed the execution 627 of the suspension, then placed the license on probation for five years 628 effective November 18, 2020 subject to certain terms enumerated within the 629 voluntary consent agreement. 630 631 Catherine Rose Freemen (PST.020613) Ms. Hall moved to approve the 632 request for modification of previous orders. There were no member 633 questions or public comments. The motion was adopted after a unanimous 634 vote in the affirmative. The Board granted her request for modification of 635 previous orders, removed all probationary terms from her March 2018 636 ProbationDRAFT Board Order, terminated the probationary period originally 637 scheduled to conclude on March 21, 2023 and then restored the license to 638 active and unrestricted status. 639 Page 19 of 34

640 Nancy Lynn Odom (PST.014796) Ms. Hall moved to approve the request for 641 modification of previous orders. There were no member questions or public 642 comments. The motion was adopted after a unanimous vote in the 643 affirmative. The Board granted her request for modification of previous 644 orders, then removed Article 3-f from her November 2018 Probation Board 645 Order which had prevented her from accepting an appointment as the 646 pharmacist-in-charge of a pharmacy; and further, reiterated all other 647 probationary terms shall remain in effect for the remainder of the probationary 648 period. 649 650 Amanda Schubert Balli (PST.019454) Ms. Hall moved to approve the 651 request for modification of previous orders. There were no member 652 questions or public comments. The motion was adopted after a unanimous 653 vote in the affirmative. The Board granted her request for modification of 654 previous orders, removed all probationary terms from her November 2017 655 Probation Board Order, terminated the probationary period originally 656 scheduled to conclude on November 15, 2022 and then restored the license 657 to active and unrestricted status. 658 659 Brigid Grace Himel (PST.013209): Ms. Hall moved to approve the proposed 660 voluntary consent agreement. There were no member questions or public 661 comments. The motion was adopted after a unanimous vote in the 662 affirmative. The Board suspended the license for two years and stayed the 663 execution of the suspension, then placed the license on probation for two 664 years effective November 18, 2020 subject to certain terms enumerated 665 within the voluntary consent agreement. 666 667 Finally, Ms. Hall closed her report with appreciation to her fellow 668 committeeDRAFT members for their work the previous day. 669 670 F. Reinstatement Committee 671 In the absence of Mr. Valentine, the committee chair, Mr. McKay called Page 20 of 34

672 upon the ranking member, Mr. Resweber, to deliver the committee report. 673 Mr. Resweber reported the committee met the previous day to consider three 674 referrals from the staff – all petitions for reinstatement of lapsed technician 675 certificates. The committee interviewed all three applicants and developed 676 recommendations for the Board’s consideration, which Mr. Resweber then 677 presented to the members. 678 679 Tamara Lynn Bourg (CPT.004979): Mr. Resweber moved to approve the 680 proposed voluntary consent agreement. There were no member questions or 681 public comments. The motion was adopted after a unanimous vote in the 682 affirmative. The Board granted the applicant’s request for reinstatement of the 683 lapsed certificate contingent upon the satisfaction of certain requirements 684 identified within the voluntary consent agreement prior to November 18, 2022. 685 686 Delana Rae Heltz (CPT.009588): Mr. Resweber moved to approve the 687 proposed voluntary consent agreement. There were no member questions or 688 public comments. The motion was adopted after a unanimous vote in the 689 affirmative. The Board granted the applicant’s request for reinstatement of the 690 lapsed certificate contingent upon the satisfaction of certain requirements 691 identified within the voluntary consent agreement prior to November 18, 2022. 692 693 Jaime Lynn Blanchard (CPT.001387): Mr. Resweber moved to approve the 694 proposed voluntary consent agreement. There were no member questions or 695 public comments. The motion was adopted after a unanimous vote in the 696 affirmative. The Board granted the applicant’s request for reinstatement of the 697 lapsed certificate contingent upon the satisfaction of certain requirements 698 identified within the voluntary consent agreement prior to November 18, 2022. 699 700 Mr. ResweberDRAFT closed his report with appreciation to the other committee 701 members for their work the previous day. 702 703 Page 21 of 34

704 G. Tripartite Committee 705 Mr. McKay called upon Mr. Resweber for the committee report. Mr. 706 Resweber reported the committee had not met since the previous Board 707 meeting. 708 709 H. Regulation Revision Committee 710 Mr. McKay indicated the committee had not met since the previous Board 711 meeting; however, he indicated the committee would probably meet in both 712 December and January. 713 714 At this point, Mr. McKay declared a luncheon recess. He placed the Board in recess at 715 11:20 am. The members reconvened at 12:15 pm. Mr. McKay resumed the sequence 716 of the posted agenda. 717 718 I. Executive Committee 719 Mr. McKay reported the committee had met the previous day to consider 720 the items on their posted agenda. He indicated Ms. Hall was prepared to 721 offer motions on behalf of the committee. 722 723 • Consideration of Interim Policies 724 Mr. McKay reminded the members of the various interim policies 725 issued by the Board since the beginning of the public health emergency. 726 The committee reviewed a comprehensive listing of those policies, noting 727 some of them were no longer necessary, some had been replaced by 728 permanent rules, and some were still necessary. The committee voted to 729 continue other interim policies until a later date. Ms. Hall then moved, 730 Resolved, to approve the November 2020 Review of Interim 731 Policies. 732 ThereDRAFT were no member questions or public comments. The motion was 733 adopted after a unanimous vote in the affirmative. 734 735 Page 22 of 34

736 • Consideration of Proposed New Policy re Cybersecurity Awareness 737 Mr. McKay reported the adoption of a new law by the 2020 738 Legislature mandating training on cybersecurity awareness by state 739 employees and other persons with access to state agency information 740 systems. The committee voted to recommend the approval of the new 741 policy. Ms. Hall then moved, 742 Resolved, to approve the proposed new policy entitled 743 PPM.II.D.1.g ~ Cybersecurity Awareness. 744 There were no member questions or public comments. The motion was 745 adopted after a unanimous vote in the affirmative. 746 747 • Consideration of Proposed Revision of Record Retention Policy 748 Mr. McKay reminded the members of their adoption of a preliminary 749 policy on this topic earlier in the year. Staff submitted that policy to the 750 State Archives which responded with approval pending acceptance of 751 proposed revisions. The committee voted to recommend the approval of 752 the proposed revisions. Ms. Hall then moved, 753 Resolved, to approve the proposed revisions of 754 PPM.II.D.2.a ~ Record Retention Schedule. 755 There were no member questions or public comments. The motion was 756 adopted after a unanimous vote in the affirmative. 757 758 • Consideration of Proposed Revision of Criminal Background Check Policy 759 Mr. McKay reported the federal FBI had requested some clarity in 760 the Board’s policy for criminal background check (CBC) documents 761 relative to their record retention. The committee voted to recommend the 762 approval of the proposed revision. Ms. Hall then moved, 763 Resolved, to approve the proposed revision of PPM.III.J ~ 764 DRAFTCriminal Background Checks. 765 There were no member questions or public comments. The motion was 766 adopted after a unanimous vote in the affirmative. 767 Page 23 of 34

768 • Consideration of Proposed Revision of Facility Inspection Policy 769 Mr. McKay reported staff had requested some latitude in the 770 frequency of inspections for durable medical equipment (DME) permits. 771 The committee voted to recommend the approval of the proposed revision 772 to that policy. Ms. Hall then moved, 773 Resolved, to approve the proposed revision of PPM.IV.B.2.0 774 ~ Facility Inspections – Service Reviews. 775 There were no member questions or public comments. The motion was 776 adopted after a unanimous vote in the affirmative. 777 778 • Consideration of Proposed Statement on Dispensing Prescriptions for 779 Cannabidiol (Epidiolex®) 780 Mr. McKay reminded the members the federal government had 781 placed cannabidiol into Schedule V of the federal list of controlled 782 substances when the product Epidiolex® was introduced to the market in 783 2018 and that Louisiana made the same decision legislatively. Although 784 the federal government had recently de-listed the drug, the Louisiana 785 Legislature will not have the opportunity to de-list the drug until the next 786 legislative session. The committee voted to recommend the approval of a 787 statement announcing enforcement discretion for pharmacists dispensing 788 the drug as a non-controlled substance. Ms. Hall then moved, 789 Resolved, to approve the proposed Statement on 790 Dispensing Prescriptions for Cannabidiol (Epidiolex®). 791 Mr. McKay responded to a question from one member and one guest. 792 The motion was adopted after a unanimous vote in the affirmative. 793 794 • Review of Financial Audit Report from Legislative Auditor 795 Mr. McKay reminded the members of the annual financial audit by 796 the legislativeDRAFT auditor. He reported receipt of the audit report which 797 indicated the Board’s June 30, 2020 financial statement was an accurate 798 representation of the Board’s fiscal status, and further, the audit report 799 contained no findings or recommendations. He indicated the committee Page 24 of 34

800 reviewed the report and had no recommendations for the staff. He 801 directed the members to a copy of the audit report in their meeting binder 802 and invited member comments or recommendations. None were offered. 803 804 • Review of Legislation from 2nd Special Session of 2020 Legislature 805 Mr. McKay reported the committee reviewed the legislative brief 806 prepared by staff and noted one item requiring action by the Board. In 807 particular, Senate Resolution requests the Board to study and make 808 recommendations to the legislature no later than March 1, 2021 relative to 809 two topics: (1) an update on the status of collaborative drug therapy 810 management program; and (2) a determination of the desirability and 811 feasibility of a written statewide protocol for pharmacists to test or screen 812 for and initiate treatment or therapy for qualified health conditions. 813 Mr. McKay reported that Board President Carl Aron had already 814 referred the matter to the Regulation Revision Committee. Given the 815 short deadline for the report to the legislature, Mr. McKay reported the 816 committee would meet in both December and January and have a 817 recommendation for the full Board to consider during its next meeting 818 scheduled for February 24, 2021. 819 820 • Transition to Virtual Credentials 821 Mr. McKay reminded the members that some of the Board’s 822 credentials already exist only in virtual form, meaning no paper form 823 exists. In addition, the committee had already approved the transition of 824 two credentials to virtual status in January 2021 – pharmacy intern 825 registration and pharmacy technician candidate registration. With a 826 projected loss of $300,000 credential renewal fees in the current fiscal 827 year, the committee voted to recommend the approval of a staff proposal 828 to expediteDRAFT the transition of all credentials to virtual status as soon as 829 possible. Ms. Hall then moved, 830 Resolved, to authorize staff to transition all of its credentials 831 to a virtual format as soon as possible. Page 25 of 34

832 There were no member questions or public comments. The motion was 833 adopted after a unanimous vote in the affirmative. 834 835 Finally, Mr. McKay closed his report with appreciation to the other 836 committee members for their ongoing work. 837 838 10. Staff Reports 839 J. Report of Assistant Executive Director 840 Mr. McKay called upon Mr. Fontenot for his report. He directed the 841 members to the quarterly report of the prescription monitoring program, 842 detailing the prescription transaction counts as well as queries from 843 prescribers, dispensers, and law enforcement agencies. The report also 844 included information on the dispensing of medical cannabis products in the 845 marijuana pharmacies. Mr. Fontenot reported on the implementation of a 846 new federal law which authorizes practitioners affiliated with the federal 847 Veterans Administration to have access to state-based prescription 848 monitoring programs, and further, pre-empts any contrary state laws. He 849 answered two questions from Mr. McKay. 850 Mr. Fontenot then directed the members to the requests from 20 851 pharmacies seeking a waiver from the duty to report zero prescription 852 transaction reports to the prescription monitoring program. Mr. Indovina then 853 moved, 854 Resolved, to authorize the issuance of full PMP reporting waivers 855 to: 856 > PHY.008138-NR – Alphascript (CA); 857 > PHY.008125-NR – AnnovoRx Group (TN); 858 > PHY.008093-NR – Deliverit Pharmacy (TX); 859 > PHY.004214-HOS – East Jefferson General Hospital (LA); 860 DRAFT> PHY.008114-NR – Foothills Professional Pharmacy (AZ); 861 > PHY.007904-NR – HomeCare Rx(NJ); 862 > PHY.008152-NR – Nephron Pharmacy (SC); 863 > PHY.008091-HOS – Ochsner LSU Health Shreveport – St. Mary Page 26 of 34

864 Medical Center (LA); 865 > PHY.008101-HOS – Ochsner St. Mary (LA) 866 > PHY.008100-HOS – Our Lady of Lourdes Heart Hospital (LA); 867 > PHY.008145-NR – PipelineRx (NV); 868 > PHY.008147-NR – PipelineRx (CO); 869 > PHY.008146-NR – ProLab Pharmacy (TX); 870 > PHY.007200-NR – Red Chip of Nevada (CA); 871 > PHY.008116-NR – Rite Care Pharmacy IV (TX); 872 > PHY.006122-HOS – Sabine Medical Center (LA); 873 > PHY.008133-NR – Scripts Rx Pharmacy (TX); 874 > PHY.008102-NR – Truepill NY (NY); 875 > PHY.008126-NR – Vivo Health Pharmacy at Home (NY); and 876 > PHY.001198-HOS – West Feliciana Parish Hospital (LA) 877 once they have executed the standard consent agreement for that 878 purpose. 879 Mr. Broussard replied to a question from one member. There were no further 880 member questions or public comments. The motion was adopted after a 881 unanimous vote in the affirmative. 882 Mr. Fontenot reported the program was functioning well. He reminded the 883 members of the legislative auditor recommendation to audit pharmacies to 884 ensure their reporting of all eligible transactions, and he reported that all of 885 the compliance officers were now performing such audits during their routine 886 inspections of the pharmacies 887 Mr. Broussard replied to a question from one member about the medical 888 cannabis dispensing report, explaining the use of patient zip codes in lieu of 889 other parameters which could be used to identify the dispensing pharmacy. 890 He reminded the members of the requirement to de-identify all PMP 891 information prior to public release, and that the name of the dispensing 892 pharmacyDRAFT is included in the de-identification requirement. 893 Finally, Mr. Fontenot indicated completion of his report. 894 895 Page 27 of 34

896 K. Report of General Counsel 897 Mr. Aron called upon Mr. Finalet for his report. Mr. Finalet presented the 898 following proposed voluntary consent agreements to the members for their 899 consideration. 900 901 DeShontae Sharae Mouton (CPT.013508): Ms. Hall moved to approve the 902 proposed voluntary consent agreement. There were no member questions or 903 public comments. The motion was adopted after a unanimous vote in the 904 affirmative. The Board issued a Letter of Reprimand, and further, assessed a 905 fine of $250 plus administrative costs. 906 907 LaDonna Denise Wellman (CPT.010980): Ms. Hall moved to approve the 908 proposed voluntary consent agreement. There were no member questions or 909 public comments. The motion was adopted after a unanimous vote in the 910 affirmative. The Board issued a Letter of Reprimand, and further, assessed a 911 fine of $250 plus administrative costs. 912 913 Faljaray Tiara Lewis (CPT.012886): Ms. Hall moved to approve the 914 proposed voluntary consent agreement. There were no member questions or 915 public comments. The motion was adopted after a unanimous vote in the 916 affirmative. The Board issued a Letter of Reprimand, and further, assessed a 917 fine of $250 plus administrative costs. 918 919 Cheryl Tough Alexander (CPT.015010): Ms. Hall moved to approve the 920 proposed voluntary consent agreement. There were no member questions or 921 public comments. The motion was adopted after a unanimous vote in the 922 affirmative. The Board issued a Letter of Reprimand, and further, assessed a 923 fine of $250 plus administrative costs. 924 DRAFT 925 LaQuita Nicole Garner (CPT.014004): Ms. Hall moved to approve the 926 proposed voluntary consent agreement. There were no member questions or 927 public comments. The motion was adopted after a unanimous vote in the Page 28 of 34

928 affirmative. The Board issued a Letter of Reprimand, and further, assessed a 929 fine of $250 plus administrative costs. 930 931 Raveen Symone Williams (CPT.010288): Ms. Hall moved to approve the 932 proposed voluntary consent agreement. There were no member questions or 933 public comments. The motion was adopted after a unanimous vote in the 934 affirmative. The Board issued a Letter of Reprimand, and further, assessed a 935 fine of $250 plus administrative costs. 936 937 AMSR, LLC d/b/a American Medical Sales & Rental [Centennial, CO] 938 (DME.000956): Ms. Hall moved to approve the proposed voluntary consent 939 agreement. There were no member questions or public comments. The 940 motion was adopted after a unanimous vote in the affirmative. The Board 941 issued a Letter of Reprimand, and further, assessed a fine of $2,500 plus 942 administrative costs. 943 944 Bet Pharm, LLC d/b/a Bet Pharm [Lexington, KY] (PHY.005646): Ms. Hall 945 moved to approve the proposed voluntary consent agreement. There were 946 no member questions or public comments. The motion was adopted after a 947 unanimous vote in the affirmative. The Board suspended the permit for 4 948 years plus 8 months plus 18 days and stayed the execution of the 949 suspension, then placed the permit on probation for 4 years plus 8 months 950 plus 18 days effective November 18, 2020 and terminating August 5, 2025 951 subject to certain terms enumerated within the voluntary consent agreement, 952 noting the probationary period runs concurrently with the probationary period 953 imposed on its resident state permit by the Kentucky Board of Pharmacy; and 954 further, assessed administrative costs. 955 956 PensacolaDRAFT Apothecary, Inc. d/b/a Everwell Specialty Pharmacy 957 [Pensacola, FL] (PHY.007114): Ms. Hall moved to approve the proposed 958 voluntary consent agreement. There were no member questions or public 959 comments. The motion was adopted after a unanimous vote in the Page 29 of 34

960 affirmative. The Board suspended the permit for 7 months plus 26 days and 961 stayed the execution of the suspension, then placed the permit on probation 962 for 7 months plus 26 days effective November 18, 2020 and terminating July 963 28, 2021 subject to certain terms enumerated within the voluntary consent 964 agreement, noting the probationary period runs concurrently with the 965 probationary period imposed on its resident state permit by the Florida Board 966 of Pharmacy; and further, assessed administrative costs. 967 968 Donna Jaye Durham (CPT.015154): Ms. Hall moved to approve the 969 proposed voluntary consent agreement. There were no member questions or 970 public comments. The motion was adopted after a unanimous vote in the 971 affirmative. The Board revoked the certificate effective October 2, 2020, and 972 further, permanently prohibited the acceptance of any future application for 973 the reinstatement of the certificate or any application for any other credential 974 issued by the Board. 975 976 Seth Herbert DePasquale (PST.020915): Ms. Hall moved to approve the 977 proposed voluntary consent agreement. There were no member questions or 978 public comments. The motion was adopted after a unanimous vote in the 979 affirmative. The Board suspended the license for 4 years plus 8 months plus 980 18 days and stayed the execution of the suspension, then placed the license 981 on probation for 4 years plus 8 months plus 18 days effective November 18, 982 2020 and terminating August 5, 2025 subject to certain terms enumerated 983 within the voluntary consent agreement, noting the probationary period runs 984 concurrently with the probationary period imposed on his Kentucky 985 pharmacist license by the Kentucky Board of Pharmacy; and further, 986 assessed administrative costs. 987 988 Jackie ReneeDRAFT Brisken (CPT.015149): Ms. Hall moved to approve the 989 proposed voluntary consent agreement. There were no member questions or 990 public comments. The motion was adopted after a unanimous vote in the 991 affirmative. The Board issued a Letter of Reprimand, and further, assessed a Page 30 of 34

992 fine of $250 plus administrative costs. 993 994 Janet Duplantis Tauzin (CPT.011789): Ms. Hall moved to approve the 995 proposed voluntary consent agreement. There were no member questions or 996 public comments. The motion was adopted after a unanimous vote in the 997 affirmative. The Board issued a Letter of Reprimand, and further, assessed a 998 fine of $250 plus administrative costs. 999 1000 CareDirect Rx, LLC d/b/a CareDirect Rx [Alabaster, AL] (PHY.006605): 1001 Ms. Hall moved to approve the proposed voluntary consent agreement. 1002 There were no member questions or public comments. The motion was 1003 adopted after a unanimous vote in the affirmative. The Board issued a Letter 1004 of Reprimand, and further, assessed a fine of $5,000 plus administrative 1005 costs. 1006 1007 Cynthia Willis Calvert (PST.014177): Ms. Hall moved to accept the 1008 voluntary surrender of the credential. There were no member questions or 1009 public comments. The motion was adopted after a unanimous vote in the 1010 affirmative. The Board accepted the voluntary surrender, resulting in the 1011 active suspension of the license for an indefinite period of time effective 1012 November 9, 2020. 1013 1014 Finally, Mr. Finalet indicated the completion of his report. 1015 1016 L. Report of Executive Director 1017 Mr. Aron called upon Mr. Broussard for his report. Mr. Broussard directed 1018 the members to his report in the meeting binder. He reviewed the following 1019 topics: 1020 • MeetingDRAFT Activity 1021 • Reports 1022  Internal Reports 1023 Credentials Division Page 31 of 34

1024 Census Report 1025 Licensure Activity Report 1026 Application Activity Report 1027 Exceptions Report 1028 Compliance Division 1029 Census Report 1030 Complaint Investigation Policy Monitor 1031  External Reports 1032 Board Reports to Administrative and Legislative Agencies 1033 • Examinations 1034 MPJE 1035 NAPLEX 1036 ExCPT 1037 PTCE 1038 • Operations 1039 Credentials Division 1040 Compliance Division 1041 Administrative Division 1042 Marijuana Pharmacies 1043 • State Activities 1044 2nd Extraordinary Session of 2020 Legislature 1045 • Regional & National Activities 1046 National Association of Boards of Pharmacy (NABP) 1047 NABP-AACP District 6 1048 MALTAGON 1049 • International Activities 1050 International Pharmaceutical Federation (FIP) 1051 World Health Professions Alliance (WHPA) 1052 DRAFT dotPharmacy Verified Websites Program 1053 1054 Finally, Mr. Broussard indicated the completion of his report. 1055 Page 32 of 34

1056 11. New Agenda Items Added During Meeting 1057 Mr. McKay reminder the members of the new agenda item added at the 1058 beginning of the meeting, relative to the reconsideration of its May 2019 decision to 1059 implement enforcement in January 2021 of the federal standards for the handling of 1060 hazardous drugs in healthcare facilities, found in Chapter 800 of the United States 1061 Pharmacopoeia. 1062 Mr. Mannino suggested that pharmacies which were preparing for those new 1063 federal standards had been interrupted by their need to respond to the current public 1064 health emergency. He suggested the Board should further extend the implementation 1065 of enforcement of those standards. He then moved, 1066 Resolved, to (1) delay the previously announced January 1, 2021 1067 enforcement date of the federal standards contained in USP Chapter 1068 <800> Hazardous Drug – Handling in Healthcare Settings to a future date 1069 not yet determined; (2) request the Regulation Revision Committee 1070 develop a regulatory proposal on this topic for the Board’s consideration; 1071 (3) delay enforcement of any promulgated rule on this topic for one year 1072 after the effective date of the rule; and (4) direct staff to utilize the 1073 educational approach when inspecting pharmacies handling hazardous 1074 drugs during their first year of enforcement of the new rule. 1075 Mr. McKay and Mr. Broussard replied to questions from members. There were no 1076 public comments. The motion was adopted after a unanimous vote in the affirmative. 1077 1078 12. Announcements 1079 Mr. McKay directed the members to the announcements in their meeting binder, in 1080 particular the proposed board meeting schedule for Calendar Year 2021. Mr. Resweber 1081 requested consideration of a different date for May 2021. Mr. Broussard reported he 1082 would consult the master calendar in the Board office for an alternative and report back 1083 to the members. 1084 DRAFT 1085 13. Adjourn 1086 Having completed the tasks itemized on the posted agenda, with no further business 1087 pending before the Board and without objection, Mr. McKay adjourned the meeting at Page 33 of 34

1088 1:21 p.m. 1089 1090 1091 Minutes prepared by Malcolm Broussard. 1092

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Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Report on Action Items

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

February 24, 2021

Agenda Item 5: Report on Action Items

From your February 5, 2020 meeting:

You approved a regulatory proposal to license and regulate pharmacy benefit managers. We submitted Regulatory Project 2020-4 ~ Pharmacy Benefit Managers to the Occupational Licensing Review Commission (OLRC). During their February meeting, the Commission received an objection from the Pharmaceutical Care Management Association (PCMA) on the proposed rule. The Commission voted to defer their consideration until a future date. During their September 10, 2020 meeting, the OLRC approved the initiation of the project. We published the Notice of Intent in the October 2020 edition of the state register and conducted a public hearing on November 25, 2020 to receive comments and testimony on the proposed rule. You will consider those comments and testimony during your meeting today.

From your June 25, 2020 meeting:

In response to HCR 71 from the 2020 Legislature, you adopted an Emergency Rule to suspend the collection of renewal fees from existing businesses located within the state during Fiscal Year 2020-2021. Since Emergency Rules are valid for a maximum of 120 days, we have re-published the emergency rules as needed for the entire fiscal year. The most recent was issued on February 22; it is scheduled to expire on June 22, 2021. We will need to re-publish it on June 22 and then cancel it on June 30. You considered the comments and testimony from the May 29, 2020 public hearing relative to two regulatory projects: 2020-1 ~ Prescription Monitoring Program as well as 2020-2 ~ Automated Medication Systems. You approved revisions to the original proposed rules for both projects and directed a second public hearing to receive comments and testimony on those proposed changes. We published the proposed changes in the September 2020 edition of the Louisiana Register and conducted a public hearing on October 26, 2020 to receive comments and testimony on those proposed changes. We received no further comments on the proposed changes. During their November 17, 2020 meeting, the Occupational Licensing Review Commission approved continuation of the promulgation process for both projects. We submitted the 2nd Report to the Joint Legislative Oversight Committee on Health and Welfare for both projects on December 1, 2020. With no legislative intervention, we submitted both items to the state register for publication in their January 2021 edition with an immediate effective date. Unfortunately, the register made an error in the publication of the PMP rule and neglected to print the AMS rule. With respect to the PMP rule, the register neglected to remove the antiviral drugs from the definition of ‘drug of concern’; that was the change you made to the original proposal. The state register has indicated they will re-print the PMP rule as amended as well as the AMS rule in their February 20, 2021 edition. Since the addition of gabapentin and promethazine in oral liquid formulation were intended, the effective date for the reporting of those drugs was the January 20, 2021 publication date. Since the addition of the antiviral drugs was not intended, the Board has exercised enforcement discretion until that rule is re-printed.

From your July 28, 2020 meeting:

You approved a regulatory proposal relative to recommendations for medical marijuana. You also ordered the immediate implementation of that proposal by way of an Emergency Rule. • We submitted Regulatory Project 2020-8 ~ Marijuana Recommendations to the OLRC on July 30, 2020. During their September 10, 2020 meeting, they granted permission to initiate the promulgation process. We published the Notice of Intent in the October 2020 issue of the state register, and we conducted a public hearing on November 25, 2020 to solicit comments and testimony on that proposal. With only two verbal comments in support of the proposed rule and no requests for revision, we submitted the proposal to the OLRC for their second review on January 7, 2021. They approved the continuation of the promulgation process, and we submitted our 2nd Report to the Joint Legislative Oversight Committee on Health & Welfare the following day. With no legislative intervention, we published the original proposed rule without amendments as a Final Rule in the February 20, 2021 edition of the state register with an immediate effective date. • We issued the Emergency Rule effective August 1, 2020. We re-issued it on November 25, 2020; it was scheduled to expire on March 24, 2021. However, with the publication of the Final Rule on February 20, 2021, the Emergency Rule was cancelled.

From your August 13, 2020 meeting:

• You approved a regulatory proposal to amend your rules for licensing of military families. We submitted that proposal to the OLRC on August 13, 2020; during their September 10, 2020 meeting, they granted permission to initiate the promulgation process. We published the Notice of Intent for Regulatory Project 2020-9 ~ Licensing for Military Families in the October 2020 issue of the state register; during the November 25, 2020 public hearing, we received no comments or request for changes. During their January 7, 2021 meeting, the OLRC approved the continuation of that project. We submitted our 2nd Report to the Joint Legislative Oversight Committee on Health & Welfare the next day. With no legislative intervention, the Board published the original proposed rule without amendment as a Final Rule in the February 20, 2021 edition of the state register with an immediate effective date. • You approved a regulatory proposal to amend your controlled substance rules to add a new category of CDS license for hemp facilities. We submitted Regulatory Project 2020-10 ~ CDS License for Hemp Facility to the OLRC on October 20, 2020. During their November 17, 2020 meeting, the Commission granted permission to initiate the promulgation process. We published the Notice of Intent in the January 2021 edition of the state register, and we will conduct a public hearing on February 25, 2021 to solicit comments and testimony on that proposal. • You approved two separate regulatory proposals relative to medical marijuana – one to consolidate some of the product labeling standards and one to authorize delivery of dispensed medical marijuana products to patients. We combined both proposals into a single project and submitted Regulatory Project 2020-11 ~ Labeling and Delivery of Marijuana Products to the OLRC on October 20. During their November 17, 2020 meeting, they granted permission to initiate the promulgation process. We published the Notice of Intent in the January 2021 edition of the state register, and we will conduct a public hearing on February 25, 2021 to solicit comments and testimony on that proposal. • You approved a regulatory proposal to increase the amount of medication which could be dispensed for an emergency prescription during a state of emergency. We submitted Regulatory Project 2020-12 ~ State of Emergency to the OLRC on October 20, 2020. During their November 17, 2020 meeting, they granted permission to initiate the promulgation process. We published the Notice of Intent in the January 2021 edition of the state register, and we will conduct a public hearing on February 25, 2021 to solicit comments and testimony on that proposal. • With respect to our comprehensive rule review in Regulatory Project 454-2019, you addressed the last three remaining proposals from the Regulation Revision Committee. You rejected two proposals, one for medication administration by pharmacy technicians and one for staffing ratios for pharmacy technicians. You approved one proposal for telepharmacy dispensing sites. Of the 48 original requests received from that June 2019 public hearing on this project, the Board referred 20 items to the Regulation Revision Committee. The Committee returned all 20 items back the Board with recommendations. The Board ultimately approved 14 items for new rulemaking. We combined all 14 of those items into a single regulatory project. We submitted Regulatory Project 2021-1 ~ Pharmacists, Pharmacies and Prescriptions to the OLRC on October 20, 2020. During their November 17, 2020 meeting, they granted permission to initiate the promulgation process. We published the Notice of Intent in the January 2021 edition of the state register, and we will conduct a public hearing on February 25, 2021 to solicit comments and testimony on that proposal.

From your November 18, 2020 administrative hearing and meeting:

The formal administrative hearing had one case on the docket, a pharmacy technician who did not appear. You received testimony and reviewed exhibits from the prosecutor, and you issued an order rendering disciplinary action against the technician certificate. Shortly thereafter, the technician contacted the office and explained her absence from both the preliminary hearing with the Violations Committee as well as the formal hearing. With the consent of the administrative hearing officer, we offered the original consent agreement which is the committee-approved standard for that fact pattern. The technician executed the consent agreement and it will be presented for your re- consideration today.

During the report from the Finance Committee, you approved the Proposed Budget for Fiscal Year 2021-2022. We reported that budget document to all the required recipients on December 8, 2020.

During the reports from the Violations, Impairment and Reinstatement Committees as well as the report from the General Counsel, you approved board orders for a number of credentials. We entered those decisions in the eLicense system which enables their public access in the credential verification module of the Board’s website. We filed the required reports on those actions to the NABP Disciplinary Clearinghouse and the National Practitioner Data Bank (NPDB). We also published all of your actions in the October 2020 edition of your quarterly newsletter, in compliance with your newly revised policy.

Within the report from the Impairment Committee, the committee chair reported the recommendation for reinstatement of the technician certificate held by Kimiko Austin on probation for a period of 10 years. The Board voted to approve that recommendation. In fact, the recommendation was for a 5-year term and not a 10-year term and Ms. Austin had agreed to the 5-year term. I apologize for my error in drafting the committee chair’s report.

During the report from the Executive Committee, you approved several items. • You reviewed the 26 interim policies issued since the beginning of the public health emergency, noting some items had been transitioned to permanent rules, some were no longer necessary, and some were still necessary. You assigned expiration dates to all of the policies. We communicated those decisions to all of your licensees on December 2, 2020 and posted that information on your website. • You approved a new policy relative to cybersecurity awareness. We have implemented the training requirement for members and staff and are tracking compliance. • You approved a revision of the record retention policy recommended by State Archives. We notified State Archives of your approval. • You approved a revision of the criminal background check policy recommended by the FBI, and we have implemented the monitoring and enforcement of the training requirements. • You approved a revision of the frequency of inspections for DME permits. We have alerted the compliance and credential personnel of that policy change. • You approved a Statement on Dispensing of Prescriptions for Cannabidiol. We posted that document on your website and included a discussion of it in your January 2021 newsletter. • You approved the transitioning of your credentials to virtual format. We have begun that transition with pharmacy technician candidate registrations, pharmacy intern registrations, special work permits, and some of the CDS licenses. As we progress through the year, we will add pharmacy permits and pharmacist licenses.

During the report from the Assistant Executive Director, you approved requests from 20 pharmacies for waivers from the PMP reporting requirement contingent upon their execution of the standard consent agreement for that purpose. We forwarded those consent agreements to the requesting pharmacies and recorded the exceptions for those pharmacies properly executing those agreements.

During the discussion on new business items, you approved an extension on the delayed enforcement of the provisions for USP Chapter 800 until some future date beyond Calendar Year 2021. We notified all of your licensees with notice of that decision in your January 2021 newsletter.

The following resources are appended to this report: • Cumulative Project Promulgation Record • Legislative Action Plan Implementation Report

Respectfully submitted, Malcolm J Broussard Executive Director Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2021-1 Pharmacists, Pharmacies & Prescriptions 1/20/2021 2/25/2021 [Source: Regulatory Project 454-2019] 11/17/2020 OLRC approved initiation of promulgation

2020-12 State of Emergency 1/20/2021 2/25/2021 11/17/2020 OLRC approved initation of promulgation

2020-11 Labeling & Delivery of Marijuana Products 1/20/2021 2/25/2021 11/17/2020 OLRC approved initiation of promulgation

2020-10 CDS License for Hemp Facility 1/20/2021 2/25/2021 11/17/2020 OLRC approved initiation of promulgation

2020-9 Licensing for Military Families 10/20/2020 11/25/2020 1/8/2021 [none] 2/20/2021 8/27/2020 OLRC approved initiation of promulgation 1/7/2021 OLRC approved completion of project

2020-8 Marijuana Recommendations 10/20/2020 11/25/2020 1/8/2021 [none] 2/20/2021 8/27/2020 OLRC approved initiation of promulgation 1/7/2021 OLRC approved completion of project 8/1/2020 Emergency Rule #1 issued; expired on 11/28/2020. 11/25/2020 Emergency Rule #2 issued; scheduled to expire on 3/25/2021; cancelled on 2/20/2021 by Final Rule.

2020-7 Suspension of Renewal Fees 6/30/2020 Emergency Rule #1 issued; expired on 10/27/2020. 10/27/2020 Emergency Rule #2 issued; expired on 2/23/2021. 2/22/2021 Emergency Rule #3 issued; will expire 6/22/2021

2020-6 COVID-19 Dispensing Limitations 3/22/2020 Emergency Rule issued; rescinded 3/23/2020

2020-5 Marijuana Pharmacy 4/20/2020 5/29/2020 7/23/2020 [none] 9/20/2020 2/28/2020 OLRC approved initiation of promulgation 7/23/2020 OLRC approved completion of project

2020-4 Pharmacy Benefit Managers 10/20/2020 11/25/2020 2/28/2020 OLRC deferred consideration 9/10/2020 OLOL approved initiation of promulgation

Last update: 02-23-2021 Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2020-3 Pharmacist Display of License 4/20/2020 5/29/2020 7/23/2020 [none] 9/20/2020 2/28/2020 OLRC approved initiation of promulgation 7/23/2020 OLRC approved completion of project

2020-2 Automated Medication Systems 4/20/2020 5/29/2020 Comments prompted substantive revision, requiring a second public hearing 2/28/2020 OLRC approved initiation of promulgation 11/17/2020 OLRC approved completion of project 10/26/2020 12/1/2020 [none] 2/20/2021

2020-1 Prescription Monitoring Program 4/20/2020 5/29/2020 Comments prompted substantive revision, requiring a second public hearing 2/28/2020 OLRC approved initiation of promulgation 11/17/2020 OLRC approved completion of project 10/26/2020 12/1/2020 [none] 2/20/2021

2019-18 Cannabis MDI 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 9/3/2019 OLRC issued waiver from 1st review 2/28/2020 OLRC approved completion of project

2019-17 Pharmacy Records 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 8/29/2019 OLRC approved initiation of promulgation 2/28/2020 OLRC approved completion of project

2019-16 Pharmacy Compounding 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 8/29/2019 OLRC approved initiation of promulgation 2/28/2020 OLRC approved completion of project

2019-15 Drug Disposal by Pharmacies 11/20/2019 12/27/2019 Comments prompted substantive revision, requiring a second public hearing 8/29/2019 OLRC approved initiation of promulgation 4/27/2020 OLRC approved completion of project 4/27/2020 4/28/2020 [none] 6/20/2020 8/1/2020

454-2019 Comments on Entirety of Rules 5/20/2019 6/26/2019 Comments resulted in 14 proposals, combined into Regulatory Project 2021-1; see above.

2019-14 Rulemaking Procedures 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 4/22/2019 OLRC issued waiver from 1st review 2/28/2020 OLRC approved completion of project

2019-13 CDS License for 3PL Providers 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 4/22/2019 OLRC issued waiver from 1st review 2/28/2020 OLRC approved completion of project

2019-12 Partial Fill of C-II Prescriptions 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 4/22/2019 OLRC issued waiver from 1st review 2/28/2020 OLRC approved completion of project

Last update: 02-23-2021 Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2019-11 Continuing Education Records 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 8/29/2019 OLRC approved initiation of promulgation 2/28/2020 OLRC approved completion of project

2019-10 License Transfer for Pharmacy Technicians 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 8/29/2019 OLRC approved initiation of promulgation 2/28/2020 OLRC approved completion of project

2019-9 Delays of Licensure Examinations 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 8/29/2019 OLRC approved initiation of promulgation 2/28/2020 OLRC approved completion of project

2019-8 Dispensing of Prescription Refills 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 4/12/2019 OLRC issued waiver from 1st review 2/28/2020 OLRC approved completion of project

2019-7 Veterinary Hospital Pharmacy 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 4/12/2019 OLRC issued waiver from 1st review 2/28/2020 OLRC approved completion of project

2019-6 Prescription Monitoring Program With additional PMP-related regulatory proposals, this project was deferred in favor of Project 2020-1 (see above). 4/12/2019 OLRC issued waiver from 1st review

2019-5 Correctional Center Pharmacies 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 4/12/2019 OLRC issued waiver from 1st review 2/28/2020 OLRC approved completion of project

2019-4 Telepharmacy Dispensing Sites 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 8/29/2019 OLRC approved initation of promulgation 2/28/2020 OLRC approved completion of project

2019-3 Investigational Drugs 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 4/12/2019 OLRC issued waiver from 1st review 2/28/2020 OLRC approved completion of project

2019-2 Pharmacy Immunizations 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 4/12/2019 OLRC issued waiver from 1st review 2/28/2020 OLRC approved completion of project

2019-1B Licensing of Marijuana Pharmacies 11/20/2019 12/27/2019 3/6/2020 [none] 4/20/2020 8/1/2020 8/29/2019 OLRC approved initiation of promulgation 2/28/2020 OLRC approved completion of project

Last update: 02-23-2021 Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2019-1A Marijuana Pharmacies 4/20/2019 5/29/2019 9/3/2019 [none] 10/20/2019 8/1/2020 1/31/2020 3/20/2019 OLRC issued waiver from 1st review 9/3/2019 OLRC issued waiver from 2nd review

2018-3 Drugs of Concern - Naloxone 9/20/2018 10/26/2018 12/3/2018 [none] 1/20/2019 8/1/2019 2/26/2019

2018-2 La. Uniform Prior Authorization 8/20/2018 9/28/2018 10/25/2018 [none] 12/20/2018 8/1/2019 2/26/2019 Delayed effective date: 1/1/2019

2018-1 Pharmacy Benefit Managers 5/20/2018 6/25/2018 9/11/2018 10/8/2018 Sen. H&W Cmte rejected proposed rule.

2017-2 Equivalent Drug Product Interchange 4/20/2017 5/30/2017 9/27/2017 [none] 11/20/2017 11/20/2017 2/6/2018

2017-1 Internship Requirements 4/20/2017 5/30/2017 9/27/2017 [none] 11/20/2017 1/1/2018 2/6/2018 Delayed effective date: 1/1/2018

2016-6 Marijuana Pharmacy 1/20/2017 3/2/2017 Comments prompted substantive revision, requiring a second public hearing 6/26/2017 7/5/2017 [none] 8/20/2017 11/1/2017 2/6/2018

2016-5 Reinstatement of CDS License 11/17/20/16 Emergency Rule #1 issued; expired 3/17/2017 3/15/2017 Emergency Rule #2 issued; cancelled upon publication of Final Rule on 5/20/2017

1/20/2017 3/1/2017 3/27/2017 [none] 5/20/2017 11/1/2017 2/6/2018

2016-4 Standing Orders for Distribution of Naloxone 8/10/2016 Emergency Rule #1 issued; expired 12/8/2016 12/7/2016 Emergency Rule #2 issued; expired 4/6/2017 4/5/2017 Emergency Rule #3 issued; cancelled upon publication of Final Rule on 5/20/2017

1/20/2017 3/1/2017 3/27/2017 [none] 5/20/2017 11/1/2017 2/6/2018

2016-3 Medication Synchronization 4/20/2016 5/25/2016 8/1/2016 [none] 9/20/2016 2016 2/1/2017

2016-2 Pharmacist-in-Charge of Nonresident Pharma 4/20/2016 5/25/2016 11/14/2016 [none] 1/20/2017 2017 2/6/2018

2016-1 CDS Prescriptions 4/20/2016 5/25/2016 6/3/2016 [none] 7/20/2016 2016 2/1/2017

Last update: 02-23-2021 Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2015-9 Accreditation of Technician Training Program 11/30/2015 Emergency Rule #1 issued; it expired 3/28/2016. 3/24/2016 Emergency Rule #2 issued; it expired 7/22/2016. 7/21/2016 Emergency Rule #3 issued; it expired 11/18/2016. 11/17/2016 Revised Emergency Rule issued; it expired 3/17/2017 3/15/2017 Revised Emergency Rule #2 issued; it expired 7/13/2017 7/10/2017 Revised Emergency Rule #3 issued; it expired 11/7/2017 11/6/2017 Revised Emergency Rule #4 issued; cancelled upon effective date of Final Rule on 1/1/2018

1/20/2017 3/1/2017 Comments prompted substantive revision, requiring a second public hearing 6/26/2017 11/6/2017 [none] 12/20/2017 1/1/2018 2/6/2018 Delayed effective date: 1/1/2018

2015-8 Remote Access to Medical Orders 7/20/2015 8/26/2015 9/8/2015 [none] 10/20/2015 2016 2/22/2016

2015-7 Remote Processor Pharmacy Permit 7/20/2015 8/26/2015 9/8/2015 [none] 10/20/2015 2016 2/22/2016

2015-6 Telepharmacy Services Permit 7/20/2015 8/26/2015 9/8/2015 [none] 10/20/2015 2016 2/22/2016

2015-5 Electronic Signature on Fax Prescription 6/1/2015 Emergency Rule #1 issued; expired 9/30/2015 9/21/2015 Emergency Rule #2 issued; cancelled upon publication of Final Rule on 10/20/2015

7/20/2015 8/26/2015 9/8/2015 [none] 10/20/2015 2016 2/22/2016

2015-4 Compounding for Office Use for Veterinarians 6/1/2015 Emergency Rule #1 issued; expired 9/28/2015 9/21/2015 Emergency Rule #2 issued; expired 1/19/2016 1/15/2016 Emergency Rule #3 issued; expired 5/14/2016 2/24/2016 Emergency Rule #4 issued; cancelled upon publication of Final Rule on 6/20/2016

7/20/2015 8/26/2015 Comments prompted substantive revision, requiring a second public hearing 4/19/2016 5/10/2016 [none] 6/20/2016 2016 2/1/2017

2015-3 Electronic Product Verification 4/20/2015 6/25/2015 6/29/2015 [none] 8/20/2015 2016 2/22/2016

Last update: 02-23-2021 Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2015-2 Expiration Date of Schedule II Prescriptions 12/20/2014 1/28/2015 3/3/2015 [none] 4/20/2015 2016 2/22/2016

2015-1 Dispenser Reporting to PMP 12/20/2014 1/28/2015 3/3/2015 [none] 4/20/2015 2016 2/22/2016

2014-6 Special Event Pharmacy Permit 9/20/2014 10/30/2014 11/18/2014 [none] 1/20/2015 3/15/2015 2/22/2016

2014-5 Prescriptions 6/20/2014 7/28/2014 Comments prompted substantive revision, requiring a second public hearing 10/30/2014 11/18/2014 [none] 1/20/2015 3/15/2015 2/22/2016

2014-4 Pharmacy Compounding 8/8/2014 Emergency Rule #1 issued; expired 12/8/2014 12/5/2014 Emergency Rule #2 issued; cancelled upon publication of Final Rule on 1/20/2015

9/20/2014 10/30/2014 11/18/2014 [none] 1/20/2015 3/15/2015 2/22/2016

2014-3 Pharmacy Records 3/20/2014 4/29/2014 Comments prompted substantive revision, requiring a second public hearing 9/30/2014 10/3/2014 [none] 11/20/2014 3/15/2015 3/13/2015

2014-2 Veterinarian Exclusion from PMP 3/20/2014 4/29/2014 5/8/2014 [none] 6/20/2014 3/15/2015 3/13/2015

2014-1 PMP Delegates 3/20/2014 4/29/2014 5/8/2014 [none] 6/20/2014 3/15/2015 3/13/2015

2013-06 Penal Pharmacy Permit Revision 7/20/2013 8/27/2013 10/3/2013 [none] 11/20/2013 1/15/2014 2/7/2014

2013-05 Collaborative Drug Therapy Management 7/20/2013 8/27/2013 11/8/2013 [none] 12/20/2013 1/15/2014 2/7/2014

2013-04 Preferential Licensing for Military Personnel 7/20/2013 8/27/2013 9/23/2013 [none] 11/20/2013 1/15/2014 2/7/2014

2013-03 Technician Training Programs [Chap. 9] 4/20/2013 5/30/2013 6/4/2013 [none] 7/20/2013 1/15/2014 2/7/2014

2013-02 Hospital Off-Site Satellite Pharmacies [Chap. 1/20/2013 2/27/2013 3/15/2013 [none] 5/20/2013 1/15/2014 2/7/2014

Last update: 02-23-2021 Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2013-01 Compounding for Prescriber Use ~ ER-1 12/13/2012 Emergency Rule issued 1/18/2013 Sen H&W Cmte rejected Emergency Rule

Compounding for Prescriber Use ~ ER-2 1/31/2013 Replacement Emergency Rule #1 issued; expired 5/31/2013 5/29/2013 Replacement Emergency Rule #2 issued; expired 9/29/2013 9/27/2013 Replacement Emergency Rule #3 issued; expired 1/24/2014 2/6/2014 Replacement Emergency Rule #4 issued; expired 4/4/2014 4/4/2014 Replacement Emergency Rule #5 issued; expired 8/4/2014; see Project 2014-4 above for new ER

Compounding for Prescriber Use [Chap 25] 1/20/2013 2/27/2013 Comments prompted substantive revision, requiring a second public hearing 5/30/2013 Comments prompted substantive revision; additional hearing required 1/20/2014 Time has expired for the 2013 Notice of Intent - New Project & Notice of Intent required.

2012-11 DME Permit [Chapter 24] 11/20/2012 12/27/2012 1/5/2013 [none] 3/20/2013 4/15/2013 2/7/2014

2012-10 PMP [Chapter 29] 7/20/2012 8/27/2012 1/2/2013 [none] 2/20/2013 4/15/2013 3/8/2013

2012-09 CDS in EDK [§1713, 2743] 7/20/2012 8/27/2012 1/2/2013 [none] 2/20/2013 4/15/2013 3/8/2013

2012-08 CDS Lic. For Non-Resident Distributor [§2705 7/20/2012 8/27/2012 1/2/2013 [none] 2/20/2013 4/15/2013 3/8/2013

2012-07 Security of Rx Dept [§1103] 7/20/2012 8/27/2012 1/2/2013 [none] 2/20/2013 4/15/2013 3/8/2013

2012-06 Interstate Remote Processing [§1139, 1143] 7/20/2012 8/27/2012 1/2/2013 [none] 2/20/2013 4/15/2013 3/8/2013

2012-05 Institutional Pharmacy [§1705, 1727] 7/20/2012 8/27/2012 1/2/2013 [none] 2/20/2013 4/15/2013 3/8/2013

2012-04 Chapter 24 - DME Permits ~ Emergency Rule 5/2/2012 Emergency Rule - valid for 120 days 8/31/2012 Emergency Rule re-issued - valid for 120 days 12/28/2012 Emergency Rule re-issued - valid for 120 days Permanent rule promulgated with Project 2012-11 (see above

2012-03 Remote Processing [§1143, 1525] 1/20/2012 2/28/2012 3/19/2012 [none] 5/20/2012 4/15/2013 3/8/2013

2012-02 Hospital Pharmacy [§1501, 1512, 1513] 1/20/2012 2/28/2012 3/19/2012 [none] 5/20/2012 4/15/2013 3/8/2013

Last update: 02-23-2021 Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2012-01 E-Communications [§505, 905, 1203] 1/20/2012 2/28/2012 3/19/2012 [none] 5/20/2012 4/15/2013 3/8/2013

2011-07 Penal Pharmacy [Chapter 18] 1/20/2012 2/28/2012 3/19/2012 [none] 5/20/2012 4/15/2013 3/8/2013

2011-02 Cognitive Services [§525] 1/20/2012 2/28/2012 3/19/2012 [none] 5/20/2012 4/15/2013 3/8/2013

2011-01 PIC Requirements [§1105] 1/20/2012 2/28/2012 3/19/2012 [none] 5/20/2012 4/15/2013 3/8/2013

2009-04 Digital Imaging of Prescriptions [§1123] 12/20/2009 1/27/2010 2/26/2010 [none] 4/20/2010 1/31/2011 4/5/2011

2009-03 Prescription Transfers [§2523] 12/20/2009 1/27/2010 2/26/2010 [none] 4/20/2010 1/31/2011 4/5/2011

2009-02 Pharmacy Interns [§709] 12/20/2009 1/27/2010 2/26/2010 [none] 4/20/2010 1/31/2011 4/5/2011

2009-01 Drugs of Concern [§2901] 12/20/2009 1/27/2010 2/26/2010 [none] 4/20/2010 1/31/2011 4/5/2011

2008-03 CDS [Chapter 27] 6/20/2008 7/30/2008 8/21/2008 [none] 10/20/2008 1/31/2011 3/16/2009

2008-02 Pharmacies [§1107.B + §1727] 4/20/2008 5/28/2008 6/2/2008 [none] 7/20/2008 1/31/2011 3/16/2009

2008-01 Pharmacy Interns [ §521.G + §705.C] 4/20/2008 5/28/2008 6/2/2008 [none] 7/20/2008 1/31/2011 3/16/2009

2007-01 Prescription Monitoring Program [Chapter 29] 4/20/2007 5/30/2007 6/5/2007 [none] 7/20/2007 1/31/2011 2/13/2008

2006-03 Pharmacy Practice 11/20/2006 12/27/2006 Comments prompted substantive revision, requiring a second public hearing 3/30/2007 4/20/2007 5/3/2007 [none] 6/20/2007 1/31/2011 2/13/2008

2006-02 Proposal No. 2006-11 - Certified Preceptors 9/20/2006 10/30/2006 11/1/2006 [none] 12/20/2006 1/31/2011 3/30/2007

2006-01 Proposal No. 2006-11 - Certified Preceptors 9/1/2006 Emergency Rule - valid for 120 days [none] N/A N/A 3/30/2007

2005-03 §705 - Practical Experience for Interns 12/20/2005 1/25/2006 1/30/2006 [none] 4/20/2006 9/1/2006 3/30/2007

Last update: 02-23-2021 Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2005-02 §705 - Practical Experience for Interns 12/20/2005 Emergency Rule - valid for 120 days [none] N/A N/A 3/30/2007

2005-01 §907 - Scope of Practice for Technicians 6/20/2005 7/27/2005 8/25/2005 Refiled report due to disruption caused by Hurricanes Katrina & Rita 1/30/2006 2/14/2006 6/20/2006 9/1/2006 3/30/2007

2004-01 Chapter 8 →Chapter 9: Pharmacy Technician 8/20/2004 9/27/2004 10/5/2004 [none] 11/20/2004 1/1/2005 3/18/2005

2003-01 Complete Revision of Board Rules 7/20/2003 8/26/2003 8/28/2003 [none] 10/20/2003 1/1/2004 2/27/2004

2001-01 §1109 - Prescription Forms 9/20/2001 10/25/2001 11/5/2001 [none] 11/20/2001 1/1/2002 N/A

2000-04 Chapter 7 - Pharmacy Interns 6/20/2000 7/27/2000 8/28/2000 [none] 10/20/2000 12/1/2000 N/A

2000-03 Chapter 8 - Pharmacy Technicians 4/20/2000 5/30/2000 7/5/2000 Comments prompted substantive revisions, requiring a 2nd hearing 7/20/2000 8/24/2000 8/28/2000 [none] 10/20/2000 12/1/2000 N/A

2000-02 §3517 - Drug Donations / Charitable Pharmac 4/20/2000 5/30/2000 6/20/2000 [none] 8/20/2000 10/1/2000 N/A

2000-01 §3517 - Drug Donations / Charitable Pharmac 3/20/2000 Emergency Rule - valid for 120 days [none] N/A N/A N/A

1999-01 Chapter 12 - Automated Medication Systems 9/20/1999 11/29/1999 3/13/2000 [none] 6/20/2000 6/1/2000 N/A

Last update: 02-23-2021 Louisiana Board of Pharmacy Implementation of Legislation from 2nd Special Session in 2020 Bill Act Topic Citation(s) Law Book Rules PPM Guidance Forms Completion SB 71 2020-ES2-43 Teleconferencing meeting requirements 42:17.1 SR 39 Study request re CDTM Louisiana Board of Pharmacy Implementation of Legislation from 2020 Regular Session Bill Act Topic Citation(s) Law Book Rules PPM Guidance Forms Completion HB 089 2020-010 Update to CDS schedules 40:964 8/1/2020 8/1/2020 HB 418 2020-147 Extended immunity for medical marijuana 40:966(F)(6), (7), (8) 8/1/2020 8/1/2020 HB 613 2020-200 Occupational licenses for military families 37:3651 8/1/2020 LAC 46:LIII.506 and 904 2/20/2021 HB 619 2020-202 Licensure fees for PBMs 37:1184 8/1/2020 8/1/2020 HB 633 2020-155 Cybersecurity training for employees 42:1267 PPM.II.D.1.g DSCS 11/18/2020 HB 819 2020-286 Recommendations for medical marijuana 40:1046(A) 8/1/2020 LAC 46:LIII.2457 2/20/2021 HB 843 2020-344 Hemp-derived cannabidiol products 3:1481 through 1485 8/1/2020 8/1/2020 HCR 071 Temporary suspension of licensing fees Reg. Project 2020-7 ER in effect HCR 081 Task Force - Cannabis Industry Workforce PPM.I.B.6 10/28/2020 SB 273 2020-117 IT managed service providers to state agencies 51:2111 through 2116 Div. Admin. 12/31/2020

Louisiana Board of Pharmacy Implementation of Legislation from 2019 Regular Session Bill Act Topic Citation(s) Law Book Rules PPM Guidance Forms Completion HB 138 2019-354 Revised definitions; new drugs in Schedule I 40:961 and 964 8/1/2019 8/1/2019 HB 243 2019-423 Reporting of opioid-related overdoses 40:978.2.1 8/1/2019 8/1/2019 HB 284 2019-426 Prescriber overrides of 7-day supply 40:978(G)(2) 8/1/2019 8/1/2019 HB 358 2019-284 Cannabis metered-dose inhalers 40:1046(A)(1) 8/1/2019 LAC 46:LIII.2443.C.1.h 4/20/2020 HB 375 2019-219 CBC for CDS license applicants 40:973.1 8/1/2019 5/1/2020 5/1/2020 HB 423 2019-227 Repeal of student loan disqualifications 37:2951 repealed 8/1/2019 8/1/2019 HB 433 2019-161 Pharmacist may decline to fill prescription 37:1219(D through F) 8/1/2019 Board determined no rule needed 8/14/2019 HB 452 2019-231 Scheduling of mitragynine 40:964 and 40:989.3 8/1/2019 8/1/2019 HB 491 2019-164 Hemp-derived CBD oil products 40:961.1 8/1/2019 8/14/2019 8/14/2019 HB 507 2019-331 7% tax on gross sales of marijuana products 40:1046(H)(8)(a) 8/1/2019 8/1/2019 HB 614 2019-256 Public notice for public records 44:33.1(B) 8/1/2019 SB 41 2019-124 Licensure and regulation of PBMs 37:1252 et seq; 40:2861 et seq 8/1/2019 Reg. Project 2020-4 in process SB 53 2019-080 Access to PMP by federal jurisdictions 40:1007(G) 8/1/2019 LAC 46:LIII.2921.N 1/20/2021 SB 99 2019-052 Board member qualifications 37:1174(A)(4) 8/1/2019 Board determined no rule needed 8/14/2019 SB 119 2019-351 Palliative Care Advisory Council 40:2018.6 PPM.I.B.6 8/14/2019 SB 241 2019-204 Revision of APA re small business impact 49:953 et seq OSR 10/7/2019

Louisiana Board of Pharmacy Implementation of Legislation from 2018 Regular Session Bill Act Topic Citation(s) Law Book Rules PPM Guidance Forms Operations Completion HB 45 2018-186 CDS license for 3rd party logistics providers 40:961(42); 972(B)(7); 973(A)(1) 8/1/2018 LAC 46:LIII.Chapter 27 4/20/2020 HB 150 2018-063 Military spouse renewal fee waiver 37:1208.1 8/1/2018 No rule required PST-MS #12-MS 11/1/2018 HB 151 2018-064 Definition of 'approved school of pharmacy' 37:1164(2) 8/1/2018 No rule required 11/1/2018 HB 153 2018-119 New substances to Schedules I and II 40:964 8/1/2018 8/1/2018 HB 165 2018-677 Penalties for CS violations 40:966; 967 8/1/2018 8/1/2018 HB 186 2018-199 Penalties for CS violations 40:979 8/1/2018 8/1/2018 HB 188 2018-200 Acceptance of gifts by public servants 42:1115.2 8/1/2019 HB 189 2018-454 Rulemaking procedures 49:953(C) 8/1/2018 LAC 46:LIII.113 4/20/2020 HB 224 2018-203 Penalties for legend drug violations 40:1060(13); (15) 8/1/2018 8/1/2018 HB 326 2018-206 Technical corrections to practice acts 37:1164; 1182; 1226.1; 1226.2 8/1/2018 8/1/2018 HB 372 2018-623 Occupational licensing review commission 37:41-47 1/31/2019 1/31/2019 HB 579 2018-708 New indications for therapeutic marijuana 40:1046 8/1/2018 8/1/2018 HB 627 2018-496 New indications for therapeutic marijuana 40:1046 8/1/2018 8/1/2018 HB 748 2018-693 Occupational licensing review by Gov office 49:903 3/14/2019 HB 823 2018-715 Delay termination date of marijuana program 40:1046(J) 8/1/2018 8/1/2018 HCR 70 Review of military licensing procedures anticipated 8/1/2019 SB 27 2018-644 Nominations to Medicaid P&T Cmte 46:153.3(D) 8/15/2018 8/15/2018 SB 28 2018-219 Exemptions for veterinarians 37:1251(D); 40:978(F)(3); 978.3(E) 8/1/2018 8/1/2018 SB 29 2018-423 Uniform prior authorization form 22:1006.1; 1651(J); 46:460.33 1/20/2018 §1129 & 1130 1/1/2019 SB 40 2018-515 Consumer members to licensing boards 37:1172(A); 1174(B) 8/1/2018 8/1/2018 SB 75 2018-405 Prescriber licensing boards re PMP access 40:978(F)(2) 8/1/2018 8/1/2018 SB 90 2018-028 Voluntary nonopioid directive form 40:1156.1 8/1/2018 LDH 11/1/2018 SB 109 2018-232 Epidemiologist access to PMP 40:1007(E)(8) 8/1/2018 LAC 46:LIII.2921.I 1/20/2021 SB 110 2018-146 PMP definition of 'drugs of concern' 40:1003(10) 8/1/2018 §2901 1/20/2019 SB 131 2018-031 Pharmacist licensure by reciprocity 37:1202; 1203 8/1/2018 No rule required 11/1/2018 SB 134 2018-032 Partial fills for all Schedule II drugs 40:978(A) 8/1/2018 LAC 46:LIII.2747.B.5.a 4/20/2020 SB 241 2018-317 Pharmacist communication with patients 22:1657; 37:1219 8/1/2018 No rule required 11/1/2018 SB 260 2018-655 Complaints re board actions or procedures 37:23.1; 23.2 11/1/2018 11/1/2018 SB 391 2018-669 Internet filters in state agency offices 8/1/2018 8/1/2018 SB 477 2018-602 Chart orders for institutional patients 37:1164(59); 1226.4 8/1/2018 LAC 46:LIII (multiple chapters) 4/20/2020 SCR 83 Military licensing info on website 10/1/2018

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Finance Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Finance Committee

Interim Report Fiscal Year 2020-2021

February 24, 2021

Don L. Resweber Chair Louisiana Board of Pharmacy Fiscal Year 2020-2021 Statement of Net Position

FY 19-20 FY 20-21 Final (A) Q2 12/31/2020 ASSETS & DEFERRED OUTFLOWS Assets > Current Assets * Cash General Operations HancockWhitney Bank 228,272.24 228,377.98 First Horizon Bank [f/k/a Iberia] 730,093.15 1,030,444.07 Investment Accounts - First Horizon Bank Money Market Funds 638,356.84 618,622.56 Funds Maturing Within One Year 3,011,851.06 3,828,921.62 * Total Cash & Cash Equivalents 4,608,573.29 5,706,366.23

* Accounts Receivable Subscriptions 240.00 0.00 Returned Checks & Consent Orders 180.00 0.00 * Total Accounts Receivable 420.00 0.00

* Accrued Interest Receivable 11,361.22 7,488.93

* Prepaid Expenses Appriss Additional Deliverables 882.30 0.00 Essential Solutions 2,500.00 374.61 PMP Gateway Integration Project 647,199.11 258,879.65 RxCheck Maintenance Fee 12,898.63 1,842.67 Information Systems 7,385.19 3,505.26 * Total Prepaid Expenses 670,865.23 264,602.19

Total Current Assets 5,291,219.74 5,978,457.35

> Noncurrent Assets * Investment Accounts First Horizon Bank - General Reserve Fund 0.00 0.00 First Horizon Bank - OPEB Reserve Fund 0.00 0.00 First Horizon Bank - Pension Reserve Fund 789,970.63 0.00 789,970.63 0.00 * 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 1,354,876.72 1,354,876.72 Office Equipment 170,019.03 170,019.03 Furniture 155,620.46 155,620.46 Software: Licensure & Website 408,560.00 408,560.00 Accumulated Depreciation (910,246.88) (941,326.83) 2,183,769.23 2,152,689.28

Total Noncurrent Assets 2,973,739.86 2,152,689.28

Total Assets 8,264,959.60 8,131,146.63 Louisiana Board of Pharmacy Fiscal Year 2020-2021 Statement of Net Position

FY 19-20 FY 20-21 Final (A) Q2 12/31/2020 Deferred Outflows of Resources OPEB Reserve Fund 126,364.00 126,364.00 Pension Reserve Fund 1,331,670.00 1,331,670.00 Total Deferred Outflows of Resources 1,458,034.00 1,458,034.00

TOTAL ASSETS & DEFERRED OUTFLOWS 9,722,993.60 9,589,180.63

LIABILITIES, DEFERRED INFLOWS, & EQUITY Liabilities > Current Liabilites Unearned grant revenue 647,199.12 258,879.66 Accrued salaries and benefits 66,228.42 0.00 Unemployment taxes payable 87.08 45.66 Payroll taxes payable 17.48 0.00 Accounts payable 13,577.38 0.00 Compensated absences (ST) 47,623.39 47,623.39 Other post employment benefits (OPEB) payable 45,611.58 45,611.58 PES fees payable 0.00 98,900.00 Total Current Liabilities 820,344.45 451,060.29

> Long Term Liabilities Compensated absences (LT) 111,479.26 111,479.26 Other post employment benefits (OPEB) payable 1,744,850.42 1,744,850.42 Net pension liability 6,298,728.00 6,298,728.00 Total Long Term Liabilities 8,155,057.68 8,155,057.68

Total Liabilities 8,975,402.13 8,606,117.97

Deferred Inflows of Resources OPEB Reserve Fund 321,265.00 321,265.00 Pension Reserve Fund 38,794.00 38,794.00 Total Deferred Inflows of Resources 360,059.00 360,059.00

Equity Fund Balance at End of Prior Year (1,372,910.15) (2,015,806.81) Fund Balance - designated 250,650.00 250,650.00 Invested in Capital Assets 2,183,769.23 2,152,689.28 Net Income (673,976.61) 235,471.19 Total Equity 387,532.47 623,003.66

TOTAL LIABILITIES, DEFERRED INFLOWS, & EQUITY 9,722,993.60 9,589,180.63 Louisiana Board of Pharmacy Fiscal Year 2020-2021 Statement of Equity

FY 19-20 FY 20-21 Final (A) Q2 12/31/2020

Balance of Equity at Beginning of Year 1,061,509.08 387,532.47

Restatement due to implementation of GASB Statement 75 ~ Accounting & Financial Reporting for OPEB 0.00 0.00

Net Income (673,976.61) 235,471.19

Balance of Equity at End of 2nd Quarter 387,532.47 623,003.66

Components of Equity: Fund Balance at End of Prior Year (1,372,910.15) (2,015,806.81)

Fund Balance - designated 250,650.00 250,650.00

Invested in Fixed Assets 2,183,769.23 2,152,689.28 1,061,509.08 387,532.47 Louisiana Board of Pharmacy Fiscal Year 2020-2021 Statement of Revenue, Expenses, and Budget Performance

Revenue FY 19-20 FY 20-21 FY 20-21 Final (A) Q2 12/31/2020 Budget (A#1) Licensing Fees PST License Application Fee 169,500.00 39,300.00 170,000.00 PST License Reciprocity Application Fee 42,450.00 17,050.00 45,000.00 PST License Renewal Fee 885,450.00 840,350.00 890,000.00 PNT Registration Application Fee 3,360.00 2,720.00 3,500.00 PTC Registration Application Fee 25,525.00 15,400.00 28,000.00 CPT Certificate Application Fee 41,100.00 25,525.00 50,000.00 CPT Certificate Renewal Fee 305,075.00 50,175.00 340,000.00 PHY Permit Application & Renewal Fee 275,425.00 87,350.00 75,000.00 AMS Registration Application & Renewal Fee 25,350.00 8,250.00 0.00 DME Permit Application & Renewal Fee 85,975.00 41,850.00 37,500.00 EDK Permit Application & Renewal Fee 10,625.00 2,175.00 0.00 CDS License Application & Renewal Fee 542,345.00 231,440.00 500,000.00 Credential Reinstatement Fee 28,450.00 15,200.00 28,000.00 Delinquent Renewal Fee for PST & CPT 13,637.50 3,275.00 14,000.00 Delinquent Renewal Fee for PHY & CDS 12,745.00 7,957.50 12,500.00

Sales of Goods & Services Product Charge for Duplicate Credentials 3,445.00 1,500.00 3,500.00 Product Charge for Pharmacist Original Certificate 5,550.00 2,850.00 5,750.00 Product Charge for Pharmacist Silver Certificate 600.00 200.00 500.00 Product Charge for Law Book & Supplement 510.00 75.00 500.00 Product Charge for Official List of Licensees 25,050.00 13,050.00 25,000.00 Product Charge for Document Copies 27.50 22.00 0.00 Service Charge for Document Certification 3,540.00 1,060.00 3,500.00 Service Charge for PNT Practical Experience 340.00 130.00 250.00 Disposal of Assets 0.00 0.00 0.00

Administrative Fees Recovery of Bank Charges for NSF Fees 300.00 150.00 250.00 Handling & Mailing Fees 160.00 65.25 250.00

Enforcement Activities Administrative Hearing Fee 18,750.00 12,500.00 10,000.00 Fines 271,000.00 180,842.41 150,000.00 Cost Recoveries 24,652.82 9,320.67 10,000.00

Prescription Monitoring Program (PMP) PMP Assessments 607,875.00 307,650.00 608,000.00

Grants Private Grants 0.00 42,260.00 42,000.00 Government Grants 796,100.64 388,319.46 647,000.00

Miscellaneous Revenue 23.01 0.64 0.00

TOTAL REVENUE 4,224,936.47 2,348,012.93 3,700,000.00 Louisiana Board of Pharmacy Fiscal Year 2020-2021 Statement of Revenue, Expenses, and Budget Performance Expenses FY 19-20 FY 20-21 FY 19-20 Final (A) Q2 12/31/2020 Budget (A#1) Operations Equipment Rentals 14,651.45 5,518.67 15,000.00 Equipment Maintenance 2,239.92 2,239.92 2,300.00 Telephone 17,946.06 6,933.60 20,000.00 Printing 36,871.37 11,480.62 37,000.00 Postage 56,075.33 30,105.06 60,000.00 Dues & Subscriptions 13,246.87 8,541.52 14,000.00 Financial Service Charges 61,038.45 48,657.85 65,000.00 Office Meeting Expenses 2,896.19 480.00 5,000.00 Office Supply Expenses 20,663.33 8,329.88 22,000.00 Utilities 9,302.46 3,995.14 10,000.00 Civil Service Assessments (DSCS) 8,321.00 9,582.00 8,400.00 Office Insurance (ORM) 21,269.00 24,305.00 22,000.00 Depreciation of Fixed Assets 58,351.04 31,079.95 58,300.00 Acquisitions 10,546.34 2,799.93 20,000.00 Miscellaneous Expenses 38.86 272.02 0.00 Personal Services Salaries for Employees 1,772,765.00 844,917.19 1,825,000.00 Wages for Temporary Labor 9,416.35 8,379.25 20,000.00 Payroll Taxes (FICA & FUTA) 28,752.14 13,428.34 28,000.00 Health Insurance Premiums (SEGBP) 142,267.16 94,455.82 182,000.00 Pension Plan Premiums (LASERS) 1,312,323.15 338,797.31 732,000.00 Other Post-Employment Benefits (OPEB) 19,288.00 0.00 20,000.00 Board Member Per Diem 17,475.00 5,850.00 30,000.00 Professional Services Accounting & Expense Reimbursement 32,528.00 19,766.00 32,000.00 Legal & Expense Reimbursement 1,260.00 60.00 5,000.00 Information Systems 130,404.35 79,907.50 160,000.00 Prescription Monitoring Program 258,894.11 139,155.67 175,000.00 PMP Statewide Integration Project 779,192.92 323,599.55 647,000.00 Drug Price Transparency Website 60,167.72 0.00 42,000.00 Property Management 22,132.08 9,004.12 25,000.00 Staff Expenses Executive Director 2,719.90 0.00 0.00 General Counsel 5,997.02 375.00 500.00 Assistant Executive Director 2,184.96 0.00 0.00 Compliance Officer - Travel 3,005.21 1,938.95 3,000.00 Compliance Officer - Rental Cars 3,733.92 2,070.20 4,000.00 Compliance Officer - Fuel for Rental Cars 1,931.20 922.46 2,000.00 Compliance Officer - Conference Travel Expenses 13,782.28 75.00 0.00 House Staff Travel & Education 386.80 0.00 0.00 Mileage 36,525.06 16,750.59 35,000.00 Board Expenses Board Meetings 11,653.61 7,834.55 3,000.00 Committee Meetings 4,019.11 9,390.49 7,000.00 Conference Travel Expenses 3,139.40 0.00 0.00 President's Expenses 4,263.65 112.00 0.00 Mileage - Members & President 13,117.83 5,192.35 15,000.00 TOTAL EXPENSES 5,026,783.60 2,116,303.50 4,351,500.00 Louisiana Board of Pharmacy Fiscal Year 2020-2021 Summary of Income and Fund Balance Changes

Summary

FY 19-20 FY 20-21 FY 20-21 Final (A) Q2 12/31/2020 Budget (A#1)

Income Statement

Total Revenue 4,224,936.47 2,348,012.93 3,700,000.00

Total Expenses 5,026,783.60 2,116,303.50 4,351,500.00

Net Ordinary Income (801,847.13) 231,709.43 (651,500.00)

Other Income & Expenses

Investments 131,182.04 3,761.76 0.00

Disposal of Assets (3,311.52) 0.00 0.00

Net Income (673,976.61) 235,471.19 (651,500.00)

Fund Balance

Beginning Fund Balance 1,061,509.08 387,532.47 387,532.47

Total Income 4,356,118.51 2,351,774.69 3,700,000.00

Total Expenses 5,030,095.12 2,116,303.50 4,351,500.00

GASB Restatements 0.00 0.00 0.00

Ending Fund Balance 387,532.47 623,003.66 (263,967.53)

Reservations of Fund Balance 1,750,000.00 250,000.00 250,000.00

Unreserved Fund Balance (1,362,467.53) 373,003.66 (513,967.53)

Notes on Reservation of Fund Balance Unfunded Pension Liability 1,000,000.00 0.00 0.00 Unfunded OPEB Liability 600,000.00 0.00 0.00 Compensated Absences 150,000.00 250,000.00 250,000.00 Total 1,750,000.00 250,000.00 250,000.00 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Application Review Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Reciprocity Committee

New Pharmacist Credentials Issued by Reciprocity Issued Since 11/05/2020

Applicant Interviewer Result 1 Ana Victoria Molina (FL) Waived PST.023707 issued 11/12/20 2 Toni Myvette Pitre (TX) Waived PST.023708 issued 11/12/20 3 Nicholas Lanier Gaston (FL) Waived PST.023710 issued 11/19/20 4 Eamon Mahmood Darbandi (OK) Waived PST.023711 issued 11/19/20 5 Celeste Daniele Davis (AR) Waived PST.023712 issued 11/19/20 6 Kenneth Wayne Johnson (IN) Waived PST.023714 issued 11/19/20 7 Shamaine Elizabeth Narvaez (NM) Waived PST.023717 issued 12/01/20 8 Aaron Randolph Beckner (UT) Waived PST.023725 issued 12/04/20 9 Taylor James Scully (PA) Waived PST.023726 issued 12/04/20 10 Ronnie Darell Tyson (NC) Waived PST.023729 issued 12/09/20 11 Yewande Mofiropo Dayo (VA) Waived PST.023731 issued 12/18/20 12 Lisa Marie Gagliardi (FL) Waived PST.023735 issued 01/04/21 13 Jennifer Jooeun Kil (IL) Waived PST.023736 issued 01/04/21 14 Nasiredin Mir Mohammad Sadeghi (IL) Waived PST.023737 issued 01/04/21 15 Brooke Renee Burgess (FL) Waived PST.023738 issued 01/04/21 16 Coralyn Elizabeth Strodtman (MN) Waived PST.023739 issued 01/04/21 17 Emily McGuire Kennell (SC) Waived PST.023740 issued 01/04/21 18 Rohitkumar Bhalendrabhai Chaudhary (FL) Waived PST.023741 issued 01/04/21 19 Kenneth Mutah Awasung (MA) Waived PST.023743 issued 01/04/21 20 Lovleen Kaur Chatrath (NJ) Waived PST.023744 issued 01/04/21 21 Julia Kelleher Sanchez (MO) Waived PST.023745 issued 01/04/21 22 Lauren Elise Lawson (CA) Waived PST.023746 issued 01/04/21 23 Joseph Kyrillos Bishay (FL) Waived PST.023747 issued 01/04/21 24 Whitney Johnson Walker (TN) Waived PST.023748 issued 01/04/21 25 Maressa Barry (MA) Waived PST.023752 issued 01/04/21 26 Kristin Leigh Kellett (OK) Waived PST.023753 issued 01/04/21 27 Monica Candelaria (TX) Waived PST.023754 issued 01/04/21 28 Katherine Bettina Galutera Dauz (NY) Waived PST.023755 issued 01/04/21 29 Abdullah Molki (TX) Waived PST.023756 issued 01/04/21 30 Charlene Beckham Dawson (TX) Waived PST.023757 issued 01/04/21 31 Micah Lee Cheak (KY) Waived PST.023758 issued 01/04/21 32 Stephen Odysseus Oradesky (NY) Waived PST.023762 issued 01/06/21 33 Suzanne Bristow-Marcalus (DE) Waived PST.023763 issued 01/06/21 34 Kestlie Patrice Morelus (NH) Waived PST.023764 issued 01/06/21 35 Maryam Emadi (TX) Waived PST.023766 issued 01/06/21 36 Diviesh Patel (NJ) Waived PST.023767 issued 01/06/21 37 Brian Joel Huseby (MT) Waived PST.023768 issued 01/06/21 38 George Michael Cullina (MN) Waived PST.023769 issued 01/07/21 39 Frank Anthony Juliano (AZ) Waived PST.023770 issued 01/08/21 40 Sarah Ackerman Carter (KY) Waived PST.023771-MS issued 01/09/21 41 Krystian Cymone Volair (TX) Waived PST.023772 issued 01/14/21 42 Maria Margaret Gentry (KY) Waived PST.023773 issued 01/14/21 43 Shannon Marie Somero (AZ) Waived PST.023774 issued 01/14/21 44 Susan Lynne Anderson (MN) Waived PST.023775 issued 01/14/21 45 Sidney Wayne Seal (MS) Waived PST.023776 issued 01/14/21 46 Shibu John (NY) Waived PST.023777 issued 01/14/21 47 David Jacob Roark (AR) Waived PST.023778 issued 01/14/21 48 Edward Robert Breslow (FL) Waived PST.023779 issued 01/14/21 49 Courtney Allyson Sullens (GA) Waived PST.023780 issued 01/15/21 50 Joshua Marshall Andersen (IN) Waived PST.023781 issued 01/15/21 51 Tien Minh Le (PA) Waived PST.023782 issued 01/15/21 52 Amanda Louise Berishaj (MI) Waived PST.023783 issued 01/15/21 53 Samuel Hugh Wilson (GA) Waived PST.023784 issued 01/25/21 54 Trevor Bryan Strenchock (PA) Waived PST.023785 issued 01/25/21 55 Shmuel Stuart Winzelberg (NY) Waived PST.023786 issued 01/25/21 56 Alicia Marie Morris (TX) Waived PST.023787 issued 01/25/21 57 Helen Elizabeth Pennington (AR) Waived PST.023788 issued 02/01/21 58 Ayoyinka Oladipupo Ojutalayo (VA) Waived PST.023789 issued 02/01/21 59 Roocha Saurabh Joshi (FL) Waived PST.023790 issued 02/05/21 60 Allison Dahye Ahn (TX) Waived PST.023791 issued 02/05/21 61 Christopher James Razor (KY) Waived PST.023793 issued 02/05/21 62 Jennifer Golo Gandhi (AR) Waived PST.023794 issued 02/05/21 63 Deekshith Kumar Reddy Katta (MD) Waived PST.023795 issued 02/05/21 64 Timothy Brandon Barclift (AL) Waived PST.023801 issued 02/11/21 65 Michael Shawn Wallace (TX) Waived PST.023802 issued 02/11/21 66 Jared Joshua Gabriel Chiusano (NC) Waived PST.023803 issued 02/11/21 67 Katie Marie Martin (MI) Waived PST.023804 issued 02/11/21 68 Robert Paul Savoy (TX) Waived PST.023805 issued 02/11/21 69 Samantha Anne Delgado (FL) Waived PST.023806 issued 02/11/21

Total: 69 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Violations Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Impairment Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Reinstatement Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ Email: [email protected]

NOTICE IS HEREBY GIVEN that the meeting of the Reinstatement Committee originally scheduled for February 18, 2021 in Baton Rouge, Louisiana was cancelled.

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 02-16-2021

1. Call to Order

2. Quorum Call

3. Call for Additional Agenda Items & Adoption of Agenda

4. Opportunity for Public Comment

5. Consideration of Applications

A. Petitions for Reinstatement (suspended + lapsed > 5 years or staff referral)

B. Petitions for Modification of Previous Orders

C. Petitions for Return of Inactive or Relinquished Licenses to Active Status

[Note: Appearances are not required for the remaining applicants.]

D. Petitions for Reinstatement (suspended + lapsed > 5 years + chair’s discretion)

E. Applications for Reinstatement of CDS Licenses Lapsed > 5 years (01) CDS.030437-MD – Cherie Rene Many (02) CDS.033144.MD – Anish P. Shah (03) CDS.025080.MD – David Michael Murdock (04) CDS.036772-ETL – Beth W. Brewster (05) CDS.025087-MD – Daniel Martinez (06) CDS.029808-MD – Joel Drew Thibodeaux

NOTE: Pursuant to the Open Meetings Law at 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. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. NOTE: While it is possible members of the Board who are not members of this committee may attend this committee meeting in sufficient number to constitute a quorum of the Board, no action taken at this committee meeting may be construed as an action of the entire Board. F. Discretionary Approvals by Committee Chair (lapsed > 1 year but < 5 years) (01) CDS.036090-MD – Trenton A. Hinds (02) CDS.042140-OD – Geesala Saummya Garvin (03) CDS.037095-MD – Gordon Hampton Clark (04) CDS.049421.MD – Jamie Lee Hardeman (05) CDS.033673.DVM – Jennifer M. Ahr (06) CDS.052720.DVM – Nancy Hannah Pesses (07) CDS.048018.APN – Ronald Boa Miller (08) CDS.048144.MD – Susan Louise Sterlacci (09) CPT.008467 – Melissa Renee Gentry (10) CDS.050082.OD – Shamekia Ann Nwafor (11) CPT.011089 – Alicia Marie Bercegeay (12) CPT.007158 – Angel Marie Fusilier (13) CDS.012770.MD – Rao Vera Puvvada (14) CDS.012863.MD – Erin Theresa O'Sullivan (15) CDS.040169.APN – Marguerite Catherine Collins (16) CDS.052375.INT – Nicholas Arabion Taylor (17) PST.019771 – William Allan Stuart (18) CDS.045487-APN – Marla Nelson (19) CDS.052941.MD – Turky Abdullah Alsubahi (20) CDS.050958.MD – Marloe Prince (21) CDS.045904.APN – Dana Michelle Vines (22) CDS.044191.DDS – Charles Paul Silvia (23) CDS.045487.APN – Marla Nelson (24) CDS.018947.DDS – Wayne Edward Lyerly (25) CDS.049586.MD – Catherine Downs Linzay (26) CDS.015821.MD – Edward Matthew Campbell III (27) CDS.039872.PA – Benjamin Blythe Erwin (28) CPT.013315 – Justin Craig Wallace (29) CPT.010380 – Mignon Omi Barnes (30) CPT.013074 – Tannette Patrice Williams (31) CDS.049864-DDS – Jessica Maria Wilkins (32) CDS.044769-MD – Michael Leigh Larson (33) CDS.050711-APN – Holly Anne McNab (34) CDS.052398-MD – Jayalakshmi Narayan Bhat (35) CDS.052335-INT – Katherine Marie Oakden (36) CPT.013411 – Catherine Nichole Picou (37) CPT.004865 – Dayle Elizabeth Davis (38) CDS.036320-DVM – Kelly Elizabeth Rachal (39) CPT.009336 – Leslie Ann Cortez Sanchez (40) CPT.010279 – Jason Wayne Ducote (41) PST.014947 – Sybil Marie Richard (42) CDS.053044-INT – Ashley Rose Meyn (43) CDS.053266-MD – Hind Hamad Alrowais (44) CDS.045804-OD – Amy Allison Snell

NOTE: Pursuant to the Open Meetings Law at 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. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. NOTE: While it is possible members of the Board who are not members of this committee may attend this committee meeting in sufficient number to constitute a quorum of the Board, no action taken at this committee meeting may be construed as an action of the entire Board. (45) CDS.015038-DDS – Velma H. Jackson (46) CDS.053575-DDS – Asher B. Adamec (47) CDS.041622-MD – Philip Boysen (48) CPT.013925 – Katelyn Elyse Trahan (49) CPT.013156 – Amber Noelle Higginbotham (50) PST.019986 – Sarah-Anne Swann Blackburn (51) CDS.052963-INT – Dhruv Choudhry (52) CDS.051379-APN – Barbara Lynn Bruner (53) CDS.053056-INT – Veeruijay Nijjar (54) CDS.052939-INT – David Gordon Allan (55) CDS.052936-INT – Akinbolaji A. Akingbola (56) CDS.052988-INT – Richa Goel (57) CDS.052966-INT – Adam M. Cloninger (58) CDS.043449-MD – Shane Paul Prejean (59) CDS.045853-PA – Sidney Michael Jackler

G. Staff Approvals by Board Policy (lapsed < 1 year) (01) CDS.053303-MD – Marcus Alexander Bachhuber (02) CDS.035898-DVM – John Jerome Fontenot (03) CDS.031715-MD – Angelle Levatino Klar (04) CDS.055929-INT – Nicole Alexandria Neal (05) CDS.009334-DDS – John Stephen Picou (06) CDS.052720-DVM – Nancy Hannah Pesses (07) CDS.055938-INT – Jaron Lee Pettis (08) CDS.052965-MD – Leeanna Marie Clevenger (09) CDS.009146-MD – Laney Joseph Chouest (10) CDS.044945-MD – Elizabeth Marie Goodly (11) CDS.054509-MD – Julie Kaye Johnson (12) CDS.043292-DVM – Elizabeth Kathryn Harris (13) CDS.053264-INT – Thomas Joseph Faucheaux, IV (14) CDS.055725-INT – Thomas George Block, III (15) CDS.016936-MD – Steven Hedlesky (16) CDS.052948-INT – Ryan Singh Bedi (17) CPT.007940 – Nicole Janette Staples (18) CDS.053295-INT – Shaheena Cherelle Anene (19) CDS.021430-MD – Pamela Marie Conley (20) CDS.055952-INT – Spencer Lee Robichaux (21) CDS.042316-DDS – Daniel Joseph Cassis (22) CDS.047040-APN – Katherine Delorse Washington (23) CDS.049592-MD – Long Thanh Nguyen (24) CDS.046890-APN – Brandee Marsh Yarbrough (25) CDS.041812-DVM – Caroline Andry Landry (26) CDS.052024-APN – Christine Flegeance Castille (27) CDS.053664-INT – Ryley Adam McPeters (28) CDS.034156-APN – Demetrice Hoskins Smith

NOTE: Pursuant to the Open Meetings Law at 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. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. NOTE: While it is possible members of the Board who are not members of this committee may attend this committee meeting in sufficient number to constitute a quorum of the Board, no action taken at this committee meeting may be construed as an action of the entire Board. (29) CDS.040900-MD – Anuia Veluvolu (30) CDS.043722-DVM – Lauren Todd Oray (31) CDS.034754-MD – Susan Elizabeth Uhrich (32) CDS.033615-DDS – Daniel Goddard Lester (33) CDS.055721-INT – Peyton Matthew Roteff (34) CDS.015223-DDS – John J. Campo, Jr. (35) CDS.050174-APN – Shanna Elizabeth Money (36) CDS.023840-MD – Renata Pilatova (37) CDS.031723-APN – Glen P. Carbo (38) CDS.014039-DVM – Boyer Britton Stringer (39) CDS.048921-DVM – Gwen M. Rutkowski (40) CDS.007231-MD – Robert L. Mimeles (41) CDS.050419-DVM – Timothy Nathan Thibodeaux (42) CDS.052325-INT – Emma Rebecca Cassidy (43) CDS.050382-APN – Mia M. Trupiano (44) CDS.055633-DDS – Daniel Edward Adler (45) CDS.019708-MD – John Phillip Epling, Jr. (46) CDS.054683-APN – Monica Idoyaga (47) CDS.034844-MD – Eliana Amparo Soto (48) CDS.015278-DDS – Richard W. Campbell (49) CDS.052820-APN – Heather Maddox Ducote (50) CDS.048930-DVM – Dana Nicole Chapman (51) CDS.045191-APN – Angelle Marie Lew (52) CDS.027639-DVM – Amy Virginia Grayson (53) CDS.052744-APN – Jena Weber Berry (54) CDS.055100-MD – Christopher Paul Martin (55) CDS.055614-INT – Zachary Andrew Davis (56) CDS.008479-DDS – Arthur W. Dickerson, II (57) CDS.052527-APN – Kristin Sills Anderson (58) CDS.053058-INT – Ivana Erekawhevwe Okor (59) CDS.043790-MD – Timothy P. Desmond (60) CDS.030796-APN – Charlotte Marie Cline (61) CDS.055369-APN – Vanisha Faye Williams (62) CDS.052884-APN – Dominique Nicole Howard (63) CDS.033898-APN – Daphne Jackson Dureau (64) CDS.015475-DDS – Charles Bradley Foy, Jr. (65) CDS.041933-APN – Daraka Yamika Miles (66) CDS.049755-APN – Keith Wayne Norman (67) CDS.042831-APN – Jaime Rebecca Loebner (68) CDS.056103-DVM – Adam Christopher Caro (69) CDS.052072-DVM – Erin Rose Rogers (70) CDS.010637-DDS – Charles Kenneth Sherman (71) CDS.032669-MD – Philip Herbert Glogover (72) CDS.008163-MD – Thomas H. Burguieres (73) CDS.009535-MD – Tristan Robert Schultis

NOTE: Pursuant to the Open Meetings Law at 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. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. NOTE: While it is possible members of the Board who are not members of this committee may attend this committee meeting in sufficient number to constitute a quorum of the Board, no action taken at this committee meeting may be construed as an action of the entire Board. (74) CDS.054817-DPM – Gabrielle Sharon Clark (75) CDS.009121-MD – Simeon Heninger Wall (76) CDS.049616-MD – Anthony Keith Woodall (77) CDS.026935-MD – Vernon Edvert Chee (78) CDS.053205-INT – Katharine Terese Veale (79) CDS.024047-MD – Scott Joseph Daigle (80) CDS.013336-MD – James Douglas Perry (81) CDS.026366-DDS – Daniel Scott Gammage (82) CDS.047925-PA – Patricia Alexis Reed (83) CDS.035563-MD – Stephanie Emily Mathijsen (84) CDS.053177-INT – Sushma Komati Reddy (85) CDS.037631-DPM – George Edward Ray (86) CDS.044542-MD – Alison Trappey Penton (87) CDS.053088-MD – Israel Wootton (88) CDS.010177-MD – Hulon Augustus Lott, Jr. (89) CDS.049768-APN – Kristin Blair Segura (90) CDS.051306-DIS – Axum Medical Supples, LLC (91) DME.001075 – XpressMed Urgent Care (92) CDS.045400-APN – Jennifer Bouffard (93) CDS.049866-DVM – Jessica Brou Price (94) CDS.033836-OD – Trever J. Mitchell (95) CDS.014038-DVM – Lushen Aldon Stewart, Jr. (96) CDS.055188-INT – Morgan Elizabeth Laurent (97) CDS.055706-INT – Claire Allison Caraway (98) CDS.040611-MD – Quan Dang Le (99) CDS.056171-INT – Christopher James Clark (100) CDS.053160-DVM – Sita Selina Withers (101) CDs.035768.DDS – Reena Suresh Oza (102) PST.014652 – Gino James Agnelly (103) CPT.015099 – Bianca Renee Harvey (104) CPT.010595 – Pankitkumar Ramanbhai Patel (105) CDS.009733-DDS – Scott C. Kogler (106) CDS.015194-DDS – Gayle M. Sanchez (107) CDS.045491-MD – Dana Marie LeBlanc (108) CDS.003176-MD – Herbert Aldon Nesom, Jr. (109) CDS.030316-MD – John E. Britt (110) CDS.040677-DVM – Brennan Kel Fitzgerald (111) CDS.016382-DDS – Thomas K. Murphy (112) CDS.031777-APN – Mark Craig Collier (113) CDS.055191-INT – Kevin Patrick Kenney (114) CDS.055175-INT – Madeline Moore Dills (115) CDS.055546-APN – Miosha Sutherland Bailey (116) CDS.027288-DDS – Kay Jordan (117) CDS.054554-INT – Adele Plaisance Williams (118) CDS.037965-DVM – Jill Laubersheimer Yates

NOTE: Pursuant to the Open Meetings Law at 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. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. NOTE: While it is possible members of the Board who are not members of this committee may attend this committee meeting in sufficient number to constitute a quorum of the Board, no action taken at this committee meeting may be construed as an action of the entire Board. (119) CDS.045476-MD – Mark Nelson Singleton (120) CDS.055026-PA – Case Anthony Rappelet (121) CDS.034386-MD – Lan Thi Nguyen (122) CDS.043886-DDS – Justin Lecian Wu (123) CDS.049088-APN – Christal Safford Waller (124) CDS.053495-INT – Pirthpal Singh Kular (125) CDS.052380-INT – Joshua Brian Campo (126) CDS.051243-INT – Christopher Martin Schneider (127) CDS.040789-MD – Joseph A. Rutz, Jr. (128) DME.001056 – Ethos Therapy Solutions (129) CDS.031880-MD – Jeanette Ng (130) CDS.055240-INT – Bradley Thomas Landwehr (131) CDS.015343-MD – Barry Scott Edwards (132) CDS.038337-DDS – Justin L. Wu (133) CDS.052521-APN – Edwin Njoroge Njenga (134) CDS.045336-MD – Phillip Wesley Nowlin (135) CDS.040756-DDS – Joshua Keith Girod (136) CDS.048773-APN – Jean Nicole Webb (137) CDS.049024-APN – Maximo Martell (138) CDS.051904-MD – Kabiul Haque (139) CDS.039820-APN – Margaret Snowden Evans (140) CDS.050557-DVM – Carlos R.F. Pinto (141) CDS.052068-PA – Brittany Karner Lipoma (142) CDS.045505-APN – Kathleen Denise Moore (143) CDS.050377-MD – Hoangvy Le (144) CDS.030821-DDS – John Jared Harmon (145) CDS.044773-MD – Walter Torrence Smith (146) CDS.015963-MD – Susan Cameron Emerson (147) CDS.053470-INT – Mary Katherine Keith (148) CDS.052379-INT – Brian Thomas Carr, II (149) CDS.053323-MD – Furqan Akhtar (150) CDS.025779-MD – Brian Allan Heise (151) CDS.052721-MD – Ayush Pitu Motwani (152) CDS.053570-MD – Lihua Zhang (153) CDS.033924-MD – Karen Lynn Paul (154) CDS.052320-INT – Matthew Grant Hogan (155) CDS.053696-INT – Caleb Scott Manasco (156) CDS.027411-MD – Martha Samson Paterson (157) CDS.016733-DDS – Ronald Frank Baldo (158) CDS.042421-DVM – Jenny Ostroske Luke (159) CDS.040799-MD – Jose Luis Veras Pola (160) CDS.055265-MD – Krystle Lashell Pew (161) CDS.032855-MD – Ana R. de Aguiar (162) CDS.054765-APN – Penny Meyers Thomas (163) CDS.030616-DDS – Bridget A. Brahney

NOTE: Pursuant to the Open Meetings Law at 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. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. NOTE: While it is possible members of the Board who are not members of this committee may attend this committee meeting in sufficient number to constitute a quorum of the Board, no action taken at this committee meeting may be construed as an action of the entire Board. (164) CDS.050682-MD – George Andrews (165) CDS.053739-MFR – Monarch PCM, LLC (166) CDS.53737.DIS – Monarch PCM, LLC (167) CDS.029351.LAX – St. Tammany Parish Sheriff's Office Criminalistics Lab (168) DME.000970 – BlueWater Healthcare (169) CDS.042452-DDS – Katie L. Medine (170) CDS.050605-DVM – Linda Joy Paul (171) CDS.053822-MD – Laura Katherine Jeter (172) CDS.045930-MD – Robert Neal Barker (173) CDS.024007-MD – Hassan Moawad Ibrahim (174) CDS.053698-INT – Arch Gerald Martin, IV (175) CDS.053442-INT – Angelle Aubin Billiot (176) CDS.052949-INT – Jordan Leigh Berg (177) CDS.052997-INT – Jakayla M. Harrell-Mohamed (178) CDS.050755-MD – Yogesh Bipin Pancholi (179) CDS.041340-DDS – Anitra Michelle Craig (180) CDS.006297-MD – Robert Keene Fell (181) CDS.056100-DDS – John Johnson McElveen, Jr. (182) CDS.056302-DDS – John Johnson McElveen, Jr. (183) CDS.056301-DDS – John Johnson McElveen, Jr. (184) CDS.056303-DDS – John Johnson McElveen, Jr. (185) CDS.056299-DDS – John Johnson McElveen, Jr. (186) CDS.055088-DDS – Funmi O. Abosede (187) CDS.037260-PA – Misty Carlson (188) CDS.055879-INT – Gregory Conner Reese (189) CDS.050087-DVM – Rebecca Sue McConnico (190) CDS.041966-DDS – Aimee Russo-Mounger (191) CDS.036494-DVM – Jennifer Acosta Reeb (192) CDS.021415-MD – Jake Mitchell Majors (193) CDS.048827-MD – Kimberly Tran (194) CDS.043872.RES – David Joseph Lefer (195) CDS.034797.RES – Christopher C. Austin (196) CPT.012621 – Bianca Lanay Moore (197) CPT.012511 – Chelsea Angelle Guillory (198) CDS.002404-MD – James Arthur Rogers (199) CDS.017515-MD – Thomas Paul Alderson (200) CDS.052138-MD – Jessica Mei-Ling Chong (201) CDS.032939-MD – Emile Joseph Pierre (202) CDS.053675-INT – Tseng-Che Tseng (203) CDS.053053-INT – Michael Anthony Nammour (204) CDS.037730-APN – Bridgette Dawn Mitchell (205) CDS.042582-APN – Stephanie Linton Nolan (206) CDS.053556-INT – Tat Wa Yau (207) CDS.055094-MD – Yaima Alonso-Jeckell (208) CDS.019536-MD – William Ross Knight

NOTE: Pursuant to the Open Meetings Law at 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. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. NOTE: While it is possible members of the Board who are not members of this committee may attend this committee meeting in sufficient number to constitute a quorum of the Board, no action taken at this committee meeting may be construed as an action of the entire Board. (209) CDS.018882-MD – Carol Ann Lambert-Lanasa (210) CDS.052256-INT – Allison Leigh Mak (211) CDS.055174-INT – Danielle Alexandra Dooley (212) CDS.041117-MD – Ismail Suhail Penukonda (213) CDS.050546-DVM – Heidi Elise Banse (214) CDS.050758-DVM – Rebecca Renae Gillen (215) CDS.028328-DVM – Angela Marie Darby (216) CDS.033863-DVM – Brooke A. Mc Gee (217) CDS.053334-APN – Adrian Cale Brouillette (218) CDS.055617-INT – Omar Akhtar Ali (219) CDS.043737-MD – April Danielle Sorrel (220) CDS.053828-INT – Aditya Sithamrju (221) CDS.056439-APN – Savannah Bleu-Case Murray (222) CDS.022249-DDS – Teresa M. Perkins (223) CDS.045747-APN – Sheila Carzettie Burrell (224) CDS.053549-DVM – Armando Luis Moya (225) CDS.056522-INT – Leslie Rachel Miller (226) CDS.055878-MD – Smitha Devi Neerukonda (227) CDS.055293-INT – Lauren Jane Auerbach (228) CDS.046219-PA – Lauren Elizabeth Duhon (229) CPT.011487 – Ashley Lynn Silver (230) CDS.053815-INT – Joseph Evan Devillier (231) CDS.051793-DDS – Lisa Marie Judge (232) CDS.053819-INT – Enrique Jose Andrade Rondon (233) CDS.040877-APN – Jan Simon Bruckmeier (234) CDS.036117-MD – Greg Edward Parker (235) CDS.035048-DVM – Julie Hillary Hackney (236) CDS.053521-MD – Jason Robert Deleon (237) CDS.053750-MD – Ronak Vishnubhai Patel (238) CDS.036166-APN – Mary Amelia Duncan (239) CDS.056507-MD – Timothy Kipper Copeland (240) CDS.049167-RES – Mimi Cecile Sammarco (241) CDS.053778-ETL – Catherine Wilbert (242) CDS.036162-APN – Sarah Jordan Cooling (243) CDS.052454-DDS – Unique Trichelle Williams (244) CDS.032999-OD – Timothy J. Leach (245) CDS.053924-APN – Dana Nelson Eason (246) CDS.055939-MD – Farnoosh Shariati (247) CDS.047248-APN – LaKenda Diane Johnson (248) CDS.035447-APN – Patricia D. McGovern (249) CDS.051875-MD – Virginia Ann Brown (250) CDS.056383-APN – Emily Margaret Cleland (251) CDS.031884-MD – Charles Edward Schlosser, III (252) CDS.056263-MD – Kendall Sawyer Douglass (253) CDS.053817-INT – Sarah Thorne Flanagan

NOTE: Pursuant to the Open Meetings Law at 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. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. NOTE: While it is possible members of the Board who are not members of this committee may attend this committee meeting in sufficient number to constitute a quorum of the Board, no action taken at this committee meeting may be construed as an action of the entire Board. (254) CDS.029182-DDS – Tahisa Patric Colbert (255) CDS.047332-APN – Jessica Stewart (256) CDS.056221-APN – Mika Lea Bates (257) CDS.019568-MD – Andre’ Baugh (258) CDS.039911-PA – Ashley Rougeou Ramsey (259) CDS.056209-MD – Glenn William Ray (260) CDS.056452-DVM – Jennifer Melissa Zamora (261) CDS.044311-DVM – Carlos A. Perez (262) CDS.032955-OD – Jennifer Floyd (263) CDS.055886-INT – Ravi Kiran Chilukuri (264) CDS.056490-DDS – Gordon Douglas Delcambre (265) CDS.013571-MD – Suzanne Crater-Craig (266) CDS.055314-MD – Peomia Chela Brown (267) CDS.052361-INT – Rachel Matheson Williams (268) CDS.050730-MD – Patricia Babette Manhire (269) CDS.055148-INT – Andrea Slaweika Ito (270) CDS.054511-MD – Louis McCall Schruff, Jr. (271) CDS.056046-APN – Matthew Ryan Ladouceur (272) CDS.045700-DVM – Erin Daniels Legarde (273) DME.001043 – Spectrum Healthcare, Inc. (274) CDS.025785-MD – Lolita Carmen Gonzales (275) CDS.046644-MD – Brandon Nicholas Michel (276) CDS.052878-DDS – Ernest B. Erian (277) CDS.016831-DDS – Andrew Wade Porter (278) CDS.053847-MD – Terrance Joseph Wickman (279) CDS.035617-MD – Duncan Frederick Hanby (280) CDS.049100-DVM – Adam Scott McMahan (281) CDS.021544-MD – Victoria Lynn Snider (282) CDS.035532-OD – Jeffrey S. Silbernagel (283) CDS.045779-OD – Patrick Steven Tate (284) CDS.038338-MD – Erin Farrell (285) CDS.023998-DDS – Sally Bowie Daly (286) CDS.030159-MD – Katherine Hester Smith (287) CDS.055958-MD – Ayodele R. Osasona (288) CDS.056504-INT – Muhammad Waqas Khan (289) CDS.049078-APN – Jennifer Anne Duncan (290) CDS.048440-DVM – Natalie Janae Cormier (291) CDS.047056-MD – Frederick Allen Bowers (292) CDS.049530-MD – Frank Tuin Wong Chin, Jr. (293) CDS.055892-INT – Nicholas Daniel Cappadona (294) CDS.021460-DDS – Peter Joseph Dorsey (295) CDS.055894-INT – Ayman Mohammad Alghamdi (296) CDS.055942-INT – Nicole Marie Fossas (297) CDS.053170-INT – Alexander Francis Picariello (298) CDS.055944-INT – Harsh Kanubhai Patel

NOTE: Pursuant to the Open Meetings Law at 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. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. NOTE: While it is possible members of the Board who are not members of this committee may attend this committee meeting in sufficient number to constitute a quorum of the Board, no action taken at this committee meeting may be construed as an action of the entire Board. (299) CDS.053015-INT – Harmanjot Singh Khaira (300) CDS.055890-INT – Mohammad Tanvir Sultan (301) CDS.055924-INT – Austin Wayne Tutor (302) CDS.055928-INT – Vanessa Sholeh Vakili (303) CDS.049056-DDS – Michelle Lee Zoccolillo (304) PST.013839 – Bridget Anne Octave (305) CDS.039876-MD – Eddye Gene Blossom, II (306) CDS.055917-MD – Thomas Nelson Hawken (307) CDS.045886-DVM – Bernard Brown Butler, III (308) CDS.050849-APN – Penny Cummins Montcalm (309) CDS.045697-DDS – Allyson Ayms Hanson (310) CDS.047433-PA – Kelly Celeste Mondello (311) CDS.042251-DVM – Sarah Elizabeth Lyles (312) CDS.042857-DVM – Sarah Elizabeth Lyles (313) CDS.036237-DVM – Andra Michelle Ponson (314) CDS.042119-DVM – Susan Talbert Bennett (315) CDS.052314-DDS – Syed Husain Asghar (316) CDS.044052-MD – Samuel Edward Sprehe (317) PHY.005528-NR – CVS Caremark

6. New Agenda Items Added During Meeting

7. Adjourn

NOTE: Pursuant to the Open Meetings Law at 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. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. NOTE: While it is possible members of the Board who are not members of this committee may attend this committee meeting in sufficient number to constitute a quorum of the Board, no action taken at this committee meeting may be construed as an action of the entire Board. Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Tripartite Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Regulation Revision Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Public Hearing Record

November 25, 2020

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Table of Contents

Notice of Intent 03

Hearing Agenda 06

Guest Register 07

Hearing Transcript 08

Summary of Comments & Testimony 57

Comment Letter 1 from Pharmaceutical Care Management Association 58

Audited Financial Statement—the financial statement and related disclosures prepared by an independent certified public accountant in accordance with United States Generally Accepted Accounting Principles (GAAP) of the specific entity or licensee intending to operate or operating in Louisiana. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1253. HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 46: NOTICE OF INTENT §3003. Pharmacy Benefit Manager Permit A. A pharmacy benefit manager, as defined at R.S. Department of Health 40:2863, shall obtain and maintain a pharmacy benefit Board of Pharmacy manager permit from the board prior to conducting business in Louisiana if it administers, develops, maintains, performs, Pharmacy Benefit Managers (LAC 46:LIII.Chapter 30) or provides one or more of the pharmacy services enumerated in R.S. 40:2868 in the state or that affects one or In accordance with the provisions of the Administrative more beneficiaries of a pharmacy benefit management plan, Procedure Act (R.S. 49:950 et seq.), the Pharmacy Benefit as defined at R.S. 40:2863, administered by the pharmacy Manager Licensing Law (R.S. 40:2861 et seq.), and the benefit manager. Pharmacy Practice Act (R.S. 37:1161 et seq.), the Louisiana B. A pharmacy benefit manager permit shall authorize Board of Pharmacy hereby gives notice of its intent to the permit holder to administer pharmacy benefit promulgate a new chapter of rules for pharmacy benefit management services. managers (PBMs). The new rule is intended to implement C. The board shall not issue a pharmacy benefit manager the provisions of Act 124 of the 2019 Legislature which permit to any person or other entity which has not yet requires the Board of Pharmacy to license and regulate registered with the Louisiana Secretary of State to conduct PBMs when they engage in one or more of the following business within the state. activities construed to be within the scope of the practice of D. A pharmacy benefit manager permit is not pharmacy: (1) adjudication of appeals or grievances related transferable from the original owner. The permit shall not be to prescription drug coverage. (2) disease management subject to sale, assignment or other transfer, voluntary or programs. (3) drug formularies. (4) drug regimen reviews. involuntary. Moreover, in the event the ownership of the (5) prescription drug management programs. (6) processing pharmacy benefit manager changes by 50 percent or more of prior authorization requests. (7) quality care dosing after the initial issuance of the permit, the ownership will be services. (8) step therapy procedures. (9) utilization deemed sufficiently different as to require a new pharmacy management and utilization reviews. (10) any other act, benefit manager permit. The continued operation of a service, operation, or transaction incidental to or forming a pharmacy benefit manager permit after its ownership has part of the compounding, filling, dispensing, exchanging, changed by 50 percent or more shall constitute sufficient giving, offering for sale, or selling drugs, medicines, basis for the board to issue a finding for the operation of a poisons, or devices in this state by pharmacists or pharmacy benefit manager without a valid permit, in pharmacies, pursuant to a prescription or an order of violation of R.S. 40:2865. physicians, dentists, veterinarians, or other licensed AUTHORITY NOTE: Promulgated in accordance with R.S. practitioners, requiring, involving, or employing the science 37:1253. or art of any branch of the pharmacy profession, study, or HISTORICAL NOTE: Promulgated by the Department of training. Section 3001 provides for definitions of certain Health, Board of Pharmacy, LR 46: terms. Section 3003 requires a PBM engaged in any of the §3005. Permitting Procedures activities enumerated within R.S. 40:2868 to obtain a PBM A. Application for Initial Issuance of Permit permit from the board, requires the PBM to register with the 1. The board shall develop an application form secretary of state, and provides that a PBM permit is not suitable for the pharmacy benefit manager permit. The board transferable from one owner to another. Section 3005 may revise that application form on its own initiative in provides the procedures for the board to follow with respect order to collect the information it deems necessary to to applications for the initial issuance of the permit, the properly evaluate an applicant. renewal of the permit, applications for the reinstatement of 2. The application shall include copies of the disciplined permits, as well as the permanent closure of a following documents: permit. a. governance documents, including articles of Title 46 incorporation, articles of association, partnership PROFESSIONAL AND OCCUPATIONAL agreements, trade name certificates, trust agreements, STANDARDS shareholder agreements, and all amendments to such Part LIII. Pharmacists documents; Chapter 30. Pharmacy Benefit Managers b. the applicant’s standard generic contract template §3001. Definitions which it uses for contracts entered into by the applicant and A. The following terms shall have the meaning ascribed pharmacies or pharmacy services administrative to them in this Section: organizations in this state in the administration of pharmacy benefits for healthcare insurers, providers, or payors;

Louisiana Register Vol. 46, No. 10 October 20, 2020 1438 c. an audited financial statement for the applicant’s 2. The notice required in this Subsection shall include previous fiscal year. an acknowledgement of the firm’s obligation to maintain 3. The board shall not process applications received copies of all records for all patients and pharmacies in by facsimile, or that are incomplete, or submitted with the Louisiana for a minimum of two years following the date of incorrect fee. closure and surrender of its permit, and further, the point of 4. Once received by the board, an application for the contact for all inquiries and requests for such records during permit shall expire one year thereafter. that two-year period of time. 5. In the event any information contained in the AUTHORITY NOTE: Promulgated in accordance with R.S. application or accompanying documents changes after being 37:1253. submitted to the board and before the issuance of the permit, HISTORICAL NOTE: Promulgated by the Department of the applicant shall immediately notify the board in writing Health, Board of Pharmacy, LR and provide corrected information. Family Impact Statement 6. The applicant may be required to personally appear In accordance with Section 953 of Title 49 of the before the board or any of its committees prior to any Louisiana Revised Statutes, there is hereby submitted a decision on the permit application. family impact statement on the Rule proposed for adoption, 7. Upon approval of the application, the board shall repeal, or amendment. The following statements will be issue the pharmacy benefit manager permit to the applicant. published in the Louisiana Register with the proposed B. Application for Renewal of Permit agency Rule. 1. All pharmacy benefit manager permits shall expire 1. The Effect on the Stability of the Family. The two years after the date of its initial issuance and the proposed Rule will have no effect on the stability of the renewals shall family. 2. The Effect on the Authority and Rights of Parents expire every two years thereafter on that anniversary date. Regarding the Education and Supervision of their Children. 2. The board shall not process applications received The proposed Rule will have no effect on the authority and by facsimile, or that are incomplete. rights of parents regarding the education and supervision of 3. In the event a pharmacy benefit manager does no their children. submit a properly completed renewal application to the 3. The Effect on the Functioning of the Family. The board prior to the expiration of the permit, the permit shall proposed Rule will have no effect on the functioning of the be rendered null and void. The continued operation of a family. pharmacy benefit manager with an expired permit shall 4. The Effect on Family Earnings and Family Budget. constitute sufficient basis for the board to issue a finding for The proposed Rule will have no effect on family earnings or the operation of a pharmacy benefit manager without a valid family budget. permit, in violation of R.S. 40:2865. 5. The Effect on the Behavior and Personal 4. A pharmacy benefit manager permit not renewed by Responsibility of Children. The proposed Rule will have no 30 days after the expiration date shall be automatically effect on the behavior and personal responsibility of terminated by the board. children. C. Application for Reinstatement of Terminated, 6. The Ability of the Family or a Local Government to Suspended, or Revoked Permit Perform the Function as Contained in the Proposed Rule. 1. The applicant shall complete the application form The proposed Rule will have no effect on the ability of the for this specific purpose supplied by the board. family or a local government to perform the activity as 2. Upon the receipt of a properly completed contained in the proposed Rule. application form, the board staff shall refer the application to Poverty Impact Statement the board’s In accordance with Section 973 of Title 49 of the reinstatement committee for its consideration and shall Louisiana Revised Statutes, there is hereby submitted a notify the applicant of the time and place for the committee poverty impact statement on the Rule proposed for adoption, meeting. repeal, or amendment. D. Maintenance of Permit 1. The Effect on Household Income, Assets, and 1. A pharmacy benefit manager permit shall be valid Financial Security. The proposed Rule will have no effect on for the entity to whom it is issued and shall not be subject to household income, assets, or financial security. sale, assignment or other transfer, voluntary or involuntary. 2. The Effect on Early Childhood Development and 2. Upon receipt of a written request and payment of Preschool through Postsecondary Education Development. the fee authorized in R.S. 37:1184, the board shall issue a The proposed Rule will have no effect on early childhood duplicate or development or preschool through postsecondary education replacement permit to the applicant; however, such development. duplicate or replacement permit shall not serve or be used as 3. The Effect on Employment and Workforce an additional or second permit. Development. The proposed Rule will have no effect on E. Permanent Closure of Permit employment or workforce development. 1. In the event the pharmacy benefit manager 4. The Effect on Taxes and Tax Credits. The proposed contemplates permanent closure of the pharmacy benefit Rule will have no effect on taxes or tax credits. manager business, the owner of the permit shall notify the 5. The Effect on Child and Dependent Care, Housing, board, in writing, 10 days prior to the anticipated date of Health Care, Nutrition, Transportation, and Utilities closure and surrender its permit. Assistance. The proposed Rule will have no effect on child

1439 Louisiana Register Vol. 46, No. 10 October 20, 2020 and dependent care, housing, health care, nutrition, views, or arguments, either orally or in writing. The deadline transportation, or utilities assistance. for the receipt of all comments is 12 p.m. noon that same Small Business Analysis day. To request reasonable accommodations for persons with In accordance with Section 965 of Title 49 of the disabilities, please call the board office at 225.925.6496. Louisiana Revised Statutes, there is hereby submitted a regulatory flexibility analysis on the Rule proposed for Malcolm J Broussard adoption, repeal, or amendment. This will certify the agency Executive Director has considered, without limitation, each of the following methods of reducing the impact of the proposed Rule on FISCAL AND ECONOMIC IMPACT STATEMENT small businesses: FOR ADMINISTRATIVE RULES 1. The Establishment of Less Stringent Compliance or RULE TITLE: Pharmacy Benefit Managers Reporting Requirements for Small Businesses. The proposed Rule contains no compliance or reporting requirements. I. ESTIMATED IMPLEMENTATION COSTS (SAVINGS) TO STATE OR LOCAL GOVERNMENT UNITS (Summary) 2. The Establishment of Less Stringent Schedules or The proposed will require the Louisiana Board of Deadlines for Compliance or Reporting Requirements for Pharmacy (LBP) to license and regulate any pharmacy benefit Small Businesses. The proposed Rule contains no schedules manager (PBM) operating within the state and engaging in one or deadlines for compliance or reporting requirements. or more of ten specifically identified activities construed to be 3. The Consolidation or Simplification of Compliance within the practice of pharmacy. or Reporting Requirements for Small Businesses. The The proposed rule will require LBP to publish the proposed proposed Rule contains no compliance or reporting and final rules in the state register, at a cost of $2,000 in FY 21. requirements. To operationalize the credentialing aspect of the rule, the Board 4. The Establishment of Performance Standards for will incur a fee of $500 per year to create and maintain the PBM permit in its licensure information system. There will be Small Businesses to Replace Design or Operational no additional expenditures or cost savings for other state or Standards Required in the Proposed Rule. There no design or local governmental units. operational standards in the proposed Rule. II. ESTIMATED EFFECT ON REVENUE COLLECTIONS OF STATE 5. The Exemption of Small Businesses from All or OR LOCAL GOVERNMENTAL UNITS (Summary) Any Part of the Requirements Contained in the Proposed The proposed rule will generate approximately $20,000 per Rule. There are no exemptions for small businesses. fiscal year for LBP from permit fees paid by pharmacy benefit Provider Impact Statement managers. The proposed rule will not affect revenue collections In accordance with House Concurrent Resolution No. 170 for other state or local governmental units. of the Regular Session of the 2014 Legislature, there is III. ESTIMATED COSTS AND/OR ECONOMIC BENEFITS TO DIRECTLY AFFECTED PERSONS, SMALL BUSINESSES, OR hereby submitted a provider impact statement on the Rule NONGOVERNMENTAL GROUPS (Summary) proposed for adoption, repeal, or amendment. This will The proposed rule will require a PBM operating within the certify the agency has considered, without limitation, the state to obtain and maintain a PBM permit from LBP at a cost following effects on the providers of services to individuals of $500 per year. with developmental disabilities: IV. ESTIMATED EFFECT ON COMPETITION AND EMPLOYMENT 1. The effect on the staffing level requirements or (Summary) qualifications required to provide the same level of service. The proposed rule will not affect competition or The proposed Rule will have no effect on the staffing level employment. requirements or the qualifications for that staff to provide the Malcolm J. Broussard Alan M. Boxberger same level of service. Executive Director Staff Director 2. The Total Direct and Indirect Effect on the Cost to 2010#034 Legislative Fiscal Office the Provider to Provide the Same Level of Service. The proposed Rule will have no effect on the cost to the provider to provide the same level of service. 3. The Overall Effect on the Ability of the Provider to Provide the Same Level of service. The proposed Rule will have no effect on the ability of the provider to provide the same level of service. Public Comments Interested persons may submit written comments, via United States Postal Service or other mail carrier, or in the alternative by personal delivery to Malcolm J Broussard, Executive Director, at the office of the Louisiana Board of Pharmacy, 3388 Brentwood Drive, Baton Rouge, LA 70809- 1700. He is responsible for responding to inquiries regarding the proposed Rule amendment. Public Hearing A public hearing to solicit comments and testimony on the proposed Rule is scheduled for 9 am on Wednesday, November 25, 2020. During the hearing, all interested persons will be afforded an opportunity to submit data,

Louisiana Register Vol. 46, No. 10 October 20, 2020 1440 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

NOTICE IS HEREBY GIVEN that a Public Hearing has been ordered and called for 9:00 a.m. on Wednesday, November 25, 2020 at the Embassy Suites Hotel, located at 4914 Constitution Avenue in Baton Rouge, Louisiana 70808, for the purpose to wit:

A G E N D A Revised 10-20-2020

1. Call to Order

2. Appearances

3. Solicitation of Comments on Regulatory Projects

A. Project 2020-4 ~ Pharmacy Benefit Managers

B. Project 2020-8 ~ Marijuana Recommendations

C. Project 2020-9 ~ Licensing for Military Families

4. Opportunity for Public Comment

5. Adjourn

NOTICE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. NOTICE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected].

In The Matter Of: STATE OF LOUISIANA PARISH OF EAST BATON ROUGE PARISH OF EAST BATON ROUGE

Public Hearing November 25, 2020

Associated Reporters, Inc. 2431 South Acadian Thruway Suite 550 Baton Rouge, La. 70808

Original File Pharmacy Bd Pub Hrg 11252020X.TXT Min-U-Script® with Word Index 1

1 STATE OF LOUISIANA

2 PARISH OF EAST BATON ROUGE

3 LOUISIANA BOARD OF PHARMACY

4

5

6

7 An Public Hearing was held by the

8 Louisiana Board of Pharmacy, on Wednesday,

9 November 25, 2020, at Embassy Suites Hotel,

10 Assembly Meeting Room, 4914 Constitution

11 Avenue, Baton Rouge, Louisiana 70808

12 beginning at 9:00 a.m.

13

14

15

16 BEFORE:

17 Susan Erkel

18 Certified Court Reporter

19 In and For the State of

20 Louisiana

21

22

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24

25 2

1 INDEX

2

3 CAPTION...... 1

4 INDEX...... 2

5 PROCEEDINGS...... 3

6 REPORTER'S PAGE...... 39

7 REPORTER'S CERTIFICATE ...... 40

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25 3

1 PROCEEDINGS

2 MR. BROUSSARD:

3 Good morning. Today is Wednesday,

4 November 25, 2020. My name is Malcolm

5 Broussard. The time is 9:00 a.m. We

6 are assembled in the Assembly Meeting

7 Room at the Embassy Suites Hotel located

8 at 4914 Constitution Avenue in Baton

9 Rouge Louisiana 70808.

10 Again, my name is Michael Broussard

11 and I serve the Louisiana Board of

12 Pharmacy as it's Executive Director. In

13 his absence, Board President Carl Aron

14 has requested that I moderate this

15 hearing. I now call this public hearing

16 to order. As a courtesy to everyone

17 else in the room, please take this time

18 to silence cell phones and other

19 electronic devices. Further, should you

20 find it necessary to take or make a

21 telephone call, please step outside the

22 meeting room to do so.

23 Before we take comments, I have a

24 prepared statement to read into the

25 record. For your safety, the emergency 4

1 exit path from this room is through the

2 door into the hallway and then out the

3 double doors to the parking lot in front

4 of the hotel. For your comfort,

5 restrooms are located just off the

6 hallway near the exit doors to the

7 parking lot.

8 This hearing is held in accordance

9 with the Administrative Procedure Act

10 and the Open Meetings Law. As required

11 by these laws, this hearing is convened

12 pursuant to public notice, and notice

13 has been properly posted. You will

14 notice the presence of a court reporter.

15 Please ensure you're verbal comments are

16 spoken loud enough for the reporter to

17 accurately record your comments. The

18 purpose for today's hearing is to

19 receive public comments and testimony on

20 the three regulatory projects listed on

21 the agenda for today's meeting which are

22 Project No. 2020-4 - Pharmacy Benefit

23 Managers; Project 2020-8 - Marijuana

24 Recommendations; and Project 2020-9 -

25 Licensing for Military Families. 5

1 The Board published it's Notices of

2 Intent for all of these projects in the

3 October 2020 edition of the Louisiana

4 Register. Further, the Board filed its

5 first report with the Joint Legislative

6 Oversight Committee on Health and

7 Welfare on October the 7th and then

8 distributed electronic Notices of

9 Rulemaking Activity to its electronic

10 list of interested parties and all of

11 its pharmacy program licensees that same

12 day.

13 As indicated in the Notices, the

14 Board has convened this public hearing

15 to receive comments and testimony on all

16 three of these regulatory projects. The

17 Board will consider the comments and

18 testimony offered today during their

19 next meeting now set for February 24,

20 2021 to determine whether any revisions

21 to the original proposed rules are

22 necessary. We will reply to your

23 comments as soon as possible thereafter.

24 Prior to making any comments today we

25 ask that you sign the guest register for 6

1 this event.

2 Copies of today's agenda and the

3 Notices are available at the

4 registration desk. The proposed rules

5 are also available in the Public Library

6 section of the Board's website at triple

7 w.pharmacy.la.gov as well as the website

8 of the Louisiana Register.

9 While we may answer questions today

10 to clarify language and interpretation,

11 it is not our intent to debate any

12 issues today. Again, the purpose of

13 this hearing is to receive your comments

14 and testimony for the Board's

15 consideration. As indicated in the

16 notices, the deadline for all comments

17 and testimony on these proposed rules is

18 12:00 noon today.

19 We are now prepared to receive your

20 comments and testimony. And as you

21 begin your comments, we ask that you

22 identify yourself and any organization

23 you may represent. Please identify

24 which regulatory topic for which you are

25 submitting comments and testimony. And 7

1 for the record, we have received one

2 comment from Pharmaceutical Care

3 Management Association. The acronym is

4 PCMA. We received those comments buy e-

5 mail last night and we now acknowledge

6 receipt of the hard copy hand-delivered

7 earlier today.

8 Who's first?

9 MR. RIEGER:

10 Mr. Broussard, I'm Rob Rieger with

11 Adams and Reese. We represent the

12 Pharmaceutical Care Management

13 Association. If it's appropriate, we

14 would like to go ahead. We'll comment

15 on Regulatory Project 2020-4 - Pharmacy

16 Benefit Managers.

17 MR. BROUSSARD:

18 Please, go ahead.

19 MR. RIEGER:

20 Thank you very much. As you noted,

21 Mr. Broussard, PCMA has filed comments

22 to this rulemaking, fairly detailed. We

23 also attached filings that we had

24 previously made with concerns over the

25 regulation of PBM's by market 8

1 competitors. That has been the topic of

2 Carolina Dental Board versus Hall and

3 other trade related matters. I do not

4 intend to talk about that at all during

5 this hearing. Just we have filed our

6 materials and our arguments previously

7 to point out our concerns. We'd just

8 like to have them made a part of the

9 record.

10 But what I would like to talk about

11 are a number of issues that we have with

12 the rules as drafted. Again, my name is

13 Rob Rieger. I practice law at Adams and

14 Reese and proudly represent the

15 Pharmaceutical Care Management

16 Association. As we learned in 2018 when

17 this Board went through a similar

18 rulemaking exercise that ultimately led

19 to the passage of Act 124 of 2019 upon

20 which this rulemaking is founded, the

21 Board has to have certain statutory

22 authority to be able to regulate certain

23 aspects that are not directly flowing

24 from its legislative grants of authority

25 and we are concerned that several 9

1 elements that are in this current

2 rulemaking do not flow from Act 124 of

3 2019.

4 If we're going to back to '18, you'll

5 remember that the Senate Health and

6 Welfare Committee and the Joint Health

7 and Welfare Rulemaking Oversight

8 Committee voted to find that the

9 commission -- I'm sorry, that the Board

10 did not have statutory authority to

11 regulate in this area. We appeared. We

12 made argument saying that, you know, the

13 legislature can certainly give the

14 ability to regulate Pharmacy Benefit

15 Managers to this Board, but at that time

16 had not done so.

17 We also said that any regulatory

18 investiture or legislative investiture

19 or regulatory authority in this Board

20 has to be construed according by what

21 the legislature has done because folks

22 may pursue any sort of activity unless

23 they're regulatory constraints properly

24 placed on them by the legislature or in

25 this case, potentially by a regulatory 10

1 body that has some oversight over that

2 particular industry.

3 Here, the two things that we have a

4 or the main two things we have a problem

5 with are the requirements in Proposed

6 Rule Section 3005. I think it's one or

7 A(2)(c) and (b) which require audited

8 financial statements and copies of

9 templates of PBMs contract with

10 pharmacies, PSAOs and other entities

11 described. Neither one of those

12 requirements stems from any statutory

13 authorization that is in Act 124 and we

14 do not think it is reasonably implied by

15 Act 124 as well.

16 Because of that, we think those two

17 provisions on their face are

18 constitutionally and legally

19 insufficient or deficient to be able to

20 be adopted by this Board and be properly

21 enforced. We cited in our comments a

22 few cases, mainly Louisiana Supreme

23 Court cases and cases out of the

24 Louisiana First Circuit Court of Appeal

25 that would have jurisdiction over any 11

1 activity by this Board -- appellate

2 review of any activity by this board

3 that say essentially hornbook law that

4 administrative agencies and regulatory

5 bodies are limited by the legislative

6 investiture of authority.

7 As I pointed out, there is no

8 specific legislative investiture of

9 authority for either requiring audited

10 financial statements or template

11 contracts. Both of those each has their

12 own potential problem. Now if the

13 legislature had said you have to do

14 that, either one of those, we probably

15 wouldn't be having this argument. But

16 the legislature did not so hold. In all

17 the various negotiations and all the

18 various interplays in the legislative

19 process that led to Act 124, neither one

20 of those things was mentioned, nor was

21 either one the subject of any amendment

22 or was it found in the original bill or

23 in any piece of the legislation

24 throughout the process.

25 So we say that although the 12

1 legislature could have included those

2 requirements in that Act, it did not do

3 so and because it did not do so, this

4 Board is powerless to extend its

5 requirement as a condition of licensure

6 to adopt those two or compel those two

7 requirements.

8 We note that in other states that

9 have it, at least our informal research

10 is that in other states that have those

11 two requirements, they appear to be

12 statutorily based. The one possible

13 exception is the State of Mississippi.

14 I can make an argument that both of

15 those requirements of audited financials

16 and contracts with templates, you know,

17 are reasonably implied from there, but

18 Mississippi has one very big exception

19 that we do not have in these proposed

20 rules and that has to do with even if

21 you file those things, Mississippi's

22 regulations govern PBM licensure have a

23 very clear and very explicit exception

24 with regard to filing and protection of

25 confidential and propriety information. 13

1 For private companies, audited

2 financial statements are for the use of

3 its owners. You know we're not talking

4 about publicly traded entities. We're

5 not talking about anything that has

6 public requirements with the SEC or

7 other things. And there are a number

8 PBM/PCMA members that are privately held

9 such that they're financials are

10 confidential and proprietary to them.

11 They include confidential trade secret

12 information that are very, very

13 important with how they do what they do

14 and the decisions that they make.

15 As we know, Louisiana's Public

16 Records Act is one of the most liberal

17 and one of the most broad reaching in

18 the United States and that there are

19 very few protections for information

20 that would be potentially classified as

21 confidential and proprietary. And this

22 Board has not chosen to, like

23 Mississippi did, include something that

24 would at least give a filer some modicum

25 of protection that it's confidential and 14

1 propriety information would be kept

2 secret from the public at large, let

3 alone from a regulatory authority that

4 is made up of marketing competitors of

5 our PBM, potential licensees, and

6 applicants.

7 So we think those two provisions are

8 highly problematic and we strongly

9 suggest that the Board take them out.

10 And I again, I'm referring to in Section

11 3005, Permitting Procedures, Section

12 A(2). We would eliminate sections 2(b)

13 and 2(c). There are three other

14 provisions that are also problematic

15 although not quite to the scope and

16 scale as those two.

17 We suggest that the Board craft an

18 application form and put the form into

19 the rules themselves that way everybody

20 knows exactly what is required. You can

21 put it up. You'd have it adopted. It

22 would go through this proceeding. If

23 you don't have that, especially for

24 mature industries like pharmacy benefit

25 managers who been around for years and 15

1 are now just for the first time in

2 Louisiana being regulated by this Board

3 putting through formalized forms as it

4 were through the rulemaking process,

5 let's everybody know where they stand

6 and goes through the oversight breath of

7 fresh air and everything else that goes

8 with that.

9 We think that the public would be

10 well served by having everybody know

11 what the rules are and what the form

12 looks like on the way through. A second

13 thing that we have that's problematic is

14 that there's not any sort of affirmative

15 piece in the rules that say, that notify

16 an applicant, number one, that their

17 application is complete. And number

18 two, the Board is not compelled to do

19 something to approve, reject or do

20 whatever within a certain period of

21 time.

22 We are familiar that there are

23 provisions in other parts of the

24 Pharmacy Practice Act that we submit

25 possibly could be borrowed for something 16

1 like that that would give applicants the

2 assurance that they would be notified

3 that their application is complete and

4 ready for consideration in that regard.

5 That's one thing.

6 And two, once it's done, once it is

7 complete, the application would be acted

8 on within a certain period of time. I

9 know the Pharmacy Practice Act and

10 another piece has a 14-day requirement I

11 believe. We recommend 30 in our rule

12 comments, but we certainly would take a

13 lesser period of time which we think

14 serves the public interest. Again,

15 because this is a mature industry and

16 you don't want to do anything that is

17 going to upset or interrupt the ability

18 for folks to continue to get their drugs

19 and their medications.

20 There is also a problematic provision

21 in 3005, Section A(5) which compels the

22 applicant to notify the Board of any

23 changes or "information contained in the

24 application or accompanying documents."

25 We suggest that you insert the modifier 17

1 material before changes. For instance,

2 if a director on a board has changed, we

3 don't think that would necessarily be

4 material. If our regulatory template or

5 contract, not that we have one per se,

6 because all of our contracts, as best I

7 can tell from our members, you know, are

8 customized for the particular customer

9 or the relationship that the PBM has.

10 Those things may change over time and

11 it's difficult for a requirement that

12 calls for a template to say that this is

13 the template, it's going to be the

14 change, it's got to the be the same

15 throughout. These are not documents

16 that are static and they stay the same

17 way for years and years and years.

18 This is a continuously evolving

19 industry and these relationships are

20 extraordinarily complex and they change

21 as different considerations come up.

22 It's very dynamic especially when you

23 look in the large group benefit like

24 State Employee Group Benefits or

25 Municipal Group Benefit program or other 18

1 contractual relationships that PBMs

2 have. All of these things change.

3 That would be something that would be

4 very helpful for the applicants and

5 streamline the application process.

6 Again, just any changes to the

7 application that would be deemed

8 material because if you look at any

9 changes that is so broad, we think that

10 is just a trap for the unwary in that

11 the Board, not that it would do that,

12 but if the Board said, well, it doesn't

13 look like you have the most recent or

14 current templates or financials or

15 statement of officers or Articles of

16 Incorporation or Bylaws, all of those

17 things. We think as long as it's not a

18 material change, it's going to have

19 something to do with the application or

20 change the consideration of the Board,

21 that that sort of requirement is just

22 too broad.

23 We understand why it's there, but we

24 think it's just too much. Another thing

25 that we have as a concern also in 3005 19

1 here in Section A(4) that talks about an

2 application may expire after one year.

3 We're not really understanding why

4 that's there other than if you've got

5 someone that filed an application and it

6 would be somewhat dormant. Again, this

7 goes back to our concerns that we

8 previously articulated about they're not

9 being time period for the Board to act.

10 If the Board were to adopt some sort

11 of mandatory, it must act within 14-

12 days, the concern over the one year

13 period for us were attenuated,

14 essentially would go away. But we don't

15 understand why that is there and what

16 good it serves the public.

17 Okay, Mr. Broussard, let me have one

18 minute to consult with my client.

19 Okay, Mr. Broussard. Again, PCMA

20 appreciates the opportunity to present

21 these comments and talk a little bit

22 about what the filings we have our

23 concerns about the Board exceeding its

24 statutory authority with regard to these

25 two elements and some of the other 20

1 looseness that we perceive the rules to

2 be. We think they're just a few minor

3 tweaks that can be done that would put

4 these things into a condition that our

5 clients could come into compliance with

6 quickly and so we don't interrupt the

7 provision of services to millions of

8 Louisiana citizens.

9 We would appreciate responses to our

10 concerns and the couple of questions

11 that we have in there and I know we will

12 expect it forthwith. I did have a

13 question for you. Is there -- you said

14 the Board will meet in February to

15 consider any adoption -- consider the

16 rule potential amendments and so forth.

17 Will the response to questions come

18 after that or will it be prior to that?

19 I was just a little confused on that.

20 MR. BROUSSARD:

21 And the normal process for the Board

22 to consider comments and testimony, the

23 staff would not reply to a commentator

24 prior to the Board's consideration

25 because it could only issue a staff 21

1 interpretation. That's not appropriate.

2 So staff wait for the Board to consider

3 the comments and testimony and determine

4 whether any revisions are necessary.

5 If they determine no revisions are

6 necessary, then we reply thank you for

7 the comment. We'll determine no

8 revisions are necessary.

9 MR. RIEGER:

10 Right.

11 MR. BROUSSARD:

12 If they determine revisions are

13 necessary, depending upon how

14 significant the revisions are, if

15 they're minor, technical, they may make

16 those changes -- well, they make that

17 determination right then and there and

18 we reply. If they believe the proposed

19 revision needs consideration, they

20 typically refer that back to the

21 Regulation Revision Committee, let them

22 configure what the proposed revision is,

23 come back to the Board with the proposed

24 revision. If th Board approves that,

25 then we have to have another public 22

1 hearing on any changes to the proposed

2 rule.

3 So if there's changes, we typically

4 make the responses after all the

5 potential for changes have been made.

6 So if we have another public hearing to

7 consider comments and testimony on the

8 proposed changes, the Board says, that's

9 good, then we'll change it. Send that

10 to the Oversight Committee. Before I do

11 that, I file replies to all the

12 commentators, this is -- we received

13 your comments. The Board considered it.

14 They either made no changes or they made

15 the following changes. We send you that

16 because we're going to include your

17 comment and the changes and the replies

18 and our comprehensive report to the

19 Oversight Committee.

20 MR. RIEGER:

21 Yes, sir. So I think I understand

22 but let me make sure. So let's say for

23 purposes of argument that the Board were

24 to agree the PCMA suggestions might be

25 good with regard to the financial 23

1 statement. So they could adopt those

2 changes at the February 24th, '21 Board

3 meeting and that could potentially end

4 the process or would you call another

5 public hearing to consider the rule?

6 MR. BROUSSARD:

7 If you do any revision, we must hold

8 a second public hearing.

9 MR. RIEGER:

10 Okay. That's fine. No matter how

11 slight, if there are any revisions it

12 has to go through the --

13 MR. BROUSSARD:

14 That's a state policy. It's done as

15 a Notice of Intent with what they call a

16 Potpourri.

17 MR. RIEGER:

18 Potpourri. Well very good. With

19 those responses to my questions, I'll

20 bring my comments to a close. Should

21 you have any questions, I'm prepared to

22 respond to them.

23 MR. BROUSSARD:

24 Thank you. I do have a couple.

25 MR. RIEGER: 24

1 Yes, sir.

2 MR. BROUSSARD:

3 I wanted to make sure I understood

4 clearly on 3005.A.5, the concern in that

5 any information contained changes after

6 being submitted.

7 MR. RIEGER:

8 Yes, sir.

9 MR. BROUSSARD:

10 As I recorded, you're suggesting that

11 it be changed to say "any material" --

12 I'm sorry.

13 MR. RIEGER:

14 Yeah, material change. Yes.

15 MR. BROUSSARD:

16 Any material changes?

17 MR. RIEGER:

18 To the offer of the documents. Yes,

19 sir.

20 MR. BROUSSARD:

21 All right. How do we define

22 "material"?

23 MR. RIEGER:

24 Well, material is something that

25 would -- 25

1 MR. BROUSSARD:

2 I guess my point is, if we put that

3 word in there, are we not subjecting

4 then to further inquiring and

5 interpretation? If the Board wants to

6 go there, that's going to be well, how

7 do we define material?

8 MR. RIEGER:

9 So material would mean something that

10 of the Board did not know it or did know

11 it, it would change the Board's

12 consideration eligibility of an

13 applicant. That's the way I would look

14 at it. For instance, let's go to the

15 example I used with the template. Like

16 I said, templates are dynamic things.

17 Contracts are dynamic things and it's

18 very difficult to get a template that is

19 going to be the template, you know,

20 during the pendency of an application

21 period.

22 The way I understand it, these things

23 would change or vary, as I use the word

24 "dynamic". That they're not static and

25 there would be appropriate for any one 26

1 moment in time. But if you go and you

2 change a clause or you go and change a

3 word, you go and change something down

4 the line, it is not the most current

5 thing that the company has.

6 Now if you tell the company, you

7 know, that at the time that you're

8 submitting the application it is the

9 most current and it's the one you're

10 using at that snapshot in time, that

11 might work. Otherwise, you need a

12 materiality clause because folks are

13 going to worry if they change, you know,

14 a definite pronoun to an indefinite

15 pronoun and stuff like that. And that's

16 going to cast doubt on whether an

17 application is ever complete. And if

18 it's never complete, you guys can't act

19 on it. That's the concern that our

20 clients have and our members have.

21 And I understand yours, you know,

22 what is "material", like I said.

23 MR. BROUSSARD:

24 What we don't know is how can we make

25 a determination of whether or not it was 27

1 material?

2 MR. RIEGER:

3 Well, you know, you all have to tell

4 us what is material going in. You know

5 material change might be a huge

6 financial loss. If you're going to go

7 down that piece of it which I suggest

8 you don't, but that or something else

9 that may not be in the application. A

10 change of corporate name I would agree

11 is a material change, right, that we

12 need to let you know and if you change

13 your registration with the Secretary of

14 State, that's a material change or if

15 your Secretary of State registration

16 gets revoked for whatever reason or it's

17 not in full effect, that's a material

18 change. All the things that are --

19 MR. BROUSSARD:

20 And I agree with that and I guess I'm

21 just trying to carry through. If we

22 make that change to say a material

23 change, publish the rule, we the receive

24 an application and then we learn later

25 after we issue the permit there had been 28

1 a change, then if we would have known

2 might have changed the consideration of

3 the application.

4 But then I think there might be room

5 for challenge on whether it was

6 material. So that's going to be

7 something they have to consider how

8 tight they want to nail that down.

9 MR. RIEGER:

10 I agree. But one of the things, for

11 purposes of materiality, the easy way to

12 look at it I think is those things that

13 are in Act 124 that you're required to

14 have, I would say that each one of those

15 elements is material. That's the way I

16 would go. That's a pretty straight

17 bright line.

18 MR. BROUSSARD:

19 It is.

20 MR. RIEGER:

21 If you do it that way your good. And

22 again, you don't get into materiality,

23 you know, or issues of materiality if

24 you take out the template question. You

25 take all that out, you take it to the 29

1 side, we don't need to worry about what

2 is the most current template that we

3 have and how that shifts over time.

4 That would be an administrative

5 convenience thing for the Board because

6 we'd only come forward and say, this is

7 everything. It's exactly the way we say

8 it is. Please, you know we filed

9 everything. We said, yes, checked the

10 box, it's all there. Please give us our

11 license.

12 That would make it a lot easier for

13 the Board. I suggest that the audit

14 financials and the templates, you know,

15 are really the persnickety elements here

16 that are not statutorily required.

17 MR. BROUSSARD:

18 Thank you for that. I have one

19 other.

20 MR. RIEGER:

21 Yes, sir.

22 MR. BROUSSARD:

23 You questioned the expiration date of

24 an application. And in other licensing

25 activities the Board frequently 30

1 encounters what we call abandoned

2 applications.

3 MR. RIEGER:

4 Yes, sir.

5 MR. BROUSSARD:

6 We received it. They are incomplete.

7 We request additional information, but

8 we never hear back?

9 MR. RIEGER:

10 Uh-huh.

11 MR. BROUSSARD:

12 So we have a standard in our

13 licensing rules that applications expire

14 one year after date of their receipt and

15 all fees attached thereto are forfeited

16 at that time.

17 MR. RIEGER:

18 Uh-huh.

19 MR. BROUSSARD:

20 The forfeiture of fees, but that's

21 the reason for the expiration date with

22 the application, in the event it is

23 abandoned we don't have to keep it open.

24 MR. RIEGER:

25 I understand and I got that and 31

1 completely agree with it. Hence, using

2 the word "incomplete", right. If you

3 put the word incomplete in the Rule, it

4 accomplishes exactly what you're looking

5 for which is an absolutely sound

6 administrative principal. But it tells

7 us on our side, if you put incomplete --

8 once you tell us it's complete, we got

9 nothing to worry about. And that's

10 where I was saying our other suggested

11 changes all mesh together to make it a

12 cleaner process such that if our clients

13 and members present you with a clean

14 application, y'all can move quickly and

15 that's the goal for all of us. Make it

16 as quick and easy as possible.

17 MR. BROUSSARD:

18 Thank you.

19 MR. RIEGER:

20 Thank you very much. Happy

21 Thanksgiving to you.

22 MR. BROUSSARD:

23 Thanks. You too. Who's next?

24 Just so you know, we're here til

25 12:00 noon. I'm obliged to sit here. 32

1 If you have that much free time, God

2 bless you.

3 MR. PREVOT:

4 Well, I guess, Malcolm, I can come up

5 and talk for a moment. Do you need me

6 to state my name or anything like that?

7 MR. BROUSSARD:

8 For the record, please.

9 MR. PREVOT:

10 Sure. Peter Prevot, Louisiana

11 Association for Therapeutic

12 Alternatives. And so we submitted

13 several pages or written comments

14 related to this regulatory project back

15 in July. And we discussed them in depth

16 at the emergency meeting that happened

17 in July and so I really just wanted to

18 come in to reiterate that we've been

19 operating under the emergency rule using

20 basically these same regs since that

21 time throughout the pharmacies.

22 Just wanted to kind of reiterate that

23 those comments we made at that time

24 still stand and that, you know, we

25 believe that the rules are solid and 33

1 have led to --

2 MR. BROUSSARD:

3 Just so you know, those comments that

4 you made at that time were not made

5 pursuant to the publication of the

6 Notice of Intent.

7 MR. PREVOT:

8 Okay.

9 MR. BROUSSARD:

10 So they are not considered part of

11 this hearing record.

12 MR. PREVOT:

13 Okay.

14 MR. BROUSSARD:

15 So if you would like to resubmit

16 those --

17 MR. PREVOT:

18 They're all reflected in the draft.

19 The comments we made at that time have

20 now been reflected into this draft. So

21 actually I guess I don't need to make

22 them again.

23 MR. BROUSSARD:

24 If you're satisfied with the rule, a

25 comment to that effect would be 34

1 appropriate, but I'm just saying if you

2 made verbal or written comments at that

3 time, they were received and considered

4 by the Board --

5 MR. PREVOT:

6 Got it. So it's a separate issue.

7 MR. BROUSSARD:

8 -- prior to the publication of the

9 Notice of Intent on October the 20th.

10 So I can only consider from October

11 20th, 12:00 noon today.

12 MR. PREVOT:

13 Okay. I understand. So, yeah, I

14 guess the comment that I would make is

15 that the pharmacies in Atlanta are happy

16 with the rules as they exist and we

17 think you did a great job.

18 MR. BROUSSARD:

19 Thank you.

20 MR. PREVOT:

21 Thank you.

22 MR. IRVING:

23 Jacob Irving with Ilera Holistic

24 Healthcare. Mr. Broussard, I just

25 wanted to reiterate what Peter just 35

1 said. I mean we've kind of been

2 operating under these rules already. I

3 mean as you know, it's kind of a

4 statutory change that led to an

5 emergency rule and so these rules have

6 practically been in effect for awhile.

7 We've had a good experience with them

8 and I would just mainly -- my only

9 comment would be the value of

10 consistency in this new industry would

11 be appreciated. So just the rules as

12 they are would be perfectly fine with

13 us. Thank you.

14 MR. BROUSSARD:

15 Thank you.

16 MR. PREVOT:

17 And Malcolm, just to be clear, if

18 someone came in before noon and made

19 more comments that would then lead to an

20 additional discussion but not today, in

21 the future?

22 MR. BROUSSARD:

23 If we receive any more comments, the

24 Board will consider those comments at

25 their meeting in February. 36

1 MR. PREVOT:

2 I guess we receive notice ahead of

3 time if that was going to be an

4 additional discussion?

5 MR. BROUSSARD:

6 Yes. On our Board Meeting Agenda, it

7 would say consider -- and it does. It

8 says consideration of comments and

9 testimony from November 25, 2020 public

10 hearing.

11 MR. PREVOT:

12 Got it. Okay.

13 MR. BROUSSARD:

14 So that let's people know they're

15 going to consider whatever we received

16 since October 20th to today, through

17 12:00 noon today and what we hear until

18 12:00 noon today.

19 What I'm interpreting is what if

20 someone else says something, you want to

21 know what they say, right?

22 MR. PREVOT:

23 Yes.

24 MR. BROUSSARD:

25 If anybody says anything, we'll bring 37

1 that and that'll be a part of the

2 comments and testimony that they

3 consider.

4 MR. PREVOT:

5 And that'll be published?

6 MR. BROUSSARD:

7 It'll show up -- if you're familiar

8 with our Public Meeting binder.

9 MR. PREVOT:

10 Yes.

11 MR. BROUSSARD:

12 Yes, because I have to put all that

13 material for the Board's consideration

14 in the Public Meeting Binder and the

15 agenda will say, "Consideration of

16 comments and testimony from Public

17 Hearing", and you'll see that it's

18 usually posted the day before the Board

19 meeting.

20 MR. PREVOT:

21 Perfect. All right. Thank you.

22 MR. BROUSSARD:

23 You're welcome.

24 MR. PREVOT:

25 Happy Thanksgiving. 38

1 MR. BROUSSARD:

2 Thanks. You too.

3 The time is 9:36. There's no one

4 else left in the room besides the

5 reported and myself. We will recess

6 this hearing.

7 (The meeting was recessed.)

8 MR. BROUSSARD:

9 The time is 10:30. I'm now

10 convening the hearing back into session.

11 We are still in an empty room. No one

12 is here to make a comment. No one has

13 indicated they would be coming and no

14 one is in the hallway into the room.

15 This hearing is adjourned at 10:30.

16

17 (THE HEARING ADJOURNED AT 10:30 A.M.)

18

19

20

21

22

23

24

25 39

1 REPORTER'S PAGE

2

3 I, SUSAN ERKEL, Certified Court Reporter in

4 and for the State of Louisiana, before whom this

5 hearing was taken, do hereby state on the Record:

6 That due to the interaction in the

7 spontaneous discourse of this proceeding, dashes

8 (--) have been used to indicate pauses, changes

9 in thought, and/or talkovers;

10 That same is the proper method for a Court

11 Reporter's transcription of proceedings, and that

12 the dashes (--) do not indicate that words or

13 phrases have been left out of this transcript;

14 That any words and/or names which could not

15 be verified through reference material have been

16 denoted with the phrase "(spelled phonetically)."

17

18

19 ______

20 SUSAN ERKEL

21 CERTIFIED COURT REPORTER

22 LICENSE NO. 24005

23

24

25 40

1 CERTIFICATE

2 This certification is valid only for a

3 transcript accompanied by my original signature

4 and official seal on this page.

5 I, SUSAN ERKEL, Certified Court Reporter, in

6 and for the State of Louisiana, as the officer

7 before whom this hearing was taken, do hereby

8 certify that the foregoing 38 pages were reported

9 by me in the voice-writing method, and was

10 prepared and transcribed by me or under my

11 personal direction and supervision, and is a true

12 and correct transcript to the best of my ability

13 and understanding;

14 That the transcript has been prepared in

15 compliance with transcript format guidelines

16 required by statute or by rules of the board, and

17 that I am informed about the complete

18 arrangement, financial or otherwise, with the

19 person or entity making arrangements for

20 deposition services;

21 That I have acted in compliance with the

22 prohibition on contractual relationships, as

23 defined by Louisiana Code of Civil Procedure

24 Article 1434 and in rules and advisory opinions

25 of the board; 41

1 That I have no actual knowledge of any

2 prohibited employment or contractual

3 relationship, direct or indirect, between a court

4 reporting firm and any party litigant in this

5 matter nor is there any such relationship between

6 myself and a party litigant in this matter; and

7 That I am not related to counsel or to the

8 parties herein, nor am I otherwise interested in

9 the outcome of this matter.

10

11

12 ______

13 SUSAN ERKEL

14 CERTIFIED COURT REPORTER

15 LICENSE NO. 24005

16

17

18

19

20

21

22

23

24

25

STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing PARISH OF EAST BATON ROUGE November 25, 2020

15:14 9:11 4:22;7:16;9:14; Bylaws (1) A Again (10) argument (4) 14:24;17:23,25 18:16 3:10;6:12;8:12; 9:12;11:15;12:14; Benefits (1) A2 (1) 14:10;16:14;18:6; 22:23 17:24 C 14:12 19:6,19;28:22;33:22 arguments (1) besides (1) A2c (1) agencies (1) 8:6 38:4 call (5) 10:7 11:4 Aron (1) best (1) 3:15,21;23:4,15; A4 (1) agenda (4) 3:13 17:6 30:1 19:1 4:21;6:2;36:6; around (1) big (1) calls (1) A5 (1) 37:15 14:25 12:18 17:12 16:21 agree (5) Articles (1) bill (1) came (1) abandoned (2) 22:24;27:10,20; 18:15 11:22 35:18 30:1,23 28:10;31:1 articulated (1) binder (2) can (9) ability (2) ahead (3) 19:8 37:8,14 9:13;12:14;14:20; 9:14;16:17 7:14,18;36:2 aspects (1) bit (1) 17:7;20:3;26:24; able (2) air (1) 8:23 19:21 31:14;32:4;34:10 8:22;10:19 15:7 assembled (1) bless (1) Care (3) absence (1) alone (1) 3:6 32:2 7:2,12;8:15 3:13 14:3 Assembly (1) Board (47) Carl (1) absolutely (1) Alternatives (1) 3:6 3:11,13;5:1,4,14, 3:13 31:5 32:12 Association (4) 17;8:2,17,21;9:9,15, Carolina (1) accompanying (1) although (2) 7:3,13;8:16;32:11 19;10:20;11:1,2;12:4; 8:2 16:24 11:25;14:15 assurance (1) 13:22;14:9,17;15:2, carry (1) accomplishes (1) amendment (1) 16:2 18;16:22;17:2;18:11, 27:21 31:4 11:21 Atlanta (1) 12,20;19:9,10,23; case (1) accordance (1) amendments (1) 34:15 20:14,21;21:2,23,24; 9:25 4:8 20:16 attached (2) 22:8,13,23;23:2;25:5, cases (3) according (1) and/or (2) 7:23;30:15 10;29:5,13,25;34:4; 10:22,23,23 9:20 39:9,14 attenuated (1) 35:24;36:6;37:18 cast (1) accurately (1) Appeal (1) 19:13 Board's (5) 26:16 4:17 10:24 audit (1) 6:6,14;20:24;25:11; cell (1) acknowledge (1) appear (1) 29:13 37:13 3:18 7:5 12:11 audited (4) bodies (1) certain (4) acronym (1) appeared (1) 10:7;11:9;12:15; 11:5 8:21,22;15:20;16:8 7:3 9:11 13:1 body (1) certainly (2) Act (14) appellate (1) authority (8) 10:1 9:13;16:12 4:9;8:19;9:2;10:13, 11:1 8:22,24;9:10,19; borrowed (1) Certified (2) 15;11:19;12:2;13:16; applicant (3) 11:6,9;14:3;19:24 15:25 39:3,21 15:24;16:9;19:9,11; 15:16;16:22;25:13 authorization (1) Both (2) challenge (1) 26:18;28:13 applicants (3) 10:13 11:11;12:14 28:5 acted (1) 14:6;16:1;18:4 available (2) box (1) change (24) 16:7 application (19) 6:3,5 29:10 17:10,14,20;18:2, activities (1) 14:18;15:17;16:3,7, Avenue (1) breath (1) 18,20;22:9;24:14; 29:25 24;18:5,7,19;19:2,5; 3:8 15:6 25:11,23;26:2,2,3,13; Activity (4) 25:20;26:8,17;27:9, away (1) bright (1) 27:5,10,11,12,14,18, 5:9;9:22;11:1,2 24;28:3;29:24;30:22; 19:14 28:17 22,23;28:1;35:4 actually (1) 31:14 awhile (1) bring (2) changed (3) 33:21 applications (2) 35:6 23:20;36:25 17:2;24:11;28:2 Adams (2) 30:2,13 broad (3) changes (17) 7:11;8:13 appreciate (1) B 13:17;18:9,22 16:23;17:1;18:6,9; additional (3) 20:9 BROUSSARD (46) 21:16;22:1,3,5,8,14, 30:7;35:20;36:4 appreciated (1) back (7) 3:2,5,10;7:10,17, 15,17;23:2;24:5,16; adjourned (2) 35:11 9:4;19:7;21:20,23; 21;19:17,19;20:20; 31:11;39:8 38:15,17 appreciates (1) 30:8;32:14;38:10 21:11;23:6,13,23; checked (1) Administrative (4) 19:20 based (1) 24:2,9,15,20;25:1; 29:9 4:9;11:4;29:4;31:6 appropriate (4) 12:12 26:23;27:19;28:18; chosen (1) adopt (3) 7:13;21:1;25:25; basically (1) 29:17,22;30:5,11,19; 13:22 12:6;19:10;23:1 34:1 32:20 31:17,22;32:7;33:2,9, Circuit (1) adopted (2) approve (1) Baton (1) 14,23;34:7,18,24; 10:24 10:20;14:21 15:19 3:8 35:14,22;36:5,13,24; cited (1) adoption (1) approves (1) begin (1) 37:6,11,22;38:1,8 10:21 20:15 21:24 6:21 buy (1) citizens (1) affirmative (1) area (1) Benefit (6) 7:4 20:8

Min-U-Script® Associated Reporters, Inc. (1) A2 - citizens 225 216 2036 STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing PARISH OF EAST BATON ROUGE November 25, 2020 clarify (1) complex (1) convenience (1) detailed (1) 28:11;31:16 6:10 17:20 29:5 7:22 edition (1) classified (1) compliance (1) convening (1) determination (2) 5:3 13:20 20:5 38:10 21:17;26:25 effect (3) clause (2) comprehensive (1) Copies (2) determine (5) 27:17;33:25;35:6 26:2,12 22:18 6:2;10:8 5:20;21:3,5,7,12 either (4) clean (1) concern (4) copy (1) devices (1) 11:9,14,21;22:14 31:13 18:25;19:12;24:4; 7:6 3:19 electronic (3) cleaner (1) 26:19 corporate (1) different (1) 3:19;5:8,9 31:12 concerned (1) 27:10 17:21 elements (4) clear (2) 8:25 couple (2) difficult (2) 9:1;19:25;28:15; 12:23;35:17 concerns (5) 20:10;23:24 17:11;25:18 29:15 clearly (1) 7:24;8:7;19:7,23; court (6) directly (1) eligibility (1) 24:4 20:10 4:14;10:23,24;39:3, 8:23 25:12 client (1) condition (2) 10,21 Director (2) eliminate (1) 19:18 12:5;20:4 courtesy (1) 3:12;17:2 14:12 clients (3) confidential (5) 3:16 discourse (1) else (5) 20:5;26:20;31:12 12:25;13:10,11,21, craft (1) 39:7 3:17;15:7;27:8; close (1) 25 14:17 discussed (1) 36:20;38:4 23:20 configure (1) current (5) 32:15 Embassy (1) comfort (1) 21:22 9:1;18:14;26:4,9; discussion (2) 3:7 4:4 confused (1) 29:2 35:20;36:4 emergency (4) coming (1) 20:19 customer (1) distributed (1) 3:25;32:16,19;35:5 38:13 consider (13) 17:8 5:8 Employee (1) comment (8) 5:17;20:15,15,22; customized (1) documents (3) 17:24 7:2,14;21:7;22:17; 21:2;22:7;23:5;28:7; 17:8 16:24;17:15;24:18 empty (1) 33:25;34:14;35:9; 34:10;35:24;36:7,15; done (5) 38:11 38:12 37:3 D 9:16,21;16:6;20:3; encounters (1) commentator (1) consideration (10) 23:14 30:1 20:23 6:15;16:4;18:20; dashes (2) door (1) end (1) commentators (1) 20:24;21:19;25:12; 39:7,12 4:2 23:3 22:12 28:2;36:8;37:13,15 date (3) doors (2) enforced (1) comments (34) considerations (1) 29:23;30:14,21 4:3,6 10:21 3:23;4:15,17,19; 17:21 day (2) dormant (1) enough (1) 5:15,17,23,24;6:13, considered (3) 5:12;37:18 19:6 4:16 16,20,21,25;7:4,21; 22:13;33:10;34:3 days (1) double (1) ensure (1) 10:21;16:12;19:21; consistency (1) 19:12 4:3 4:15 20:22;21:3;22:7,13; 35:10 deadline (1) doubt (1) entities (2) 23:20;32:13,23;33:3, Constitution (1) 6:16 26:16 10:10;13:4 19;34:2;35:19,23,24; 3:8 debate (1) down (3) ERKEL (2) 36:8;37:2,16 constitutionally (1) 6:11 26:3;27:7;28:8 39:3,20 commission (1) 10:18 decisions (1) draft (2) especially (2) 9:9 constraints (1) 13:14 33:18,20 14:23;17:22 Committee (6) 9:23 deemed (1) drafted (1) essentially (2) 5:6;9:6,8;21:21; construed (1) 18:7 8:12 11:3;19:14 22:10,19 9:20 deficient (1) drugs (1) even (1) companies (1) consult (1) 10:19 16:18 12:20 13:1 19:18 define (2) due (1) event (2) company (2) contained (2) 24:21;25:7 39:6 6:1;30:22 26:5,6 16:23;24:5 definite (1) during (3) everybody (3) compel (1) continue (1) 26:14 5:18;8:4;25:20 14:19;15:5,10 12:6 16:18 denoted (1) dynamic (4) everyone (1) compelled (1) continuously (1) 39:16 17:22;25:16,17,24 3:16 15:18 17:18 Dental (1) evolving (1) compels (1) contract (2) 8:2 E 17:18 16:21 10:9;17:5 depending (1) exactly (3) competitors (2) contracts (4) 21:13 e- (1) 14:20;29:7;31:4 8:1;14:4 11:11;12:16;17:6; depth (1) 7:4 example (1) complete (6) 25:17 32:15 earlier (1) 25:15 15:17;16:3,7;26:17, contractual (1) described (1) 7:7 exceeding (1) 18;31:8 18:1 10:11 easier (1) 19:23 completely (1) convened (2) desk (1) 29:12 exception (3) 31:1 4:11;5:14 6:4 easy (2) 12:13,18,23

Min-U-Script® Associated Reporters, Inc. (2) clarify - exception 225 216 2036 STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing PARISH OF EAST BATON ROUGE November 25, 2020

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Min-U-Script® Associated Reporters, Inc. (3) Executive - Legislative 225 216 2036 STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing PARISH OF EAST BATON ROUGE November 25, 2020

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Min-U-Script® Associated Reporters, Inc. (4) legislature - perceive 225 216 2036 STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing PARISH OF EAST BATON ROUGE November 25, 2020

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Min-U-Script® Associated Reporters, Inc. (5) Perfect - RIEGER 225 216 2036 STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing PARISH OF EAST BATON ROUGE November 25, 2020

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Min-U-Script® Associated Reporters, Inc. (6) Right - verified 225 216 2036 STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing PARISH OF EAST BATON ROUGE November 25, 2020

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Min-U-Script® Associated Reporters, Inc. (7) versus - 9:36 225 216 2036 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Summary of Testimony & Public Comments re Regulatory Project 2020-4 ~ Pharmacy Benefit Managers at November 25, 2020 Public Hearing

1. Letter received November 24, 2020 from Robert Rieger and Grant Guillot on behalf of Pharmaceutical Care Management Association (PCMA) PCMA requested specific revisions of the proposed rule, as follows:

§3005. Permitting Procedures A. Application for Initial Issuance of Permit 1. The board shall develop an application form suitable for the pharmacy benefit manager permit. The board may revise that application form on its own initiative in order to collect the information it deems necessary to properly evaluate an applicant. The board shall publish the proposed permit application form in the Louisiana Register and take comments from potential permittees and interested persons. Once finalized, any subsequent proposed changes to the form shall also be formally noticed in the Louisiana Register and a rulemaking proceeding undertaken. 2. The application shall include copies of the following documents: a. Governance documents, including Articles of Incorporation, Articles of Association, partnership agreements, trade name certificates, trust agreements, shareholder agreements, and all amendments to such documents. b. The applicant’s standard generic contract template which it uses for contracts entered into by the applicant and pharmacies or pharmacy services administrative organizations in this state in the administration of pharmacy benefits for healthcare insurers, providers, or payors. c. An audited financial statement for the applicant’s previous fiscal year. 3. The board shall not process applications received by facsimile, or that are incomplete, or submitted with the incorrect fee. 4. Once received by the board, an incomplete application for the permit shall expire one year thereafter. Once the board deems the application to be complete, the applicant will be notified of a completed application in writing. The board will act on completed applications within 30 days of an application being completed. 5. In the event any information contained in the application or accompanying documents material changes after being submitted to the board and before the issuance of the permit, the applicant shall immediately notify the board in writing and provide corrected information. 6. The applicant may be required to personally appear before the board or any of its committees prior to any decision on the permit application. 7. Upon approval of the application, the board shall issue the pharmacy benefit manager permit to the applicant.

In addition, PCMA seeks clarification whether PBMs currently operating within the state may continue to do so pending processing of their applications, and further, suggest the Board establish a date by which PBMs with ongoing operations in the state submit permit applications.

2. Verbal testimony from Robert Rieger on behalf of Pharmaceutical Care Management Association (PCMA) Mr. Rieger summarized the written comments previously submitted and requested clarification of the remainder of the rulemaking process.

Regulatory Proposal 2021-A ~ Collaborative Practice Draft #1 - coded

1 Louisiana Administrative Code 2 3 Title 46 – Professional and Occupational Standards 4 5 Part LIII: Pharmacists 6 7 Chapter 5. Pharmacists 8 9 Subchapter B. Professional Practice Procedures 10 11 §523. Collaborative Drug Therapy Management Practice 12 A. Definitions. As used in this Chapter, the following terms shall have the meaning ascribed to them in this 13 Section: 14 Board – the Louisiana Board of Pharmacy. 15 Collaborative Drug Therapy Management or Drug Therapy Management – that practice in which a pharmacist 16 voluntarily agrees with a physician to manage the disease specific drug therapy of one or more patients of such 17 physician, within a predetermined range of medication selected by the physician and set forth in a patient specific 18 written order set. Drug therapy management shall be limited to: 19 a. monitoring and modifying a disease specific drug therapy; 20 b. collecting and reviewing patient history; 21 c. obtaining and reviewing vital signs, including pulse, temperature, blood pressure, and respiration; 22 d. ordering, evaluating, and applying the results of laboratory tests directly related to the disease specific drug 23 therapy being managed under an order set, provided such tests do not require the pharmacist to interpret such 24 testing or formulate a diagnosis; and 25 e. providing disease or condition specific patient education and counseling. 26 Controlled Substance – any substance defined, enumerated, or included in federal or state statute or regulations, or 27 any substance which may hereafter be designated as a controlled substance by amendment or supplementation of 28 such statute or regulations. 29 Disease Specific Drug Therapy – a specific drug or drugs prescribed by a physician for a specific patient of such 30 physician that is generally accepted within the standard of care for treatment of the diseases or condition. 31 Drug – 32 (a) any substance recognized as a drug in the official compendium, or supplement thereto, designated by the board 33 for use in the diagnosis, DRAFTcure, mitigation, treatment or prevention of diseases in humans or animals; 34 (b) any substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of diseases in humans 35 or other animals, or 36 (c) any substance other than food intended to affect the structure or any function of the body of humans or other 37 animals.

CODING: Words in struck through type are deletions from existing rule; words underscored are additions. Regulatory Proposal 2021-A ~ Collaborative Practice Draft #1 - coded

38 Drugs of Concern – a drug that is not a controlled substance but which is nevertheless defined and identified in 39 accordance with procedures established by the Louisiana Prescription Monitoring Program Act, R.S. 40:1001 - 40 1014, as a drug with the potential for abuse. 41 Pharmacist – for purposes of this Section, an individual who has a current unrestricted license to practice pharmacy 42 in this state duly licensed by the board, who is approved by the board to engage in collaborative practice for a 43 specific disease or condition based on the pharmacist’s training and experience. 44 Physician – an individual lawfully entitled to engage in the practice of medicine in this state as evidenced by a 45 current, unrestricted license duly issued by the Louisiana State Board of Medical Examiners. 46 Prescribe – a request or order transmitted in writing, orally, electronically or by other means of telecommunication 47 for a drug or device that is issued in good faith, in the usual course of professional practice and for a legitimate 48 medical purpose, by a physician for the purpose of correcting a physical, mental or bodily ailment of his patient. 49 Order Set – a written set of directives or instructions containing each of the components specified elsewhere in this 50 Section for collaborative drug therapy management of disease specific drug therapy for a specific patient. The 51 order set shall be signed by the physician and represents the physician orders for the collaborative drug therapy 52 management to be provided to the patient. 53 Protocol – a guideline referenced in a collaborative practice agreement that outlines the processes for patient care 54 services. 55 B. Registration 56 1. Eligibility 57 a. No pharmacist shall engage in collaborative drug therapy management in this state until registered 58 with the board in accordance with this Section. To be eligible for registration, a pharmacist shall, as 59 of the date of the application: 60 i. possess a current, unrestricted license to practice pharmacy issued by the board and not be the 61 subject of a pending investigation or complaint by the board or by the pharmacy licensing 62 authority of any other state or jurisdiction; 63 ii. be actively engaged in the practice of pharmacy in this state and the provision of pharmacist 64 care similar to the activities anticipated in the collaborative drug therapy management 65 agreement. 66 b. A pharmacist shall be deemed ineligible for registration of collaborative drug therapy management 67 who: 68 i. doesDRAFT not possess the qualifications prescribed by §523.B.1.a; 69 ii. has voluntarily surrendered or had suspended, revoked, or restricted his controlled dangerous 70 substance license, permit, or registration (state or federal); 71 iii. has had an application for pharmacist licensure rejected or denied; or 72 iv. has been, or is currently in the process of being denied, terminated, suspended, refused, 73 limited, placed on probation or under other disciplinary action with respect to participation in

CODING: Words in struck through type are deletions from existing rule; words underscored are additions.

Regulatory Proposal 2021-A ~ Collaborative Practice Draft #1 - coded

74 any private, state, or federal health insurance program. 75 a. The board may, in its discretion, waive the limitations referenced in Subparagraph B.1.b of this 76 Section on a case-by-case basis. 77 d. The board may deny registration to an otherwise eligible pharmacist for any of the causes 78 enumerated in causes enumerated in R.S. 37:1241.A, or any other violation of the provisions of the 79 Pharmacy Practice Act or the board’s rules. 80 e. The burden of satisfying the board as to the eligibility of a pharmacist for registration to engage in 81 collaborative drug therapy management shall be upon the pharmacist. A pharmacist shall not be 82 deemed to possess such qualifications unless and until the pharmacist demonstrates and evidences 83 such qualifications in the manner prescribed by and to the satisfaction of the board. 84 2. Application and Issuance 85 a. Application for registration to engage in collaborative drug therapy management shall be made upon 86 forms supplied by the board. Application forms and instructions may be obtained from the board’s 87 website or by contacting the board’s office. 88 b. An application for registration to engage in collaborative drug therapy management shall include: 89 i. the pharmacist’s full name, license number, mailing address of record, and emergency contact 90 information; 91 ii. the nature of the collaborative drug therapy management activities contemplated, i.e., the 92 disease or condition proposed for management; 93 iii. a description of the pharmacist’s professional education that qualifies him to engage in 94 collaborative drug therapy management activities described in the application; 95 iv. proof documented in a form satisfactory to the board that the pharmacist possesses the 96 qualifications set forth in this Section; and 97 v. such other information and documentation as the board may require to evidence qualification 98 for registration. 99 c. The board may reject or refuse to consider any application for registration which is not complete in 100 every detail required by the board. The board may, in its discretion, require a more detailed or 101 complete response to any request for information set forth in the application as a condition to 102 consideration. 103 b. A pharmacist seeking registration to engage in collaborative drug therapy management shall be 104 required DRAFTto appear before the board or its designee if the board has questions concerning the nature or 105 scope of the pharmacist’s application, finds discrepancies in the application, or for other good cause 106 as determined by the board. 107 c. When all the qualifications, requirements, and procedures of this Section are met to the satisfaction 108 of the board, the board shall approve and register a pharmacist to engage in collaborative drug

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Regulatory Proposal 2021-A ~ Collaborative Practice Draft #1 - coded

109 therapy management. Registration of authority to engage in collaborative drug therapy management 110 shall not be effective until the pharmacist receives notification of approval from the board. 111 d. Although a pharmacist shall notify the board each time he intends to engage in collaborative drug 112 therapy management with a physician other than the physician identified in the pharmacist’s original 113 application, registration with the board is only required once. The board shall maintain a list of 114 pharmacists who are registered to engage in collaborative drug therapy management. 115 e. Each pharmacist registered to engage in collaborative drug therapy management shall be responsible 116 for updating the board within 10 days in the event of any change in the information recorded in the 117 original application. 118 1. Expiration of Registration; Renewal 119 a. A pharmacist’s registration to engage in collaborative drug therapy management with a physician 120 shall terminate and become void, null and without effect upon the earlier of: 121 i. death of either the pharmacist or physician; 122 ii. loss of license of the pharmacist; 123 iii. disciplinary action limiting the ability of the pharmacist to enter into collaborative drug 124 therapy management; 125 iv. notification to the board that the pharmacist has withdrawn from collaborative drug therapy 126 management; 127 v. a finding by the board of any of the causes that would render a pharmacist ineligible for 128 registration; or 129 vi. expiration of a pharmacist’s license or registration to engage in collaborative drug therapy 130 management for failure to timely renew such license or registration. 131 b. Registration of authority to engage in collaborative drug therapy management shall expire annually 132 on the same day as a pharmacist’s license unless renewed by the pharmacist by completing the 133 application form supplied by the board. An application for registration renewal shall be made part 134 of and/or accompany a pharmacist’s renewal application for pharmacist licensure. 135 c. The timely submission of an application for renewal of registration shall operate to continue the 136 expiring registration in effect pending renewal of registration or other final action by the board on 137 such application for renewal. 138 C. Advisory Committee. The Collaborative Drug Therapy Management Advisory Committee, constituted as 139 provided for in LACDRAFT 46:XLV.7417, shall assist the Board of Medical Examiners and the Board of Pharmacy 140 on matters relative to collaborative drug therapy management. The President of the Board of Pharmacy shall 141 appoint a pharmacist to serve on the committee, and said pharmacist shall serve at the pleasure of the Board of 142 Pharmacy. 143 D B. Standards of Practice 144 1. Authority, and Responsibility, and Limitations of Collaborative Drug Therapy Management

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145 a. A pharmacist registered with holding an active and unrestricted license issued by the board under 146 this Section may, independently or in conjunction with one or more similarly licensed pharmacists, 147 engage in collaborative drug therapy management practice with a physician one or more 148 practitioners in accordance with a patient specific, drug specific, disease specific order set 149 collaborative practice agreement satisfying the requirements of this Section. 150 b. A pharmacist engaged in collaborative drug therapy management practice shall: 151 i. retain professional responsibility to his patient for the management of their drug therapy for his 152 patient’s treatment outcomes within the scope of his practice authority; 153 ii. establish and maintain a pharmacist-patient relationship with each patient subject to 154 collaborative drug therapy management; 155 iii. be geographically located to be physically present to provide pharmacist care to a patient 156 subject to collaborative drug therapy management; 157 iv. provide on a scheduled basis no less than every three months, a status report on the patient, 158 including but not limited to, any problem, complication, or other issues relating to patient non- 159 compliance with drug therapy management. This requirement may be met by entering the 160 information in the patient’s medical record; and 161 v. be available through direct telecommunication for consultation, assistance, and direction. 162 c. A pharmacist’s registration to engage in collaborative drug therapy management with a physician is 163 personal to the pharmacist. A pharmacist registered to engage in drug therapy management shall not 164 allow another pharmacist not so registered or any other individual to exercise the authority conferred 165 by such registration. 166 d. Collaborative drug therapy management shall only be utilized for disease specific drug therapy as 167 defined in this Section. 168 e. The scope of the collaborative drug therapy management shall not include: 169 i. any patient of the physician for whom such physician has not prepared a patient specific, drug 170 specific, disease or condition specific order set based on a face-to-face visit with the patient; 171 ii. initiation or discontinuance of drug therapy by a pharmacist, except as specified in the order 172 set; 173 iii. the management of controlled substances or drugs of concern; or 174 iv. substitution of a drug prescribed by a physician without the explicit written consent of such 175 physician.DRAFT 176 c. The collaborative practice agreement shall identify the: 177 i. collaborating pharmacist(s) and practitioner(s). 178 ii. patient care services intended to achieve optimal medication use and desired patient outcomes. 179 iii. protocol(s) to be used by the collaborators. 180 iv. appropriate mechanism(s) to initiate a therapeutic relationship with a patient.

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Regulatory Proposal 2021-A ~ Collaborative Practice Draft #1 - coded

181 2. Informed Patient Consent 182 a. A pharmacist shall not engage in collaborative drug therapy management of provide collaborative 183 practice services to a patient without the patient’s written informed consent as directed by the 184 applicable state law. 185 b. In addition to the requirements provided by law for obtaining a patient’s informed consent, each 186 patient who is subject to collaborative drug therapy management shall be the pharmacist or 187 practitioner shall: 188 i. informed of the collaborative nature of drug therapy management for the patient’s specific 189 medical disease or condition and provided instructions and contact information for follow-up 190 visits with the pharmacist and physician provide the patient with information so that he 191 understands the role of the pharmacist and practitioner in the collaborative relationship; 192 ii. informed he may decline to participate in a collaborative drug therapy management practice and 193 may withdraw at any time without terminating the physician-patient or pharmacist-patient 194 relationship assure the patient understands he may decline to receive services from the 195 pharmacist at the initial encounter or in the future without compromising his relationship with 196 the practitioner; and 197 iii. provided written disclosure of any contractual or financial arrangement with any other party that 198 may impact one of the party’s decision to participate in the agreement between the 199 pharmacist(s) and the practitioner(s). 200 c. All services provided shall be performed in a setting which insures patient privacy and 201 confidentiality. 202 3. Order Sets Initiation of Services 203 a. A separate order set shall be written for each patient to be managed by collaborative drug therapy 204 management. A copy of each order set shall be: 205 i. provided to the collaborating physician and pharmacist; and 206 ii. made part of the patient’s pharmacy record. 207 b. A physician shall develop a patient specific order set for a particular patient or utilize a standard 208 written protocol order set , incorporating what patient specific deviations, if any, the physician may 209 deem necessary or appropriate for such patient. In either event, an order set for disease specific drug 210 therapy shall adhere to generally accepted standards of care and shall identify, at a minimum: 211 i. theDRAFT pharmacist, the physician, and telephone number and other contact information for each; 212 ii. the patient’s name, address, gender, date of birth, and telephone number; 213 iii. the disease or condition to be managed; 214 iv. the disease specific drug or drugs to be utilized; 215 v. the type and extent of drug therapy management the physician authorizes the pharmacist to 216 perform;

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Regulatory Proposal 2021-A ~ Collaborative Practice Draft #1 - coded

217 vi. the specific responsibilities of the pharmacist and physician; 218 vii. the procedures, criteria, or plan the pharmacist is required to follow in connection with drug 219 therapy management; 220 viii. the specific laboratory test or tests, if any, directly related to drug therapy management the 221 physician authorizes the pharmacist to order and evaluate; 222 ix. the reporting and documentation requirements of the pharmacist and physician respecting the 223 patient and schedule by which such are to take place; 224 x. the conditions and events upon which the pharmacist and physician are required to notify one 225 another; and 226 xi. procedures to accommodate immediate consultation by telephone or direct telecommunication 227 with, between, or among the pharmacist, physician, and the patient. 228 c. Each order set utilized for collaborative drug therapy management of a patient shall be reviewed 229 annually by the collaborating physician, or more frequently as such physician deems necessary, to 230 address patient needs and to insure compliance with the requirements of this Section. The 231 physician’s signature and date of review shall be noted on the order set and maintained by the 232 pharmacist in accordance with this Section. 233 a. The mechanism to initiate a therapeutic relationship with a patient shall include the patient’s consent 234 to treatment and shall be recorded and archived for review consistent with all recordkeeping 235 standards. 236 i. Protocols that anticipate the practitioner identifying the patient and personalizing the treatment 237 plan may be initiated through a patient-specific order that references the protocol for the medical 238 condition or drug therapy identified in the collaborative practice agreement. 239 ii. Protocols that anticipate the pharmacist initiating the therapeutic relationship with the patient 240 should include a mechanism for referral of the patient to the appropriate practitioner within a 241 specified time limit that affirms and supports the value of a medical home led by a practitioner. 242 4. Reporting Obligations and Responsibilities 243 a. A pharmacist engaged in collaborative drug therapy management shall report annually, as a 244 condition to the renewal of his registration, whether or not and the extent to which the pharmacist is 245 engaged in collaborative drug therapy management and such other information as the board may 246 request. 247 b. A pharmacistDRAFT engaged in collaborative drug therapy management shall comply with reasonable 248 requests by the board for personal appearances or information relative to the functions, activities, 249 and performance of a pharmacist or physician engaged in collaborative drug therapy management. 250 5. Records 251 a. The following information shall be included in the pharmacy’s record of a patient subject to 252 collaborative drug therapy management:

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Regulatory Proposal 2021-A ~ Collaborative Practice Draft #1 - coded

253 i. the prescription or order implementing collaborative drug therapy management; 254 ii. the order set applicable to the patient evidencing documentation of the physician’s annual 255 review; 256 iii. documentation of all activities performed by the pharmacist; 257 iv. consultations and status reports by and between the pharmacist and physician; and 258 v. documentation of the patient’s informed consent to collaborative drug therapy management. 259 b. A pharmacist registered to engage in collaborative drug therapy management shall maintain and 260 produce, upon inspection conducted by or at the request of a representative of the board, a copy of 261 any order sets and such other records or documentation as may be requested by the board to assess a 262 pharmacist’s compliance with requirements of this Section, the Pharmacy Practice Act, or other 263 applicable board rules. 264 E C. Sanctions 265 1. Action Against Registration. For noncompliance with any of the provisions of this Section, the board 266 may, in addition to or in lieu of administrative proceedings against a pharmacist’s license, suspend or 267 revoke a pharmacist’s registration to engage in collaborative drug therapy management, or may impose 268 such terms, conditions, or restrictions thereon as the board may deem necessary or appropriate. 269 2. Action Against Pharmacist License. Any violation or failure to comply with the provisions of this 270 Section shall be deemed a violation of R.S. 37:1241.A.1, as well as a violation of any other applicable 271 provisions of R.S. 37:1241.A, providing cause for the board to take any of the actions permitted in 272 R.S. 37:1241.A against the pharmacist’s license. 273 3. Unauthorized Practice. Nothing in this Section shall be construed as authorizing a pharmacist to issue 274 prescriptions, exercise independent medical judgment, render diagnoses, provide treatment, assume 275 independent responsibility for patient care, or otherwise engage in the practice of medicine as defined in 276 the Louisiana Medical Practice Act. Any person who engages in such activities, in the absence of medical 277 licensure issued by the Louisiana State Board of Medical Examiners, shall be engaged in the unauthorized 278 practice of medicine and subject to the penalties prescribed by the Louisiana Medical Practice Act. 279 1. The failure of a pharmacist to comply with the provisions of this Section shall constitute unprofessional 280 conduct and provide sufficient basis for the board to take any of the disciplinary actions identified in R.S. 281 37:1241(A). 282 283 AUTHORITY NOTE: PromulgatedDRAFT in accordance with R.S. 37:1164(37)(b)(i) 1182. 284 HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1125 285 (June 2007), amended LR 39:3291 (December 2013), amended by the Department of Health, Board of Pharmacy, 286 LR 287

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1 Louisiana Administrative Code 2 3 Title 46 – Professional and Occupational Standards 4 5 Part LIII: Pharmacists 6 7 Chapter 5. Pharmacists 8 9 Subchapter B. Professional Practice Procedures 10 11 §523. Collaborative Practice 12 A. Definitions. As used in this Chapter, the following terms shall have the meaning ascribed to them in this 13 Section: 14 Prescribe – a request or order transmitted in writing, orally, electronically or by other means of telecommunication 15 for a drug or device that is issued in good faith, in the usual course of professional practice and for a legitimate 16 medical purpose, for the purpose of correcting a physical, mental or bodily ailment. 17 Protocol – a guideline referenced in a collaborative practice agreement that outlines the processes for patient care 18 services. 19 B. Standards of Practice 20 1. Authority and Responsibility 21 a. A pharmacist holding an active and unrestricted license issued by the board may, independently or in 22 conjunction with one or more similarly licensed pharmacists, engage in collaborative practice with 23 one or more practitioners in accordance with a collaborative practice agreement satisfying the 24 requirements of this Section. 25 b. A pharmacist engaged in collaborative practice shall: 26 i. retain professional responsibility for his patient’s treatment outcomes within the scope of his 27 practice authority; 28 ii. be available through direct communication for consultation, assistance, and direction. 29 c. The collaborative practice agreement shall identify the: 30 i. collaborating pharmacist(s) and practitioner(s). 31 ii. patient care services intended to achieve optimal medication use and desired patient outcomes. 32 iii. protocol(s) to be used by the collaborators. 33 iv. appropriateDRAFT mechanism(s) to initiate a therapeutic relationship with a patient. 34 2. Patient Consent 35 a. A pharmacist shall not provide collaborative practice services to a patient without the patient’s 36 consent as directed by the applicable state law. 37 b. In addition to the requirements provided by law for obtaining a patient’s consent, the pharmacist or 38 practitioner shall: Regulatory Proposal 2021-A ~ Collaborative Practice Draft #1 - clean

39 i. provide the patient with information so that he understands the role of the pharmacist and 40 practitioner in the collaborative relationship. 41 ii. assure the patient understands he may decline to receive services from the pharmacist at the 42 initial encounter or in the future without compromising his relationship with the practitioner. 43 iii. provided written disclosure of any contractual or financial arrangement between the 44 pharmacist(s) and the practitioner(s). 45 3. Initiation of Services 46 a. The mechanism to initiate a therapeutic relationship with a patient shall include the patient’s consent 47 to treatment and shall be recorded and archived for review consistent with all recordkeeping 48 standards. 49 i. Protocols that anticipate the practitioner identifying the patient and personalizing the treatment 50 plan may be initiated through a patient-specific order that references the protocol for the medical 51 condition or drug therapy identified in the collaborative practice agreement. 52 ii. Protocols that anticipate the pharmacist initiating the therapeutic relationship with the patient 53 should include a mechanism for referral of the patient to the appropriate practitioner within a 54 specified time limit that affirms and supports the value of a medical home led by a practitioner. 55 C. Sanctions 56 1. The failure of a pharmacist to comply with the provisions of this Section shall constitute unprofessional 57 conduct and provide sufficient basis for the board to take any of the disciplinary actions identified in R.S. 58 37:1241(A). 59 60 AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. 61 HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1125 62 (June 2007), amended LR 39:3291 (December 2013), amended by the Department of Health, Board of Pharmacy, 63 LR 64 DRAFT

Legislative Proposal 2021-C ~ Collaborative Practice Draft #1

1 HLS/SLS 21-

2 Regular Session, 2021

3 House/Senate Bill No. _____

4 By Representative/Senator _____

5

6 HEALTH CARE: Provides relative to collaborative practice by pharmacists.

7

8 AN ACT

9

10 To amend and reenact R.S. 37:1164(39), relative to pharmacy collaborative drug therapy

11 management, to enact R.S. 37:1164(60), relative to collaborative practice agreement, and to

12 enact R.S. 37:1220, relative to collaborative practice by pharmacists.

13 Be it enacted by the Legislature of Louisiana:

14 Section 1. R.S. 37:1164(39) is hereby amended and reenacted and R.S. 37:1164(60) is

15 hereby enacted to read as follows:

16 §1164. Definitions

17 As used in this Chapter, the following terms have the meaning ascribed to them by this

18 Section:

19 * * *

20 (39)(a) “Pharmacy collaborative drug therapy management” means that practice whereby 21 a pharmacistDRAFT or pharmacists have, on a voluntary basis, agreed to manage the 22 disease-specific drug therapy of a patient under written protocol, working in

23 conjunction with a physician licensed to practice medicine by the Louisiana State

24 Board of Medical Examiners. Pharmacy collaborative drug therapy management

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25 does not include the substitution by the pharmacist of a product that is not an

26 equivalent drug product to the product originally prescribed by the physician or

27 practitioner without the explicit consent of the physician or practitioner. Any

28 pharmacy collaborative drug therapy management protocol shall adhere to rules

29 and regulations promulgated by the board.

30 (b) (i) The Louisiana State Board of Medical Examiners and the Louisiana Board

31 of Pharmacy shall initiate the rulemaking process in accordance with the

32 provisions of the Administrative Procedure Act by publishing their

33 respective notices of intent no later than one hundred twenty days

34 following August 15, 2006.

35 (ii) If both boards have not initiated the rulemaking process in accordance

36 with the provisions of the Administrative Procedure Act by publishing

37 their respective notices of intent by one hundred twenty days following

38 August 15, 2006, then the board shall appoint a committee composed of

39 three physicians and three pharmacists, the physicians by the Louisiana

40 State Board of Medical Examiners and the pharmacists by the Louisiana

41 Board of Pharmacy. The committee shall compete the drafting process no

42 later than one hundred eighty days following August 15, 2006.

43 (iii) If the boards have not initiated the rulemaking process in accordance with

44 the provisions of the Administrative Procedure Act by publishing their 45 DRAFTrespective notices of intent by one hundred eighty days following August 46 15, 2006, then the Louisiana Board of Pharmacy shall have the authority

47 to promulgate the rule required in R.S. 37:1164(37) independently of the

48 Louisiana Board of Medical Examiners.

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49

50 (39) “Collaborative practice” is that practice of pharmacy whereby one or more

51 pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with

52 one or more practitioners to provide patient care services under protocol to

53 achieve optimal medication use and desired patient outcomes. Collaborative

54 practice activities shall comply with administrative rules promulgated by the

55 board.

56 (60) “Collaborative practice agreement” is a written and signed agreement between

57 one or more pharmacists and one or more practitioners that provides for

58 collaborative practice as defined in this Chapter.

59 Section 2. R.S. 37:1220 is hereby enacted to read as follows:

60 §1220. Collaborative practice

61 A. A pharmacist holding an active and unrestricted license issued by the board

62 may, independently or in conjunction with one or more similarly licensed

63 pharmacists, engage in collaborative practice with one or more practitioners

64 in accordance with a collaborative practice agreement, subject to

65 administrative rules promulgated by the board.

66 Section 3. The Louisiana State Law Institute is hereby authorized and directed to

67 alphabetize the entries in R.S. 37:1164.

[end] 68 [end] 69 DRAFT

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1 HLS/SLS 21-

2 Regular Session, 2021

3 House/Senate Bill No. _____

4 By Representative/Senator _____

5

6 HEALTH CARE: Provides relative to collaborative practice and limited prescriptive authority

7 by formulary or protocol for pharmacists.

8

9 AN ACT

10

11 To enact R.S. 37:1220, relative to collaborative practice and limited prescriptive authority by

12 protocol or formulary for pharmacists, and to enact R.S. 37:1220.1, relative to the

13 Pharmacy Formulary and Protocol Advisory Committee.

14 Be it enacted by the Legislature of Louisiana:

15 Section 1. R.S. 37:1220 is hereby enacted to read as follows:

16 §1220. Collaborative practice; limited prescriptive authority by protocol or formulary for

17 pharmacists

18 A. A pharmacist holding an active and unrestricted license issued by the board may,

19 independently or in conjunction with one or more similarly licensed pharmacists,

20 engage in collaborative practice with one or more practitioners in accordance with a 21 collaborativeDRAFT practice agreement, subject to administrative rules promulgated by the 22 board.

23 B. A pharmacist may, pursuant to a statewide drug therapy management protocol

24 developed by the Pharmacy Formulary and Protocol Advisory Committee convened

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25 pursuant to R.S. 37:1220.1 and adopted by administrative rule, provide approved

26 patient care services including, but not limited to, smoking cessation therapy and

27 travel health services.

28 C. The board shall establish by administrative rule a formulary of drugs and devices,

29 as recommended by the Pharmacy Formulary and Protocol Advisory Committee,

30 that a pharmacist may prescribe and dispense to a patient pursuant to a diagnosis by

31 a practitioner. The formulary may include post-diagnostic drugs and devices

32 including, but not limited to, emergency refills of insulin, diabetic testing supplies,

33 albuterol inhalers, spacers, epinephrine autoinjectors, smoking cessation aids,

34 discharge medications for transitions of care, and rapid strep tests.

35 D. A pharmacist may order and interpret post-diagnostic laboratory assessments,

36 subject to administrative rules promulgated by the board.

37 E. The board shall promulgate administrative rules in accordance with the

38 Administrative Procedure Act to implement the provisions of this Section.

39 §1220.1 Pharmacy Formulary and Protocol Advisory Committee

40 A. The board shall convene a Pharmacy Formulary and Protocol Advisory Committee

41 consisting of seven members, appointed by the Governor, for the purpose of

42 advising the board to promulgate administrative rules to implement the provisions

43 of R.S. 37:1220. The members of the committee shall be:

44 1. Two physicians licensed to practice medicine by the Louisiana State Board of 45 MedicalDRAFT Examiners. 46 2. Two advanced practice registered nurses with prescriptive authority licensed to

47 practice nursing by the Louisiana State Board of Nursing.

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48 3. Three pharmacists licensed to practice pharmacy by the Louisiana Board of

49 Pharmacy, at least one of whom shall be employed as a community pharmacist

50 and at least one of whom shall be employed as a health system pharmacist.

51 B. The Louisiana State Board of Medical Examiners, the Louisiana State Board of

52 Nursing and the Louisiana Board of Pharmacy shall each submit to the Governor a

53 list of up to three names of individuals to be considered for membership for each of

54 the vacancies required to be filled by licensees of each board.

55 C. The term of each member of the committee is two years. A member whose term

56 has expired shall continue to serve until a successor is appointed. If a vacancy

57 occurs, a person who is a representative of the same board as the departing member

58 shall serve for the reminder of the term.

59 D. A member of the committee who fails to attend two consecutive committee

60 meetings shall be removed from the committee unless the failure to attend was due

61 to a serious health condition of the member or family member of the member.

62 E. The committee shall elect one of its members to serve as chairperson.

63 F. Committee members are entitled to reimbursement of their travel expenses as

64 provided by R.S. 39:231, to be paid by the Board of Pharmacy.

65 G. The committee shall recommend to the board for adoption by administrative rule a

66 formulary of drugs and devices that a pharmacist may prescribe and dispense to a

67 patient pursuant to a diagnosis by a practitioner qualified to make the diagnosis. 68 The committeeDRAFT shall periodically review the formulary and recommend revisions to 69 the board for adoption by administrative rule.

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70 H. A pharmacist or practitioner may petition the committee for the addition of a drug

71 or device to the formulary by submitting such request using a form for this purpose

72 supplied by the board.

[end] 73 [end]

74

DRAFT

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§ 1220. Collaborative Practice and Limited Prescription Formularies are unacceptable. A Authority by Protocol or formulary for pharmacists formulary will restrict innovation and be used by LSBME to essentially stymie this effort. As we have seen it done in other states.

Beyond that, this is about services to improve the public health and safety. It should NOT be about specific products or devices.

A. A pharmacist holding an active and unrestricted license issued by the board may, I independently or in conjunction with one or more similarly licensed pharmacists, engage in collaborative practice with one or more practitioners in accordance with a collaborative practice agreement, subject to administrative rules promulgated by the board.

B. A pharmacist may, pursuant to a statewide drug therapy Formularies are unacceptable. A management protocol developed by the Pharmacy Formulary formulary will restrict innovation and Protocol Advisory Committee convened pursuant to R.S. and be used by LSBME to essentially 37:1220.1 and adopted by administrative rule, provide approved stymie this effort. As we have seen it patient care services. including, but not limited to, smoking done in other states. In particular cessation therapy and travel health services. initial lists of drugs or devices will give an excuse not to allow evolution or improvements. D. A pharmacist may order and interpret post-diagnostic laboratory assessments, subject to administrative rules promulgated by the board.

E. The board shall promulgate administrative rules in accordance with the Administrative Procedure Act to implement the provisions of this

Section. §1220.1 Pharmacy Formulary and Protocol Advisory Committee

A. The board shall convene a Pharmacy Formulary and Protocol Advisory Committee consisting of seven five members, appointed by the Governor, for the purpose of advising the board to promulgate administrative rules to implement the provisions 42 of R.S. 37:1220. The members of the committee shall be:

1. Two One physician licensed to practice medicine by the The physician is on the PPAC to Louisiana State Board of Medical Examiners. advise – NOT to direct or control.

2. Two One advanced practice registered nurses with prescriptive authority licensed to practice nursing by the Louisiana State Board of Nursing.

3. Three pharmacists licensed to practice pharmacy by the The qualification for appointment Louisiana Board of Pharmacy, at least one of whom shall be should be pertinent experience or employed as a community pharmacist and at least one of whom training not practice setting. shall be employed as a health system pharmacist. Who have training and experience in point-of-care testing or pharmacist- initiated care.

B. The Louisiana State Board of Medical Examiners, the Louisiana State Board of Nursing and the Louisiana Board of Pharmacy shall each submit to the Governor a list of up to three names of individuals to be considered for membership for each of the vacancies required to be filled by licensees of each board.

C. The term of each member of the committee is two years. A member whose term has expired shall continue to serve until a successor is appointed. If a vacancy occurs, a person who is a representative of the same board as the departing member shall serve for the reminder of the term.

D. A member of the committee who fails to attend two consecutive committee meetings shall be removed from the committee unless the failure to attend was due to a serious health condition of the member or family member of the member.

E. The committee shall elect one of its members to serve as chairperson.

F. Committee members are entitled to reimbursement of their travel expenses as provided by R.S. 39:231, to be paid by the Board of Pharmacy.

G. The committee shall recommend to the board for adoption by administrative rule a formulary of drugs and devices protocols for the care of patients that a pharmacist may follow to prescribe and dispense to a patient pursuant to a diagnosis by a practitioner qualified to make the diagnosis. The committee shall periodically review the formulary these protocols and recommend revisions to the board for adoption by administrative rule.

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

March 1, 2021

Senator Fred H. Mills, Jr., Chair Senator Regina A. Barrow, Vice Chair Committee on Health and Welfare Committee on Health and Welfare Louisiana Senate Louisiana Senate Post Office Box 94183 Post Office Box 94183 Baton Rouge, Louisiana 70804 Baton Rouge, Louisiana 70804 Via E-mail: [email protected] Via E-mail: [email protected]

Re: Senate Resolution 39 of 2nd Extraordinary Session of 2020 Legislature

Dear Senators Mills and Barrow:

As requested by Senator Barrow’s resolution, the Board reviewed the status of the collaborative drug therapy management program in the state as well as the desirability and feasibility of written statewide protocols for pharmacists to test or screen for and initiate treatment or therapy for qualified health conditions. We now submit our findings, recommendations and proposed legislation to the Senate Committee on Health and Welfare.

We appreciate the opportunity to review current pharmacy legislation and regulation with a goal of improving healthcare access and patient outcomes. Pharmacists are the most well-trained healthcare providers with respect to the management of medication therapy. Given the shortage of primary healthcare providers in the state, pharmacists are in an excellent position to collaborate with those providers in the area of drug therapy management. Moreover, pharmacists are qualified to perform testing and screening and initiate post-diagnostic treatment pursuant to written protocols.

We look forward to working with you to improve healthcare access and outcomes by extending the authority for pharmacist care . If you have any questions or need more information about any of our findings or recommendations, please let us know. For the Board: DRAFT Malcolm J Broussard Executive Director Collaborative Drug Therapy Management

Collaborative drug therapy management (CDTM) means that practice whereby a pharmacist or pharmacists have, on a voluntary basis, agreed to manage the disease- specific drug therapy of a patient under written protocol, working in conjunction with a physician licensed to practice medicine by the Louisiana State Board of Medical Examiners. [La. R.S. 37:1161(39)] Drug therapy management includes the following activities: • Collecting and reviewing patient history; • Obtaining and reviewing patient vital signs, including pulse, temperature, blood pressure, and respiration; • Ordering, evaluating, and applying the results of laboratory tests directly related to the drug therapy being managed, provided that a pharmacist shall not interpret such testing to formulate a diagnosis; • Monitoring and modifying a disease specific drug therapy; and • Providing disease or condition specific patient education and counseling. The statutory definition goes on to require all collaborative practice protocols to adhere to rules jointly promulgated by the medical and pharmacy boards. The original legislation authorizing CDTM was adopted in 1999. Unfortunately, the medical board did not prioritize this topic in their rulemaking activity despite multiple requests from the pharmacy board. The 2006 Legislature adopted an addendum to the statutory definition requiring the medical board to initiate their rulemaking on this topic within 180 days of the effective date of that legislative act or allow the pharmacy board to promulgate rules independently from the medical board. The CDTM rules were jointly promulgated by the medical and pharmacy boards in 2007. The 2007 rule: • limited CDTM activities to certain specific health conditions – diabetes, asthma, dyslipidemia, anticoagulation therapy, smoking cessation therapy and administrationDRAFT of disease-specific vaccines. • required physicians and pharmacists to obtain an additional registration from their licensing board to engage in CDTM, and further, required the submission of their contemplated collaborative practice agreements for review and approval by the CDTM Advisory Committee, a subunit of the medical board composed of four physicians and three pharmacists. • required the pharmacist to submit monthly patient reports to the collaborating physician; required the use of patient-specific protocols; and required significant administrative recordkeeping. The Board received complaints from both pharmacists and physicians of the significant regulatory burden. From the promulgation of the rule in 2007 until the rule was amended in 2013, the Board issued CDTM registrations to only 44 pharmacists; by comparison, the 2013 census reflected 4,980 pharmacists in the state. The CDTM rule amendments were jointly promulgated by both boards in 2013. The 2013 rule: • removed the limitation on specific health conditions; • maintained the requirement for an additional registration from the licensing board but removed the requirement for submission and approval of the contemplated collaborative practice agreement, requiring instead the disclosure of the health conditions contemplated for management. • reduced the required patient reports by the pharmacist from monthly to quarterly; replaced patient-specific protocols with patient-specific order sets; and retained the administrative recordkeeping. The Board continues to receive comments from both pharmacists and physicians of the still significant regulatory burden. Since the promulgation of the rule amendment in 2013, the Board has issued an additional 60 CDTM registrations. Of the total 104 CDTM registrations issued since 2007, 95 registrations are still active. By comparison, the current census reflects 5,730 pharmacists in the state. Our analysis of the health conditions under management by the pharmacists seeking CDTM registrations reflects a limited range of conditions. 34.9% of the declared health conditions submitted by pharmacists were for diabetes, 24.5% for hypertension, 14.3% for chronic obstructive pulmonary disease (COPD), 12.4% for anticoagulation therapy, 4.8% for congestive heart failure, with other entries including antimicrobial therapy,DRAFT human immunodeficiency virus (HIV), hepatitis C, dyslipidemia, smoking cessation, depression and anxiety. Our analysis of the sites of care of those pharmacists seeking CDTM registrations reflect an overwhelming limitation to large health systems with Ochsner Health System accounting for 80%. There was only one community clinic pharmacy setting in the central part of the state. We are aware of one independent study of the impact of the current regulatory burden on the utilization of CDTM in Louisiana; the August 2020 edition of Preventing Chronic Disease included an essay by Hamilton and Darr with their findings. We recently approached the medical board and they agreed to work with the Board to review our CDTM rules and look for opportunities to reduce the regulatory burden. With respect to the current statute, the pharmacy law limits pharmacist collaboration with physicians. Of the 48 states which permit CDTM, 23 states permit pharmacists to collaborate with any practitioner with prescriptive authority, and an additional three states authorize such collaboration with physicians or nurse practitioners. Louisiana has several categories of practitioners with prescriptive authority, all of whom with patients who could benefit from collaborative drug therapy management by pharmacists. The Board recommends an amendment of the statutory definition to include all practitioners with prescriptive authority.

Limited Prescriptive Authority by Protocol

The Clinical Laboratory Improvement Amendments (CLIA) was adopted by the U.S. Congress in 1988 to improve the quality of testing in all laboratories. CLIA recognizes three levels for all laboratory testing – waived, moderately complex and high complexity. CLIA-waived tests are generally simple and non-technical and employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible. There are over 1,400 CLIA-waived tests. The high complexity tests are reserved for accredited medical laboratories. The performance of moderately complex testing requires specialized training, but such testing is not restricted to accredited medical laboratories. The Board has authorized pharmacists to administer waived and moderately complex laboratory testing provided they have obtained the proper education andDRAFT training and comply with the applicable CLIA requirements. Most point-of-care testing employs CLIA-waived test methodologies. Over 40 states allow pharmacists to administer screening tests and initiate treatment pursuant to written protocols for certain health conditions. The states vary by the health conditions eligible for such protocol prescribing as well as the process by which such protocols are established. Like other health professions, pharmacy education has evolved for the last few decades to provide training for more direct patient care, including physical assessment of patients and laboratory monitoring. The Board received presentations from both colleges of pharmacy in the state outlining contemporary accreditation standards for pharmacy education and how their curricular offerings prepare pharmacy students for direct patient care. For those pharmacists who completed their pharmacy education before such opportunities were available, there are post-graduate certificate programs in place to provide that training. The Board received comments from multiple pharmacy stakeholders indicating their desire and willingness to participate in point-of-care testing with limited prescriptive authority using protocol-based prescribing. After reviewing approaches used by other states, the Board believes it is feasible and beneficial for patients to establish such a program in Louisiana. The program should include representatives from medicine and nursing in the protocol development process to ensure appropriate patient referral parameters and processes are included in the protocols.

Findings

The Board’s administrative rules for collaborative drug therapy management constitute a significant regulatory burden on pharmacists, and by extension, on physicians. While regulatory oversight is necessary for public protection, it is possible to streamline the regulatory structure. The requirement for joint promulgation of rules with another licensing board further hinders the promulgation process.

The restriction allowing pharmacist collaboration only with physicians prevents pharmacists from collaborating with other prescribing practitioners who may have patients who wouldDRAFT benefit from collaborative drug therapy management by pharmacists.

Pharmacists are among the most well-trained healthcare providers with respect to drug therapy management as well as testing, screening, and management of self-limiting health conditions. The use of written protocols to guide pharmacists in those activities is well established in most of the states. Pharmacists provide additional avenues of access to healthcare services, particularly for those with poor or no access to primary healthcare practitioners.

Recommendations

The Board should reduce the regulatory burden in its collaborative practice rule by streamlining the regulatory structure, and further, the Board should continue its collaboration with the medical board to implement similar provisions in its rules.

The Board requests legislative consideration for removing the statutory restriction limiting pharmacist collaborative practice with physicians, to allow collaboration between pharmacists and any other prescribing practitioner.

The Board requests legislative consideration to authorize limited prescriptive authority for pharmacists by statewide written protocols. The protocols should include authority for pharmacists to test or screen for certain health conditions, provide for limited prescriptive authority and include parameters and processes for referral of patients to primary healthcare practitioners as appropriate. Protocol development should be guided by a multidisciplinary advisory committee including representatives from medicine, nursing and pharmacy. The protocols should be promulgated by administrative rule to ensure stakeholder input.

Appendices

A – Senate ResolutionDRAFT 39 of 2nd Extraordinary Session of 2020 Legislature

B – Proposed Amendments to Louisiana Pharmacy Practice Act

Appendix A

2020 Second Extraordinary Session ENROLLED

SENATE RESOLUTION NO. 39

BY SENATOR BARROW

A RESOLUTION

To urge and request the Louisiana Board of Pharmacy to study and make recommendations

relative to pharmacists' testing, screening, and treatment of certain health conditions.

WHEREAS, pharmacists are highly educated health care professionals who provide convenient, high-quality health care services, including medication management therapy, immunizations, long-acting injectable medications, disease management, point-of-care testing, and patient assessments and screenings to a great number of patients; and

WHEREAS, Louisiana pharmacists work in partnership with other health care entities and providers to improve patient outcomes and public health in this state; and

WHEREAS, Louisiana law provides for collaborative drug therapy management, the practice in which a pharmacist voluntarily agrees with a physician to manage the disease-specific drug therapy of one or more patients of the physician, within a predetermined range of medication selected by the physician and set forth in patient-specific written orders; and

WHEREAS, drug therapy management involves monitoring and modifying a disease-specific drug therapy; collecting and reviewing patient history; obtaining and reviewing vital signs; ordering, evaluating, and applying the results of laboratory tests directly related to the disease-specific drug therapy being managed under an order; and providing disease- or condition-specific patient education and counseling; and

WHEREAS, due to poor health outcomes and extensive health professional shortage areas, Louisiana has an especially pronounced statewide need for an expansion of access to health care.

Page 1 of 2 Appendix A

SR NO. 39 ENROLLED

THEREFORE, BE IT RESOLVED that the Senate of the Legislature of Louisiana does hereby urge and request the Louisiana Board of Pharmacy to study and make recommendations relative to pharmacists' testing, screening, and treatment of certain health conditions, including but not limited to:

(1) An update on the status of the collaborative drug therapy management program in Louisiana.

(2) A determination of the desirability and feasibility of a written statewide protocol for pharmacists to test or screen for and initiate treatment or therapy for qualified health conditions.

BE IT FURTHER RESOLVED that the Louisiana Board of Pharmacy shall submit a written report of its findings and recommendations, including proposed legislation if necessary, to the Senate Committee on Health and Welfare no later than March 1, 2021.

BE IT FURTHER RESOLVED that in complying with this Resolution, the Louisiana

Board of Pharmacy may consult with the Louisiana State Board of Medical Examiners.

BE IT FURTHER RESOLVED that a copy of this Resolution be transmitted to the executive director of the Louisiana Board of Pharmacy.

PRESIDENT OF THE SENATE

Page 2 of 2 Legislative Proposal 2021-A ~ CDS Schedule Update Draft #3

1 HLS 21-

2 Regular Session, 2021

3 House Bill No. _____

4 By Representative

5

6 CONTROLLED SUBSTANCES: Adds Beta-hydroxythiofentanyl, Brorphine, Crotonyl

7 fentanyl, Cyclopentyl fentanyl, Isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-

8 methoxybutyryl fentanyl, and Valeryl fentanyl to Schedule I, Oliceridine to Schedule II, and

9 Remimazolam to Schedule IV, and removes Cannabidiol from Schedule V.

10

11 AN ACT

12

13 To amend and reenact R.S. 40:964, relative to the composition of various schedules of controlled

14 substances.

15 Be it enacted by the Legislature of Louisiana:

16 Section 1. R.S. 40:964 is hereby amended and reenacted to read as follows:

17 §964. Composition of schedules

18 * * *

19 Schedule I

20 A. Opiates. 21 UnlessDRAFT specifically excepted or unless listed in another schedule, any of the 22 following opiates, including their isomers, esters, ethers, salts, or salts of

23 isomers, esters, and ethers, whenever the existence of such isomers, esters,

24 ethers, or salts is possible within the specific chemical designation:

CODING: Words in stricken type are proposed deletions from existing law; words underscored are proposed additions. Legislative Proposal 2021-A ~ CDS Schedule Update Draft #3

25 (1) – (71) …

26 (72) Beta-hydroxythiofentanyl (N-[1-[2-hydroxy-2-(2-thienyl)ethyl]-4-

27 piperidinyl]-N-phenylpropanamide)

28 (73) Brorphine (1-(1-(1-(4-bromophenyl) ethyl) piperidin-4-yl)-1,3-

29 dihydro-2H-benzimidazol-2-one)

30 (74) Crotonyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylbut-2-

31 enamide)

32 (75) Cyclopentyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-

33 phenylcyclopentanecarboxamide)

34 (76) Isobutyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-

35 phenylisobutyramide)

36 (77) para-chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-(1-

37 phenethylpiperidin-4-yl)isobutyramide)

38 (78) para-methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N-(1-

39 phenethylpiperidin-4-yl)butyramide)

40 (79) Valeryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylpentanamide)

41 * * *

42 Schedule II

43 * * *

44 B. Opiates 45 UnlessDRAFT specifically excepted or unless listed in another schedule any of the 46 following opiates, including its isomers, esters, ethers, salts, and salts of

47 isomers, esters, and ethers whenever the existence of such isomers, esters,

CODING: Words in stricken type are proposed deletions from existing law; words underscored are proposed additions. Legislative Proposal 2021-A ~ CDS Schedule Update Draft #3

48 ethers, and salts is possible within the specific chemical designation,

49 dextrorphan and levopropoxyphene excepted:

50 (1) – (29) …

51 (30) Oliceridine

52 * * *

53 Schedule IV

54 * * *

55 B. Depressants

56 Unless specifically excepted or unless listed in another schedule, any material,

57 compound, mixture, or preparation containing any quantity of the following

58 substances, including its salts, isomers, and salts of isomers, whenever the

59 existence of such salts, isomers, and salts of isomers is possible within the

60 specific chemical designation:

61 (1) – (56) …

62 (57) Remimazolam

63 * * *

64 Section 2. Schedule V(F)(1) is hereby repealed.

65 Section 3. The Louisiana State Law Institute is hereby authorized and directed to

66 alphabetize the entries in the Opiates section of Schedules I and II and the Depressants 67 section of ScheduleDRAFT IV.

CODING: Words in stricken type are proposed deletions from existing law; words underscored are proposed additions. Legislative Proposal 2021-B ~ Renewal Fees Draft #1

1 HLS 21-

2 Regular Session, 2021

3 House Bill No. _____

4 By Representative _____

5

6 BOARDS AND COMMISSIONS: Provides for license renewal fees assessed by the Board of

7 Pharmacy.

8

9 AN ACT

10

11 To amend and reenact R.S. 37:1184, relative to fees for the Board of Pharmacy.

12 Be it enacted by the Legislature of Louisiana:

13 Section 1. R.S. 37:1184 is hereby amended and reenacted to read as follows:

14 §1184. Fees

15 Notwithstanding any other provision of this Chapter, the fees and costs established by the

16 board in accordance with R.S. 37:1182(A)(19) shall not be less than the following schedule:

17 Minimum

18 (1) Miscellaneous fees and costs

19 (a) – (i) …

20 (j) Pharmacy intern registration $10.00 $25.00 21 (k) – DRAFT(n) … 22 (2) Licenses, permits, certifications, registrations and examinations for

23 pharmacists

24 (a)(i) Renewal fee for license, per year $100.00 $125.00

CODING: Words in struck through type are deletions from existing law; words underscored are additions. Legislative Proposal 2021-B ~ Renewal Fees Draft #1

25 (ii) …

26 (b) Delinquent fee in addition to renewal fee, per year $50.00 $62.50

27 (c) – (i) …

28 (3) Licenses, permits, certifications, registrations, and any other

29 designations for pharmacy locations

30 (a)(i) New pharmacy permit fee $150.00 $175.00

31 (ii) …

32 (b) Pharmacy change of location $150.00 $175.00

33 (c) Pharmacy change of ownership $150.00 $175.00

34 (d) Pharmacy permit renewal fee, per year $125.00 $150.00

35 (e) Delinquent permit renewal fee, per year $62.50 $75.00

36 (f) – (j) …

37 (k) Sterile compounding pharmacy permit fee, per year $500.00

38 (4) Certifications and examinations for pharmacy technicians

39 (a) …

40 (b) Renewal certification fee, per year $50.00 $60.00

41 (c) – (d) …

42 (e) Delinquent certification renewal fee, per year $25.00 $30.00

43 (f) …

44 (5) – (6) … 45 DRAFT

CODING: Words in struck through type are deletions from existing law; words underscored are additions. Legislative Proposal 2021-E ~ PMP – Audit Trail – Medicaid Draft #1

1 HLS/SLS 21-

2 Regular Session, 2021

3 House/Senate Bill No. _____

4 By Representative/Senator _____

5

6 CONTROLLED DANGEROUS SUBSTANCES: Provides relative to the prescription

7 monitoring program. (gov sig)

8

9 AN ACT

10

11 To amend and reenact R.S. 40:1007(J), relative to the prescription monitoring program; to

12 provide access to audit trail information to designated representatives of the Louisiana

13 Medicaid program.

14 Be it enacted by the Legislature of Louisiana:

15 Section 1. R.S. 40:1007(J) is hereby amended and reenacted to read as follows:

16 §1007. Access to prescription monitoring information and audit trail information

17 * * *

18 J. The board may disclose audit trail information to individuals identified in

19 Paragraphs (E)(2) and (E)(3) and Subsections F and I of this Section for use in an

20 active investigation of an individual who submitted requests for prescription 21 monitoringDRAFT information. 22 * * *

23 Section 2. This Act shall become effective on signature by the governor or, if not signed

24 by the governor, upon expiration of the time for bills to become law without signature by

CODING: Words in struck through type are deletions from existing law; words underscored are additions. Legislative Proposal 2021-E ~ PMP – Audit Trail – Medicaid Draft #1

25 the governor, as provided by Article III, Section 18 of the Constitution of Louisiana. If

26 vetoed by the governor and subsequently approved by the legislature, this Act shall

27 become effective on the day following such approval.

28

DRAFT

CODING: Words in struck through type are deletions from existing law; words underscored are additions.

MEMORANDUM OF UNDERSTANDING ADDRESSING CERTAIN DISTRIBUTIONS OF COMPOUNDED HUMAN DRUG PRODUCTS BETWEEN THE [insert STATE BOARD OF PHARMACY OR OTHER APPROPRIATE STATE AGENCY] AND THE U.S. FOOD AND DRUG ADMINISTRATION

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0910-0800 (expires 10/31/2023).

I. PURPOSE

This Memorandum of Understanding (MOU) establishes an agreement between the [insert State Board of Pharmacy or other appropriate State agency] and the U.S. Food and Drug Administration (FDA) regarding the distribution of inordinate amounts of compounded human drug products interstate1 and the appropriate investigation by the [insert State Board of Pharmacy or other appropriate State agency] of complaints relating to human drug products compounded in [insert State] and distributed outside such State.2 This is the MOU provided for by section 503A(b)(3)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 353a), and does not apply to veterinary drug products, biological products subject to licensure under section 351 of the Public Health Service Act (42 U.S.C. 262), and drugs that are compounded by outsourcing facilities under section 503B of the FD&C Act.

II. BACKGROUND

a. Section 503A of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist or licensed physician to be exempt from three sections of the FD&C Act requiring:

1. Compliance with current good manufacturing practice (section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B));

1 For purposes of this MOU, see the definitions of “inordinate amounts” and “distribution of compounded human drug products interstate” (also referred to as “distributed interstate”) in Appendix A. 2 As described herein, the State Board of Pharmacy or other appropriate State agency signatory is agreeing to take certain actions as described in Section III below. For example, if a State Board of Pharmacy signs the MOU, the State Board of Pharmacy agrees to take the actions described in Section III below with respect to drugs compounded by pharmacies in that State; in addition, the State Board of Pharmacy agrees that if it receives information about complaints or becomes aware of information about drugs compounded by physicians in the State and distributed interstate, it will forward the information to FDA and the appropriate State regulator of physicians as described in Section III.

1

2. Labeling with adequate directions for use (section 502(f)(1) (21 U.S.C. 352(f)(1)); and

3. FDA approval prior to marketing (section 505 (21 U.S.C. 355)).

b. To qualify for these exemptions, a compounded human drug product must, among other things,3 meet the conditions in section 503A(b)(3)(B) of the FD&C Act, under which the drug product is compounded in a State that:

1. Has entered into an MOU with FDA that addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State (section 503A(b)(3)(B)(i)); or

2. Has not entered into an MOU with FDA and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician (section 503A(b)(3)(B)(ii)).

c. Section 503A(b)(3) of the FD&C Act directs FDA to develop a standard MOU, in consultation with the National Association of Boards of Pharmacy (NABP), for use by the States in complying with section 503A(b)(3)(B)(i). This MOU is the standard MOU developed by FDA for this purpose.

III. SUBSTANCE OF AGREEMENT

a. Investigation of Complaints Relating to Compounded Human Drug Products Distributed Outside the State

1. The [insert State Board of Pharmacy or other appropriate State agency] will investigate complaints of adverse drug experiences and product quality issues4 relating to human drug products compounded at a pharmacy in [insert State] and distributed outside the State. Any investigations will be performed pursuant to the [insert State Board of Pharmacy or other appropriate State agency]’s established investigatory policies and procedures, including those related to prioritizing complaints, provided they are not in conflict with the terms of this MOU.

3 To qualify for the exemptions under section 503A, a compounder must obtain a prescription for an individually identified patient (section 503A(a) of the FD&C Act). This MOU does not alter this condition. 4 For purposes of this MOU, see the definitions of “adverse drug experience” and “product quality issue” in Appendix A.

2

2. Any investigations performed by the [insert State Board of Pharmacy or other appropriate State agency] under this MOU will include taking steps to assess (1) whether there is a public health risk associated with the compounded drug product; and (2) whether any public health risk associated with the product is adequately contained.

3. After the [insert State Board of Pharmacy or other appropriate State agency]’s investigation, if the complaint is substantiated, the [insert State Board of Pharmacy or other appropriate State agency], in accordance with and as permitted by State law, will take the action that the [insert State Board of Pharmacy or other appropriate State agency] considers to be appropriate and warranted to ensure that the relevant pharmacy investigates the root cause of the problem that is the subject of the complaint and undertakes sufficient corrective action to address any identified public health risk relating to the problem, including the risk that future similar problems may occur.

4. The [insert State Board of Pharmacy or other appropriate State agency] will maintain records of the complaint about adverse drug experiences or product quality issues relating to human drug products compounded at a pharmacy, the investigation of the complaint, and any response to or action taken as a result of the complaint, beginning when the [insert State Board of Pharmacy or other appropriate State agency] receives notice of the complaint. The [insert State Board of Pharmacy or other appropriate State agency] will maintain these records for at least 3 years. The 3-year period begins on the date of final action on a complaint, or the date of a decision that the complaint requires no action.

5. As soon as possible, but no later than 5 business days after receiving a complaint involving a serious adverse drug experience or serious product quality issue relating to a drug product compounded at a pharmacy and distributed outside the State, the [insert State Board of Pharmacy or other appropriate State agency] will, by submission to an Information Sharing Network5 or by email to [email protected], provide FDA with the information described in the Submission and Disclosure of Information section of this MOU (section III.c.1.a.i-iii).6

5 For purposes of this MOU, see the definitions of “serious adverse drug experience,” “serious product quality issue,” and “Information Sharing Network” in Appendix A. 6 The information includes the following: (i) Name and contact information of the complainant, if available; (ii) Name and address of the pharmacy that is the subject of the complaint; and (iii) Description of the complaint, including a description of any compounded human drug product that is the subject of the complaint.

3

6. After the [insert State Board of Pharmacy or other appropriate State agency] concludes its investigation of a complaint assessed to involve a serious adverse drug experience or serious product quality issue relating to a drug product compounded at a pharmacy and distributed outside the State, the [insert State Board of Pharmacy or other appropriate State agency] will share with FDA, as described in the Submission and Disclosure of Information section of this MOU (section III.c.1.a.iv-v),7 the results of the investigation as permitted by State law.

7. If the [insert State Board of Pharmacy or other appropriate State agency] receives a complaint involving an adverse drug experience or product quality issue relating to a human drug product compounded by a physician and distributed outside the State, the [insert State Board of Pharmacy or other appropriate State agency] will notify the appropriate regulator of physicians within the State. The [insert State Board of Pharmacy or other appropriate State agency] will also notify FDA by submission to an Information Sharing Network or by sending an email to [email protected] with the information described in the Submission and Disclosure of Information section of this MOU (section III.c.2.a.-c), if available, as soon as possible, but no later than 5 business days, after receiving the complaint.

b. Distribution of Inordinate Amounts of Compounded Human Drug Products Interstate8

1. For purposes of this MOU, a pharmacy has distributed an inordinate amount of compounded human drug products interstate if the number of prescription orders for compounded human drug products that the pharmacy distributed interstate during any calendar year is greater than 50 percent of the sum of:

(i) the number of prescription orders for compounded human drug products that the pharmacy sent out of (or caused to be sent out of) the facility in which the drug products were compounded during that same calendar year; plus

(ii) the number of prescription orders for compounded human drug products that were dispensed (e.g., picked up by a patient) at the

7 The information includes: (i) [Insert State Board of Pharmacy or other appropriate State agency]’s assessment of whether the complaint was substantiated, if available; and (ii) Description and date of any actions the [insert State Board of Pharmacy or other appropriate State agency] has taken to address the complaint. 8 The distribution of inordinate amounts of compounded human drug products interstate is a threshold for the [insert State Board of Pharmacy or other appropriate State agency] to identify and report certain information to FDA, not a limit on the distribution of compounded human drug products interstate.

4

facility in which they were compounded during that same calendar year.

5

Figure 1. Calculating an Inordinate Amount

= , where: 𝐴𝐴 A = Number of prescription orders for𝐵𝐵 compounded𝑋𝑋 human drug products that the pharmacy distributed interstate during any calendar year B = The sum of the number of prescription orders for compounded human drug products (i) that the pharmacy sent out of (or caused to be sent out of) the facility in which the drug products were compounded during that same calendar year; plus (ii) the number of prescription orders for compounded human drug products that were dispensed (e.g., picked up by a patient) at the facility in which they were compounded during that same calendar year

If X is greater than 0.5, it is an inordinate amount and is a threshold for certain information identification and reporting under the MOU.

2. On an annual basis, the [insert State Board of Pharmacy or other appropriate State agency] will identify, using surveys, reviews of records during inspections, data submitted to an Information Sharing Network, or other mechanisms available to the [insert State Board of Pharmacy or other appropriate State agency], pharmacies that distribute inordinate amounts of compounded human drug products interstate.

3. For pharmacies that have been identified as distributing inordinate amounts of compounded human drug products interstate during any calendar year, the [insert State Board of Pharmacy or other appropriate State agency] will identify, using data submitted to an Information Sharing Network or other available mechanisms, during that same calendar year: a. the total number of prescription orders for sterile compounded human drugs distributed interstate; b. the names of States in which the pharmacy is licensed; c. the names of States into which the pharmacy distributed compounded human drug products; and d. whether the State inspected for and found during its most recent inspection that the pharmacy distributed compounded human drug products without valid prescription orders for individually identified patients.

4. The [insert State Board of Pharmacy or other appropriate State agency] will, within 30 business days of identifying a pharmacy that has distributed inordinate amounts of compounded human drug products interstate, notify FDA of such pharmacy, through an Information Sharing Network or by email to [email protected], and will include the

6

information described in the Submission and Disclosure of Information section of this MOU (section III.c.1.b).

5. If the [insert State Board of Pharmacy or other appropriate State agency] becomes aware of a physician who is distributing any amount of compounded human drug products interstate, the [insert State Board of Pharmacy or other appropriate State agency] will notify the appropriate regulator of physicians within the State. The [insert State Board of Pharmacy or other appropriate State agency] will, within 30 business days of identifying a physician who is distributing any amount of compounded human drug products interstate, also notify FDA by submission to an Information Sharing Network or by email to [email protected]. c. Submission and Disclosure of Information 1. When submitting information using [email protected] regarding complaints relating to human drug products compounded by a pharmacy and distributed outside the State, or regarding distribution of inordinate amounts of human drug products compounded by a pharmacy interstate, the following minimum information will be included. Note, this information can be submitted to an Information Sharing Network for sharing with FDA.

a. Complaints:

i. Name and contact information of the complainant, if available;

ii. Name and address of the pharmacy that is the subject of the complaint;

iii. Description of the complaint, including a description of any compounded human drug product that is the subject of the complaint;

iv. [Insert State Board of Pharmacy or other appropriate State agency]’s assessment of whether the complaint was substantiated, if available; and

v. Description and date of any actions the [insert State Board of Pharmacy or other appropriate State agency] has taken to address the complaint.

b. Inordinate Amounts:

7

i. Name and address of the pharmacy that distributed inordinate amounts of compounded human drug products interstate;

ii. The number of prescription orders for compounded human drug products that the pharmacy sent out of (or caused to be sent out of) the facility in which the drug products were compounded during that same calendar year;

iii. The number of prescription orders for compounded human drug products that were dispensed (e.g., picked up by a patient) at the facility in which they were compounded during that same calendar year;

iv. The total number of prescription orders for compounded human drug products distributed interstate during that same calendar year;

v. The total number of prescription orders for sterile compounded human drug products distributed interstate during that same calendar year;

vi. The names of States in which the pharmacy is licensed and the names of States into which the pharmacy distributed compounded human drug products during that same calendar year; and

vii. Whether the [insert State Board of Pharmacy or other appropriate State agency] inspected for and found during its most recent inspection that the pharmacy distributed compounded human drug products without valid prescription orders for individually identified patients during that same calendar year.

2. When submitting information using [email protected] regarding complaints relating to human drug products compounded by a physician, or regarding distribution of any amount of human drug products compounded by a physician interstate, the following minimum information will be included, if available. Note, this information can be submitted to an Information Sharing Network for sharing with FDA.

a. Name and contact information of the complainant or notifier;

b. Name and address of the physician that is the subject of the complaint or notification; and

8

c. Description of the complaint or notification, including a description of any compounded human drug product that is the subject of the complaint or notification.

3. The parties to this MOU will share information consistent with applicable statutes and regulations. The parties recognize that a separate agreement under 21 CFR 20.88 may be necessary before FDA can share information that is protected from public disclosure. Such an agreement will govern FDA’s sharing of the following types of information:

• Confidential commercial information, such as information that would be protected from public disclosure under Exemption 4 of the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)(4));

• Personal privacy information, such as information that would be protected from public disclosure under Exemption 6 or 7(C) of the FOIA (5 U.S.C. 552(b)(6) and(7)(C)); or

• Information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., the Trade Secrets Act (18 U.S.C. 1905), the Privacy Act (5 U.S.C. 552a), other FOIA exemptions not mentioned above (5 U.S.C. 552(b)), the Health Insurance Portability and Accountability Act (Public Law 104-191), and FDA’s regulations in parts 20 and 21 (21 CFR parts 20 and 21)).

FDA agrees that information provided to FDA by the [insert State Board of Pharmacy or other appropriate State agency] will only be disclosed consistent with applicable Federal law and regulations governing the disclosure of such information, including the FOIA (5 U.S.C. 552(b)), the FD&C Act (21 U.S.C. 301 et seq.), 21 U.S.C. 331(j), 21 U.S.C. 360j(c), the Trade Secrets Act (18 U.S.C. 1905), FDA’s regulations in 21 CFR parts 20 and 21, and other pertinent laws and regulations.

IV. ENFORCEMENT AUTHORITIES AND LEGAL STATUS OF AGREEMENT

The parties to this MOU recognize that FDA and the [insert State Board of Pharmacy or other appropriate State agency] retain the statutory and regulatory authorities provided by the FD&C Act, other Federal statutes and attendant regulations, and State statutes and regulations. The parties also recognize that this agreement does not restrict FDA or any other Federal agency from taking

9

enforcement action, when appropriate, to ensure compliance with Federal statutes, including the FD&C Act and attendant regulations, or prevent the [insert State Board of Pharmacy or other appropriate State agency] from taking enforcement action, as appropriate, to ensure compliance with applicable State statutes and regulations. This MOU does not create or confer any rights for or on any person. By signing this MOU, the [insert State Board of Pharmacy or other appropriate State agency] affirms that it now possesses and will maintain, at the discretion of the State legislature, the legal authority (under State statutes and/or regulations) and the resources necessary to effectively carry out all aspects of this MOU. If State law changes such that the [insert State Board of Pharmacy or other appropriate State agency] no longer has the legal authority or resources necessary to effectively carry out all aspects of this MOU, the [insert State Board of Pharmacy or other appropriate State agency] will notify FDA within 60 calendar days of the change in legal authority.

V. NAME AND ADDRESS OF PARTICIPATING AGENCIES

U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Compliance Office of Unapproved Drugs and Labeling Compliance 10903 New Hampshire Avenue Bldg. 51, Suite 5100 Silver Spring, MD 20993-0002 Telephone: (301) 796-3110 Email: [email protected]

[Insert State Board of Pharmacy or other appropriate State agency and its contact information]

Upon signing the MOU, each party must designate one or more liaisons to act as points of contact. Each party may designate new liaisons at any time by notifying the other party’s liaison(s) in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the parties will name a new liaison within 2 weeks and notify the other party’s liaison(s).

VI. PERIOD OF AGREEMENT

a. When accepted by both parties, this MOU will be effective from the date of the last signature and will continue until terminated by either party. It may be terminated in writing by either party, upon a 60 calendar day notice of termination. Notice of termination will be sent to the address listed in section V of this MOU.

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b. If the [State Board of Pharmacy or other appropriate State agency] does not adhere to the provisions of this MOU, including conducting an investigation of complaints related to compounded human drug products distributed outside the State, the MOU may be terminated upon a 60 calendar day notice of termination.

In case of termination, FDA will post a notice of the termination on its Web site and the [insert State Board of Pharmacy or other appropriate State agency] will notify all pharmacies that compound drug products in the State and notify the State authority that licenses or regulates physicians of the termination and advise them that as of 60 calendar days from the date of the posting of the termination notice, compounded human drug products may be distributed (or caused to be distributed) out of the State only “in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed” by the licensed pharmacy or physician (section 503A(b)(3)(B)(ii) of the FD&C Act).

VII. APPROVALS

APPROVED AND ACCEPTED FOR APPROVED AND ACCEPTED FOR THE U.S. FOOD AND DRUG [insert State Board of Pharmacy or ADMINISTRATION other appropriate State agency]

By (Type Name) By (Type Name) Title Title Date Date

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Appendix A. Definition of Terms for the Purposes of this MOU

• Adverse Drug Experience: Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose, whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action (21 CFR 310.305(b)).

• Distribution of compounded human drug products interstate: Means that a pharmacy or physician has sent (or caused to be sent) a compounded drug product out of the State in which the drug was compounded.

• Information Sharing Network: An information sharing network designated by FDA for purposes of this MOU to collect, assess, and allow review and sharing of information pursuant to this MOU.

• Inordinate Amounts: A pharmacy has distributed an inordinate amount of compounded human drug products interstate if the number of prescription orders for compounded human drug products that the pharmacy distributed interstate during any calendar year is greater than 50 percent of the sum of: (i) the number of prescription orders for compounded human drug products that the pharmacy sent out of (or caused to be sent out of) the facility in which the drug products were compounded during that same calendar year; plus (ii) the number of prescription orders for compounded human drug products that were dispensed (e.g., picked up by a patient) at the facility in which they were compounded during that same calendar year.9

• Product Quality Issue: Information concerning (1) any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article; or (2) any bacteriological contamination; any significant chemical, physical, or other change or deterioration in the distributed drug product; or any failure of one or more distributed batches of the drug product to meet the applicable specifications (21 CFR 314.81(b)(1)). Contamination in general, including but not limited to mold, fungal, bacterial, or particulate contamination, is a product quality issue.

• Serious Adverse Drug Experience: Any adverse drug experience occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital

9 The definition of inordinate amounts in this MOU is separate and distinct from and should not be used in relation to the term inordinate amounts as it is used in section 503A(b)(1)(D) of the FD&C Act (pertaining to compounding a drug product that is essentially a copy of a commercially available drug product). The interpretation of this term in each instance necessarily is based on the particular context of the distinct provisions within 503A in which the term appears.

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anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse (21 CFR 310.305(b)).

• Serious Product Quality Issue: Any product quality issue that may have the potential to cause a serious adverse drug experience (e.g., possible contamination, superpotent product).

13 Regulatory Proposal 2021-B ~ Transfer of Marijuana Recommendations Draft #1

1 Louisiana Administrative Code 2 3 Title 46 – Professional and Occupational Standards 4 5 Part LIII: Pharmacists 6 7 Chapter 24. Limited Service Providers 8 9 Subchapter E. Marijuana Pharmacy 10 11 §2457. Standards of Practice 12 A. – D.5. … 13 E. Professional Practice Standards 14 1. Recommendation/opinion/referral (hereinafter, “request”) for Therapeutic Marijuana 15 a. – c. … 16 d. A marijuana pharmacy shall transfer an unexpired request for marijuana product to another 17 marijuana pharmacy when requested by the patient or his caregiver. 18 2. – 6.e.iv. … 19 20 AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1046. 21 HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 43:1550 (August 2017), 22 amended LR 45:1473 (October 2019) 23 DRAFT 1 Louisiana Board of Pharmacy Policies & Procedures 2 3 Title: COVID-19 Public Health Emergency: Policy No. I.D.28 4 Guidance for Licensees re PREP Act Declaration by HHS 5 6 Approved: Draft #2 7 8 9 1. The Public Readiness and Emergency Preparedness Act (PREP Act) was 10 enacted on December 30, 2005 as Division C, Section 2 of Public Law 109-148. 11 The act authorizes the Secretary of the United States Department of Health and 12 Human Services (HHS) to issue a Declaration to provide liability immunity to 13 certain individuals and entities (Covered Persons) against any claim of loss by, 14 arising out of, relating to, or resulting from the manufacture, distribution, 15 administration, or use of medical countermeasures (Covered Countermeasures), 16 except for claims involving “willful misconduct” as defined in the PREP Act. The 17 Declaration is subject to amendment as circumstances warrant. 18 19 2. Pursuant to the federal declaration of the COVID-19 public health emergency on 20 January 31, 2020, the HHS Secretary issued a Declaration Under PREP Act for 21 Medical Countermeasures Against COVID-19 (85 FR 15198) on March 10, 2020 22 with a retroactive effective date of February 4, 2020. The Declaration describes 23 the Covered Persons and Covered Countermeasures eligible for liability 24 immunity under the PREP Act. The Declaration also provides for a termination 25 date of October 1, 2024, and further, provides an additional one year period for 26 the disposition of Covered Countermeasures. 27 28 3. On April 8, 2020, the Assistant Secretary for Health (ASOH) in HHS issued 29 guidance relative to the PREP Act Declaration authorizing licensed pharmacists 30 to order and administer COVID-19 tests, including serology tests, which have 31 been authorized by FDA. The guidance indicated such pharmacists qualify as 32 Covered Persons under the PREP Act and may receive the immunity protections 33 available under the PREP Act. 34 35 4. The HHS Secretary issued the First Amendment to the Declaration Under PREP 36 Act for Medical Countermeasures Against COVID-19 (85 FR 21012) on April 15, 37 2020. The amendment added respiratory protective devices approved by the 38 National Institute for Occupational Safety and Health (NIOSH) to the list of 39 Covered Countermeasures eligible for liability immunity under the PREP Act. 40 41 5. The General Counsel of HHS issued Advisory Opinion 20-02 relative to the 42 PREP Act Declaration on May 19, 2020. This opinion concludes the PREP Act and the SecretaryDRAFT’s March 10, 2020 Declaration preempts any local or state 43 44 requirement that prohibits or effectively prohibits a pharmacist from ordering and 45 administering a COVID-19 diagnostic test that the FDA has authorized 46 47 6. The HHS Secretary issued the Second Amendment to the Declaration Under 48 PREP Act for Medical Countermeasures Against COVID-19 (85 FR 35100) on 49 June 8, 2020. The amendment clarified the Secretary’s intent with respect to the 50 original Declaration that the Covered Countermeasures should have also 51 included “products that limit the harm such a pandemic or epidemic might 52 otherwise cause”, citing as an example the pandemic-related shortages of FDA- 53 approved drugs and devices. 54 55 7. The HHS Secretary issued the Third Amendment to the Declaration Under PREP 56 Act for Medical Countermeasures Against COVID-19 (85 FR 52136) on August 57 24, 2020. 58 A. The Secretary amended Section V of the Declaration to identify as 59 Covered Persons (1) certain state-licensed pharmacists to order and 60 administer, and (2) pharmacy interns [who are licensed or registered by 61 their state board of pharmacy and acting under the supervision of a state- 62 licensed pharmacist] to administer, any vaccine that the Advisory 63 Committee on Immunization Practices (ACIP) recommends to persons 64 ages three through 18 according to ACIP’s standard immunization 65 schedule (ACIP-recommended vaccines). The Secretary conditioned the 66 inclusion of pharmacists and pharmacy interns as Covered Persons on 67 their compliance with the following eight requirements: 68 (1) The vaccine must be FDA-authorized or FDA-approved. 69 (2) The vaccination must be ordered and administered according to 70 ACIP’s standard immunization schedule. 71 (3) The licensed pharmacist must complete a practical training 72 program of at least 20 hours that is approved by the Accreditation 73 Council for Pharmacy Education (ACPE). This training program 74 must include hands-on injection technique, clinical evaluation of 75 indications and contraindications of vaccines, and the recognition 76 and treatment of emergency reactions to vaccines. 77 (4) The licensed or registered pharmacy intern must complete a 78 practical training program that approved by the ACPE. This training 79 program must include hands-on injection technique, clinical 80 evaluation of indications and contraindications of vaccines, and the 81 recognition and treatment of emergency reactions to vaccines. 82 (5) The licensed pharmacist and licensed or registered pharmacy 83 intern must have a current certificate in basic cardiopulmonary 84 resuscitation. 85 (6) The licensed pharmacist must complete a minimum of two hours of 86 ACPE-approved, immunization-related continuing pharmacy 87 education during each state licensing period. 88 (7) The licensed pharmacist must comply with recordkeeping and 89 reporting requirements of the jurisdiction in which he or she 90 administers vaccines, including informing the patient’s primary care 91 provider when available, submitting the required immunization 92 DRAFTinformation to the state or local immunization information system 93 (vaccine registry), complying with requirements with respect to 94 reporting adverse events, and complying with requirements 95 whereby the person administering a vaccine must review the 96 vaccine registry or other vaccination records prior to administering 97 a vaccine. 98 (8) The licensed pharmacist must inform his or her childhood 99 vaccination patients and the adult caregiver accompanying the child 100 of the importance of a well-child visit with a pediatrician or other 101 licensed primary care provider and refer patients as appropriate. 102 B. The Secretary amended Section VIII of the Declaration to identify 103 conditions warranting the use of Covered Countermeasures to include not 104 only the COVID-19 disease caused by SARS-CoV-2 or a virus mutating 105 therefrom, but also other diseases, health conditions, or threats that may 106 have been caused by COVID-19, SARS-CoV-2, or a virus mutating 107 therefrom, including the decrease in the rate of childhood immunizations, 108 which will lead to an increase in the rate of infectious diseases. 109 110 8. On September 3, 2020, the ASOH in HHS issued additional guidance relative to 111 the PREP Act Declaration. This guidance authorizes (1) state-licensed 112 pharmacists to order and administer, and (2) state-licensed or registered 113 pharmacy interns acting under the supervision of the qualified pharmacist to 114 administer, to persons ages three or older COVID-19 vaccinations that have 115 been authorized or licensed by the FDA. In addition to the eight requirements 116 cited in the Secretary’s Third Amendment issued on August 24, 2020, this 117 guidance added an additional requirement: 118 (9) The licensed pharmacist and the licensed or registered pharmacy 119 intern must comply with any applicable requirements (or conditions 120 of use) as set forth in the Centers for Disease Control and 121 Prevention (CDC) COVID-19 vaccination provider agreement and 122 any other federal requirements that apply to the administration of 123 COVID-19 vaccine(s). 124 125 9. On October 20, 2020, the ASOH in HHS issued additional guidance relative to 126 the PREP Act Declaration. This guidance extended the applicability of the 127 Secretary’s Third Amendment to include “authorized pharmacy interns” and 128 “qualified pharmacy technicians.” 129 A. The Third Amendment authorizes licensed or registered pharmacy interns 130 to administer vaccines under the supervision of a pharmacist; however, 131 some states do not license or register pharmacy interns. This guidance 132 clarifies the pharmacy intern must be authorized by the state or board of 133 pharmacy in the state in which the practical pharmacy internship occurs, 134 but the authorization need not take the form of a license or registration 135 with the state board of pharmacy. 136 B. The guidance describes “qualified pharmacy technicians.” Pharmacy 137 technicians working in states with licensure or registration requirements 138 must be licensed or registered in accordance with state requirements; 139 pharmacy technicians working in states without licensure registration 140 requirements must have a Certified Pharmacy Technician (CPhT) 141 designationDRAFT from either the Pharmacy Technician Certification Board or 142 National Healthcareer Association. 143 C. Subject to the requirements cited below, this guidance authorizes both 144 qualified pharmacy technicians and state-authorized pharmacy interns 145 acting under the supervision of a qualified pharmacist (meaning those 146 pharmacists who satisfy the requirements of the Third Amendment) to 147 administer FDA-authorized or FDA-licensed COVID-19 vaccines to 148 persons ages three or older and to administer FDA-authorized or FDA- 149 licensed ACIP-recommended vaccines to persons ages three through 18 150 according to ACIP’s standard immunization schedule. Qualified pharmacy 151 technicians and state-authorized pharmacy interns are considered 152 Covered Persons and are eligible for PREP Act immunity provided they 153 meet the following requirements: 154 (1) The vaccination must be ordered by the supervising qualified 155 pharmacist. 156 (2) The supervising qualified pharmacist must be readily and 157 immediately available to the immunizing qualified pharmacy 158 technician. 159 (3) The vaccine must be FDA-authorized or FDA-licensed. 160 (4) In the case of a COVID-19 vaccine, the vaccination must be 161 ordered and administered according to ACIP’s COVID-19 vaccine 162 recommendation(s). 163 (5) In the case of a childhood vaccine, the vaccination must be ordered 164 and administered according to ACIP’s standard immunization 165 schedule. 166 (6) The qualified pharmacy technician or state-authorized pharmacy 167 intern must complete a practical training program that is approved 168 by the Accreditation Council for Pharmacy Education (ACPE). This 169 training program must include hands-on injection technique and the 170 recognition and treatment of emergency reactions to vaccines. 171 (7) The qualified pharmacy technician or state-authorized pharmacy 172 intern must have a current certificate in basic cardiopulmonary 173 resuscitation. 174 (8) The qualified pharmacy technician must complete a minimum of 175 two hours of ACPE-approved, immunization-related continuing 176 pharmacy education during the relevant state licensing period(s). 177 (9) The supervising qualified pharmacist must comply with 178 recordkeeping and reporting requirements of the jurisdiction in 179 which he or she administers vaccines, including informing the 180 patient’s primary care provider when available and submitting the 181 required immunization information to the state or local 182 immunizations information system (vaccine registry). 183 (10) The supervising qualified pharmacist is responsible for complying 184 with requirements related to reporting adverse events. 185 (11) The supervising qualified pharmacist must review the vaccine 186 registry or other vaccination records prior to ordering the 187 vaccination to be administered by the qualified pharmacy technician 188 or state-authorized pharmacy intern. 189 (12) The qualified pharmacy technician and state-authorized pharmacy 190 DRAFTintern must, if the patient is 18 years of age or younger, inform the 191 patient and the adult caregiver accompanying the patient of the 192 importance of a well-child visit with a pediatrician or other licensed 193 primary care provider and refer patients as appropriate. 194 (13) The supervising qualified pharmacist must comply with any 195 applicable requirements (or conditions of use) as set forth in CDC’s 196 COVID-19 vaccination provider agreement and any other federal 197 requirements that apply to the administration of COVID-19 198 vaccine(s). 199 D. The guidance document authorizes qualified pharmacy technicians and 200 state-authorized pharmacy interns to administer COVID-19 tests, including 201 serology tests, that the FDA has approved, cleared, or authorized. By 202 doing so, qualified pharmacy technicians and state-authorized pharmacy 203 interns will qualify as Covered Persons under the PREP Act and may 204 receive immunity under that same law. 205 206 10. The General Counsel of HHS issued Advisory Opinion 20-03 on October 23, 207 2020 to address three vaccination-related issues under the PREP Act: 208 (1) Does the PREP Act preempt state licensing laws that are less stringent 209 than the federal standards under the Third Amendment to the Secretary’s 210 March 10, 2020 Declaration? [short answer: no] 211 (2) May a state require a pharmacist to enter into a collaborative practice 212 agreement with a licensed physician as a condition of administering ACIP- 213 recommended vaccines to children between ages 3 and 18? [short 214 answer: no] 215 (3) Is epinephrine, when used to treat a severe acute vaccine reaction, a 216 Covered Countermeasure within the meaning of the PREP Act? [short 217 answer: yes] 218 219 11. The General Counsel of HHS issued Advisory Opinion 20-04 on October 23, 220 2020 to address the scope and meaning of a “program planner” under the PREP 221 Act as well as the breadth of PREP Act immunity. One of the examples cited in 222 the opinion is that of a pharmacy administering COVID-19 vaccines according to 223 CDC-recommended population priorities in the face of limited vaccine availability. 224 Pharmacies participating in vaccine administration may wish to review this 225 opinion. 226 227 12. On October 29, 2020, the ASOH in HHS issued additional guidance relative to 228 the PREP Act Declaration. This guidance extended the applicability of the 229 Secretary’s Third Amendment to include pharmacies as Covered Persons when 230 their staff pharmacists order and administer, or their pharmacy interns and 231 pharmacy technicians administer, Covered Countermeasures consistent with the 232 terms and conditions of the Secretary’s Declaration and guidance, as of the date 233 that these staff pharmacists, pharmacy interns and pharmacy technicians were 234 authorized to order and administer these Covered Countermeasures. The 235 guidance indicates this recognition authorizes pharmacies to submit claims for 236 reimbursement for testing or vaccine administration carried out by its staff 237 pharmacists, pharmacy interns and pharmacy technicians. 238 239 13. The HHS SecretaryDRAFT issued the Fourth Amendment to the Declaration Under 240 PREP Act for Medical Countermeasures Against COVID-19 (85 FR 79190) on 241 December 3, 2020. This amendment recognizes that multiple advisory opinions 242 and guidance documents have been issued since the Declaration was issued on 243 March 10, 2020. The Secretary republishes the Declaration as amended, in full, 244 to incorporate all prior amendments, advisory opinions and guidance. 245 A. Section V. Covered Persons was amended to add a new category: 246 healthcare personnel who are permitted to order and administer a 247 Covered Countermeasure through telehealth in a state may do so for 248 patients in another state as long as the healthcare personnel comply with 249 the legal requirements of the state in which the healthcare personnel are 250 permitted to order and administer Covered Countermeasures by means of 251 telehealth. 252 B. Section V. Covered Persons was also amended to make explicit that the 253 requirement for qualified persons to have a current certificate in basic 254 cardiopulmonary resuscitation is satisfied, by among other things, a 255 certification in basic cardiopulmonary resuscitation by an online program 256 that has received accreditation from the American Nurses Credentialing 257 Center (ANCC), the Accreditation Council for Pharmacy Education 258 (ACPE), or the Accreditation Council for Continuing Medical Education 259 (ACCME). 260 C. Section V. Covered Persons was further amended to specify the licensed 261 pharmacist desiring to order or administer vaccines must have completed 262 the immunization training that the licensing state requires in order for 263 pharmacists to administer vaccines. If the state does not specify training 264 requirements for licensed pharmacists to order and administer vaccines, 265 the licensed pharmacist must complete a vaccination training program of 266 at least 20 hours that is approved by the Accreditation Council for 267 Pharmacy Education (ACPE) to order administer vaccines. This training 268 program must include hands-on injection technique, clinical evaluation of 269 indications and contraindications of vaccines, and the recognition and 270 treatment of emergency reactions to vaccines. 271 D. Section XII. Effective Time Period was amended to clarify that liability 272 protections under the PREP Act began with the declaration of the public 273 health emergency on January 31, 2020 and will terminate upon the 274 earliest of (a) the final day the Declaration of Emergency is in effect, or (b) 275 October 1, 2024. An exception exists with respect to qualified persons 276 who order or administer a routine childhood vaccination that ACIP 277 recommends to persons ages three through 18 according to ACIP 278 standard immunization schedule; for these persons and countermeasures, 279 PREP Act coverage began on August 24, 2020. The termination date 280 shall be the same for all other Covered Persons and Covered 281 Countermeasures. 282 283 14. The General Counsel of HHS issued Advisory Opinion 21-01 on January 8, 2021 284 to address the scope of the preemption of the PREP Act. That office had 285 received numerous questions whether the PREP Act applies where a Covered 286 Person declined to use a Covered Countermeasure when it arguably ought to 287 have been use. The inquiries were stimulated by multiple lawsuits where 288 patients or theirDRAFT estates allege that patients contracted COVID-19 because the 289 healthcare facility failed to provide its staff with personal protective equipment 290 (PPE), failed to teach the staff how to properly use that equipment, or failed to 291 ensure that its staff used the PPE that it had been given. The Advisory Opinion 292 addresses those and other questions relative to the scope of the preemption of 293 the PREP Act. 294 295 15. The General Counsel of HHS issued Advisory Opinion 21-02 on January 12, 296 2021 in response to requests to clarify the meaning of the requirement that a 297 COVID-19 vaccination “must be ordered and administered according to ACIP’s 298 COVID-19 vaccine recommendations.” Some have raised concerns that 299 satisfying the Advisory Committee on Immunization Practices (ACIP) allocation 300 recommendations is a precondition of PREP Act coverage. It is not. 301

DRAFT 1 Louisiana Board of Pharmacy Policies & Procedures 2 3 Title: COVID-19 Public Health Emergency: Policy No. I.D.28 4 Guidance for Licensees re PREP Act Declaration by HHS 5 6 Approved: Draft #3 7 8 9 1. The Public Readiness and Emergency Preparedness Act (PREP Act) was 10 enacted on December 30, 2005 as Division C, Section 2 of Public Law 109-148. 11 The act authorizes the Secretary of the United States Department of Health and 12 Human Services (HHS) to issue a Declaration to provide liability immunity to 13 certain individuals and entities (Covered Persons) against any claim of loss by, 14 arising out of, relating to, or resulting from the manufacture, distribution, 15 administration, or use of medical countermeasures (Covered Countermeasures), 16 except for claims involving “willful misconduct” as defined in the PREP Act. The 17 Declaration is subject to amendment as circumstances warrant. 18 19 2. Pursuant to the federal declaration of the COVID-19 public health emergency on 20 January 31, 2020, the HHS Secretary issued a Declaration Under PREP Act for 21 Medical Countermeasures Against COVID-19 (85 FR 15198) on March 10, 2020 22 with a retroactive effective date of February 4, 2020. The Declaration describes 23 the Covered Persons and Covered Countermeasures eligible for liability 24 immunity under the PREP Act. The Declaration also provides for a termination 25 date of October 1, 2024, and further, provides an additional one year period for 26 the disposition of Covered Countermeasures. 27 28 3. On April 8, 2020, the Assistant Secretary for Health (ASOH) in HHS issued 29 guidance relative to the PREP Act Declaration authorizing licensed pharmacists 30 to order and administer COVID-19 tests, including serology tests, which have 31 been authorized by FDA. The guidance indicated such pharmacists qualify as 32 Covered Persons under the PREP Act and may receive the immunity protections 33 available under the PREP Act. 34 35 4. The HHS Secretary issued the First Amendment to the Declaration Under PREP 36 Act for Medical Countermeasures Against COVID-19 (85 FR 21012) on April 15, 37 2020. The amendment added respiratory protective devices approved by the 38 National Institute for Occupational Safety and Health (NIOSH) to the list of 39 Covered Countermeasures eligible for liability immunity under the PREP Act. 40 41 5. The General Counsel of HHS issued Advisory Opinion 20-02 relative to the 42 PREP Act Declaration on May 19, 2020. This opinion concludes the PREP Act and the SecretaryDRAFT’s March 10, 2020 Declaration preempts any local or state 43 44 requirement that prohibits or effectively prohibits a pharmacist from ordering and 45 administering a COVID-19 diagnostic test that the FDA has authorized 46 47 6. The HHS Secretary issued the Second Amendment to the Declaration Under 48 PREP Act for Medical Countermeasures Against COVID-19 (85 FR 35100) on 49 June 8, 2020. The amendment clarified the Secretary’s intent with respect to the 50 original Declaration that the Covered Countermeasures should have also 51 included “products that limit the harm such a pandemic or epidemic might 52 otherwise cause”, citing as an example the pandemic-related shortages of FDA- 53 approved drugs and devices. 54 55 7. The HHS Secretary issued the Third Amendment to the Declaration Under PREP 56 Act for Medical Countermeasures Against COVID-19 (85 FR 52136) on August 57 24, 2020. 58 A. The Secretary amended Section V of the Declaration to identify as 59 Covered Persons (1) certain state-licensed pharmacists to order and 60 administer, and (2) pharmacy interns [who are licensed or registered by 61 their state board of pharmacy and acting under the supervision of a state- 62 licensed pharmacist] to administer, any vaccine that the Advisory 63 Committee on Immunization Practices (ACIP) recommends to persons 64 ages three through 18 according to ACIP’s standard immunization 65 schedule (ACIP-recommended vaccines). The Secretary conditioned the 66 inclusion of pharmacists and pharmacy interns as Covered Persons on 67 their compliance with the following eight requirements: 68 (1) The vaccine must be FDA-authorized or FDA-approved. 69 (2) The vaccination must be ordered and administered according to 70 ACIP’s standard immunization schedule. 71 (3) The licensed pharmacist must complete a practical training 72 program of at least 20 hours that is approved by the Accreditation 73 Council for Pharmacy Education (ACPE). This training program 74 must include hands-on injection technique, clinical evaluation of 75 indications and contraindications of vaccines, and the recognition 76 and treatment of emergency reactions to vaccines. 77 (4) The licensed or registered pharmacy intern must complete a 78 practical training program that approved by the ACPE. This training 79 program must include hands-on injection technique, clinical 80 evaluation of indications and contraindications of vaccines, and the 81 recognition and treatment of emergency reactions to vaccines. 82 (5) The licensed pharmacist and licensed or registered pharmacy 83 intern must have a current certificate in basic cardiopulmonary 84 resuscitation. 85 (6) The licensed pharmacist must complete a minimum of two hours of 86 ACPE-approved, immunization-related continuing pharmacy 87 education during each state licensing period. 88 (7) The licensed pharmacist must comply with recordkeeping and 89 reporting requirements of the jurisdiction in which he or she 90 administers vaccines, including informing the patient’s primary care 91 provider when available, submitting the required immunization 92 DRAFTinformation to the state or local immunization information system 93 (vaccine registry), complying with requirements with respect to 94 reporting adverse events, and complying with requirements 95 whereby the person administering a vaccine must review the 96 vaccine registry or other vaccination records prior to administering 97 a vaccine. 98 (8) The licensed pharmacist must inform his or her childhood 99 vaccination patients and the adult caregiver accompanying the child 100 of the importance of a well-child visit with a pediatrician or other 101 licensed primary care provider and refer patients as appropriate. 102 B. The Secretary amended Section VIII of the Declaration to identify 103 conditions warranting the use of Covered Countermeasures to include not 104 only the COVID-19 disease caused by SARS-CoV-2 or a virus mutating 105 therefrom, but also other diseases, health conditions, or threats that may 106 have been caused by COVID-19, SARS-CoV-2, or a virus mutating 107 therefrom, including the decrease in the rate of childhood immunizations, 108 which will lead to an increase in the rate of infectious diseases. 109 110 8. On September 3, 2020, the ASOH in HHS issued additional guidance relative to 111 the PREP Act Declaration. This guidance authorizes (1) state-licensed 112 pharmacists to order and administer, and (2) state-licensed or registered 113 pharmacy interns acting under the supervision of the qualified pharmacist to 114 administer, to persons ages three or older COVID-19 vaccinations that have 115 been authorized or licensed by the FDA. In addition to the eight requirements 116 cited in the Secretary’s Third Amendment issued on August 24, 2020, this 117 guidance added an additional requirement: 118 (9) The licensed pharmacist and the licensed or registered pharmacy 119 intern must comply with any applicable requirements (or conditions 120 of use) as set forth in the Centers for Disease Control and 121 Prevention (CDC) COVID-19 vaccination provider agreement and 122 any other federal requirements that apply to the administration of 123 COVID-19 vaccine(s). 124 125 9. On October 20, 2020, the ASOH in HHS issued additional guidance relative to 126 the PREP Act Declaration. This guidance extended the applicability of the 127 Secretary’s Third Amendment to include “authorized pharmacy interns” and 128 “qualified pharmacy technicians.” 129 A. The Third Amendment authorizes licensed or registered pharmacy interns 130 to administer vaccines under the supervision of a pharmacist; however, 131 some states do not license or register pharmacy interns. This guidance 132 clarifies the pharmacy intern must be authorized by the state or board of 133 pharmacy in the state in which the practical pharmacy internship occurs, 134 but the authorization need not take the form of a license or registration 135 with the state board of pharmacy. 136 B. The guidance describes “qualified pharmacy technicians.” Pharmacy 137 technicians working in states with licensure or registration requirements 138 must be licensed or registered in accordance with state requirements; 139 pharmacy technicians working in states without licensure registration 140 requirements must have a Certified Pharmacy Technician (CPhT) 141 designationDRAFT from either the Pharmacy Technician Certification Board or 142 National Healthcareer Association. 143 C. Subject to the requirements cited below, this guidance authorizes both 144 qualified pharmacy technicians and state-authorized pharmacy interns 145 acting under the supervision of a qualified pharmacist (meaning those 146 pharmacists who satisfy the requirements of the Third Amendment) to 147 administer FDA-authorized or FDA-licensed COVID-19 vaccines to 148 persons ages three or older and to administer FDA-authorized or FDA- 149 licensed ACIP-recommended vaccines to persons ages three through 18 150 according to ACIP’s standard immunization schedule. Qualified pharmacy 151 technicians and state-authorized pharmacy interns are considered 152 Covered Persons and are eligible for PREP Act immunity provided they 153 meet the following requirements: 154 (1) The vaccination must be ordered by the supervising qualified 155 pharmacist. 156 (2) The supervising qualified pharmacist must be readily and 157 immediately available to the immunizing qualified pharmacy 158 technician. 159 (3) The vaccine must be FDA-authorized or FDA-licensed. 160 (4) In the case of a COVID-19 vaccine, the vaccination must be 161 ordered and administered according to ACIP’s COVID-19 vaccine 162 recommendation(s). 163 (5) In the case of a childhood vaccine, the vaccination must be ordered 164 and administered according to ACIP’s standard immunization 165 schedule. 166 (6) The qualified pharmacy technician or state-authorized pharmacy 167 intern must complete a practical training program that is approved 168 by the Accreditation Council for Pharmacy Education (ACPE). This 169 training program must include hands-on injection technique and the 170 recognition and treatment of emergency reactions to vaccines. 171 (7) The qualified pharmacy technician or state-authorized pharmacy 172 intern must have a current certificate in basic cardiopulmonary 173 resuscitation. 174 (8) The qualified pharmacy technician must complete a minimum of 175 two hours of ACPE-approved, immunization-related continuing 176 pharmacy education during the relevant state licensing period(s). 177 (9) The supervising qualified pharmacist must comply with 178 recordkeeping and reporting requirements of the jurisdiction in 179 which he or she administers vaccines, including informing the 180 patient’s primary care provider when available and submitting the 181 required immunization information to the state or local 182 immunizations information system (vaccine registry). 183 (10) The supervising qualified pharmacist is responsible for complying 184 with requirements related to reporting adverse events. 185 (11) The supervising qualified pharmacist must review the vaccine 186 registry or other vaccination records prior to ordering the 187 vaccination to be administered by the qualified pharmacy technician 188 or state-authorized pharmacy intern. 189 (12) The qualified pharmacy technician and state-authorized pharmacy 190 DRAFTintern must, if the patient is 18 years of age or younger, inform the 191 patient and the adult caregiver accompanying the patient of the 192 importance of a well-child visit with a pediatrician or other licensed 193 primary care provider and refer patients as appropriate. 194 (13) The supervising qualified pharmacist must comply with any 195 applicable requirements (or conditions of use) as set forth in CDC’s 196 COVID-19 vaccination provider agreement and any other federal 197 requirements that apply to the administration of COVID-19 198 vaccine(s). 199 D. The guidance document authorizes qualified pharmacy technicians and 200 state-authorized pharmacy interns to administer COVID-19 tests, including 201 serology tests, that the FDA has approved, cleared, or authorized. By 202 doing so, qualified pharmacy technicians and state-authorized pharmacy 203 interns will qualify as Covered Persons under the PREP Act and may 204 receive immunity under that same law. 205 206 10. The General Counsel of HHS issued Advisory Opinion 20-03 on October 23, 207 2020 to address three vaccination-related issues under the PREP Act: 208 (1) Does the PREP Act preempt state licensing laws that are less stringent 209 than the federal standards under the Third Amendment to the Secretary’s 210 March 10, 2020 Declaration? [short answer: no] 211 (2) May a state require a pharmacist to enter into a collaborative practice 212 agreement with a licensed physician as a condition of administering ACIP- 213 recommended vaccines to children between ages 3 and 18? [short 214 answer: no] 215 (3) Is epinephrine, when used to treat a severe acute vaccine reaction, a 216 Covered Countermeasure within the meaning of the PREP Act? [short 217 answer: yes] 218 219 11. The General Counsel of HHS issued Advisory Opinion 20-04 on October 23, 220 2020 to address the scope and meaning of a “program planner” under the PREP 221 Act as well as the breadth of PREP Act immunity. One of the examples cited in 222 the opinion is that of a pharmacy administering COVID-19 vaccines according to 223 CDC-recommended population priorities in the face of limited vaccine availability. 224 Pharmacies participating in vaccine administration may wish to review this 225 opinion. 226 227 12. On October 29, 2020, the ASOH in HHS issued additional guidance relative to 228 the PREP Act Declaration. This guidance extended the applicability of the 229 Secretary’s Third Amendment to include pharmacies as Covered Persons when 230 their staff pharmacists order and administer, or their pharmacy interns and 231 pharmacy technicians administer, Covered Countermeasures consistent with the 232 terms and conditions of the Secretary’s Declaration and guidance, as of the date 233 that these staff pharmacists, pharmacy interns and pharmacy technicians were 234 authorized to order and administer these Covered Countermeasures. The 235 guidance indicates this recognition authorizes pharmacies to submit claims for 236 reimbursement for testing or vaccine administration carried out by its staff 237 pharmacists, pharmacy interns and pharmacy technicians. 238 239 13. The HHS SecretaryDRAFT issued the Fourth Amendment to the Declaration Under 240 PREP Act for Medical Countermeasures Against COVID-19 (85 FR 79190) on 241 December 3, 2020. This amendment recognizes that multiple advisory opinions 242 and guidance documents have been issued since the Declaration was issued on 243 March 10, 2020. The Secretary republishes the Declaration as amended, in full, 244 to incorporate all prior amendments, advisory opinions and guidance. 245 A. Section V. Covered Persons was amended to add a new category: 246 healthcare personnel who are permitted to order and administer a 247 Covered Countermeasure through telehealth in a state may do so for 248 patients in another state as long as the healthcare personnel comply with 249 the legal requirements of the state in which the healthcare personnel are 250 permitted to order and administer Covered Countermeasures by means of 251 telehealth. 252 B. Section V. Covered Persons was also amended to make explicit that the 253 requirement for qualified persons to have a current certificate in basic 254 cardiopulmonary resuscitation is satisfied, by among other things, a 255 certification in basic cardiopulmonary resuscitation by an online program 256 that has received accreditation from the American Nurses Credentialing 257 Center (ANCC), the Accreditation Council for Pharmacy Education 258 (ACPE), or the Accreditation Council for Continuing Medical Education 259 (ACCME). 260 C. Section V. Covered Persons was further amended to specify the licensed 261 pharmacist desiring to order or administer vaccines must have completed 262 the immunization training that the licensing state requires in order for 263 pharmacists to administer vaccines. If the state does not specify training 264 requirements for licensed pharmacists to order and administer vaccines, 265 the licensed pharmacist must complete a vaccination training program of 266 at least 20 hours that is approved by the Accreditation Council for 267 Pharmacy Education (ACPE) to order administer vaccines. This training 268 program must include hands-on injection technique, clinical evaluation of 269 indications and contraindications of vaccines, and the recognition and 270 treatment of emergency reactions to vaccines. 271 D. Section XII. Effective Time Period was amended to clarify that liability 272 protections under the PREP Act began with the declaration of the public 273 health emergency on January 31, 2020 and will terminate upon the 274 earliest of (a) the final day the Declaration of Emergency is in effect, or (b) 275 October 1, 2024. An exception exists with respect to qualified persons 276 who order or administer a routine childhood vaccination that ACIP 277 recommends to persons ages three through 18 according to ACIP 278 standard immunization schedule; for these persons and countermeasures, 279 PREP Act coverage began on August 24, 2020. The termination date 280 shall be the same for all other Covered Persons and Covered 281 Countermeasures. 282 283 14. The General Counsel of HHS issued Advisory Opinion 21-01 on January 8, 2021 284 to address the scope of the preemption of the PREP Act. That office had 285 received numerous questions whether the PREP Act applies where a Covered 286 Person declined to use a Covered Countermeasure when it arguably ought to 287 have been use. The inquiries were stimulated by multiple lawsuits where 288 patients or theirDRAFT estates allege that patients contracted COVID-19 because the 289 healthcare facility failed to provide its staff with personal protective equipment 290 (PPE), failed to teach the staff how to properly use that equipment, or failed to 291 ensure that its staff used the PPE that it had been given. The Advisory Opinion 292 addresses those and other questions relative to the scope of the preemption of 293 the PREP Act. 294 295 15. The General Counsel of HHS issued Advisory Opinion 21-02 on January 12, 296 2021 in response to requests to clarify the meaning of the requirement that a 297 COVID-19 vaccination “must be ordered and administered according to ACIP’s 298 COVID-19 vaccine recommendations.” Some have raised concerns that 299 satisfying the Advisory Committee on Immunization Practices (ACIP) allocation 300 recommendations is a precondition of PREP Act coverage. It is not. 301 302 16. The HHS Secretary issued the Fifth Amendment to the Declaration Under PREP 303 Act for Medical Countermeasures Against COVID-19 (86 FR 7872) on January 304 28, 2021. The amendment adds two additional categories of personnel to 305 Section V. Covered Persons: 306 A. Any healthcare professional who holds a license to prescribe, dispense or 307 administer COVID-19 vaccines under the law of any state as of the 308 effective date of the amendment who prescribes, dispenses or administers 309 COVID-19 vaccines in any jurisdiction where the PREP Act applies, other 310 than the state in which the license is held, in association with a COVID-19 311 vaccination effort by a federal, state, local, tribal or territorial authority or 312 by an institution in the state, provided however that the license has not 313 been suspended or restricted by any licensing authority, surrendered while 314 under suspension, discipline or investigation by a licensing authority or 315 surrendered following an arrest and that the individual is not on the List of 316 Excluded Individuals maintained by the HHS Office of Inspector General, 317 subject to: 318 (1) Documentation of completion of the Centers for Disease Control & 319 Prevention (CDC) Vaccine Training Modules, and 320 (2) For those healthcare providers who are not currently practicing, 321 documentation of an observation period by a currently practicing 322 healthcare professional adequately experienced in vaccination who 323 confirms competency of the healthcare provider in preparation and 324 administration of the particular COVID-19 vaccine(s) to be 325 administered. 326 B. Any physician, advanced practice registered nurse, registered nurse or 327 practical nurse who has held an active license or certification to prescribe, 328 dispense or administer vaccines under the law of any state within the past 329 five years, which is inactive, expired or lapsed who prescribes, dispenses 330 or administers COVID-19 vaccines in any jurisdiction where the PREP Act 331 applies in association with a COVID-19 vaccination effort by a federal, 332 state, local, tribal or territorial authority or by an institution, provided 333 however that the license was active and in good standing prior to the date 334 it went inactive, expired or lapsed and was not revoked by the licensing 335 authority, surrendered while under suspension, discipline or investigation 336 by a licensing authority or surrendered following an arrest and that the 337 individualDRAFT is not on the List of Excluded Individuals maintained by the HHS 338 Office of Inspector General, subject to: 339 (1) Documentation of completion of the CDC Vaccine Training 340 Modules, and 341 (2) Documentation of an observation period by a currently practicing 342 healthcare professional adequately experienced in vaccination who 343 confirms competency of the healthcare provider in preparation and 344 administration of the particular COVID-19 vaccine(s) to be 345 administered. 346 347 17. The HHS Acting Secretary issued the Sixth Amendment to the Declaration Under 348 PREP Act for Medical Countermeasures Against COVID-19 (86 FR 9516) 349 effective February 16, 2021. This amendment adds one additional category of 350 personnel to Section V. Covered Persons – any federal government employee, 351 contractor, or volunteer who prescribes, administers, delivers, distributes or 352 dispenses a Covered Countermeasure. Such federal government employees, 353 contractors, or volunteers are qualified persons if the following requirement is 354 met: the executive department or agency by or for which the federal employee, 355 contractor, or volunteer is employed, contracts, or volunteers has authorized or 356 could authorize that employee, contractor, or volunteer to prescribe, administer, 357 deliver, distribute or dispense the Covered Countermeasure as any part of the 358 duties or responsibilities of that employee, contractor, or volunteer, even if those 359 authorized duties or responsibilities ordinarily would not extend to members of 360 the public or otherwise would be more limited in scope than the activities such 361 employees, contractors, or volunteers are authorized to carry out under this 362 declaration. 363 One practical application of this expansion will be pharmacy personnel 364 recruited by the Federal Emergency Management Agency (FEMA) to staff 365 federally supported vaccination sites. 366

DRAFT 1 Louisiana Board of Pharmacy Policies & Procedures 2 3 Title: Allowance for Virtual Competency Demonstration 4 For Certification in Basic Cardiopulmonary 5 Resuscitation Policy No. I.A.34 6 7 Approved: Draft #1 8 9 10 1. Section 521 of the Board’s rules establish the requirements to qualify for the 11 Medication Administration (MA) registration, one of which is the acquisition and 12 maintenance of a current certification in the American Heart Association’s Basic 13 Cardiac Life Support for Healthcare Provider, its successor, or board-approved 14 equivalent. 15 16 2. One of the consequences of the physical distancing requirements during the 17 COVID-19 public health emergency has been the disruption of services from 18 providers offering education and training for certification in basic cardiopulmonary 19 resuscitation. In particular, the providers have not been able to offer their usual 20 opportunities for hands-on demonstrations of competency in traditional physical 21 settings. 22 23 3. Some providers have constructed alternative options employing virtual 24 demonstrations of competency, and further, have enhanced the quality of their 25 instructional programs by achieving accreditation through one or more of three 26 accrediting organizations: American Nurses Credentialing Center (ANCC), the 27 Accreditation Council for Pharmacy Education (ACPE), or the Accreditation 28 Council for Continuing Medical Education (ACCME). 29 30 4. Several stakeholders have requested guidance from the Board as to whether 31 certifications in basic cardiopulmonary resuscitation obtained pursuant to virtual 32 competency demonstrations acquired from accredited program providers are 33 compliant with the requirements identified in Section 521 of the Board’s rules. 34 35 5. The Board now interprets LAC 46:LIII.521 such that a certification in basic 36 cardiopulmonary resuscitation, at the Basic Cardiac Life Support for Healthcare 37 Provider level, its successor, or board-approved equivalent, which employs 38 virtual competency demonstrations within an educational program accredited by 39 the American Nurses Credentialing Center (ANCC), the Accreditation Council for 40 Pharmacy Education (ACPE), or the Accreditation Council for Continuing Medical 41 Education (ACCME), complies with the requirements of that rule. 42 DRAFT Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Executive Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

M E M O R A N D U M

To: Board Members

From: Malcolm Broussard

Date: February 24, 2021

Re: Review of Interim Policies

The state declaration of the COVID-19 public health emergency was issued on March 11, 2020, has been renewed continuously since then, and is now scheduled to conclude on March 3, 2021 unless extended or terminated sooner.

Current Exp Proposed Exp

PPM.I.D.1 State of Emergency Duration of PHE Same Reg. Project 2020-12 @ Public Hearing

PPM.I.D.2 Sterile Cmpdg Allowances CDC Duration of PHE Same

PPM.I.D.4 Cmpdg Hand Sanitizer OTC Sale Duration of PHE Same

PPM.I.D.5 Temp Ext Exp Date of MA Registration 02-28-2021 02-28-2021 Noticed 12-03-2020

PPM.I.D.7 PHY-HOS (Storage, Cmpdg, OutPt) Duration of PHE Same

PPM.I.D.8 PHY-TM (Deliveries) Duration of PHE Same Reg Project 2020-11 @ Public Hearing

PPM.I.D.9 Remote Practice for all licensees Duration of PHE Same

PPM.I.D.10 EDK Inspections Duration of PHE Same

PPM.I.D.12 Flexible Staffing Ratios 02-28-2021 02-28-2021 Noticed 12-03-2020

NOTICE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. NOTICE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about the Board’s actions or procedures. You may submit such complaints to one or more of the following: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr., Baton Rouge, La 70809; 225.925.6496; [email protected] (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected] (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]

Current Exp Proposed Exp

PPM.I.D.14 Temporary Closure of Pharmacies Duration of PHE Same

PPM.I.D.15 Criminal History Record Checks 02-28-2021 02-28-2021 Noticed 12-03-2020

PPM.I.D.16 Verbal C-II Prescriptions Duration of PHE Same

PPM.I.D.18 Re-stocking AMS devices 02-28-2021 02-28-2021 Noticed 12-03-2020

PPM.I.D.19 CE for PST Renewal for 2021 02-28-2021 02-28-2021 Noticed 12-03-2020

PPM.I.D.20 Therapeutic Interchange Duration of PHE Same

PPM.I.D.21 Distribution of Controlled Substances Duration of PHE Same

PPM.I.D.22 Marijuana Recommendations via email Duration of PHE Same

PPM.I.D.24 PHY-HOS Outpt Dispensing Limits Duration of PHE Same

PPM.I.D.27 Special Work Permit Non-Licensed PST Duration of PHE 02-28-2021

The state declaration of emergency for Hurricane Laura was issued on August 21, 2020, has been renewed continuously since then, and is now scheduled to conclude on February 16, 2021 unless extended or terminated sooner.

PPM.I.D.26 Verbal TM orders for SOE-Laura 02-28-2021 02-28-2021 Noticed 12-03-2020

The following interim policies have already expired:

PPM.I.D.3 Remote Practice for Pharmacists 04-20-2020

PPM.I.D.6 Credentialing Actions (PNT, PTC, CDS) 09-30-2020

PPM.I.D.11 Dispensing Limitations CQ/HCQ 11-18-2020

PPM.I.D.13 Passport Non-licensed Personnel 07-31-2020

PPM.I.D.17 CDS Annual Inventory 11-18-2020

PPM.I.D.23 Dispensing Limits Marijuana Products 09-20-2020

PPM.I.D.25 Non-licensed PST/CPT for SOE-Laura 11-18-2020

NOTICE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. NOTICE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about the Board’s actions or procedures. You may submit such complaints to one or more of the following: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr., Baton Rouge, La 70809; 225.925.6496; [email protected] (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected] (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]

1 Louisiana Board of Pharmacy Policies & Procedures 2 3 Title: Governance Policy No. I.B.2 4 5 Approved: 08-15-2018 Draft #1 6 7 8 1. The organization and governance of the Board is described at RS 37:1179. 9 10 2. The organization and governance of the Board is also described at LAC 11 46:LIII.103. 12 13 3. Officers; Duties 14 A. President 15 (1). The president is the executive officer of the board. 16 (2) The president shall preside at all meetings of the board and shall 17 be responsible for the performance of all duties and functions of the 18 board required or permitted by the Pharmacy Practice Act. 19 (3) The president shall sign all checks or other methods of 20 disbursement, together with the executive director. 21 (4) The president may administer oaths in connection with the duties of 22 the board. 23 (5) The president may review and respond to requests for exceptions 24 to laws, rules, and policies in the interim between meetings of the 25 board. 26 B. First Vice President 27 (1) In the absence of the president, the first vice president shall 28 preside at meetings of the board. 29 (2) The first vice president shall perform other duties as assigned by 30 the board. 31 (3) In the event the president is unable to act, the first vice president 32 may sign all checks or other methods of disbursement, together 33 with the executive director. 34 C. Second Vice President 35 (1) In the absence of the president and first vice president, the second 36 vice president shall preside at meetings of the board. 37 (2) The second vice president shall perform other duties as assigned 38 by the board. 39 (3) In the event the president and first vice president are unable to act, 40 the second vice president may sign all checks or other methods of 41 disbursement, together with the executive director. 42 D. Third Vice President (1) DRAFTIn the absence of the president and other vice presidents, the third 43 44 vice president shall preside at meetings of the board. 45 (2). The third vice president shall perform other duties as assigned by 46 the board. 47 (3) In the event the president, first vice president and second vice 48 president are unable to act, the third vice president may sign all 49 checks or other methods of disbursement, together with the 50 executive director. 51 E. Secretary 52 (1) The secretary of the board shall be responsible for supervising the 53 board member nomination election process. 54 a. The secretary shall ensure the distribution of nomination 55 election ballots to every licensed pharmacist in the pharmacy 56 district in which a vacancy is anticipated or has occurred. 57 b. The secretary shall supervise the counting of the nomination 58 election ballots. 59 c. The secretary shall certify to the governor the names of the 60 three nominees receiving the highest number of nominations 61 d. In the absence of the secretary, or in the event of his 62 inability or failure to act, the duties of the secretary with 63 respect to the mailing and counting of ballots and the 64 certification to the governor shall be performed by the 65 president of the board. 66 (2) Following their approval by the board, the secretary shall sign the 67 minutes of board meetings and ensure their posting in the Minute 68 Book. 69 (3) The secretary may administer oaths in connection with the duties of 70 the board. 71 72 4. Election of Officers; Term; Removal 73 A. The officers shall be elected by the board members, for a term beginning 74 on the day of their election and ending upon election of their successors. 75 B. The board shall conduct officer elections annually. By tradition, the 76 election is conducted during the final scheduled board meeting of a 77 calendar year, which historically has been the month of November. 78 C. The president may call a special election at any board meeting to fill a 79 vacancy in one or more officer positions. An officer elected to a vacant 80 position shall serve for the remainder of that term, at which time an 81 election shall occur commensurate with the annual election. 82 D. Any officer may be removed from office by majority vote of the board, for 83 proper cause after due notice and an opportunity to be heard. 84 85 86 87 88 89 90 91 92 DRAFT 93 94 95 96 97 98 99 Revision History 100 101 102 02-24-2021 (1) Re-numbered items. 103 (2) Added provisions for each of the vice presidents to have 104 signature authority for checks and other financial 105 disbursements in the event higher-ranking officers are 106 unable to act. 107 108

DRAFT 1 Louisiana Board of Pharmacy Policies & Procedures 2 3 Title: Application for New Resident Pharmacy Permit (in-state) Policy No. III.B.6 4 5 Approved: 02-19-2019 Draft #1 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 through 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. 25 i. by collecting specific information for every natural person with any 26 direct or indirect ownership interest in the pharmacy, specifically: 27 (a) Full legal name, date of birth, and Social Security number; 28 (b) Mailing address and telephone number; 29 (c) Percentage of ownership or fraction thereof; 30 (d) Evidence of any professional license or other credential 31 issued by any state government agency (either legible copy 32 or website verification thereof), and further, whether or not 33 the credential has ever been sanctioned or disciplined by 34 any state licensing agency or by any local, state, or federal 35 government agency, or by any local, state, or federal court. 36 In the event of any such sanction or discipline, or in the 37 event an application for such credential has ever been 38 denied or refused by any jurisdiction, a copy of the board, 39 agency, or court decision document shall be included in the 40 application; provided however, 41 (e) For natural persons holding less than 5% ownership, the 42 production of the following data may be waived: 43 DRAFT> date of birth; 44 > Social Security number; and 45 > professional licensure information. 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 (a) Full legal name and Federal Employment Identification 50 Number, as evidenced by a copy of the Internal Revenue 51 Service (IRS) letter assigning that number, or in the 52 alternative, a signed W-9 form; 53 (b) Mailing address and telephone number; 54 (c) Percentage of ownership or fraction thereof; and 55 (d) An accounting of 100% of the ownership thereof. 56 C. Describe the pharmacy’s location and credentials issued by other 57 agencies; 58 D. Identify the special professional services intended for Louisiana residents; 59 E. Identify the Pharmacist-in-Charge, and further, assist in the determination 60 of his fitness for practice in that capacity; and 61 F. Confirm the owner’s consent for the Pharmacist-in-Charge to submit the 62 application for the pharmacy permit on behalf of the owner. 63 64 4. The application form shall instruct the applicant to cause the following persons 65 identified in their application to submit to a criminal background check (CBC): 66 A. Pharmacist-in-Charge; and 67 B. Any natural person holding 20% or more ownership interest at the direct or 68 indirect level; provided, however, that this requirement may be waived in 69 the event that person has already submitted to such CBC for the Board 70 and that CBC report was received less than five years prior to the date of 71 the application for the permit. 72 73 5. The application package should also contain additional guidance information for 74 the applicant as well as a summary checklist designed to ensure the submission 75 of all additional required documents. 76 77 6. All applications shall be referred to the Credentials Division staff for processing. 78 A. In the event the staff determines there are deficiencies in the application 79 or supporting materials, the staff shall communicate with the applicant to 80 assist them in compiling a complete application. 81 B. In the event the staff determines there is information (e.g., prior 82 disciplinary or legal action) impacting qualifications or fitness for practice, 83 staff shall refer the completed application to an administrative officer, for a 84 determination as to whether a referral to a Board committee is warranted. 85 i. In the event the administrative officer determines no committee 86 referral is warranted, the administrative officer shall annotate the 87 application form and return it to licensing staff for final 88 administrative review and issuance of the permit. 89 ii. In the event the administrative officer determines a referral to a 90 Board committee is warranted, he shall assign a case number to 91 DRAFTthe application, schedule a hearing before the appropriate 92 committee, and notify the applicant of the hearing, ensuring 93 compliance with due process requirements. 94 C. In the event staff determines the applicant does not meet all of the 95 licensing criteria and the applicant wishes to appeal that staff 96 determination, staff shall direct the applicant to submit a written appeal to 97 the Executive Director. The Executive Director shall present the appeal 98 and relevant information from the applicant’s file to the Board President. 99 The Board President shall have the authority to review such appeals and 100 determine whether to grant such requests, either in part or in full. The 101 Executive Director shall notify the applicant and the licensing staff of the 102 President’s decision. 103 104 7. When the licensing staff has compiled a completed application, the applicant 105 shall be instructed to contact the pharmacist compliance officer for that part of 106 the state to arrange a site inspection at a mutually agreeable time. When the 107 compliance officer has completed the inspection and verified compliance with the 108 minimum standards, the compliance officer shall notify the licensing staff to issue 109 the permit. ascertain whether the applicant is prepared to open for business 110 immediately or in the alternative requests an additional period of time before 111 opening for business. 112 113 8. When the licensing staff has completed the processing of the application, the 114 staff may issue the permit if they have been delegated the authority to issue it, or 115 in the alternative, shall refer the application to the licensing manager for final 116 review and issuance of the permit. 117 A. In the event the applicant intends to open for business immediately, the 118 permit shall be issued in active status with a notation it is valid for practice. 119 1. The compliance officer shall monitor the permit to ensure it is open 120 for business no later than 30 days after the issuance of the permit. 121 2. In the event the pharmacy has not opened for business, the 122 compliance officer shall request the permit holder relinquish the 123 permit. In the event the permit holder refuses to relinquish the 124 permit, the licensing staff shall inactivate the permit. 125 B. In the event the applicant requests an additional period of time before 126 opening for business, the permit shall be issued in active status with a 127 notation it is not yet open for business. 128 i. When a permit was issued with a notation it is not yet open for 129 business, the permit holder shall contact the compliance officer for 130 a second site inspection before opening for business. When the 131 compliance officer has completed the inspection and verified 132 compliance with the minimum standards, the compliance officer 133 shall notify the licensing staff to update the status of the permit to 134 active and valid for practice. 135 ii. No permit shall remain in active status with a notation it is not yet 136 open for business for a period of time longer than nine months. In 137 the event such permit is unable to open for business within nine 138 months, the permit holder shall relinquish the permit. In the event 139 the permit holder refuses to relinquish the permit, the licensing staff 140 DRAFTshall inactivate the permit. 141 iii. The holder of a permit in active status with a notation it is not yet 142 open for business may renew that permit while in that status. 143 iv. The holder of a relinquished permit may not renew it but may apply 144 for the reinstatement of it. 145 Revision History 146 147 148 02-24-2021 > Amended Item 7 to provide an opportunity for a new 149 pharmacy permit to temporarily delay its opening for 150 business while it pursues contracts and agreements 151 necessary for its business operations. 152 > Amended Item 8 to provide procedures for permits not yet 153 open for business. 154 155 02-19-2019 > Amended Item 3.B.i to add new (e) to allow for a waiver 156 from the requirement to declare certain information for 157 persons holding less than 5% share ownership. 158 159 11-14-2018 > Re-numbered policy; 160 > Added Item 7 to add the requirement for an initial 161 inspection prior to issuing the permit. 162 163 02-21-2018 > Amended the definition of “indirect” ownership in Item 3.B 164 to remove the multiple levels. 165 > Deleted the previous exclusion from the requirement for 166 the provision of information relative to prior disciplinary 167 actions originally found in Item 3.B.i.(d). 168 > Deleted the requirement for complete information for all 169 levels of indirect ownership originally found in Item 3.B.ii.(d). 170 > Deleted the requirement for the identification of the 171 pharmacy’s registered agent for the service of process 172 originally found in Item 3.D. 173 > Deleted the requirement for the identification of the 174 Owner’s Managing Officer originally found in Item 3.F. 175 > Added a new requirement at Item 3.F for a corporate 176 resolution authorizing the Pharmacist-in-Charge to execute 177 the application for the applicant. 178 > Deleted the requirement for a criminal background check 179 (CBC) for the Owner’s Managing Officer, originally found at 180 Item 4.A. 181 DRAFT Technician Program Information

Sullivan University

http://www.sullivan.edu/

2100 Gardiner Lane Code: KY-02 Louisville KY 40205

Accreditation Status: Accredited Category: Technical Training Organization Type: University Sub-Category: Entry and Advanced (400 or 600)

Program Director Reporting Administrator

Misty Stutz Pharm.D. Cindy Stowe Pharm. D.

(502) 413-8964 (502) 413-8640

Email: [email protected] Email: [email protected]

Program Contact

Sarah Lisenby B.A., CPhT

(502) 413-8996

Email: [email protected]

Certicate Degree

Prerequisite course work: High School Prerequisite course work: High School Diploma/ GED Diploma/ GED

Didactic course work: 302 Contact Hours Didactic course work: 362 Contact Hours

Laboratory course work: 50 Contact Hours Laboratory course work: 100 Contact Hours

Experiential Training: 200 Contact Hours Experiential Training: 300 Contact Hours

Lecture class size: 10-20 Lecture class size: 10-20

Laboratory class size: 5-10 Laboratory class size: 5-10

Spaces per entering class: 30 Spaces per entering class: 30

Total Hours of Program: 552 General education courses: 8 Credit Hours

Other: Entry-Level Program- 36 Credit Hours Total: 762 Contact Hours Other: Advanced Level Program- 56 Credit

Hours

Faculty or Sta Enrollment

Pharmacists: 22 Interview required: No

Technicians: 1 Flexible scheduling allowed: Yes

Lab/clerical support: 1 Tuition costs: $320/hour

Director: Misty M Stutz PharmD Book/Supply costs: $600/quarter

Core Instructors: Sarah Lisenby CPhT Uniform costs: Included

Pharmacy students: Yes Lab/other fees: lncluded

Ph.D: Yes- Pharmaceutical Sciences Liability insurance: Included

Department Enrollment fee: $30/quarter

Dept. chair: Misty M Stutz PharmD Drug screening: Required

Secretarial support: Karen Nelson PTCB exam fee: Included

Training Manage/Coordinator: Sarah College credits: Yes Lisenby CPhT Background check fee: Included

Required testing: Immunizations for Health Care Providers

Class Scheduling: Day/Full-time

Laptop Computer: Technology requirements for on-line curriculum

Experiential Training Sites Technician Training Demographics

Community pharmacy: Varies per state Special Program Features: Sullivan

Hospital: Varies per state University oers an on-line community pharmacy technician certicate (entry-level) Managed care: Varies per state to prepare students for a career in

Nuclear pharmacy: Varies per state community pharmacy. We also oer a

Long-term care: Varies per state diploma (advanced-level) to prepare students for a career in institutional pharmacy. The Compounding Pharmacy: Varies per state pharmacy technician program is housed Home infusion: Varies per state within the College of Pharmacy and Health Other: Aliation Agreements managed Sciences and provides a progressive through the Oce of Experiential Education curriculum taught by pharmacists and certied pharmacy technicians. This program is an American Society of Health-System Pharmacists and American Council for Pharmacy Education accredited educational training program. The program prepares pharmacy technician students to pursue their

Pharmacy Technician Certication Board certied pharmacy technician (CPhT) credential. For more information, please visit our website: : https://sullivan.edu/college-of- pharmacy-and-health-sciences/”

Acceptance Requirements: H.S. diploma or GED equivalency, ACT/SAT scores, Sullivan University admission test score, transcripts.

General Location Training Sites: Louisville metropolitan area

Special Requirements : Drug screen, background check, immunizations for health- care providers

Academic Degree: Certicate/ Diploma

Program Comment: Certicate PHT 101 Intro to Pharmacy Technician

PHT 105 Pharmaceutical Calculations

MSS 104 Medical Terminology

PHT 150 Pharmacotherapeutics I

MSS 154 Health and Safety Techniques

PHT 203 Community Pharmacy Operations

PHT 151 Pharmacotherapeutics II

PHT 201 Pharmacy Law and Ethics PHT 299 Pharmacy Externship Total Credit Hours 36

Diploma

FYE 101 Information Literacy MSS 104 Medical Terminology MSS 154 Health and Safety Techniques MTH 101 College Mathematics PHT 101 Introduction to Pharmacy Technician PHT 105 Pharmaceutical Calculations PHT 150 Pharmacotherapeutics I PHT 151 Pharmacotherapeutics II PHT 201 Pharmacy Law and Ethics PHT 203 Community Pharmacy Operations

PHT 204 Institutional Pharmacy Operations

PHT 206 Sterile Compounding

PHT 209 Medication Safety

PHT 297 Pharmacy Externship

PHT 299 Pharmacy Externship

Total Credit Hours 56

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My eBooks Library ASHP Foundation 1-866-279-0681  ASHP Advantage SafeMedication.com

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23 October 2020 Prepared for: Malcolm J. Broussard, LA Board of Pharmacy, Baton Rouge, LA 70809

LBP CONTENT MANAGEMENT SYSTEM UPGRADE & WEBSITE REDESIGN PROPOSAL

Covalent Logic proposes to upgrade the Louisiana Board of Pharmacy (LBP) current content management system (CMS) to the newest Covalent framework. In addition to the upgrade, Covalent Logic will re-integrate the current website design into the new CMS. The CMS is engineered to place ultimate control in your hands, while providing a wide range of aesthetic and functional flexibility. Some of the improvements offered by the new Covalent CMS will include:

• Implementation of an SEO-friendly URL structure • Page builder templates • Drag-and-drop page builder page segments • Drag-and-drop file manager • Multiple navigation levels • Mega menus • Image cropping and resizing from within the file manager tool • Automatic file renaming from within the file manager tool • Event instance management from within the calendar manager tool • Auto-complete/predictive searching from the website • Enhanced form manager with more layout customization features • Mobile-friendly CMS interface • Faster load speeds • Increased security against DDOS, SQL injection and phishing attacks

The LBP content management system includes these modules to be upgraded:

NAVIGATION MANAGER Dynamically controls the site's navigation and creates new page titles. It allows the administrator to control the order of navigation as well as the navigation hierarchy.

HOME PAGE MANAGER Allows a site administrator to manipulate what is visible on the home page, such as a Latest Updates section, promotional imagery or other content.

ADMINISTRATOR MANAGER Allows master administrators to create sub-administrators for delegating tasks and assigning editing privileges for specific pages and tools.

PAGE BUILDER Allows the site administrator to create, edit and delete custom general information pages. Central to this feature is a word processing tool that gives the user a familiar environment to create, edit and delete content; create tables; add images; and format content.

NEWSROOM Press releases, white papers and articles, as well as web resources (such as Word docs, PowerPoint presentations and website links), are organized in categories for easy establishment of each item’s value and urgency. Each “article” can be associated with a caption, image, teaser, etc. Articles are then shown on the site by date and paginate on the Newsroom page. News headlines and teasers can be listed on the home page where design dictates. Headlines will link to the full news article page, file or off-site URL. This tool includes RSS feeds and an embedded video player.

FILE MANAGER Allows the site administrator to upload, delete, move, rename, crop and resize files and create a storage directory structure for files uploaded to pages and other tools. There is no storage limit associated with this space.

CALENDAR Allows the site administrator to add, delete and edit multiple event listings and enables management of multiple and recurring instances. Each event can be organized into categories and can include a URL link, description, location and time details or any other specific information necessary.

COMMUNICATION MANAGER This tool enables you to develop and send sophisticated, professional and attractive messages to your audience segments by the demographics that make the most sense for your organization. This system is different from any other off-the-shelf communications tool because it allows your organization to keep all information and communications central to one system and database.

2

URL ALIAS A URL alias provides a simpler way for a visitor to get to a specific location within your website by simply typing its corresponding alias into the address bar. In this tool you can set up dozens of URL aliases for your website simply by picking an alias (yourwebsite.com/alias) and a resolved URL (the actual location of the page). The tool also allows you to edit or delete prior URL aliases you have set up.

FORM MANAGER Forms provide a convenient way for users to submit information to you. Using text fields, radio buttons, checkboxes and drop-down menus, you can create unlimited forms that will send information via email and store submissions in a secure database.

GLOBAL PROPERTIES Global Properties allows you to update site-wide properties such as default page title, meta tags in the 'head' area, and content in the footer area of your web pages. These properties help search engines find your site and display relevant information properly.

RESTRICTED AREA MANAGER Restricted Area Manager will allow specific LBP users and/or user groups access to files and information intended for their eyes only. Cost: $45,365

DATA MIGRATION

All existing data in the current LBP CMS will need to be programmatically moved to the upgraded content management system. Cost: $4,485

3

WEBSITE REDESIGN

More than simply an attractive façade applied to an old website, LBP desires to redesign its website and content to be a more modern design and easily navigated across desktop, mobile and tablet devices, enhancing accessibility to its users. If developed properly and managed effectively, your website can help serve the process of achieving its goals and objectives by guiding all strategic communications going forward. The current website needs the following upgrades:

• A modern aesthetic coordinated with the look and feel of the other Louisiana government boards and agencies • A responsive design that works on mobile, tablet and desktop • An upgraded WYSIWYG (what you see is what you get) editor

The Covalent Logic website design process begins with two to three graphic variations, mock- ups of the home page. From this presentation, the chosen creative direction is refined based on your feedback and a second presentation is made. Additional input is gathered prior to a final presentation. The site will be fully responsive, allowing the site to be fully optimized on all mobile platforms including smartphone and tablet, horizontal and vertical. Features will adjust so that the whole site is viewable on any size device, allowing users ultimate flexibility. This site design will include a custom look and feel, color palette and font styles. The site will include Google Analytics, and social sharing will be implemented on the site. Covalent Logic will update the What You See Is What You Get (WYSIWYG) editor in the content management system (CMS) to the latest version, as well as updating the styles of the content management tool to work with the new site design wrapper. Once the creative direction is approved, a multitude of page templates and style elements will be designed to fully flesh out the site including: • Page Builder • Newsroom • Calendar • Forms • Email Newsletter Template Each template is allotted two rounds of client revisions. Once complete and approved, the design is optimized and tested in multiple browsers and will be integrated with a content management system. Cost: $25,000

4

COLDFUSION, MYSQL & SERVER CONFIGURATION

Includes:

• Adobe ColdFusion 2020 Server Installation/Configuration* • MySQL Server Installation/Configuration • Web Server (IIS) Configuration • Web Application Deployment

Cost: $1,475

* Adobe ColdFusion 2020 to be purchased by LBP

PROJECT INITIATION AGREEMENT

During this project, the client will receive programming services as described in this proposal. The lump sum price for this project is $76,325. A date-specific timeline detailing the work process and estimated delivery dates shall be provided upon initiation of development. Services beyond the scope of this project will be identified, estimated and billed at the following hourly rates:

Programming: $250 / hour Consulting: $250 / hour Graphic and Web Design: $200 / hour

Copywriting: $125 / hour Project Management: $150 / hour Audio/Video: $150 / hour Data Entry: $75 / hour Research: $75 / hour Web Maintenance: $50 / hour

If the client should choose to terminate development at any time in the process of this project, Covalent Logic will process bill for the work completed. All invoices are due upon receipt. To initiate this project, please sign below indicating acceptance of the proposed scope of services and payment terms.

5

LBP Representative Covalent Logic Representative

Signature Date Signature Date

6 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Report of Assistant Executive Director

PRESCRIPTION MONITORING PROGRAM (PMP)

BOARD MEETING – FEBRUARY 24, 2021

1 Number of Eligible Prescription Transactions Reported to the PMP

Reporting through 12/31/2020

14,000,000

12,000,000

10,000,000

8,000,000

6,000,000

4,000,000

2,000,000

0 2,011 2,012 2,013 2,014 2,015 2,016 2,017 2,018 2,019 2,020 RXs 12,584,423 12,989,950 13,032,083 13,020,364 12,350,904 12,289,457 11,967,339 11,303,599 10,847,175 10,288,692 2 PMP Reporting Comparisons

Reporting through 12/31/2020

14,000,000 All RXs Reported to PMP

Only CDS RXs for LA Residents 12,000,000 Opioid RXs for LA Residents 10,000,000

8,000,000

6,000,000

4,000,000 Number of Prescriptions 2,000,000

0 CY2015 CY2016 CY2017 CY2018 CY2019 CY2020 All RXs Reported to PMP 12,350,904 12,289,457 11,967,339 11,303,599 10,847,175 10,288,692 Only CDS RXs for LA Residents 11,595,884 11,611,045 11,308,677 10,679,449 10,222,392 9,683,654 3 Opioid RXs for LA Residents 5,520,061 5,451,228 5,171,676 4,636,580 4,278,909 3,886,659 Opioid Prescriptions for Louisiana Residents

6,000,000

5,000,000

4,000,000

3,000,000 Opioid RXs for LA Residents

Opioid RXs Not Including Number of Prescriptions of Number 2,000,000 Opiate Partial Agonists

1,000,000

0 CY2015 CY2016 CY2017 CY2018 CY2019 CY2020 Opioid RXs for LA Residents 5,520,061 5,451,228 5,171,676 4,636,580 4,278,909 3,886,659 Opioid RXs Not Including Opiate Partial Agonists 5,218,939 5,157,618 4,882,586 4,353,572 3,988,576 3,589,380 4 2020 Top 10 Controlled Substance Prescriptions Dispensed to Louisiana Patients by Generic Drug Name

5 2020 Top 10 Controlled Substance Prescriptions Dispensed to Louisiana Patients by Drug Label Name

6 Hydrocodone /APAP Dispensing by Number of Prescriptions to Louisiana Residents

3,000,000

2,372,111 2,500,000 2,304,313 2,141,223 2,000,000 1,907,472 1,746,499 1,603,541 1,500,000

1,000,000

Number of Prescriptions 500,000

0 2015 2016 2017 2018 2019 2020 7 Calendar Year Hydrocodone /APAP Dispensing by Number of Dosage Units to Louisiana Residents

160,000,000 142,638,418 140,000,000 135,928,408 122,545,454 120,000,000 105,128,176 93,016,762 100,000,000 84,231,522 80,000,000

60,000,000

Number of Dosage Units Dosage of Number 40,000,000

20,000,000

0 2015 2016 2017 2018 2019 2020 Calendar Year 8 Hydrocodone /APAP Dispensing by Number of Louisiana Patients

900,000 825,198 813,119 800,000 770,346 693,181 700,000 638,109 576,566 600,000

500,000

400,000

300,000 Number of Patients 200,000

100,000

0 2015 2016 2017 2018 2019 2020 Calendar Year 9 PMP User Stats for 2020Q4 (10/01/2020 - 12/31/2020) Number of Providers Number of Number of PMP Number of PMP Eligible Providers with Requests by Requests by for PMP Access Active PMP Access Providers through Providers through (as of 12/30/2020) Privileges (as of AWARxE® Gateway® 12/30/2020) During 2020Q4 During 2020Q4 PMP Healthcare Provider Role Physician (MD, DO) 13,380 8,853 443,852 3,711,498 Nurse Practitioner (APRN) 4,038 3,161 177,237 409,686 Dentist (DDS) 2,249 1,520 4,915 529 Physician Assistant (PA) 1,083 818 24,447 48,260 Optometrist (OD) 370 156 4 0 Podiatrist (DPM) 163 108 1,186 0 Medical Psychologist (MP) 95 88 11,431 4,599 Medical Intern/Resident 1,625 1,293 11,156 1,752 Prescriber's Delegate NA 3,012 197,841 0 Pharmacist (PST) 9,407 4,704 899,992 1,751,008 Pharmacist's Delegate NA 1,307 82,083 0 Totals 32,410 25,020 1,854,144 5,927,332

PMP User Stats for 2020Q3 (07/01/2020 - 09/30/2020) Number of Providers Number of Number of PMP Number of PMP Eligible Providers with Requests by Requests by for PMP Access Active PMP Access Providers through Providers through (as of 09/30/2020) Privileges (as of AWARxE® Gateway® 09/30/2020) During 2020Q3 During 2020Q3 PMP Healthcare Provider Role Physician (MD, DO) 13,369 8,933 452,588 3,543,026 Nurse Practitioner (APRN) 3,986 3,096 170,679 390,678 Dentist (DDS) 2,254 1,558 5,168 471 Physician Assistant (PA) 1,057 790 22,138 37,802 Optometrist (OD) 365 156 3 0 Podiatrist (DPM) 168 112 925 0 Medical Psychologist (MP) 92 85 11,518 4,276 Medical Intern/Resident 1,682 1,308 7,274 1,497 Prescriber's Delegate NA 2,918 206,072 0 Pharmacist (PST) 9,354 4,609 885,776 1,686,135 Pharmacist's Delegate NA 1,250 75,886 0 10 Totals 32,327 24,815 1,838,027 5,663,885 PMP User Stats for 2020Q2 (04/01/2020 - 06/30/2020) Number of Providers Number of Number of PMP Number of PMP Eligible Providers with Requests by Requests by for PMP Access Active PMP Access Providers through Providers through (as of 06/30/2020) Privileges (as of AWARxE® Gateway® 06/30/2020) During 2020Q2 During 2020Q2 PMP Healthcare Provider Role Physician (MD, DO) 13,425 8,798 403,406 2,368,679 Nurse Practitioner (APRN) 3,880 2,997 137,058 331,578 Dentist (DDS) 2,327 1,551 4,489 388 Physician Assistant (PA) 1,030 766 19,460 32,194 Optometrist (OD) 363 153 5 0 Podiatrist (DPM) 167 109 619 0 Medical Psychologist (MP) 93 86 7,090 3,302 Medical Intern/Resident 1,211 1,145 6,163 1,415 Prescriber's Delegate NA 2,851 185,906 0 Pharmacist (PST) 9,147 4,448 690,478 1,513,016 Pharmacist's Delegate NA 1,171 60,637 0 Totals 31,643 24,075 1,515,311 4,250,572

PMP User Stats for 2020Q1 (01/01/2020 - 03/31/2020) Number of Providers Number of Number of PMP Number of PMP Eligible Providers with Requests by Requests by for PMP Access Active PMP Access Providers through Providers through (as of 04/30/2020) Privileges (as of AWARxE® Gateway® 04/30/2020) During 2020Q1 During 2020Q1 PMP Healthcare Provider Role Physician (MD, DO) 13,256 8,787 432,010 2,909,780 Nurse Practitioner (APRN) 3,816 2,962 125,520 411,263 Dentist (DDS) 2,272 1,552 5,694 634 Physician Assistant (PA) 1,014 765 22,884 50,595 Optometrist (OD) 359 154 10 0 Podiatrist (DPM) 164 110 481 0 Medical Psychologist (MP) 93 86 6,613 0 Medical Intern/Resident 1,206 1,128 6,122 0 Prescriber's Delegate NA 2,790 207,340 0 Pharmacist (PST) 9,098 4,411 529,249 1,685,883 Pharmacist's Delegate NA 1,116 52,975 0 11 Totals 31,278 23,861 1,388,898 5,058,155 Louisiana Prescriber & Pharmacist Searches through AWARxE® and Gateway®

(Ending 12/31/2020) 25,000,000 AWARxE (website) 20,899,944 20,000,000 Gateway (integration)

15,000,000 12,647,016

10,000,000

5,175,260 6,596,380 4,383,714 5,000,000 3,512,840 4,028,104 Number Number of PMP Searches 2,514,374 2,906,904 918,973 0 155,730 0 2015 2016 2017 2018 2019 2020 Calendar Year

12 PMP Statewide Integration Project through Gateway®

As of January 1, 2021, the Louisiana PMP is interoperable with 236 licensees (EHRs and pharmacy management systems) across the state. The 236 licensees represent more than 1,962 facilities in Louisiana and are responsible for 2,047,701 PMP requests in the month of December 2020.

13 PMP Interstate Data Sharing through PMP InterConnect®

As of December 31, 2020, the Louisiana PMP is sharing with 33 PMPs (1 federal district, 1 territory, 1 federal jurisdiction, and 30 states).

Alabama Alaska Arizona Arkansas Connecticut Delaware D.C. Florida Idaho Indiana Iowa Kansas Maine Massachusetts MHS-DOD Michigan Minnesota Mississippi Montana Nevada New Mexico North Carolina North Dakota Oklahoma Pennsylvania Puerto Rico South Carolina South Dakota Tennessee Texas Virginia West Virginia

14 Law Enforcement, Prosecutorial Officials, and Specialty Court PMP Requests

Requests through 12/31/2020 1,600 1,398 1,400 1,230 1,224 Requests 1,150 1,113 1,200 Processed 1,011 1,000 889 845 843 823 800 680 670 600

400 Number Number of Requests

200

0 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Calendar Year 15 Therapeutic Marijuana (TM) Dispensing

Patient Count Percentage Reporting through 12/31/2020 by Age Band Total Prescription Count = 44,099 Ages 1 To 17 1% Total Unique Patient Count = 11,813 Ages 18 To 24 2% Total Unique Prescriber Count = 202 Ages 25 To 34 10% Ages 35 To 44 19% Ages 45 To 54 19% Ages 55 To 64 23% Ages 65 To 74 18% Ages 75+ 8%

Aug-19 Sep-19 Oct-19 Nov-19 Dec-19 Jan-20 Feb-20 Mar-20 Apr-20 May-20 Jun-20 Jul-20 Aug-20 Sep-20 Oct-20 Nov-20 Dec-20 RX Count 2,447 1,886 2,012 1,821 1,683 1,818 1,637 1,977 1,671 1,995 2,318 2,787 3,033 3,603 3,922 4,040 5,449 Patient Count 1,864 1,512 1,647 1,502 1,375 1,473 1,337 1,568 1,339 1,630 1,876 2,202 2,412 2,734 2,868 2,889 3,358 Prescriber Count 51 57 62 67 66 72 73 81 77 81 88 85 104 117 126 141 155 16 TM Patient Count by Patient Postal Code

Reporting through 12/31/2020 Reporting through 10/31/2020

17 Requests for Full Exemption from PMP Reporting February 24, 2021

In accordance with LA.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 DEA City State Type 8137 NR A & M Pharmacy Independent retail Yes Orlando FL pharmacy 8215 NR Advanced Diabetes Diabetic supplies Yes Carlsbad CA Supply 8169 NR Advanced Intrathecal compounding Yes Dallas TX InfusionCare pharmacy 8207 NR AlleReach Closed door medium-risk Yes Dallas TX Pharmacy sterile compounding pharmacy 8189 NR BioPlus Specialty Specialty pharmacy Yes Altamonte FL Pharmacy Services Springs 7756 PEX Bossier Sheriff's Correctional facility, closed Yes Plain Dealing LA Correctional door pharmacy Facility Pharmacy 8190 NR ClearMD Non-sterile compounding No Millburn NJ Pharmacy, LLC pharmacy focused on dermatological conditions 8179 NR Costco Pharmacy Central fill that does not Yes Jeffersonville IN #1347 ship controls 8156 HOS CuraHealth New Two in-patient hospitals Yes New Orleans LA Orleans 8195 IR Diabetes Independent retail Yes New Orleans LA Management & pharmacy - Diabetic Supplies supplies 8176 NR First Choice Home Specialty pharmacy Yes Hendersonville TN Infusion/Specialty Pharmacy 8194 NR Marley Drug Independent retail Yes Winston- NC pharmacy Salem 8174 NR MedWiseRx Phone-based medication No Gainesville FL therapy management services 8177 NR MedWiseRx Medication therapy No Tucson AZ management services Permit Permit Name Scope of Practice DEA City State Type 8216 NR MVP Pharmacy Walk-in community Yes Arlington TX pharmacy 7027 SAT Ochsner Health Ambulatory surgery center Yes Covington LA Center - Covington Pharmacy 8208 NR Omnicare of Provides clinical rejection Yes Des Plaines IL Northern Illinois solution, Non-dispensing pharmacy role 8192 NR Pet Supplies Veterinary medications only No La Vista NE Delivered 8004 NR PharmaCorr Closed door pharmacy Yes Oklahoma City OK

7592 NR PharMerica Long term care pharmacy Yes Tyler TX

7920 NR Pharmscript of Long term care pharmacy Yes Tyler TX Texas North 8151 NU RLS (USA) Nuclear pharmacy No New Orleans LA

8200 NR RVL Pharmacy, Mail order pharmacy No Sayreville NJ LLC 7702 NR S & K Med Independent, community, Yes Houston TX Pharmacy retail pharmacy 2045 HOS Shriners Hospital Hospital pharmacy Yes Shreveport LA for Children Pharmacy 7124 IR Union Care Infusion pharmacy Yes Houma LA Pharmacy 8161 SAT WCH Cancer and Non-hazardous sterile No Lafayette LA Infusion Center compounding 8159 NR Y Medical Specialty pharmacy Yes Irving TX Associates, Inc.

Staff Recommendation Approve the proposed waivers conditioned upon execution of the standard Consent Agreement:

EXEMPTION TO PRESCRIPTION MONITORING PROGRAM 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 following sanction: 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. Request for Partial Exemption from PMP Reporting February 24, 2021

In accordance with LA.R.S:40.4.X-A.1006.C. The board may issue a partial 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 DEA City State Type 8178 IR Institutional Long term care (nursing homes, Yes Scott LA Pharmacies of hospitals, and correctional Louisiana centers)

Staff Recommendation Approve the proposed waivers conditioned upon execution of the standard Consent Agreement:

PARTIAL EXEMPTION TO PRESCRIPTION MONITORING PROGRAM REPORTING REQUIREMENTS CONSENT AGREEMENT

WHEREAS, in order to facilitate the pharmacy’s request for a PARTIAL EXEMPTION to the reporting requirements of 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 only be exempt from reporting eligible prescription transactions dispensed for hospital in-patient administration, but the pharmacy shall report all other eligible prescription transactions as required by law. (2) Upon the first instance of receipt of evidence by the Board indicating the Pharmacy failed to report non-exempt eligible prescription transactions, the Pharmacy agrees to the following sanction: 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 failed to report non-exempt eligible prescription transactions, 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 ~ E-mail: [email protected]

Report of General Counsel

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Report of Executive Director

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

February 24, 2021

Agenda Item 10-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. November 19 MALTAGON Conference December 16 LSMS Board of Governors January 7 Occupational Licensing Review Commission January 13 Louisiana Pharmacy Congress January 14 Drug Policy Board

2. Reports A. Internal Reports (posted in the Library) 1. Credentials Division a. Census Report b. Licensure Activity Report c. Pending Applications Report d. Exceptions Report 2. Compliance Division a. Census Report – Practitioner Recovery Program & Disciplinary Status b. Complaint Investigation Policy Monitor

B. External Reports Since the last Board meeting, we have filed the following reports on your behalf: 1. La. Office of the Governor – Boards & Commissions a. Annual Report 2. La. Office of the Governor – Drug Policy Board / HOPE Advisory Council a. Naloxone Dispensing Report 3. La. Div. of Administration – Office of the Commissioner a. Quarterly Report of Legal Judgments [Act 2018-627] b. Annual Report for Sexual Harassment Complaints [Act 2018-270] 4. La. Div. of Administration – Boards & Commissions a. Annual LaTrac Report of Board Activity [Act 2009-12] b. Quarterly Report of Member Expense Reimbursements c. Ad hoc reports of personnel salaries, meeting notices, and budgets 5. La. Div. of Administration – Facility Planning & Control a. Semiannual Report of Leased Office Space [Act 2016-66]

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6. La. Div. of Administration – Property Assistance Agency a. Annual Inventory of Property & Equipment b. Annual Asset Certification Report c. Monthly Agency Fleet Mileage Report 7. La. Div. of Administration – Office of Group Benefits a. Annual Designations of Master User & Agency Coordinator b. Ad hoc reports of non-discrimination testing 8. La. Div. of Administration – Office of Risk Management a. Annual Agency Driver Authorization Report b. Annual Loss Prevention Compliance Audit c. Semiannual Property Exposure Report d. Quarterly Risk Exposure Report e. Quarterly Property Safety & Maintenance Inspections f. Monthly Loss Claims Report g. Monthly Report re Transitional Return to Work 9. La. Div. of Administration – Office of State Procurement a. Monthly Report on Status of Professional Contracts [Act 2015-87] b. Ad hoc reports on contractor performance review 10. La. Div. of Administration – Office of State Register a. Ad hoc notices for rulemaking projects 11. La. Div. of Administration – Office of Statewide Reporting & Accounting Policy a. Comprehensive Annual Financial Report b. Annual Report of Taxable Compensation c. Quarterly Report of Accounts Receivable [Act 1995-745] 12. La. Dept. of Children & Family Services a. Ad hoc rosters for credential renewals for pharmacists and technicians 13. La. Dept. of Culture, Recreation, & Tourism – State Library of Louisiana a. Annual Publications Report Form b. Semiannual Roster & Agency Inventory of Agency Publications c. Ad hoc document publication reports 14. La. Dept. of Economic Development a. Ad hoc rulemaking notices 15. La. Dept. of Health – Bureau of Health Services Financing a. Monthly Report of Pharmacy Openings & Closures 16. La. Dept. of Health – Office of Public Health a. Semi-annual Report of Active MA Registrations 17. La. Dept. of Insurance a. Annual Report of Investigation Referrals [Act 2009-251] 18. La. Dept. of Justice – Office of the Attorney General a. Quarterly Report of Private Legal Fees Paid [Act 2006-611] b. Quarterly Report of Legal Judgments [Act 2018-627] c. Ad hoc notices for emergency rules 19. La. Dept. of Revenue a. Quarterly Employer’s Return of State Withholding Tax b. Ad hoc rosters for credential renewals for pharmacists and technicians 20. La. Dept. of State – Division of Archives a. Annual Report of Records Officer Designation 21. La. Dept. of State Civil Service a. Annual Confirmation of Agency EEO Policy b. Annual Report of Performance Evaluations c. Ad hoc Payroll Comparison Report d. Annual Report of Cybersecurity Awareness Training [Act 2020-155] 22. La. Dept. of Treasury – Cash Management Review Board a. Quarterly Report of Agency Bank Accounts [Act 2016-587] 23. La. Board of Regents – ULM College of Pharmacy a. Annual Report of Pharmacy Education Support Fees Collected 24. La. State Employees Retirement System a. Monthly Report of Employer & Employee Contributions

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25. La. Workforce Commission a. Quarterly Report of Employer’s Unemployment Tax 26. La. House of Representatives – Office of the Speaker a. Annual Report of Rulemaking Activity b. Ad hoc notices for rulemaking projects 27. La. House of Representatives – Poynter Legislative Research Library a. Annual Filing of Legislative Reports 28. La. House of Representatives – Committee on Appropriations a. Quarterly Report of Legal Judgments [Act 2018-627] 29. La. House of Representatives – Committee on Commerce a. Annual Report of Licensed Ex-Offenders [Act 2017-262] 30. La. House of Representatives – Committee on House & Governmental Affairs a. Quarterly Report of Board Complaints [Act 2018-655] 31. La. House of Representatives – Committee on Health & Welfare a. Annual LaTrac Report on Board Activity [Act 2009-12] b. Annual Report on Rulemaking Activity c. Annual Notice of Budget Adoption d. Comprehensive Annual Financial Report e. Ad hoc notices for rulemaking projects 32. La. Senate – Office of the President a. Annual Report on Rulemaking Activity b. Ad hoc notices for rulemaking projects 33. La. Senate – Committee on Finance a. Quarterly Report on Legal Judgments [Act 2018-627] 34. La. Senate – Committee on Health & Welfare a. Annual LaTrac Report on Board Activity [Act 2009-12] b. Annual Report on Rulemaking Activity c. Annual Notice of Budget Adoption d. Comprehensive Annual Financial Report e. Ad hoc notices for rulemaking projects 35. La. Senate – Committee on Senate & Governmental Affairs a. Annual Report on Boards & Commissions b. Quarterly Report of Board Complaints [Act 2018-655] 36. La. Legislature – Legislative Auditor a. Comprehensive Annual Financial Report b. Annual Inventory of Property & Equipment c. Annual Asset Certification Report d. Annual Notice of Budget Adoption 37. La. Legislature – Legislative Fiscal Office a. Annual Notice of Budget Adoption b. Annual LaTrac Report of Board Activity [Act 2009-12] c. Ad hoc impact statements for rulemaking projects 38. La. Legislature – Joint Legislative Committee on the Budget a. Annual Notice of Budget Adoption b. Annual LaTrac Report of Board Activity [Act 2009-12] 39. U.S. Dept. of Commerce – Census Bureau a. Annual Survey of Public Employment & Payroll 40. U.S. Dept. of Health & Human Services – Office of Public Health a. Quarterly Report to ESAR-VHP 41. U.S. Dept. of Labor – Bureau of Labor Statistics a. Monthly Survey of Current Employment Statistics 42. U. S. Dept. of Treasury – Internal Revenue Service a. Annual Filings (Forms 1094, 1095-C, 1096, 1099, W-2, & W-3) b. Quarterly Report of Form 941 – Employer’s Federal Tax Return

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3. Examinations A. Pharmacists

1. MPJE – the results for the final trimester of 2020 are presented in this report.

2. NAPLEX – the results for the final trimester of 2020 are presented in this report.

Every five years, NABP conducts the National Pharmacy Practice Analysis Survey to reevaluate its NAPLEX examination blueprint. As part of the process, practicing pharmacists are asked to evaluate the relative frequency and importance of the activities contained in each of the blueprint’s competency statements. NABP conducted the most recent survey in November 2019. Their analysis of the results of the survey produced changes in the blueprint for the NAPLEX, increasing the number of practice domain areas from two to six. The updated blueprint took effect on January 18, 2021. At the same time, NABP announced a change in how examination scores are reported. While the passing score remains 75, numeric scores are no longer reported, only Pass/Fail. Those candidates who fail the test still receive a detailed report indicating in which competency areas they were deficient.

B. Technicians

1. NHA – the results for the fourth quarter of 2020 are presented in this report.

2. PTCB – the results for the second half of 2020 are presented in this report.

4. Operations A. Credentials Division As of February 9, 2021, we had 73,523 active credentials under management by the Board. That number reflects a 1.5% decrease from the beginning of the fiscal year and a 5.1% increase from the beginning of the previous fiscal year. We attribute the decrease to the extension in expiration dates you have authorized for several categories of credentials. As those extensions have now been terminated, we expect a return to our normal growth pattern in the number of active credentials under management. We opened the renewal cycle for pharmacists, pharmacies and CDS licenses for pharmacies on November 1 and the renewal period closed on December 31. • PST: We placed 9,443 licenses into renewal and mailed those renewal reminders on October 28. Of that number, 9,001 renewed timely, and of that number, 96.2% did so online. • PHY: We placed 2,029 permits into renewal and mailed those renewal reminders on October 28. As provided by the emergency rule, the permit renewal fees for in-state pharmacy permits were waived. Of that number, 1,986 renewed timely, and of that number, 91% did so online. • CDS-PHY: We placed 1,320 licenses into renewal and mailed those renewal reminders on October 28. As provided by the emergency rule, the license renewal fees for in-state CDS licenses for pharmacies were waived. Of that number, 1,272 renewed timely, and of that number, 96.7% did so online.

B. Compliance Division Our 7 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 1,426 pharmacies within the state, as well as 333 DME permits and an additional 464 various types of facilities and persons for CDS visits, including hospitals, researchers, animal euthanasia technicians, etc. In addition to their routine site visits, the compliance officers are also responsible for investigating complaints filed with the Board. We began FY 20-21 with 182 cases pending from the prior fiscal years. We have opened 249 new cases and closed 275,

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leaving 156 cases still open as of Feb. 13. Of the 275 cases closed, 56% were disposed of through staff activities and the balance through committee and Board action.

C. Administrative Division The staff will soon begin user testing of a significant upgrade to our eLicense information system. That will require processing applications and other tasks on dual simultaneous tracks – the current system as well as the upgraded system which is housed on a separate testing server. The upgrade will provide additional opportunities to automate some of our credentialing and compliance tasks.

D. Marijuana Pharmacies As you may recall, the enabling legislation adopted in 2015 limits the number of marijuana pharmacy permits in the state to a maximum of ten active permits. The Board’s rules for marijuana pharmacies adopted in August 2017 identified the nine regions of the state used by the state health department, allocated one marijuana pharmacy permit to each of those nine regions, and included a provision that the 10th permit may be awarded by the Board when it is convinced of the need for it. Following the conclusion of the competitive application process identified in its rules, the Board awarded the first nine marijuana pharmacy permits in April 2018. Medical cannabis products were made available to the pharmacies on August 6, 2019. To facilitate the Board’s determination of need for a 10th permit, we initiated a data collection process to document patient need as indicated by the ZIP code of the patients with medical cannabis transactions reported by the marijuana pharmacies to the PMP database. The quarterly PMP report now includes data relative to the number of dispensing transactions, the number of patients, and the geographical distribution of those patients. With the change in the marijuana law opening up the number of physicians and the number of medical conditions eligible for treatment with marijuana, we recommend an additional period of monitoring not to exceed one year. On that timeline, the Board should prepare to initiate the process to award the 10th permit in the spring or summer of 2021.

5. State Activities A. La. State Board of Nursing The agency published a Notice of Intent in the January 2021 edition of the Louisiana Register to update their rules for advanced practice registered nurses (APRN) to accomplish three objectives; (1) permit APRNs, within approved collaborative practice agreements with physicians, will be eligible to prescribe buprenorphine through medication-assisted treatment (MAT) for up to 100 patients per year for five years; (2) update their rules for the prescribing of controlled substances to require conformance with the prescription format requirements contained in Section 2511 [LAC 46:LIII.2511] of the Board of Pharmacy’s rules; and further, to prohibit the prescribing of controlled substances for [a] the treatment of chronic or intractable pain, [b] the treatment of obesity, or [c] for their own use, or that of a spouse, child or any other family member.

B. La. Legislature The 2021 Regular Session will convene at 12:00 noon on Monday, April 12. They are required to adjourn no later than 6:00 pm on Thursday, June 10, 2021. The deadline to request the introduction of any pre-filed bills is 5:00 pm on Wednesday, March 31. Some bills have already been pre-filed.

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, NABP plans to conduct their 117th Annual Meeting

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on May 13-14, 2021 as a virtual conference. Registration details will be provided when they are available. NABP has compiled all of the resolutions adopted at the district meetings this past fall and which will be considered for adoption during the May 2021 Annual Meeting. Copies of the resolutions were posted in the Boardroom Library for your review. Please review those items and inform the Board’s delegate of your position on those items of business.

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. Districts 6, 7, and 8 held their annual meeting by videoconference on October 13, 2020. The 2021 conference is planned for the Civana Spa, Resort & Sanctuary in Carefree, AZ on Aug. 29 – Sept. 1. The 2022 conference is planned for Oklahoma; they have not yet secured a venue or date. Registration details will be provided when they are available.

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. The Arkansas Board of Pharmacy will host the 2020 meeting by videoconference on November 19. We forwarded that meeting announcement and registration information to you on September 17 and October 15. The Alabama Board is planning to host the 2021 meeting on Oct. 18-21 in Gulf State Park, AL. Registration details will be provided when they are available. As a gentle reminder, the Louisiana Board is scheduled to host the conference in 2022. We should be prepared to provide the date and venue for that meeting during the 2021 conference.

7. International Activities A. International Pharmaceutical Federation (FIP) FIP announced the postponement of their 80th World Congress until Sep. 18-22, 2022 in Seville, . In the interim, their newly created Forum of Professional Pharmacy Regulators has conducted FIP Digital Events featuring examples of challenges faced by regulatory agencies during the current pandemic and adaptations made.

B. World Health Professions Alliance (WHPA) The alliance is composed of the five international professional membership organizations for physicians, nurses, dentists, pharmacists and physical therapists and represents 34 million health professionals in 130 countries. WHPA canceled its biennial World Health Professions Regulation Conference originally scheduled for May 16, 2020 in Geneva, Switzerland. Registration details for their next conference in May 2022 will be relayed when available. The alliance launched a global campaign on October 1, 2020 to improve work environments for health professional around the world. Stand Up for Positive Practice Environments seeks to foster healthcare settings that support excellence and decent work conditions for health professionals. The campaign has identified critical activities for healthcare professionals, managers, governments as well as other policy-setting organizations.

Respectfully submitted, Malcolm J Broussard Executive Director

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Louisiana Board of Pharmacy Pharmacy Program - Census Report

6/30/2019 6/30/2020 2/8/2021

PST.VI LA 9 12 13 NR 17 15 24 Total 26 27 37

PST-GVI LA 20 17 22 NR 6 9 11 Total 26 26 33

PST-M LA 0 0 0 NR 8 8 8 Total 8 8 8

PST-MS LA 3 5 6 NR 2 5 5 Total 5 10 11

PST-G LA 186 192 170 NR 31 32 30 Total 217 224 200

PST LA 5,795 5,661 5,729 NR 3,230 3,244 3,223 Total 9,025 8,905 8,952 PST 9,255 9,200 9,241

PNT LA 892 962 969 NR 200 247 262 Total 1,092 1,209 1,231

PNT-FPG Total 2 4 4 PNT 1,094 1,213 1,235

CPT LA 6,452 7,037 7,040 NR 147 176 181 Total 6,599 7,213 7,221

CPT-M Total 1 2 3

CPT-MS Total 1 4 6 CPT 6,601 7,219 7,230

PTC LA 1,544 1,864 1,646 NR 51 53 40 PTC 1,595 1,917 1,686 Louisiana Board of Pharmacy Pharmacy Program - Census Report

6/30/2019 6/30/2020 2/8/2021

PHY CH 9 9 8 HOS 161 165 167 HOX 5 5 5 IN 11 10 10 INX 11 11 11 IR 597 615 606 IRX 8 9 9 NR 561 587 587 NRC 1 1 3 NRN 10 10 9 NU 13 12 10 PEN 0 0 0 PEX 4 4 4 RC 596 572 577 RPP 2 1 1 SAT 6 9 9 SPL 0 0 0 TDS 0 0 0 TM 8 9 9 PHY 2,003 2,029 2,025

AMS AMS 116 146 150 AMS-X 345 310 304 AMS 461 456 454

EDK EDK 374 401 415 EDK-X 6 8 8 EDK 380 409 423

DME LA 339 341 333 NR 301 309 303 DME 640 650 636

CDTM 78 85 96

MAR 3,161 3,325 3,796

PMP 19,686 21,882 22,120

SWP 41 75 117

TMD 127 151 157

TOTAL 45,174 48,611 49,216 Louisiana Board of Pharmacy CDS Program - Census Report

6/30/2018 6/30/2019 6/30/2020 2/9/2021 Classification ACS Animal Control Shelter 0 0 0 0 AMS Automated Medication System 35 40 46 47 AMX Automated Medication System - Exempt 2 2 2 2 APN Advanced Practice Registered Nurse 2,975 3,434 3,879 3,570 ASC Ambulatory Surgical Center 0 0 0 0 CRX Correctional Center 0 0 0 0 DDS Dentist 2,174 2,224 2,327 2,178 DET Drug Detection Canine - Private Agency 0 6 7 3 DEX Drug Detection Canine - Law Enforcement 8 0 0 0 DIS Distributor 290 285 279 220 DPM Podiatrist 158 163 167 142 DVM Veterinarian 1,188 1,216 1,308 1,188 DYS Dialysis Center 0 0 0 0 EMC Emergency Center 0 0 0 0 EMS Emergency Medical Service 0 0 0 0 ETC Animal Euthanasia Tech - Cert 3 3 1 2 ETL Animal Euthanasia Tech - Lead 26 25 28 21 HOS Hospital 301 297 310 261 HOX Hospital - Exempt 5 5 5 4 INT Intern or Resident 318 1,047 1,211 1,619 LAB Analytical Laboratory 8 8 8 8 LAX Analytical Laboratory - Exempt 4 4 5 4 MD Physician 12,824 13,138 13,409 12,111 MDT Physician via Telemedicine 2 11 16 16 MED Medical Clinic 0 0 0 33 MFR Manufacturer 45 47 43 33 MP Medical Psychologist 91 91 93 89 OD Optometrist 349 360 363 346 PA Physician's Assistant 783 928 1,030 975 PHX Pharmacy - Exempt 22 24 25 25 PHY Pharmacy 1,313 1,279 1,268 1,261 REP Sales Representative 0 0 0 0 RES Researcher 104 106 127 89 RHC Rural Health Clinic 0 0 0 0 RNT APRN via Telehealth 5 1 1 1 ROF Registered Outsourcing Facility 19 19 16 16 SAC Substance Abuse Clinic 6 6 6 7 SAX Substance Abuse Clinic - Exempt 0 0 0 0 TPL Third Party Logistics Provider 0 0 0 36 MIS Other 0 0 0 0 TOTAL 23,058 24,769 25,980 24,307

Highlighted credentials subject to inspection

Total Credentials Under Board Management

Pharmacy Program 41,770 45,174 48,611 49,216 CDS Program 23,058 24,769 25,980 24,307 TOTAL 64,828 69,943 74,591 73,523 Louisiana Board of Pharmacy Pharmacy Program - Census Report

3/17/1995 6/30/1996 6/30/1997 6/30/1998 6/30/1999 6/30/2000 6/30/2001 6/30/2002

PST.VI LA NR Total

PST-GVI LA NR Total

PST-M LA NR Total

PST-MS LA NR Total

PST-G LA NR Total

PST LA 3,642 3,660 4,143 4,247 4,269 4,830 3,887 4,386 NR 377 446 1,339 1,435 1,421 944 1,901 1,453 Total 4,019 4,106 5,482 5,682 5,690 5,774 5,788 5,839 Active PST

PNT LA NR Total

PNT-FPG Total PNT 957 976

CPT LA NR Total

CPT-M Total CPT 3,216 3,453

PTC LA NR PTC 2,896 2,372 Louisiana Board of Pharmacy Pharmacy Program - Census Report

3/17/1995 6/30/1996 6/30/1997 6/30/1998 6/30/1999 6/30/2000 6/30/2001 6/30/2002

PHY CH 4 4 4 7 4 4 8 9 HOS 177 174 171 175 172 171 171 174 HOX IN 46 45 38 39 19 19 19 18 INX IR 651 634 636 609 621 602 601 595 IRX NR 122 152 168 175 216 223 262 313 NRN NRP NU 9 10 10 9 10 10 12 14 PE 78 104 102 120 102 102 102 100 PEN 13 12 12 12 12 12 12 13 PEX RC 464 473 471 493 505 520 530 535 RPP SAT SPL TDS TM PHY 1,564 1,608 1,612 1,639 1,661 1,663 1,717 1,771

AMS AMS AMS-X AMS 109

EDK EDK EDK-X EDK 468 461

DME LA NR DME

CDTM

MAR

PMP

SWP

TMD

TOTAL 5,583 5,714 7,094 7,321 7,351 7,437 15,042 14,981 Louisiana Board of Pharmacy Pharmacy Program - Census Report

6/30/2003 6/30/2004 6/30/2005 6/30/2006 6/30/2007 6/30/2008 6/30/2009 6/30/2010

PST.VI LA NR Total

PST-GVI LA NR Total

PST-M LA NR Total

PST-MS LA NR Total

PST-G LA NR Total

PST LA 4,435 4,486 4,532 4,460 4,522 4,612 4,750 4,860 NR 1,455 1,484 1,686 1,915 1,975 1,964 2,029 2,098 Total 5,890 5,970 6,218 6,375 6,497 6,576 6,779 6,958 Active PST

PNT LA 980 1,079 1,074 1,035 965 NR 109 117 67 84 153 Total 1,089 1,196 1,141 1,119 1,118

PNT-FPG Total PNT 929 995 1,154 1,089 1,196 1,141 1,119 1,118

CPT LA 4,552 4,587 4,780 4,733 5,363 NR 163 152 144 109 144 Total 4,715 4,739 4,924 4,842 5,507

CPT-M Total CPT 4,715 4,739 4,924 4,842 5,507

PTC LA 1,081 1,389 1,446 1,510 1,679 NR 32 32 23 32 35 PTC 1,113 1,421 1,469 1,542 1,714 Louisiana Board of Pharmacy Pharmacy Program - Census Report

6/30/2003 6/30/2004 6/30/2005 6/30/2006 6/30/2007 6/30/2008 6/30/2009 6/30/2010

PHY CH 11 12 12 12 12 11 12 14 HOS 179 181 181 167 164 167 167 165 HOX IN 19 27 36 35 36 37 37 27 INX IR 595 633 729 681 620 588 592 587 IRX NR 353 339 200 226 240 250 256 286 NRN NRP NU 13 13 13 17 16 16 16 16 PE 94 0 0 0 0 0 0 0 PEN 13 0 0 0 0 0 0 0 PEX RC 541 555 473 430 491 534 545 562 RPP SAT SPL TDS TM PHY 1,818 1,760 1,644 1,568 1,579 1,603 1,625 1,657

AMS AMS AMS-X AMS 136 158 174 173 212 255 306 361

EDK EDK EDK-X EDK 474 444 471 428 412 439 388 503

DME LA NR DME

CDTM

MAR

PMP

SWP

TMD

TOTAL 14,088 14,510 15,190 15,461 16,056 16,407 16,601 17,818 Louisiana Board of Pharmacy Pharmacy Program - Census Report

6/30/2011 6/30/2012 6/30/2013 6/30/2014 6/30/2015 6/30/2016 6/30/2017 6/30/2018

PST.VI LA 12 10 9 9 13 16 18 14 NR 9 10 15 14 15 16 24 20 Total 21 20 24 23 28 32 42 34

PST-GVI LA 6 13 13 12 15 26 24 NR 0 3 5 5 5 10 8 Total 6 16 18 17 20 36 32

PST-M LA 3 5 3 1 2 1 0 0 NR 11 11 11 13 10 10 9 8 Total 14 16 14 14 12 11 9 8

PST-MS LA NR Total

PST-G LA 158 157 164 166 186 204 216 194 NR 30 35 32 31 31 35 30 27 Total 188 192 196 197 217 239 246 221

PST LA 4,654 4,933 4,981 5,140 5,408 5,304 5,372 5,690 NR 2,079 2,212 2,527 2,479 2,471 2,835 2,950 3,090 Total 6,733 7,145 7,508 7,619 7,879 8,139 8,322 8,780 Active PST 6,935 7,353 7,718 7,830 8,108 8,389 8,577 9,009

PNT LA 907 938 942 948 952 957 946 910 NR 137 128 128 127 143 127 145 158 Total 1,044 1,066 1,070 1,075 1,095 1,084 1,091 1,068

PNT-FPG Total 5 0 3 6 2 4 3 2 PNT 1,049 1,066 1,073 1,081 1,097 1,088 1,094 1,070

CPT LA 5,720 5,509 5,751 6,463 6,584 6,815 6,418 6,433 NR 145 120 112 138 141 152 141 152 Total 5,865 5,629 5,863 6,601 6,725 6,967 6,559 6,585

CPT-M Total 1 0 1 2 1 2 2 1 CPT 5,866 5,629 5,864 6,603 6,726 6,969 6,561 6,586

PTC LA 1,574 1,665 1,658 1,870 1,929 1,813 1,971 1,931 NR 35 39 37 37 52 48 54 69 PTC 1,609 1,704 1,695 1,907 1,981 1,861 2,052 2,000

Louisiana Board of Pharmacy Pharmacy Program - Census Report

6/30/2011 6/30/2012 6/30/2013 6/30/2014 6/30/2015 6/30/2016 6/30/2017 6/30/2018

PHY CH 12 12 12 12 12 12 11 10 HOS 151 154 158 164 163 160 163 163 HOX 19 18 14 11 8 7 6 6 IN 14 10 12 12 11 11 12 11 INX 11 14 13 11 10 10 11 11 IR 570 568 558 583 588 576 577 584 IRX 21 19 17 10 10 7 6 6 NR 318 361 387 422 473 513 515 534 NRN 0 0 0 9 9 8 7 8 NRP 0 0 0 1 2 2 2 2 NU 15 15 15 15 14 15 14 13 PE 0 0 0 0 0 0 0 0 PEN 0 0 0 0 0 0 0 0 PEX 1 2 2 2 2 3 RC 576 587 597 619 649 671 651 630 RPP 0 0 0 1 SAT 1 3 6 6 6 SPL 0 0 0 0 TDS 0 0 0 0 TM PHY 1,707 1,758 1,784 1,871 1,951 2,000 1,983 1,988

AMS AMS 55 64 349 92 456 113 104 498 AMS-X 301 302 289 359 356 367 335 372 AMS 356 366 638 451 812 480 439 870

EDK EDK 417 435 421 464 474 454 402 435 EDK-X 13 13 10 10 10 10 9 11 EDK 430 448 431 474 484 464 411 446

DME LA 223 160 209 336 345 346 205 NR 218 281 267 287 291 437 DME 378 490 603 622 637 642

CDTM 41 41 52 59 66 69

MAR 1,617 2,037 2,383 2,603 2,820 3,073

PMP 15,835

SWP 58 78 126 38 54 48 48 45

TMD 71

TOTAL 18,031 18,651 21,405 813 824 817 768 41,770 Louisiana Board of Pharmacy CDS Program - Census Report

8/1/2006 6/30/2007 6/30/2008 6/30/2009 Classification ACS Animal Control Shelter AMS Automated Medication System AMX Automated Medication System - Exempt APN Advanced Practice Registered Nurse 220 346 479 607 ASC Ambulatory Surgical Center 94 94 101 106 CRX Correctional Center DDS Dentist 2,009 2,090 2,177 2,267 DET Drug Detection Canine - Private Agency 11 11 11 11 DEX Drug Detection Canine - Law Enforcement 8 9 9 9 DIS Distributor 236 285 322 363 DPM Podiatrist 146 147 153 161 DVM Veterinarian 817 870 936 1,000 DYS Dialysis Center 58 63 63 63 EMC Emergency Center 17 17 17 17 EMS Emergency Medical Service 56 57 58 63 ETC Animal Euthanasia Tech - Cert 29 31 39 44 ETL Animal Euthanasia Tech - Lead HOS Hospital 350 369 387 405 HOX Hospital - Exempt INT Intern or Resident LAB Analytical Laboratory 13 13 14 14 LAX Analytical Laboratory - Exempt MD Physician 12,754 13,195 13,876 14,599 MDT Physician via Telemedicine MED Medical Clinic 65 73 78 88 MFR Manufacturer 31 36 43 52 MP Medical Psychologist 30 37 44 50 OD Optometrist 196 230 253 269 PA Physician's Assistant 153 170 194 232 PHX Pharmacy - Exempt PHY Pharmacy REP Sales Representative 54 57 65 66 RES Researcher 91 100 110 119 RHC Rural Health Clinic 15 19 20 21 RNT APRN via Telehealth ROF Registered Outsourcing Facility SAC Substance Abuse Clinic 14 14 14 14 MIS Other 80 74 73 58 TOTAL 17,547 18,407 19,536 20,698

Highlighted credentials subject to inspection

Total Credentials Under Board Management

Pharmacy Program 18,031 18,651 21,405 CDS Program 18,407 19,536 20,698 TOTAL 36,438 38,187 42,103

Louisiana Board of Pharmacy CDS Program - Census Report

6/30/2010 6/30/2011 6/30/2012 6/30/2013 Classification ACS Animal Control Shelter 1 1 1 1 AMS Automated Medication System AMX Automated Medication System - Exempt APN Advanced Practice Registered Nurse 758 889 1,015 1,103 ASC Ambulatory Surgical Center 113 90 88 85 CRX Correctional Center 7 6 5 DDS Dentist 2,363 2,027 2,048 1,902 DET Drug Detection Canine - Private Agency 11 0 0 0 DEX Drug Detection Canine - Law Enforcement 11 14 12 10 DIS Distributor 400 279 288 273 DPM Podiatrist 165 139 136 118 DVM Veterinarian 1,065 922 901 852 DYS Dialysis Center 63 6 4 3 EMC Emergency Center 18 14 16 17 EMS Emergency Medical Service 66 54 50 45 ETC Animal Euthanasia Tech - Cert 49 16 7 6 ETL Animal Euthanasia Tech - Lead 12 20 21 HOS Hospital 438 280 267 263 HOX Hospital - Exempt 12 14 5 INT Intern or Resident LAB Analytical Laboratory 15 8 6 7 LAX Analytical Laboratory - Exempt 4 5 5 MD Physician 15,269 12,362 11,727 10,698 MDT Physician via Telemedicine MED Medical Clinic 102 80 86 82 MFR Manufacturer 58 48 50 45 MP Medical Psychologist 58 65 67 69 OD Optometrist 278 275 287 279 PA Physician's Assistant 272 294 326 344 PHX Pharmacy - Exempt 50 47 41 PHY Pharmacy 1,357 1,318 1,329 REP Sales Representative 88 29 20 7 RES Researcher 156 109 110 98 RHC Rural Health Clinic 23 17 12 11 RNT APRN via Telehealth ROF Registered Outsourcing Facility SAC Substance Abuse Clinic 17 7 9 9 MIS Other 59 20 14 12 TOTAL 21,916 19,487 18,957 17,745

Highlighted credentials subject to inspection

Total Credentials Under Board Management

Pharmacy Program 22,823 24,251 24,583 24,688 CDS Program 21,916 19,487 18,957 17,745 TOTAL 44,739 43,738 43,540 42,433

Louisiana Board of Pharmacy CDS Program - Census Report

6/30/2014 6/30/2015 6/30/2016 6/30/2017 Classification ACS Animal Control Shelter 1 1 0 0 AMS Automated Medication System 26 29 22 28 AMX Automated Medication System - Exempt 2 1 0 0 APN Advanced Practice Registered Nurse 1,479 1,954 2,296 2,343 ASC Ambulatory Surgical Center 89 87 21 0 CRX Correctional Center 6 4 1 0 DDS Dentist 2,123 2,133 2,134 1,929 DET Drug Detection Canine - Private Agency 0 0 0 0 DEX Drug Detection Canine - Law Enforcement 11 12 9 8 DIS Distributor 324 319 301 284 DPM Podiatrist 133 142 152 136 DVM Veterinarian 1,002 1,045 1,085 1,007 DYS Dialysis Center 4 0 0 0 EMC Emergency Center 22 26 5 0 EMS Emergency Medical Service 50 49 16 0 ETC Animal Euthanasia Tech - Cert 6 5 5 1 ETL Animal Euthanasia Tech - Lead 23 23 22 24 HOS Hospital 272 271 289 278 HOX Hospital - Exempt 6 6 5 5 INT Intern or Resident LAB Analytical Laboratory 8 8 8 7 LAX Analytical Laboratory - Exempt 5 5 4 4 MD Physician 11,913 12,124 12,360 11,575 MDT Physician via Telemedicine 2 1 0 0 MED Medical Clinic 89 81 3 0 MFR Manufacturer 42 42 37 38 MP Medical Psychologist 78 82 86 84 OD Optometrist 309 316 326 297 PA Physician's Assistant 449 487 610 667 PHX Pharmacy - Exempt 30 24 21 20 PHY Pharmacy 1,357 1,379 1,367 1,339 REP Sales Representative 0 0 0 0 RES Researcher 113 113 108 100 RHC Rural Health Clinic 12 11 2 0 RNT APRN via Telehealth ROF Registered Outsourcing Facility 8 14 13 SAC Substance Abuse Clinic 9 10 7 6 MIS Other 13 11 0 0 TOTAL 20,008 20,809 21,316 20,193

Highlighted credentials subject to inspection

Total Credentials Under Board Management

Pharmacy Program 41,770 44,025 24,583 24,688 CDS Program 20,008 20,809 21,316 20,193 TOTAL 61,778 64,834 45,899 44,881 New Credentials Issued FY 20-21 ~ 2nd Quarter October 1, 2020 - December 31, 2020

Prefix Subcategory CredentialType Total AMS Automated Medication System 39 AMS X Automated Medication System - Exempt 6 Prefix Totals 45 CDS AMS CDS License - Automated Medication System 31 CDS APN CDS License - APRN 114 CDS DDS CDS License - Dentist 28 CDS DIS CDS License - Distributor 5 CDS DVM CDS License - Veterinarian 18 CDS HOS CDS License - Hospital 1 CDS INT CDS License - Medical Intern or Resident 50 CDS MD CDS License - Physician 175 CDS MDT CDS License - Physician via Telemedicine 4 CDS MP CDS License - Medical Psychologist 3 CDS OD CDS License - Optometrist 7 CDS PA CDS License - Physician Assistant 46 CDS PHY CDS License - Pharmacy 15 CDS RES CDS License - Researcher 3 CDS ROF CDS License - Registered Outsourcing Facility 1 CDS TPL CDS License - Third-Party Logistics Provider 5 Prefix Totals 506 CDTM Collaborative Drug Therapy Management (V) 5

CPT Certified Pharmacy Technician 108

DME Durable Medical Equipment (DME) Provider 4 DME NR Durable Medical Equipment (DME) Provider - Nonresident 10 Prefix Totals 14 EDK Emergency Drug Kit 18

MA Medication Administration (V) 117

PHY IR Pharmacy - Community ~ Independent 15 PHY NR Pharmacy - Nonresident 22 PHY SAT Pharmacy - Hospital Off-Site Satellite 1 Prefix Totals 38 PIC Pharmacist-in-Charge (V) 9

PMP CDS PMP - CDS Credential (V) 160 PMP PHY PMP - PHY Dispenser Account (V) 24 PMP PST PMP - Pharmacist (V) 21 PMP VA PMP - Veteran Affairs Employee (V) 6 Prefix Totals 211 PNT Pharmacy Intern 162

PST Pharmacist 69 PST MS Pharmacist - Military Spouse 2 Prefix Totals 71 PTC Pharmacy Technician Candidate 278 SWP Special Work Permit 10

TM CPT Therapeutic Marijuana Designation - CPT (V) 1 TM PST Therapeutic Marijuana Designation - PST (V) 1 Prefix Totals 2 Grand Totals 1594 Pending Applications

PHARMACY CREDENTIALS Prefix Subcat. CredentialType 8/1/2019 11/1/2019 1/23/2020 5/21/2020 8/3/2020 11/6/2020 2/12/2021 AMS Automated Medication System 7 7 6 1 1 36 7 CPT Certified Pharmacy Technician 46 32 28 45 57 41 44 DME Durable Medical Equipment 14 10 6 7 15 7 9 EDK Emergency Drug Kit 2 2 3 3 1 3 0 PHY CH Pharmacy - Charitable 0 PHY HOS Pharmacy - Hospital Inpatient 9 8 6 1 1 2 PHY IN Pharmacy - Institutional 3 3 3 3 1 PHY IR Pharmacy - Community ~ Independent 21 22 15 18 22 12 14 PHY NR Pharmacy - Nonresident 61 41 41 32 38 42 50 PHY NRN Pharmacy - Nonresident Nuclear 0 PHY NU Pharmacy - Nuclear 1 1 0 PHY PEN Pharmacy - Penal 0 PHY RC Pharmacy - Community ~ Chain 1 1 2 1 0 PHY RPP Pharmavy - Remote Processor 0 PHY SAT Pharmacy - Hospital Off-Site Satellite 1 2 3 2 2 1 1 PHY SPL Pharmacy - Special Event 1 1 0 PHY TDS Pharmacy - Telepharmacy Site 5 5 PHY TM Pharmacy - Therapeutic Marijuana 1 0 PIC Pharmacist-in-Charge 1 0 1 1 1 0 PNT FPG Pharmacy Intern - Foreign Graduate 1 1 PNT Pharmacy Intern 57 139 86 16 37 126 36 PST Pharmacist 305 234 203 379 421 233 184 PTC Pharmacy Technician Candidate 245 232 213 198 245 258 285 Subtotal 772 731 618 706 845 768 639

CDS CREDENTIALS Prefix Subcat. CredentialType 8/1/2019 11/1/2019 1/23/2020 5/21/2020 8/3/2020 11/6/2020 2/12/2021 CDS AMS CDS - Automated Medication System 28 CDS APN CDS - APRN 10 9 11 11 13 20 19 CDS DDS CDS - Dentist 3 1 2 CDS DET CDS - Drug Detection / Canine 1 2 1 1 CDS DIS CDS - Distributor 13 2 3 2 1 2 2 CDS DPM CDS - Podiatrist 1 1 1 1 CDS DVM CDS - Veterinarian 1 3 1 1 2 1 CDS ETC CDS - Animal Euthanasia Tech, Certified CDS ETL CDS - Animal Euthanasia Tech, Lead CDS HOS CDS - Hospital 13 12 11 5 5 3 6 CDS INT CDS - Medical Intern or Resident 8 13 10 16 91 14 15 CDS MD CDS - Physician 20 8 9 22 42 24 14 CDS MFR CDS - Manufacturer CDS MP CDS - Medical Psychologist CDS OD CDS - Optometrist CDS PA CDS - Physician Assistant 14 6 3 5 9 11 8 CDS PHY CDS - Pharmacy 20 23 23 20 28 18 18 CDS PHX CDS - Pharmacy - Exempt CDS RES CDS - Researcher 5 17 16 15 13 9 5 CDS RNT CDS - APRN via Telehealth CDS ROF CDS - Registered Outsourcing Facility 1 1 1 CDS SAC CDS - Substance Abuse Clinic 1 3 3 3 3 CDS TM CDS - Therapeutic Marijuana 1 CDS TPL Third Party Logistics 1 Subtotal 107 94 96 102 211 134 91

OTHER CREDENTIALS Prefix Subcat. CredentialType 8/1/2019 11/1/2019 1/23/2020 5/21/2020 8/3/2020 8/3/2020 2/12/2021 CDTM Collaborative Drug Therapy Management 1 LB Law Book MA Medication Administration 8 8 6 6 7 4 17 PMP PMP - CDS Credential 310 287 144 82 77 7 PMP PMP - MIS Credential PMP PMP - PHY Credential PMP PMP - PST Credential 2 1 1 SWP Special Work Permit 10 10 10 12 12 12 13 TM CPT Therapeutic Marijuana Designation - CPT 26 29 24 23 26 8 8 TM OMO Therapeutic Marijuana Designation - OMO 1 TM PNT Therapeutic Marijuana Designation - PNT 2 1 1 1 TM PST Therapeutic Marijuana Designation - PST 11 16 11 12 13 6 7 Subtotal 367 352 196 137 136 39 46

TOTAL 1246 1177 910 945 1192 941 776 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

February 24, 2021

Agenda Item 10-L: Report of Executive Director

Section 2 – A – 1 – d ~ Credentials Division – 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 decision to approve such a request 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. • None since previous report.

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. • None since previous report.

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 decision to approve such a request 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 November 4, 2020, Mr. Aron and Mr. Finalet concurred to grant a request of Convidas Quinay Gustave. She had previously obtained PTC.021637 which expired on January 23, 2016. She is PTCB-certified and was issued a Special Work Permit for two years to earn the required hours of practical experience. • On November 5, 2020, Mr. Aron and Mr. Finalet concurred to grant a request of Kya Dena Parker. She had previously obtained PTC.021351 which expired on October 29, 2015. She is PTCB-certified and was issued a Special Work Permit for two years to earn the required hours of practical experience. • On December 21, 2020, Mr. Aron and Mr. Finalet concurred to grant a request of Lelia Marie Charles. She had previously obtained PTC.19991 which expired on May 1, 2013. She is enrolled in a training program and was issued a Special Work Permit for two years to earn the required hours of practical experience. • On December 22, 2020, Mr. Aron and Mr. Finalet concurred to grant a request of Kelli Gabrielle Cousin. She had previously obtained PTC.024607 which expired on April 26, 2018. She is PTCB-certified and was issued a Special Work Permit for two years to earn the required hours of practical experience.

• On December 29, 2020, Mr. Aron and Mr. Finalet concurred to grant a request of Stephanie Lynn McGee. She had previously obtained PTC.026664 which expired on September 13, 2019. She is PTCB-certified and was issued a Special Work Permit for two years to earn the required hours of practical experience. • On January 5, 2021, Mr. Aron and Mr. Finalet concurred to grant a request of Katrina

Page 1 of 2 Yvette Evans. She had previously obtained PTC.018829 which expired on November 7, 2013. She is PTCB-certified and was issued a Special Work Permit for two years to earn the required hours of practical experience. • On January 20, 2021, Mr. Aron and Mr. Finalet concurred to grant a request of Darrian Alexander Williams. He had previously obtained PTC.026410 which expired on June 28, 2019. He is enrolled in a training program and was issued a Special Work Permit for two years to earn the required hours of practical experience. • On January 21, 2021, Mr. Aron and Mr. Finalet concurred to grant a request of Johnette Latresha Sauls. She had previously obtained PTC.015345 which expired on January 13, 2011. She is enrolled in a training program and was issued a Special Work Permit for two years to earn the required hours of practical experience. • On February 1, 2021, Mr. Aron and Mr. Finalet concurred to grant a request of Tamika Lasha Burney. She had previously obtained PTC.022477 which expired on November 9, 2016. She is NHA-certified and was issued a Special Work Permit for two years to earn the required hours of practical experience. • On February 3, 2021, Mr. Aron and Mr. Finalet concurred to grant a request of Whitley Sermone Williams. She had previously obtained PTC.016439 which expired on November 24, 2011. She is NHA-certified and was issued a Special Work Permit for two years to earn the required hours of practical experience. • On February 3, 2021, Mr. Aron and Mr. Finalet concurred to grant a request of Ciera Nicole Taylor. She had previously obtained PTC.025742 which expired on January 18, 2019. She is NHA-certified and was issued a Special Work Permit for two years to earn the required hours of practical experience. • On February 10, 2021, Mr. Aron and Mr. Finalet concurred to grant a request of Ja’Naija LaJuan Miller. She had previously obtained PTC.04202 which expired on December 28, 2017. She is enrolled with CVS’ training program and was issued a Special Work Permit for two years to earn the required hours of practical experience.

Page 2 of 2 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Compliance Division Census Report

February 24, 2021

Practitioner Recovery Program • Probation Completed

02-24-2021 PST.010643 – William Coleman Honeycutt 02-24-2021 PST.019587 Andrea Katherine Bourque

• Active Probation 34 Pharmacist 7 Technician

• Active Suspension/ 39 Pharmacist Inactivation 3 Pharmacy intern 17 Technician 4 Technician candidate

Disciplinary Restrictions • Probation Completed

02-20-2021 PST.019656 Jeremy Rashad Branch

• Active Probation 13 Pharmacist 1 Pharmacy intern 2 Technician 0 Technician candidate 9 Pharmacy permit 1 CDS-PHY license

• Active Suspension/ 57 Pharmacist Inactivation 1 Pharmacy intern 87 Technician 21 Technician candidate 1 Special work permit 12 Pharmacy permit 8 CDS-PHY license Louisiana Board of Pharmacy Compliance Division

Complaint Investigation Completion Policy Monitor

FY 17-18 FY 18-19 FY 19-20 FY 20-21 FY 21-22 FY 22-23 FY 23-24 6/30/2018 6/30/2019 6/30/2020 2/13/2021

Pending at Beginning of Fiscal Year 160 180 179 182

New Cases Added 500 433 403 249

Cases Closed 480 434 400 275

Cases Remaining at End of Fiscal Year 180 179 182 156 to date

Average No. Days to Close Investigation 52 50 44

No. Investigations Closed > 180 Days 19 13 9

% Investigations Beyond Policy Limit 4.4% 3.3% 3.3%

% Cases Closed by Board Action 27% 33% 44% Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Multistate Pharmacy Jurisprudence Examination (MPJE™)

September 1 – December 31, 2020

State & National Summary Data Frequency Distribution of Scaled Scores Cumulative Data [since January 2000]

February 24, 2021

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 colleges of pharmacy and state boards on a calendar trimester basis.

Table of Contents

Current Trimester Report for University of Louisiana at Monroe 03

Cumulative Report for University of Louisiana at Monroe 07

Current Trimester Report for Xavier University of Louisiana 13

Cumulative Report for Xavier University of Louisiana 17

MPJE-23-2020 Trimester 3

Multistate Pharmacy Jurisprudence Examination® (MPJE®)

School Summary Report

University of Louisiana at Monroe

Test Window: September 1, 2020 - December 31, 2020

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 14 85.71% 77.21 4.00 Out of state 44 90.91% 79.98 4.09 State 133 77.44% 77.72 4.59 National 6515 76.81% 77.48 4.23

Table 2 All Candidates

Total Scaled Standard Candidates Pass Rate % Score Mean Deviation

In-state 19 89.47% 77.42 3.61 Out of state 48 87.50% 79.63 4.12 State 196 71.43% 76.74 4.57 National 9430 73.79% 77.03 4.09

Table 3 Total Scaled Score Min/Max Table 3 contains information on the range of scaled scores achieved by FT ACPE Min Max (First-Time, ACPE-Accredited) candidates FT ACPE 58 96 as well as the pool of all candidates. It also shows the boundaries of the Scaled Score All Candidates 58 96 Range. 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 N = 14

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] 0 0% [55,59] 0 [60,64] 0 0% [60,64] 0 [65,69] 1 7% [65,69] 1 [70,74] 1 14% [70,74] 1 [75,79] 7 64% [75,79] 7 [80,84] 5 100% [80,84] 5 [85,89] 0 100% [85,89] 0 [90,94] 0 100% [90,94] 0 [95,100] 0 100% [95,100] 0

8

7

6

5

4 Frequency 3

2

1

0

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 = 1519

Cumulative Percent of Scaled Score Frequency the Upper Limit of the Range 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] 1 0% [55,59] 1 [60,64] 1 0% [60,64] 1 [65,69] 56 4% [65,69]56 [70,74] 349 27% [70,74]349 [75,79] 739 75% [75,79]739 [80,84] 325 97% [80,84]325 [85,89] 46 100% [85,89]46 [90,94] 2 100% [90,94] 2 [95,100] 0 100% [95,100]0

800

700

600

500

400 Frequency 300

200

100

0

Scaled Score Interval

Page 4 of 4 Multistate Pharmacy Jurisprudence Examination (MPJE) University of Louisiana at Monroe College of Pharmacy 2023 2022 2021 2020 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr TOTAL CANDIDATE GROUP

No. of Candidates 67 143 34 * testing in same/different state 19 / 48 69 / 74 6 / 28

Mean Scale Score - School * 77.42/79.63 79.46/79.36 76.83/78.86 * testing in same/different state

Mean Scaled Score - State 76.74 78.07 78.67

Mean Scaled Score - National 77.03 78.44 77.33

School Pass Rate: * 89.47/87.50 91.30/90.54 66.67/92.86 * testing in same/different state

State Pass Rate: 71.43% 80.92% 79.27%

National Pass Rate: 79.79% 83.58% 75.86%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 58 131 27 * testing in same/different state 14 / 44 65 / 66 2 / 25

Mean Scaled Score - School * 77.21/79.98 79.55/79.82 76.50/79.44 * testing in same/different state

Mean Scaled Score - State 77.72 78.39 79.68

Mean Scaled Score - National 77.48 78.75 78.18

School Pass Rate: * 85.71/90.91 90.77/93.94 50.00/96.00 * testing in same/different state

State Pass Rate: 77.44% 84.04% 81.67%

National Pass Rate: 76.81% 85.74% 82.43% Multistate Pharmacy Jurisprudence Examination (MPJE) University of Louisiana at Monroe College of Pharmacy 2019 2018 2017 2016 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr TOTAL CANDIDATE GROUP

No. of Candidates 64 145 64 90 158 40 70 147 45 66 143 80 * testing in same/different state 14 / 50 77 / 68 9 / 55 24 / 66 77 / 81 9 / 31 29 / 41 80 / 67 6 / 39 15 / 51 89 / 54 7 / 73

Mean Scale Score - School * 76.57/76.82 78.62/79.26 76.67/78.17 76.71/78.30 78.77/78.84 77.89/79.39 77.17/79.34 76.61/80.63 74.50/78.67 77.67/78.71 77.42/79.20 80.14/84.04 * testing in same/different state

Mean Scaled Score - State 77.53 78.10 78.26 76.64 77.47 78.00 76.52 76.83 77.39 76.91 77.12 80.92

Mean Scaled Score - National 76.90 78.12 77.38 76.94 78.21 77.49 76.99 78.16 77.59 77.08 78.08 81.10

School Pass Rate: * 78.57/84.00 90.91/91.18 66.67/74.55 70.83/78.79 85.71/91.36 77.78/83.87 79.31/95.12 76.25/95.52 50.00/94.87 73.33/80.39 83.15/79.63 100 / 98.63 * testing in same/different state

State Pass Rate: 75.80% 84.14% 79.62% 69.19% 78.82% 82.79% 70.53% 77.13% 75.57% 75.14% 77.93% 90.23%

National Pass Rate: 72.66% 82.49% 76.77% 72.86% 83.07% 76.46% 74.01% 83.24% 76.90% 74.77% 82.66% 87.62% ACPE probation: 06-24-2017 through 06-01-2018 FIRST-TIME CANDIDATE GROUP

No. of Candidates 59 131 50 68 149 36 47 139 40 48 133 76 * testing in same/different state 11 / 48 73 / 58 4 / 46 11 / 57 73 / 76 6 / 30 12 / 35 73 / 66 4 / 36 6 / 42 84 / 49 7 / 69

Mean Scaled Score - School * 76.55/78.50 78.82/79.31 78.75/78.51 76.64/78.60 78.78/78.93 79.67/79.67 78.33/79.29 76.67/80.65 74.75/78.67 78.83/79.07 77.31/79.41 80.14/84.23 * testing in same/different state

Mean Scaled Score - State 77.82 78.34 79.25 77.19 77.56 79.02 76.88 77.00 78.28 77.33 77.10 81.58

Mean Scaled Score - National 77.41 78.39 78.09 77.46 78.50 78.26 77.52 78.41 78.31 77.61 78.24 81.84

School Pass Rate: * 81.82/83.33 91.78/89.66 75.00/76.09 81.82/80.70 84.93/92.11 100 / 86.67 83.33/97.14 78.08/95.45 50.00/94.44 66.67/83.33 82.14/77.55 100 / 98.55 * testing in same/different state

State Pass Rate: 77.31% 86.40% 86.44% 71.76% 78.37% 90.53% 72.58% 78.38% 80.85% 77.88% 77.21% 92.79%

National Pass Rate: 76.36% 84.21% 81.95% 76.03% 85.00% 82.37% 77.03% 84.89% 82.10% 78.24% 83.77% 90.71% Multistate Pharmacy Jurisprudence Examination (MPJE) University of Louisiana at Monroe College of Pharmacy 2015 2014 2013 2012 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr TOTAL CANDIDATE GROUP

No. of Candidates 56 122 42 39 122 32 30 94 47 87 126 4 * testing in same/different state 13 / 43 68 / 54 13 / 29 6 / 33 62 / 60 5 / 27 2 / 28 40 / 54 11 / 36 11 / 34 72 / 54 4 / 0

Mean Scale Score - School * 79.85/83.12 81.44/84.13 76.85/81.90 78.50/81.42 81.44/83.32 79.40/81.41 80.50/82.79 82.50/82.59 81.45/84.03 80.09/79.85 82.44/82.70 82.25 * testing in same/different state

Mean Scaled Score - State 80.05 80.56 79.81 80.13 80.18 80.36 80.43 80.82 81.33 79.62 80.91 81.18

Mean Scaled Score - National 80.91 82.40 81.32 81.08 82.52 81.04 80.52 82.50 80.92 80.55 82.43 80.41

School Pass Rate: * 84.62/95.35 94.12/98.15 76.92/93.10 83.33/87.88 95.16/96.67 100 / 85.19 100 / 92.86 95.00/98.15 100/97.22 90.91/85.29 97.22/90.74 100.00 * testing in same/different state

State Pass Rate: 96.55% 88.14% 80.69% 82.69% 86.08% 82.52% 85.21% 90.51% 93.98% 81.61% 90.69% 90.41%

National Pass Rate: 87.78% 93.04% 88.20% 88.50% 93.28% 87.62% 87.01% 92.98% 87.18% 86.85% 92.76% 84.54%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 49 120 38 33 119 29 28 93 44 70 124 4 * testing in same/different state 7 / 42 68 / 52 11 / 27 3 / 30 62 / 57 5 / 24 1 / 27 39 / 54 10 / 34 10 / 29 72 / 52 4 / 0

Mean Scaled Score - School * 78.71/83.14 81.44/84.40 76.91/82.04 78.00/81.97 81.44/83.58 79.40/82.29 82.00/83.19 82.77/82.59 81.80/84.26 80.62/79.90 82.44/83.02 82.25 * testing in same/different state

Mean Scaled Score - State 80.81 80.62 80.63 81.13 80.62 81.05 81.08 81.03 81.90 80.21 81.03 81.75

Mean Scaled Score - National 81.60 82.66 82.14 81.79 82.80 81.82 81.22 82.76 81.78 81.26 82.75 81.44

School Pass Rate: * 85.71/95.24 94.12/98.08 72.73/92.59 66.67/90.00 95.16/98.25 100 / 91.67 100 / 96.30 97.44/98.15 100.00/97.06 89.66/90.00 97.22/92.31 100.00 * testing in same/different state

State Pass Rate: 91.06% 88.77% 83.61% 84.96% 89.29% 85.88% 87.29% 91.88% 97.22% 85.71% 91.03% 93.22%

National Pass Rate: 90.35% 93.97% 91.72% 90.87% 94.34% 90.85% 90.04% 93.95% 91.08% 89.60% 93.94% 89.13% Multistate Pharmacy Jurisprudence Examination (MPJE) University of Louisiana at Monroe College of Pharmacy 2011 2010 2009 2008 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Jul - Dec Jan - Jun

TOTAL CANDIDATE GROUP

No. of Candidates 12 71 5 35 104 38 36 120 42 137 61

Mean Scaled Score - School 83.83 82.73 82.60 81.89 82.14 81.47 80.75 82.58 80.95 81.99 81.26

Mean Scaled Score - State 80.41 81.01 N/A 81.64 80.88 81.37 80.35 81.69 79.57 81.34 81.33

Mean Scaled Score - National 80.46 82.23 80.27 80.57 82.51 80.45 80.25 82.39 80.29 81.27 81.59

School Pass Rate: 100.00% 97.18% 100.00% 91.43% 90.38% 94.74% 86.11% 95.00% 88.10% 91.97% 96.72%

State Pass Rate: 90.99% 89.91% N/A 95.79% 92.64% 90.00% 85.92% 94.52% 81.03% 91.05% 91.75%

National Pass Rate: 86.24% 92.17% 96.43% 89.35% 94.83% 89.09% 87.04% 93.74% 86.23% 89.92% 90.31%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 11 66 5 30 96 34 34 117 37 127 58

Mean Scaled Score - School 84.18 83.08 82.60 82.33 82.67 82.12 81.09 82.56 81.30 82.13 81.52

Mean Scaled Score - State 81.14 81.52 N/A 82.07 80.93 82.07 80.98 81.76 79.69 81.62 81.53

Mean Scaled Score - National 81.76 82.86 81.17 80.94 82.67 80.82 80.63 82.58 80.75 81.57 81.97

School Pass Rate: 100.00% 100.00% 100.00% 93.33% 93.75% 97.06% 88.24% 94.87% 89.19% 91.34% 96.55%

State Pass Rate: 94.32% 94.06% N/A 97.56% 92.92% 93.44% 89.66% 94.34% 80.77% 91.95% 92.31%

National Pass Rate: 94.00% 96.05% 92.24% 90.79% 95.50% 90.64% 88.68% 94.30% 88.45% 91.16% 91.82%

Multistate Pharmacy Jurisprudence Examination (MPJE) University of Louisiana at Monroe College of Pharmacy 2007 2006 2005 2004 Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun

TOTAL CANDIDATE GROUP

No. of Candidates 151 50 111 68 146 59 110 62

School Average Score: 81.62 80.20 81.92 80.43 80.50 79.25 80.79 79.39

State Average Score: 81.47 80.15 81.34 80.01 80.03 80.50 80.03 78.58

National Average Score: 81.14 81.26 80.42 80.68 80.04 80.39 79.83 80.10

School Pass Rate: 92.05% 90.00% 92.79% 88.24% 87.67% 89.83% 91.82% 91.94%

State Pass Rate: 90.39% 87.18% 92.39% 91.09% 87.03% 90.55% 92.55% 86.90%

National Pass Rate: 89.78% 89.38% 87.82% 87.25% 85.69% 86.57% 84.75% 85.63%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 140 43 102 60 132 55 104 52

School Average Score: 81.83 81.05 82.14 80.80 80.66 79.33 80.96 79.73

State Average Score: 81.84 80.59 81.52 80.24 80.29 80.71 80.11 79.04

National Average Score: 81.51 81.72 80.80 81.09 80.44 80.80 80.25 80.58

School Pass Rate: 93.57% 95.35% 94.12% 91.67% 87.12% 89.09% 92.31% 92.31%

State Pass Rate: 92.49% 91.18% 93.53% 92.31% 88.69% 91.38% 92.53% 90.14%

National Pass Rate: 91.24% 91.43% 89.34% 89.41% 87.51% 88.51% 86.87% 88.16% Multistate Pharmacy Jurisprudence Examination (MPJE) University of Louisiana at Monroe

2003 2002 2001 2000 Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun

TOTAL CANDIDATE GROUP

No. of Candidates 119 77 123 59 57 100 82 125

School Average Score: 80.04 78.57 80.41 80.17 81.37 80.84 82.76 83.27

State Average Score: 78.87 77.32 79.41 80.34 80.32 80.64 80.49 81.64

National Average Score: 79.33 79.92 79.85 90.78 81.51 82.25 81.75 82.24

School Pass Rate: 88.24% 77.92% 88.62% 88.14% 91.23% 90.00% 91.46% 94.40%

State Pass Rate: 84.67% 72.88% 85.98% 92.00% 90.00% 87.84% 86.25% 89.89%

National Pass Rate: 82.61% 84.52% 84.93% 90.78% 90.54% 91.22% 90.50% 91.37%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 110 59 111 55 51 92 78 117

School Average Score: 80.22 79.31 80.58 80.22 81.78 80.89 83.14 83.67

State Average Score: 79.23 77.69 79.41 80.30 80.51 80.67 80.97 82.14

National Average Score: 79.76 80.34 80.19 82.08 81.86 82.59 82.05 82.55

School Pass Rate: 88.18% 81.36% 88.29% 89.09% 90.20% 90.22% 93.59% 96.58%

State Pass Rate: 86.55% 75.00% 86.32% 91.49% 89.77% 88.06% 87.32% 92.59%

National Pass Rate: 84.67% 86.58% 86.45% 92.15% 91.75% 92.45% 91.37% 92.57% MPJE-24-2020 Trimester 3

Multistate Pharmacy Jurisprudence Examination® (MPJE®)

School Summary Report

Xavier University of Louisiana

Test Window: September 1, 2020 - December 31, 2020

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 30 46.67% 74.17 3.53 Out of state 60 68.33% 76.47 4.34 State 133 77.44% 77.72 4.59 National 6515 76.81% 77.48 4.23

Table 2 All Candidates

Total Scaled Standard Candidates Pass Rate % Score Mean Deviation

In-state 64 53.13% 74.20 3.64 Out of state 84 66.67% 76.06 4.30 State 196 71.43% 76.74 4.57 National 9430 73.79% 77.03 4.09

Table 3 Total Scaled Score Min/Max Table 3 contains information on the range of scaled scores achieved by FT ACPE Min Max (First-Time, ACPE-Accredited) candidates FT ACPE 58 96 as well as the pool of all candidates. It also shows the boundaries of the Scaled Score All Candidates 58 96 Range. 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 N = 24

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] 0 0% [55,59] 0 [60,64] 0 0% [60,64] 0 [65,69] 4 17% [65,69] 4 [70,74] 9 54% [70,74] 9 [75,79] 9 92% [75,79] 9 [80,84] 2 100% [80,84] 2 [85,89] 0 100% [85,89] 0 [90,94] 0 100% [90,94] 0 [95,100] 0 100% [95,100] 0

10

9

8

7

6

5

Frequency 4

3

2

1

0

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 = 1519

Cumulative Percent of Scaled Score Frequency the Upper Limit of the Range 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] 1 0% [55,59] 1 [60,64] 1 0% [60,64] 1 [65,69] 56 4% [65,69]56 [70,74] 349 27% [70,74]349 [75,79] 739 75% [75,79]739 [80,84] 325 97% [80,84]325 [85,89] 46 100% [85,89]46 [90,94] 2 100% [90,94] 2 [95,100] 0 100% [95,100]0

800

700

600

500

400 Frequency 300

200

100

0

Scaled Score Interval

Page 4 of 4 Multistate Pharmacy Jurisprudence Examination (MPJE) Xavier University of Louisiana College of Pharmacy 2023 2022 2021 2020 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr TOTAL CANDIDATE GROUP

No. of Candidates 148 192 55 * testing in same/different state 64 / 84 97 / 95 10 / 45

Mean Scaled Score - School * 74.20/76.06 76.05/76.71 75.40/78.20 * testing in same/different state

Mean Scaled Score - State 76.74 78.07 78.67

Mean Scaled Score - National 77.03 78.44 77.33

School Pass Rate: * 53.13/66.67 65.98/71.58 70.00/82.22 * testing in same/different state

State Pass Rate: 71.43% 80.92% 79.27%

National Pass Rate: 73.79% 83.58% 75.86%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 90 161 36 * testing in same/different state 30 / 60 81 / 80 4 / 32

Mean Scaled Score - School * 74.17/76.47 76.49/76.89 74.50/79.03 * testing in same/different state

Mean Scaled Score - State 77.72 78.39 79.68

Mean Scaled Score - National 77.48 78.75 78.18

School Pass Rate: * 46.67/68.33 72.84/71.25 50.00/87.50 * testing in same/different state

State Pass Rate: 77.44% 84.04% 81.67%

National Pass Rate: 76.81% 85.74% 82.43% Multistate Pharmacy Jurisprudence Examination (MPJE) Xavier University of Louisiana College of Pharmacy 2019 2018 2017 2016 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr TOTAL CANDIDATE GROUP

No. of Candidates 98 193 78 159 212 71 134 187 61 130 182 111 * testing in same/different state 29 / 69 99 / 94 21 / 57 73 / 86 103 / 109 10 / 61 42 / 92 95 / 92 18 / 43 51 / 79 92 / 90 13 / 98

Mean Scaled Score - School * 75.72/75.90 77.27/76.34 74.33/76.53 74.55/75.72 76.17/77.23 76.30/76.44 75.52/75.13 76.36/76.23 74.00/75.63 75.16/76.56 75.93/77.13 75.15/79.34 * testing in same/different state

Mean Scaled Score - State 77.53 78.10 78.26 76.64 77.47 78.00 76.52 76.83 77.39 76.91 77.12 80.92

Mean Scaled Score - National 76.90 78.12 77.38 76.94 78.21 77.49 76.99 78.16 77.59 77.08 78.08 81.10

School Pass Rate: * 65.52/62.32 78.79/73.40 38.10/71.93 52.05/59.30 69.90/73.39 70.00/63.93 59.52/53.26 73.68/67.39 44.44/65.12 56.86/78.48 64.13/74.44 53.85/82.65 * testing in same/different state

State Pass Rate: 75.80% 84.14% 79.62% 69.19% 78.82% 82.79% 70.53% 77.13% 75.57% 75.14% 77.93% 90.23%

National Pass Rate: 72.66% 82.49% 76.77% 72.86% 83.07% 76.46% 74.01% 83.24% 76.90% 74.77% 82.66% 87.62%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 68 157 48 92 180 40 79 164 42 77 163 94 * testing in same/different state 16 / 52 81 / 76 6 / 42 34 / 58 93 / 87 3 / 37 18 / 61 86 / 78 6 / 36 16 / 61 83 / 80 10 / 84

Mean Scaled Score - School * 74.81/76.15 77.51/76.28 75.17/77.21 74.00/76.10 76.11/77.84 79.00/76.73 75.28/75.41 76.66/76.58 75.17/75.64 73.19/76.64 76.04/77.46 74.90/79.99 * testing in same/different state

Mean Scaled Score - State 77.82 78.34 79.25 77.19 77.56 79.02 76.88 77.00 78.28 77.33 77.10 81.58

Mean Scaled Score - National 77.41 78.39 78.09 77.46 78.50 78.26 77.52 78.41 78.31 77.61 78.24 81.84

School Pass Rate: * 50.00/65.38 81.48/69.74 50.00/78.57 41.18/60.34 68.82/79.31 100 / 64.86 66.67/55.74 75.58/70.51 50.00/66.67 31.25/77.05 65.06/76.25 50.00/88.10 * testing in same/different state

State Pass Rate: 77.31% 86.40% 86.44% 71.76% 78.37% 90.53% 72.58% 78.38% 80.85% 77.88% 77.21% 92.79%

National Pass Rate: 76.36% 84.21% 81.95% 76.03% 85.00% 82.37% 77.03% 84.39% 82.10% 78.24% 83.77% 90.71% Multistate Pharmacy Jurisprudence Examination (MPJE) Xavier University of Louisiana College of Pharmacy 2015 2014 2013 2012 Sep -Doc May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr TOTAL CANDIDATE GROUP

No. of Candidates 103 215 81 128 193 52 115 188 53 87 181 13 * testing in same/different state 33 / 70 105 / 110 26 / 55 43 / 85 82 / 111 12 / 40 46 / 69 95 / 93 6 / 47 23 / 65 94 / 87

Mean Scaled Score - School * 78.36/80.64 79.39/80.75 75.27/79.70 77.05/80.62 78.35/79.98 76 / 79.28 77.33/78.72 79.46/79.55 78.17/79.09 76.96/79.95 79.27/78.48 79.69 * testing in same/different state

Mean Scaled Score - State 80.05 80.56 79.81 80.13 80.18 80.36 80.43 80.82 81.33 79.62 80.91 81.18

Mean Scaled Score - National 80.91 82.40 81.32 81.08 82.52 81.04 80.52 82.50 80.92 80.55 82.43 80.41

School Pass Rate: * 78.79/85.71 81.90/89.09 50.00/72.73 65.12/90.59 76.83/90.09 50 / 82.50 71.74/76.81 85.26/81.72 83.33/76.60 60.87/86.15 84.04/81.61 84.62 * testing in same/different state

State Pass Rate: 86.55% 88.14% 80.69% 82.69% 86.08% 82.52% 85.21% 90.51% 93.98% 81.61% 90.69% 90.41%

National Pass Rate: 87.78% 93.04% 88.20% 88.50% 93.28% 87.62% 87.01% 92.98% 87.18% 86.85% 92.76% 84.54%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 73 193 65 98 176 43 86 171 43 70 163 9 * testing in same/different state 14 / 59 94 / 99 14 / 51 24 / 74 76 / 100 8 / 35 31 / 55 89 / 82 3 / 40 11 / 54 87 / 76

Mean Scaled Score - School * 79.00/81.47 79.24/81.07 76.29/80.28 77.33/80.86 78.83/80.23 76.63/79.31 77.03/78.85 79.66/79.94 81.33/79.38 77.55/80.57 79.34/78.70 79.78 * testing in same/different state

Mean Scaled Score - State 80.81 80.62 80.63 81.13 80.62 81.05 81.08 81.03 81.90 80.21 81.03 81.75

Mean Scaled Score - National 81.60 82.66 82.14 81.79 82.80 81.82 81.22 82.76 81.78 81.26 82.75 81.44

School Pass Rate: * 92.86/91.53 80.85/91.92 57.14/78.43 62.5 / 91.89 80.26/90.00 50 / 80 67.74/74.55 87.64/82.93 100 / 77.50 63.64/87.04 83.91/84.24 88.89 * testing in same/different state

State Pass Rate: 91.06% 88.77% 83.61% 84.96% 89.29% 85.88% 87.29% 91.88% 97.22% 85.71% 91.03% 93.22%

National Pass Rate: 90.35% 93.97% 91.72% 90.87% 94.34% 90.85% 90.04% 93.95% 91.08% 89.60% 93.94% 89.13% Multistate Pharmacy Jurisprudence Examination (MPJE) Xavier University of Louisiana College of Pharmacy 2011 2010 2009 2008 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Jul - Dec Jan - Jun

TOTAL CANDIDATE GROUP

No. of Candidates 44 77 10 83 160 42 68 162 63 208 55

Mean Scaled Score - School 78.93 79.32 76.50 78.17 79.89 78.93 78.10 80.20 78.03 79.49 78.25

Mean Scaled Score - State 80.41 81.01 N/A 81.64 80.88 81.37 80.35 81.69 79.57 81.34 81.33

Mean Scaled Score - National 80.46 82.23 80.27 80.57 82.51 80.45 80.25 82.39 80.29 81.27 81.59

School Pass Rate: 81.82% 81.82% 70.00% 78.31% 88.75% 80.95% 77.94% 88.27% 74.60% 83.17% 80.00%

State Pass Rate: 90.99% 89.91% N/A 95.79% 92.64% 90.00% 85.92% 94.52% 81.03% 91.05% 91.75%

National Pass Rate: 86.24% 92.17% 86.43% 89.35% 94.83% 89.08% 87.04% 93.74% 86.23% 89.92% 90.31%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 29 67 7 61 157 32 47 150 44 181 45

Mean Scaled Score - School 80.14 79.84 78.14 78.48 79.95 79.66 78.79 80.35 78.55 79.71 79.02

Mean Scaled Score - State 81.14 81.52 N/A 82.07 80.93 82.07 80.98 81.76 79.69 81.62 81.53

Mean Scaled Score - National 81.76 82.86 81.17 80.94 82.67 80.82 80.63 82.58 80.75 81.57 81.97

School Pass Rate: 89.66% 86.57% 85.71% 78.69% 89.17% 84.38% 82.98% 88.67% 79.55% 85.64% 88.89%

State Pass Rate: 94.32% 94.06% N/A 97.56% 92.92% 93.44% 89.66% 94.34% 80.77% 91.95% 92.31%

National Pass Rate: 94.00% 95.05% 92.24% 90.89% 95.50% 90.64% 88.68% 94.30% 88.45% 91.16% 91.82% Multistate Pharmacy Jurisprudence Examination (MPJE) Xavier University of Louisiana College of Pharmacy

2007 2006 2005 2004 Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun

TOTAL CANDIDATE GROUP

No. of Candidates 169 77 181 139 135 82 123 66

School Average Score: 79.76 78.47 79.82 79.04 78.96 78.06 78.64 77.36

State Average Score: 81.47 80.15 81.34 80.01 80.03 80.50 80.03 78.58

National Average Score: 81.14 81.26 80.42 80.68 80.04 80.39 79.83 80.10

School Pass Rate: 87.57% 77.92% 86.19% 87.77% 82.22% 76.83% 80.49% 78.79%

State Pass Rate: 90.39% 87.18% 92.39% 91.09% 87.03% 90.55% 92.55% 86.90%

National Pass Rate: 89.78% 89.38% 87.82% 87.25% 85.69% 86.57% 84.75% 85.63%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 154 62 156 121 121 63 101 56

School Average Score: 80.03 79.47 80.27 79.14 79.36 78.57 79.19 77.73

State Average Score: 81.84 80.59 81.52 80.24 80.29 80.71 80.11 79.04

National Average Score: 81.51 81.72 80.80 81.09 80.44 80.80 80.25 80.58

School Pass Rate: 88.96% 85.48% 89.10% 87.60% 85.12% 79.37% 84.16% 80.36%

State Pass Rate: 92.49% 91.18% 93.53% 92.31% 88.69% 91.38% 92.53% 90.14%

National Pass Rate: 91.24% 91.43% 89.34% 89.41% 87.51% 88.51% 86.87% 88.16% Multistate Pharmacy Jurisprudence Examination (MPJE) Xavier University of Louisiana College of Pharmacy

2003 2002 2001 2000 Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun Jul - Dec Jan - Jun

TOTAL CANDIDATE GROUP

No. of Candidates 158 71 122 43 126 53 94 25

School Average Score: 77.99 76.75 78.18 79.12 79.86 77.43 78.90 78.92

State Average Score: 78.87 77.32 79.41 80.34 80.32 80.64 80.49 81.64

National Average Score: 79.33 79.92 79.85 81.72 81.51 82.25 81.75 82.24

School Pass Rate: 75.95% 67.61% 77.05% 81.40% 88.10% 69.81% 80.85% 80.00%

State Pass Rate: 84.67% 72.88% 85.98% 92.00% 90.00% 87.84% 86.25% 89.89%

National Pass Rate: 82.61% 84.52% 84.93% 90.78% 90.54% 91.22% 90.50% 91.37%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 122 53 102 38 107 38 86 23

School Average Score: 78.48 77.04 78.18 79.58 79.92 77.58 79.01 79.04

State Average Score: 79.23 77.69 79.41 80.30 80.51 80.67 80.97 82.14

National Average Score: 79.76 80.34 80.19 82.08 81.86 82.59 82.05 82.55

School Pass Rate: 78.69% 71.70% 78.43% 86.84% 86.92% 71.05% 80.23% 78.26%

State Pass Rate: 86.55% 75.00% 86.32% 91.49% 89.77% 88.06% 87.32% 92.59%

National Pass Rate: 84.67% 86.58% 86.45% 92.15% 91.75% 92.45% 91.37% 92.57% Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

North American Pharmacist Licensure Examination (NAPLEX™)

September 1 – December 31, 2020

State & National Summary Data Frequency Distribution of Scaled Scores Cumulative Data [since January 2000]

February 24, 2021

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 as well as all the provinces in Canada. 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 colleges of pharmacy and state boards on a calendar trimester basis.

Table of Contents

Current Trimester Report for University of Louisiana 03

Cumulative Report for University of Louisiana 08

Current Trimester Report for Xavier University of Louisiana 14

Cumulative Report for Xavier University of Louisiana 19

NAPLEX-23-2020 Trimester 3

North American Pharmacist Licensure Examination® (NAPLEX®)

School Summary Report

University of Louisiana at Monroe

Test Window: September 1, 2020 - December 31, 2020

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

Area 1 Area 2 Pass Rate Total Scaled Standard Standard Standard Candidates Scaled Scaled % Score Mean Deviation Deviation Deviation Score Mean Score Mean

School 12 75.00% 87.50 17.54 12.17 1.19 12.17 1.34 State 47 57.45% 77.00 21.63 11.53 1.27 11.68 1.60 National 3121 73.57% 85.17 19.01 12.00 1.17 11.97 1.31

Table 2 All Candidates

Area 1 Area 2 Pass Rate Total Scaled Standard Standard Standard Candidates Scaled Scaled % Score Mean Deviation Deviation Deviation Score Mean Score Mean

School 22 68.18% 82.45 17.53 11.82 1.18 12.05 1.09 State 77 58.44% 77.48 19.53 11.55 1.13 11.68 1.42 National 4694 69.17% 82.67 18.37 11.83 1.13 11.86 1.27

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 11 140 candidates. It also shows the boundaries of the Scaled Score Range. All Candidates 1 140 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, 2019 and December 31, 2019.

Comparison Information Total Scaled Score Range AREA 1 AREA 2 0 - 24 8 8 25 - 49 10 10 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.

Table 5 & Graph 1 School Frequency Distribution of Scaled Scores

Based on First-Time Candidates N = 12

Cumulative Percent of Scaled Score Frequency the Upper Limit of the Range 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] 0 0% [55,59] 0 [60,64] 1 8% [60,64] 1 [65,69] 1 17% [65,69] 1 [70,74] 1 25% [70,74] 1 [75,79] 2 42% [75,79] 2 [80,84] 1 50% [80,84] 1 [85,89] 0 50% [85,89] 0 [90,94] 2 67% [90,94] 2 [95,99] 1 75% [95,99] 1 [100,104] 1 83% [100,104]1 [105,109] 0 83% [105,109]0 [110,114] 0 83% [110,114]0 [115,119] 2 100% [115,119]2 [120,124] 0 100% [120,124]0 [125,129] 0 100% [125,129]0 [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

2.5

2

1.5 Frequency 1

0.5

0

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 = 3121

Cumulative Percent of Scaled Score Frequency the Upper Limit of the Range Interval [0,4] 0 0% [0,4] 0 [5,9] 0 0% [5,9] 0 [10,14] 1 0% [10,14] 1 [15,19] 5 0% [15,19] 5 [20,24] 4 0% [20,24] 4 [25,29] 9 1% [25,29] 9 [30,34] 13 1% [30,34] 13 [35,39] 20 2% [35,39] 20 [40,44] 32 3% [40,44] 32 [45,49] 43 4% [45,49] 43 [50,54] 78 7% [50,54] 78 [55,59] 102 10% [55,59]102 [60,64] 139 14% [60,64]139 [65,69] 156 19% [65,69]156 [70,74] 223 26% [70,74]223 [75,79] 289 36% [75,79]289 [80,84] 309 46% [80,84]309 [85,89] 333 56% [85,89]333 [90,94] 335 67% [90,94]335 [95,99] 311 77% [95,99]311 [100,104] 250 85% [100,104]250 [105,109] 181 91% [105,109]181 [110,114] 145 95% [110,114]145 [115,119] 75 98% [115,119]75 [120,124] 44 99% [120,124]44 [125,129] 17 100% [125,129]17 [130,134] 6 100% [130,134]6 [135,139] 0 100% [135,139]0 [140,144] 1 100% [140,144]1 [145,150] 0 100% [145,150]0

400

350

300

250

200 Frequency 150

100

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Scaled Score Interval

Page 5 of 5 North American Pharmacist Licensure Examination (NAPLEX) University of Louisiana at Monroe College of Pharmacy

2023 2022 2021 2020 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr

TOTAL CANDIDATE GROUP

No. of Candidates 22 73 2

Mean Scaled Score - School 82.45 97.1 61.50

Mean Scaled Score - State 77.48 91.66 73.46

Mean Scaled Score - National 82.67 96.01 77.84

School Pass Rate: 68.18% 90.41% 0.00%

State Pass Rate: 58.44% 86.14% 53.85%

National Pass Rate: 69.17% 88.85% 59.65%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 12 72 None

Mean Scaled Score - School 87.50 97.67 N/A

Mean Scaled Score - State 77.00 92.67 72.40

Mean Scaled Score - National 85.17 97.85 82.63

School Pass Rate: 75.00% 91.67% N/A

State Pass Rate: 57.45% 87.26% 60.00%

National Pass Rate: 73.57% 91.70% 67.55% North American Pharmacist Licensure Examination (NAPLEX) University of Louisiana at Monroe College of Pharmacy

2019 2018 2017 2016 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr

TOTAL CANDIDATE GROUP

No. of Candidates 11 88 2 18 89 7 22 95 11 18 94 4

Mean Scaled Score - School 86.82 96.38 84.50 78.83 99.08 73.29 78.32 90.85 87.45 83.76 87.35 60.25

Mean Scaled Score - State 78.93 94.04 76.50 76.24 93.10 72.88 77.78 90.83 80.50 77.06 89.27 66.88

Mean Scaled Score - National 80.17 95.54 77.80 82.00 96.25 77.61 80.89 95.88 79.33 81.48 84.81 74.52

School Pass Rate: 81.82% 92.05% 100.00% 61.11% 95.51% 42.86% 54.55% 84.21% 81.82% 77.78% 76.60% 0.00%

State Pass Rate: 60.98% 88.17% 70.83% 50.00% 86.98% 35.29% 63.64% 82.76% 70.59% 54.72% 77.61% 22.22%

National Pass Rate: 64.55% 88.52% 61.24% 69.24% 89.57% 56.56% 65.47% 88.07% 62.73% 65.32% 85.71% 48.80%

ACPE probation: 06-24-2017 through 06-01-2018 FIRST-TIME CANDIDATE GROUP

No. of Candidates 7 86 None 8 86 None 7 92 2 4 91 1

Mean Scaled Score - School 88.43 96.81 N/A 86.00 99.42 N/A 78.14 91.55 72.50 79.67 87.62 31.00

Mean Scaled Score - State 81.62 94.68 71.33 76.04 94.10 50.00 74.81 91.6 87.50 71.05 89.71 47.33

Mean Scaled Score - National 82.58 96.80 82.00 84.56 97.54 82.20 83.79 97.19 86.04 83.02 95.9 78.95

School Pass Rate: 71.43% 93.02% N/A 62.50% 95.35% N/A 67.14% 85.87% 50.00% 50.00% 76.92% 0.00%

State Pass Rate: 61.90% 90.06% 66.67% 45.83% 89.22% 0.00% 51.85% 84.46% 75.00% 38.10% 78.07% 0.00%

National Pass Rate: 67.59% 90.59% 67.11% 72.76% 91.64% 64.48% 69.31% 90.22% 76.19% 65.64% 87.78% 57.75% North American Pharmacist Licensure Examination (NAPLEX) University of Louisiana at Monroe College of Pharmacy

2015 2014 2013 2012 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr

TOTAL CANDIDATE GROUP

No. of Candidates 9 79 4 11 68 1 7 40 3 17 80 6

Mean Scaled Score - School 83.89 94.93 82.00 82.27 95.10 101.00 88.43 100.45 92.00 85.41 97.14 75.33

Mean Scaled Score - State 85.60 95.51 82.15 80.88 96.45 73.85 86.88 98.66 77.25 86.95 98.42 81.25

Mean Scaled Score - National 88.25 100.46 83.84 89.22 101.71 80.22 87.03 102.78 80.17 88.15 102.81 83.15

School Pass Rate: 77.78% 89.87% 50.00% 63.64% 89.71% 100.00% 100.00% 90.00% 100.00% 82.35% 92.50% 83.33%

State Pass Rate: 76.00% 88.24% 69.23% 70.59% 90.75% 53.85% 81.82% 92.95% 55.56% 76.19% 93.82% 68.75%

National Pass Rate: 77.64% 92.29% 67.06% 79.77% 93.86% 63.24% 75.91% 94.65% 61.07% 77.86% 95.21% 68.33%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 5 78 1 3 68 1 4 38 3 9 80 2

Mean Scaled Score - School 83.60 94.62 74.00 92.00 95.10 101.00 92.00 101.68 92.00 87.11 97.14 49.50

Mean Scaled Score - State 86.50 96.08 77.00 83.34 96.96 85.00 88.33 99.30 80.75 91.00 99.47 84.00

Mean Scaled Score - National 91.24 101.53 94.01 93.94 102.80 90.89 92.69 104.02 92.48 95.75 104.13 94.87

School Pass Rate: 80.00% 89.74% 0.00% 66.67% 89.71% 100.00% 100.00% 92.11% 100.00% 77.78% 92.50% 50.00%

State Pass Rate: 75.00% 89.34% 33.33% 73.68% 92.12% 100.00% 83.33% 94.08% 75.00% 72.73% 95.35% 75.00%

National Pass Rate: 81.88% 93.86% 84.96% 85.36% 95.61% 83.15% 84.46% 96.57% 85.14% 90.14% 97.19% 87.69% North American Pharmacist Licensure Examination (NAPLEX) University of Louisiana at Monroe College of Pharmacy

2011 2010 2009 2008 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr

TOTAL CANDIDATE GROUP

No. of Candidates 9 91 2 6 67 3 8 91 6 12 98 11

Mean Scaled Score - School 87.22 97.40 67.50 93.17 99.97 98.00 77.25 113.84 97.83 93.83 106.39 94.73

Mean Scaled Score - State 85.27 99.66 N/A 80.13 94.22 83.15 84.32 108.26 94.80 95.41 103.31 93.70

Mean Scaled Score - National 88.08 103.27 83.97 84.90 101.11 84.75 93.62 112.51 93.72 96.61 112.08 96.76

School Pass Rate: 77.78% 89.01% 0.00% 100.00% 95.52% 100.00% 50.00% 95.60% 83.33% 83.33% 92.86% 90.91%

State Pass Rate: 73.17% 90.81% N/A 65.00% 83.24% 61.54% 63.16% 92.64% 80.00% 82.76% 90.34% 90.00%

National Pass Rate: 76.57% 94.16% 67.85% 75.20% 92.39% 65.07% 78.20% 95.03% 76.40% 81.96% 95.48% 83.11%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 3 87 1 2 67 0 3 88 3 5 97 3

Mean Scaled Score - School 84.67 99.39 62.00 97.00 99.97 0.00 78.33 115.34 93.00 95.80 106.76 110.33

Mean Scaled Score - State 83.70 100.88 N/A 90.75 94.46 92.00 84.10 108.80 86.00 95.82 104.42 96.00

Mean Scaled Score - National 96.71 105.03 96.99 94.26 103.06 100.12 102.87 114.65 106.27 103.62 114.11 106.63

School Pass Rate: 66.67% 93.10% 0.00% 100.00% 95.52% 0.00% 33.33% 96.59% 66.67% 80.00% 93.81% 100.00%

State Pass Rate: 74.07% 93.18% N/A 83.33% 84.15% 66.67% 60.00% 93.04% 57.14% 82.35% 92.35% 83.33%

National Pass Rate: 89.24% 96.57% 87.50% 86.71% 95.31% 88.38% 89.51% 97.50% 90.76% 90.66% 97.44% 92.24% North American Pharmacist Licensure Examination (NAPLEX) University of Louisiana at Monroe College of Pharmacy

2007 2006 2005 2004 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr

TOTAL CANDIDATE GROUP

No. of Candidates 23 90 3 10 60 2 17 72 9 18 64 3

School Average Score: 101.57 117.27 107.67 95.80 113.17 98.00 101.65 104.17 82.67 94.83 105.30 85.67

State Average Score: 94.73 117.29 88.00 96.07 111.87 86.67 92.50 101.77 95.00 96.71 103.47 81.33

National Average Score: 94.18 113.33 89.95 93.18 107.02 86.89 87.72 104.85 91.32 91.70 102.16 92.13

School Pass Rate: 78.26% 95.56% 100.00% 80.00% 93.33% 100.00% 94.12% 90.28% 88.89% 94.44% 96.88% 100.00%

State Pass Rate: 74.51% 95.52% 63.64% 79.31% 89.17% 77.78% 78.57% 87.83% 100.00% 100.00% 96.12% 83.33%

National Pass Rate: 78.76% 94.47% 71.38% 77.07% 90.52% 68.82% 71.73% 89.15% 82.88% 84.79% 95.11% 83.22%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 19 89 3 4 58 2 11 70 5 17 58 2

School Average Score: 103.05 117.66 107.67 125.00 114.59 98.00 110.09 105.09 81.40 93.47 107.34 87.00

State Average Score: 95.00 118.18 103.40 95.41 112.95 93.33 98.94 103.64 101.50 99.73 105.61 84.00

National Average Score: 102.19 116.00 102.16 99.96 110.34 97.18 95.89 107.67 98.84 96.60 104.14 100.14

School Pass Rate: 78.95% 95.51% 100.00% 100.00% 94.83% 100.00% 100.00% 91.43% 80.00% 94.12% 100.00% 100.00%

State Pass Rate: 76.74% 96.69% 100.00% 70.59% 90.38% 100.00% 88.89% 90.09% 100.00% 100.00% 100.00% 100.00%

National Pass Rate: 88.12% 97.23% 84.09% 84.74% 94.49% 81.12% 82.12% 92.86% 91.31% 92.22% 97.38% 95.07% North American Pharmacist Licensure Examination (NAPLEX) University of Louisiana at Monroe College of Pharmacy

2003 2002 2001 2000 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr

TOTAL CANDIDATE GROUP

No. of Candidates 24 70 10 27 62 13 10 30 40 18 47 76

School Average Score: 92.50 101.44 78.40 89.56 100.24 82.85 87.00 87.30 88.93 88.61 91.62 96.51

State Average Score: 87.33 99.40 77.50 87.48 101.46 75.50 82.05 93.82 84.66 86.05 88.52 96.75

National Average Score: 89.40 101.40 91.50 90.02 101.21 90.81 90.50 101.70 90.25 91.21 99.86 91.78

School Pass Rate: 87.50% 95.71% 60.00% 77.78% 85.48% 84.62% 90.00% 90.00% 85.00% 88.89% 82.98% 96.05%

State Pass Rate: 80.00% 94.90% 62.50% 70.37% 85.90% 50.00% 70.00% 89.29% 75.86% 77.27% 78.57% 92.50%

National Pass Rate: 79.55% 93.84% 82.77% 81.73% 93.76% 81.52% 83.69% 94.38% 81.07% 83.04% 92.05% 82.95%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 16 64 2 20 61 13 6 20 37 9 33 71

School Average Score: 98.56 102.69 73.50 92.80 100.44 82.85 90.67 86.90 88.32 94.00 96.00 97.13

State Average Score: 92.38 100.41 74.00 91.15 103.71 81.89 85.93 95.92 88.78 87.77 93.61 97.49

National Average Score: 95.88 103.38 97.39 94.62 103.00 95.13 94.22 103.35 94.54 96.48 101.85 96.51

School Pass Rate: 100.00% 96.88% 50.00% 75.00% 85.25% 84.62% 100.00% 85.00% 83.78% 100.00% 96.97% 95.77%

State Pass Rate: 90.48% 95.65% 66.67% 70.00% 90.28% 77.78% 73.33% 91.84% 83.33% 84.62% 93.18% 94.59%

National Pass Rate: 89.64% 96.54% 91.47% 88.52% 96.74% 89.27% 90.10% 96.75% 87.91% 91.39% 95.44% 91.44% NAPLEX-24-2020 Trimester 3

North American Pharmacist Licensure Examination® (NAPLEX®)

School Summary Report

Xavier University of Louisiana

Test Window: September 1, 2020 - December 31, 2020

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

Area 1 Area 2 Pass Rate Total Scaled Standard Standard Standard Candidates Scaled Scaled % Score Mean Deviation Deviation Deviation Score Mean Score Mean

School 41 48.78% 72.29 23.46 11.32 1.35 11.34 1.59 State 47 57.45% 77.00 21.63 11.53 1.27 11.68 1.60 National 3121 73.57% 85.17 19.01 12.00 1.17 11.97 1.31

Table 2 All Candidates

Area 1 Area 2 Pass Rate Total Scaled Standard Standard Standard Candidates Scaled Scaled % Score Mean Deviation Deviation Deviation Score Mean Score Mean

School 64 50.00% 72.53 22.30 11.27 1.29 11.38 1.46 State 77 58.44% 77.48 19.53 11.55 1.13 11.68 1.42 National 4694 69.17% 82.67 18.37 11.83 1.13 11.86 1.27

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 11 140 candidates. It also shows the boundaries of the Scaled Score Range. All Candidates 1 140 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, 2019 and December 31, 2019.

Comparison Information Total Scaled Score Range AREA 1 AREA 2 0 - 24 8 8 25 - 49 10 10 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.

Table 5 & Graph 1 School Frequency Distribution of Scaled Scores

Based on First-Time Candidates N = 41

Cumulative Percent of Scaled Score Frequency the Upper Limit of the Range 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] 1 2% [20,24] 1 [25,29] 0 2% [25,29] 0 [30,34] 1 5% [30,34] 1 [35,39] 1 7% [35,39] 1 [40,44] 3 15% [40,44] 3 [45,49] 2 20% [45,49] 2 [50,54] 2 24% [50,54] 2 [55,59] 2 29% [55,59] 2 [60,64] 4 39% [60,64] 4 [65,69] 2 44% [65,69] 2 [70,74] 3 51% [70,74] 3 [75,79] 3 59% [75,79] 3 [80,84] 4 68% [80,84] 4 [85,89] 4 78% [85,89] 4 [90,94] 3 85% [90,94] 3 [95,99] 0 85% [95,99] 0 [100,104] 2 90% [100,104]2 [105,109] 2 95% [105,109]2 [110,114] 1 98% [110,114]1 [115,119] 1 100% [115,119]1 [120,124] 0 100% [120,124]0 [125,129] 0 100% [125,129]0 [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

4.5

4

3.5

3

2.5

2 Frequency

1.5

1

0.5

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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 = 3121

Cumulative Percent of Scaled Score Frequency the Upper Limit of the Range Interval [0,4] 0 0% [0,4] 0 [5,9] 0 0% [5,9] 0 [10,14] 1 0% [10,14] 1 [15,19] 5 0% [15,19] 5 [20,24] 4 0% [20,24] 4 [25,29] 9 1% [25,29] 9 [30,34] 13 1% [30,34] 13 [35,39] 20 2% [35,39] 20 [40,44] 32 3% [40,44] 32 [45,49] 43 4% [45,49] 43 [50,54] 78 7% [50,54] 78 [55,59] 102 10% [55,59]102 [60,64] 139 14% [60,64]139 [65,69] 156 19% [65,69]156 [70,74] 223 26% [70,74]223 [75,79] 289 36% [75,79]289 [80,84] 309 46% [80,84]309 [85,89] 333 56% [85,89]333 [90,94] 335 67% [90,94]335 [95,99] 311 77% [95,99]311 [100,104] 250 85% [100,104]250 [105,109] 181 91% [105,109]181 [110,114] 145 95% [110,114]145 [115,119] 75 98% [115,119]75 [120,124] 44 99% [120,124]44 [125,129] 17 100% [125,129]17 [130,134] 6 100% [130,134]6 [135,139] 0 100% [135,139]0 [140,144] 1 100% [140,144]1 [145,150] 0 100% [145,150]0

400

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Page 5 of 5 North American Pharmacist Licensure Examination (NAPLEX) Xavier University of Louisiana College of Pharmacy

2023 2022 2021 2020 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr

TOTAL CANDIDATE GROUP

No. of Candidates 64 103 14

Mean Scaled Score - School 72.53 86.64 74.07

Mean Scaled Score - State 77.48 91.66 73.46

Mean Scaled Score - National 82.67 96.01 77.84

School Pass Rate: 50.00% 78.64% 50.00%

State Pass Rate: 58.44% 86.14% 53.85%

National Pass Rate: 69.17% 88.85% 59.65%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 41 90 3

Mean Scaled Score - School 72.29 88.99 75.67

Mean Scaled Score - State 77.00 92.67 72.40

Mean Scaled Score - National 85.17 97.85 82.63

School Pass Rate: 48.78% 82.22% 66.67%

State Pass Rate: 57.45% 87.26% 60.00%

National Pass Rate: 73.57% 91.70% 67.55% North American Pharmacist Licensure Examination (NAPLEX) Xavier University of Louisiana College of Phamacy

2019 2018 2017 2016 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr

TOTAL CANDIDATE GROUP

No. of Candidates 40 119 29 49 146 15 45 127 25 43 123 16

Mean Scaled Score - School 73.20 88.84 74.97 72.35 86.87 68.20 74.84 90.03 77.68 75.20 89.84 61.87

Mean Scaled Score - State 78.93 94.04 76.50 76.24 93.10 72.88 77.78 90.83 80.50 77.06 89.27 66.88

Mean Scaled Score - National 80.17 95.54 77.80 82.00 96.25 77.61 80.89 95.88 79.33 81.48 94.81 74.52

School Pass Rate: 50.00% 78.99% 65.52% 38.78% 76.71% 40.00% 55.56% 80.31% 64.00% 51.16% 78.05% 25.00%

State Pass Rate: 60.98% 88.17% 70.83% 50.00% 86.98% 35.29% 63.64% 82.76% 70.59% 54.72% 77.61% 22.22%

National Pass Rate: 64.55% 88.52% 61.24% 69.24% 89.57% 56.56% 65.47% 88.07% 62.73% 65.32% 85.71% 48.80%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 19 106 3 21 134 2 23 121 1 22 114 4

Mean Scaled Score - School 72.16 91.69 67.67 69.57 88.82 66.00 73.00 90.57 111.00 74.81 91.10 63.67

Mean Scaled Score - State 81.62 94.68 71.33 76.04 94.10 50.00 74.81 91.60 87.50 81.05 89.71 47.33

Mean Scaled Score - National 82.58 96.80 82.00 84.56 97.54 82.20 83.79 97.19 86.04 83.02 95.90 78.95

School Pass Rate: 47.37% 85.85% 66.67% 28.57% 82.09% 50.00% 39.13% 81.82% 100.00% 50.00% 80.70% 25.00%

State Pass Rate: 61.90% 90.06% 66.67% 45.83% 89.22% 0.00% 51.85% 84.46% 75.00% 38.10% 78.07% 0.00%

National Pass Rate: 67.59% 90.59% 67.11% 72.76% 91.64% 64.48% 69.31% 90.22% 76.19% 65.64% 87.78% 57.75%

North American Pharmacist Licensure Examination (NAPLEX) Xavier University of Louisiana College of Pharmacy

2015 2014 2013 2012 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr

TOTAL CANDIDATE GROUP

No. of Candidates 22 141 15 27 138 18 43 136 10 21 120 13

Mean Scaled Score - School 86.73 96.03 72.13 80.41 96.29 70.72 81.47 95.13 68.67 83.24 95.13 76.69

Mean Scaled Score - State 85.60 95.51 82.15 80.88 96.45 73.85 86.88 98.66 77.25 86.95 98.42 81.25

Mean Scaled Score - National 88.25 100.46 83.84 89.22 101.71 80.22 87.03 102.78 80.17 88.15 102.81 83.15

School Pass Rate: 86.36% 85.11% 53.33% 70.37% 92.75% 50.00% 65.12% 86.03% 40.00% 61.90% 90.00% 46.15%

State Pass Rate: 76.00% 88.24% 69.23% 70.59% 90.75% 53.85% 81.82% 92.95% 55.56% 76.19% 93.82% 68.75%

National Pass Rate: 77.64% 92.29% 67.06% 79.77% 93.86% 63.24% 75.91% 94.65% 61.07% 77.86% 95.21% 68.33%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 10 137 4 18 131 3 29 131 1 12 111 3

Mean Scaled Score - School 89.60 97.31 84.75 82.33 97.15 61.00 82.76 96.65 47.00 95.58 97.71 84.67

Mean Scaled Score - State 86.50 96.08 77.00 83.84 96.96 85.00 88.33 99.30 80.75 91.00 99.47 84.00

Mean Scaled Score - National 91.24 101.53 94.01 93.94 102.80 90.89 92.69 104.02 92.48 95.75 104.13 94.87

School Pass Rate: 80.00% 87.59% 75.00% 72.22% 93.89% 66.67% 68.97% 89.31% 0.00% 91.67% 93.69% 66.67%

State Pass Rate: 75.00% 89.34% 33.33% 73.68% 92.12% 100.00% 83.33% 94.08% 75.00% 72.73% 95.35% 75.00%

National Pass Rate: 81.88% 93.86% 84.96% 85.36% 95.61% 83.15% 84.46% 96.57% 85.14% 90.14% 97.19% 87.69% North American Pharmacist Licensure Examination (NAPLEX) Xavier University of Louisiana College of Pharmacy

2011 2010 2009 2008 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr

TOTAL CANDIDATE GROUP

No. of Candidates 45 124 25 52 148 19 28 138 18 55 138 22

Mean Scaled Score - School 85.04 99.13 76.00 77.15 89.73 73.63 86.96 97.59 80.33 89.82 96.77 81.36

Mean Scaled Score - State 85.27 99.66 80.13 94.22 83.15 84.32 108.26 94.80 95.41 103.31 93.70

Mean Scaled Score - National 88.08 103.27 83.97 84.90 101.11 84.75 93.62 112.51 93.72 96.61 112.08 96.76

School Pass Rate: 75.56% 87.10% 64.00% 59.62% 75.00% 42.11% 71.43% 83.33% 61.11% 76.36% 81.88% 68.18%

State Pass Rate: 73.17% 90.81% 65.00% 83.24% 61.54% 63.16% 92.64% 80.00% 82.76% 90.34% 90.00%

National Pass Rate: 76.57% 94.16% 67.85% 72.20% 92.39% 65.07% 78.20% 95.03% 76.40% 81.96% 95.48% 83.11%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 33 115 6 16 143 6 12 127 6 36 124 5

Mean Scaled Score - School 85.45 101.95 61.00 84.00 90.78 79.83 83.33 99.77 81.00 92.47 98.77 85.40

Mean Scaled Score - State 83.70 100.88 90.75 94.46 92.00 84.10 108.80 86.00 95.82 104.42 96.00

Mean Scaled Score - National 96.71 105.03 96.99 94.26 103.06 100.12 102.87 114.65 106.27 103.62 114.11 106.63

School Pass Rate: 81.82% 92.17% 16.67% 75.00% 76.92% 50.00% 66.67% 86.61% 50.00% 80.56% 84.68% 80.00%

State Pass Rate: 74.07% 93.18% 83.33% 84.15% 66.67% 60.00% 93.04% 57.14% 82.35% 92.35% 83.33%

National Pass Rate: 89.24% 96.57% 87.50% 86.71% 95.31% 88.38% 89.51% 97.50% 90.76% 90.66% 97.44% 92.24% North American Pharmacist Licensure Examination (NAPLEX) Xavier University of Louisiana College of Pharmacy

2007 2006 2005 2004 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr

TOTAL CANDIDATE GROUP

No. of Candidates 56 81 17 48 94 20 30 95 6 19 82 10

School Average Score: 86.77 109.07 74.18 92.81 106.20 72.15 73.07 98.92 83.00 91.68 98.99 76.40

State Average Score: 94.73 117.29 88.00 96.07 111.87 86.67 92.50 101.77 95.00 96.71 103.47 81.33

National Average Score: 94.18 113.33 89.95 93.18 107.02 86.89 87.72 104.85 91.32 91.70 102.16 92.13

School Pass Rate: 64.29% 83.95% 52.94% 77.08% 82.98% 50.00% 56.67% 86.32% 83.33% 84.21% 96.34% 70.00%

State Pass Rate: 74.51% 95.52% 63.64% 79.31% 89.17% 77.78% 78.57% 87.83% 100.00% 100.00% 96.12% 83.33%

National Pass Rate: 78.76% 94.47% 71.38% 77.07% 90.52% 68.82% 71.73% 89.15% 82.88% 84.79% 95.11% 83.22%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 46 68 3 31 87 5 19 90 3 10 79 2

School Average Score: 90.50 114.60 94.67 93.10 109.32 69.40 79.79 101.34 85.00 98.80 100.06 72.50

State Average Score: 95.00 118.18 103.40 95.41 112.95 93.33 98.94 103.64 101.50 99.73 105.61 84.00

National Average Score: 102.19 116.00 102.16 99.96 110.34 97.18 95.89 107.67 98.84 96.60 104.14 100.14

School Pass Rate: 71.74% 92.65% 100.00% 77.42% 86.21% 40.00% 68.42% 88.89% 66.67% 100.00% 98.73% 50.00%

State Pass Rate: 76.74% 96.69% 100.00% 70.59% 90.38% 100.00% 88.89% 90.09% 100.00% 100.00% 100.00% 100.00%

National Pass Rate: 88.12% 97.23% 84.09% 84.74% 94.49% 81.12% 82.12% 92.86% 91.31% 92.22% 97.38% 95.07% North American Pharmacist Licensure Examination (NAPLEX) Xavier University of Louisiana College of Pharmacy

2003 2002 2001 2000 Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr Sep - Dec May - Aug Jan - Apr

TOTAL CANDIDATE GROUP

No. of Candidates 40 90 19 48 69 22 40 85 28 43 80 10

School Average Score: 84.33 94.46 79.42 86.98 93.23 76.00 85.15 93.14 76.50 81.67 87.99 77.60

State Average Score: 87.33 99.40 77.50 87.48 101.46 75.50 82.05 93.82 84.66 86.05 88.52 96.75

National Average Score: 89.40 101.40 91.50 90.02 101.21 90.81 83.69 101.70 90.25 91.21 99.86 91.78

School Pass Rate: 75.00% 90.00% 68.42% 85.42% 79.71% 54.55% 82.50% 85.88% 57.14% 62.79% 77.50% 60.00%

State Pass Rate: 80.00% 94.90% 62.50% 70.37% 85.90% 50.00% 70.00% 89.29% 75.86% 77.27% 78.57% 92.50%

National Pass Rate: 79.55% 93.84% 82.77% 81.73% 93.76% 81.52% 83.69% 94.38% 81.07% 83.04% 92.05% 82.95%

FIRST-TIME CANDIDATE GROUP

No. of Candidates 26 83 8 40 63 8 29 74 10 23 77 1

School Average Score: 88.04 95.34 87.75 88.60 95.00 80.63 86.48 95.92 74.80 82.13 88.19 95.00

State Average Score: 92.38 100.41 74.00 91.15 103.71 81.89 85.93 95.92 88.78 87.77 93.61 97.49

National Average Score: 95.88 103.38 97.39 94.62 103.00 95.13 94.22 103.35 94.54 96.48 101.85 96.51

School Pass Rate: 80.77% 90.36% 87.50% 90.00% 84.13% 75.00% 82.76% 90.54% 50.00% 65.22% 77.92% 100.00%

State Pass Rate: 90.48% 95.65% 66.67% 70.00% 90.28% 77.78% 73.33% 91.84% 83.33% 84.62% 93.18% 94.59%

National Pass Rate: 89.64% 96.54% 91.47% 88.52% 96.74% 89.27% 90.10% 96.75% 87.91% 91.39% 95.44% 91.44% Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Examination for the Certification of Pharmacy Technicians (ExCPT™)

October 1 – December 31, 2020

Cumulative Record (since January 2018)

February 24, 2021

National Healthcareers Association ExCPT

Calendar Year 2019 Calendar Year 2018 4th Qtr 3rd Qtr 2nd Qtr 1st Qtr 4th Qtr 3rd Qtr 2nd Qtr 1st Qtr

First-Time Candidate Group No. of LA Candidates 56 58 71 48 32 34 32 7

No. of LA Candidates who passed 36 35 39 41 22 20 16 2

State Pass Rate 64% 60% 56% 85% 69% 59% 50% 29%

No of National Candidates 1602 1536 3942 1835

No. of National Candidates who passed 1183 1123 2503 1356

National Pass Rate 74% 73% 63% 74% 70% 70% 61% 66%

Multiple Attempts Group No. of LA Candidates 0 1 1 1 5 2 6 2

No. of LA Candidates who passed 0 0 1 1 2 2 3 1

State Pass Rate 0% 0% 100% 100% 40% 100% 50% 50%

No. of National Caniddates 85 72 194 172

No. of National Candidates who passed 36 37 95 94

National Pass Rate 42% 51% 49% 55% 55% 40% 47% 62% National Healthcareers Association ExCPT

Calendar Year 2021 Calendar Year 2020 4th Qtr 3rd Qtr 2nd Qtr 1st Qtr 4th Qtr 3rd Qtr 2nd Qtr 1st Qtr

First-Time Candidate Group No. of LA Candidates 26 45 25 40

No. of LA Candidates who passed 10 21 14 27

State Pass Rate 38% 47% 56% 68%

No of National Candidates 1562 1924 1475 1503

No. of National Candidates who passed 1111 1328 943 1101

National Pass Rate 71% 69% 64% 73%

Multiple Attempts Group No. of LA Candidates 2 4 0 0

No. of LA Candidates who passed 1 2

State Pass Rate 50% 50%

No. of National Caniddates 98 183 58 66

No. of National Candidates who passed 60 102 26 33

National Pass Rate 61% 56% 45% 50% Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Pharmacy Technician Certification Examination (PTCE™)

July – December 2020

Cumulative Record (since January 2000)

February 24, 2021

Pharmacy Technician Certification Examination (PTCE™)

This computer adaptive competency assessment is administered by the Pharmacy Technician Certification Board (PTCB). The examination blueprint is designed to assess the applicant’s competency in basic pharmacy practice and is recognized by pharmacy regulatory authorities in most of the states and territories within the USA. The examination is administered via an open window process; applicants may schedule the examination at a designated testing center at any time following approval by PTCB and receipt of an Authorization to Test (ATT) document from PTCB. Individual scores are available to applicants immediately after the test; certificates are mailed to the applicant within 30 days following the examination. Summary reports are provided to the state boards on a semi-annual basis.

Table of Contents

PTCE Pass Rates, National v Louisiana, July to December, 2020 03

Cumulative Report (since January 2000) 04

July 1, 2020 - December 31, 2020

First Time Test Takers Repeaters Total PTCE 3.0 Exams Graded Pass Rate Exams Graded Pass Rate Exams Graded Pass Rate Louisiana 384 59% 26 58% 410 59% National 19,131 73% 1,045 50% 20,176 72%

®​ PTCE​ performance shown in percentage of questions answered correctly by knowledge domain:

PTCE 3.0 Louisiana National Medications 61% 64% Federal Requirements 61% 68% Patient Safety and Quality Assurance 70% 74% Order Entry and Processing 63% 69%

CONFIDENTIAL Prepared for the Louisiana Board of Pharmacy Louisiana Board of Pharmacy Pharmacy Technician Certification Board (PTCB) Data

PTCE 3.0 PTCE 2.0 2021 7/1/2021 to 1/1/2021 to 2020 7/1/2020 to 1/1/2020 to 1/1/2020 to National Data 2000-2021 Totals 12/31/2021 6/30/2021 2000-2020 Totals 12/31/2020 6/30/2020 6/30/2020 2000-2019 First Attempt No. of Candidates Attempting 31,496 19,131 9,369 2,996 No. of Candidates Passing 22,607 13,966 6,933 1,708 Pass Rate 71.7% 73.0% 73.9% 57.0%

Repeaters No. of Candidates Attempting 1,956 1,045 110 801 No. of Candidates Passing 905 523 62 320 Pass Rate 46.3% 50.0% 56.4% 39.9%

Totals No. Candidates Attempting 980,518 33,452 20,176 9,479 3,797 947,066 No. Candidates Passing 678,633 23,512 14,489 6,995 2,028 655,121 Pass Rate 69.2% 70.3% 71.8% 73.8% 53.4% 69.2%

Louisiana Data First Attempt No. of Candidates Attempting 559 384 137 38 No. of Candidates Passing 335 227 86 22 Pass Rate 59.9% 59.1% 62.8% 57.9%

Repeaters No. of Candidates Attempting 49 26 1 22 No. of Candidates Passing 23 15 1 7 Pass Rate 46.9% 57.7% 100.0% 31.8%

Totals No. Candidates Attempting 18,677 608 410 138 60 18,069 No. Candidates Passing 10,992 358 242 87 29 10,634 Pass Rate 58.9% 58.9% 59.0% 63.0% 48.3% 58.9% Louisiana Board of Pharmacy Pharmacy Technician Certification Examination (PTCB) Data

2019 2018 National Data 2000-2019 Totals 7/1/2019 to 12/31/2019 1/1/2019 to 6/30/2019 2000-2018 Totals 7/1/2018 to 12/31/2018 1/1/2018 to 6/30/2018 2000-2017 First Attempt No. of Candidates Attempting 42,153 21,127 21,026 39,794 17,277 22,517 No. of Candidates Passing 25,503 12,887 12,616 24,049 10,539 13,510 Pass Rate 60.5% 60.9% 60.0% 60.0% 61.0% 59.9%

Repeaters No. of Candidates Attempting 9,600 4,990 4,610 9,049 4,235 4,814 No. of Candidates Passing 4,462 2,295 2,167 4,114 1,948 2,166 Pass Rate 45.5% 45.9% 47.0% 45.0% 45.9% 44.9%

Totals No. Candidates Attempting 947,066 51,753 26,117 25,636 895,313 48,843 21,512 27,331 846,470 No. Candidates Passing 655,121 29,965 15,182 14,783 625,156 28,056 12,477 15,579 597,100 Pass Rate 69.2% 57.9% 58.1% 57.7% 69.8% 57.0% 58.0% 57.0% 70.5%

Louisiana Data First Attempt No. of Candidates Attempting 733 331 402 852 400 452 No. of Candidates Passing 345 152 193 383 184 199 Pass Rate 47.1% 45.9% 48.0% 44.9% 46.0% 44.0%

Repeaters No. of Candidates Attempting 274 136 138 377 172 205 No. of Candidates Passing 105 54 51 145 71 74 Pass Rate 38.3% 39.7% 36.9% 38.5% 41.3% 36.1%

Totals No. Candidates Attempting 18,069 1,007 467 540 17,062 1,229 572 657 15,833 No. Candidates Passing 10,634 449 206 243 10,185 521 252 269 9,664 Pass Rate 58.9% 44.6% 44.1% 45.0% 59.7% 42.4% 44.1% 40.9% 61.0% Louisiana Board of Pharmacy Pharmacy Technician Certification Examination (PTCB) Data

National Data 2000-2015 7/1/2015 to 12/31/2015 1/1/2015 to 06/30/2015 2000-2014 7/1/2014 to 12/31/2014 1/1/2014 to 6/30/2014 2000-2013 No. of Candidates Attempting 740,829 36,167 22,197 682,465 27,085 26,423 628,957 No. of Candidates Passing 535,961 21,643 13,280 501,038 15,125 15,233 470,680 Pass Rate 72.3% 59.8% 59.8% 73.4% 55.8% 57.7% 74.8%

Louisiana Data No. of Candidates Attempting 13,314 632 480 12,200 568 630 11,002 No. of Candidates Passing 8,562 304 255 8,003 265 287 7,451 Pass Rate 64.3% 48.1% 53.1% 65.6% 46.7% 45.6% 67.7%

National Data 2000-2017 1/1/2017 to 12/31/2017 2000-2016 1/1/2016 to 12/31/2016 First Attempt No. of Candidates Attempting 846,470 43,180 43,958 No. of Candidates Passing 597,232 25,908 26,814 Pass Rate 71% 60% 61%

Repeaters No. of Candidates Attempting 9,131 9,372 No. of Candidates Passing 4,200 4,217 Pass Rate 46% 45%

Totals No. Candidates Attempting 846,470 52,311 794,159 53,330 No. Candidates Passing 597,100 30,108 566,992 31,031 Pass Rate 71% 58% 71% 58% Louisiana Data First Attempt No. of Candidates Attempting 843 840 No. of Candidates Passing 405 412 Pass Rate 48% 49%

Repeaters No. of Candidates Attempting 378 458 No. of Candidates Passing 129 156 Pass Rate 34% 34%

Totals No. Candidates Attempting 15,833 1,221 14,612 1,298 No. Candidates Passing 9,664 534 9,130 568 Pass Rate 61% 44% 62% 44% Louisiana Board of Pharmacy Pharmacy Technician Certification Examination (PTCB) Data

Changed to semi-annual reports 2000-2012 10/1/2012 7/1/2012 4/1/2012 1/1/2012 2000-2011 National Data 7/1/2013 to 12/31/2013 1/1/2013 to 6/30/2013 Data 12/31/2012 9/30/2012 6/30/2012 3/31/2012 Data

No. of Candidates Attempting 28,797 25,448 574,712 11,180 14,375 14,356 11,851 522,950 No. of Candidates Passing 21,745 19,581 429,354 8,471 10,982 11,044 9,232 389,625

Pass Rate 76% 77% 75% 76% 76% 77% 78% 75%

Louisiana Data

No. of Candidates Attempting 537 622 13,460 239 329 368 246 12,278 No. of Candidates Passing 351 412 9,119 168 226 269 158 8,298

Pass Rate 65% 66% 68% 70% 69% 73% 64% 68%

10/1/2011 7/1/2011 4/1/2011 1/1/2011 2000-2010 10/1/2010 7/1/2010 4/1/2010 1/1/2010 2000-2009 National Data 12/31/2011 9/30/2011 6/30/2011 3/31/2011 Data 12/31/2010 9/30/2010 6/30/2010 3/31/2010 Data

No. of Candidates Attempting 14,031 12,356 14,026 11,219 471,318 12,774 16,025 15,033 11,611 415,875 No. of Candidates Passing 10,826 9,565 10,472 8,366 350,396 9,275 12,349 11,216 8,521 309,035

Pass Rate 77% 77% 75% 75% 74% 73% 77% 75% 73% 74%

Louisiana Data

No. of Candidates Attempting 257 268 437 247 11,069 268 320 421 217 9,843 No. of Candidates Passing 168 182 306 161 7,481 166 219 287 121 6,688

Pass Rate 65% 68% 70% 65% 68% 62% 68% 68% 56% 68% Louisiana Board of Pharmacy Pharmacy Technician Certification Examination (PTCB) Data

10/1/2009 7/1/2009 4/1/2009 1/1/2009 2000-2008 11/10/2008 8/18/2008 4/28/2008 2/4/2008 2000-2007 National Data 12/31/2009 9/30/2009 6/30/2009 3/31/2009 Data 12/19/2008 10/10/2008 6/20/2008 3/14/2008 Data

No. of Candidates Attempting 10,674 13,735 8,424 13,087 369,955 11,792 16,385 14,291 7,547 319,940 No. of Candidates Passing 7,682 10,067 6,363 9,141 275,782 7,770 11,781 10,155 5,165 240,911

Pass Rate 72% 73% 76% 70% 75% 66% 72% 72% 68% 75%

Louisiana Data

No. of Candidates Attempting 218 238 260 301 8,826 215 304 392 128 7,787 No. of Candidates Passing 137 166 196 184 6,005 118 182 233 72 5,400

Pass Rate 63% 70% 75% 61% 68% 55% 60% 59% 56% 69%

11/26/2007 8/27/2007 4/24/2007 2/5/2007 2000-2006 Changed to quarterly reports 2000-2005 National Data 12/31/2007 9/28/2007 5/25/2007 3/9/2007 Data 11/18/2006 9/9/2006 7/22/2006 3/11/2006 Data

No. of Candidates Attempting 10,881 14,666 10,730 8,768 274,895 15,285 3,029 18,992 12,383 225,206 No. of Candidates Passing 7,472 10,497 7,487 6,034 209,421 9,145 2,006 12,609 8,559 177,102

Pass Rate 69% 72% 70% 69% 76% 60% 66% 66% 69% 79%

Louisiana Data

No. of Candidates Attempting 207 266 306 216 6,792 312 59 420 288 5,713 No. of Candidates Passing 121 177 196 133 4,773 137 37 239 181 4,179

Pass Rate 58% 67% 64% 62% 70% 44% 63% 57% 63% 73%

Louisiana Board of Pharmacy Pharmacy Technician Certification Examination (PTCB) Data

2000-2002 National Data 11/19/2005 7/23/2005 3/19/2005 11/13/2004 7/17/2004 3/20/2004 11/15/2003 7/26/2003 3/29/2003 Data

No. of Candidates Attempting 14,068 18,250 13,673 13,795 15,942 11,508 13,401 14,162 12,147 98,260 No. of Candidates Passing 10,583 14,246 11,009 10,818 12,196 9,100 11,006 11,720 9,506 76,918

Pass Rate 75% 78% 81% 78% 77% 79% 82% 83% 78% 78%

Louisiana Data

No. of Candidates Attempting 216 488 337 290 382 285 351 384 385 2,595 No. of Candidates Passing 167 351 274 214 281 211 271 286 294 1,830

Pass Rate 77% 72% 81% 74% 74% 74% 77% 74% 76% 71%

1995-1999 National Data 11/16/2002 7/27/2002 3/16/2002 11/10/2001 7/14/2001 3/10/2001 11/18/2000 7/22/2000 3/25/2000 Data

No. of Candidates Attempting 11,521 13,399 8,874 10,608 12,057 8,442 12,941 12,317 8,101 58,382 No. of Candidates Passing 9,164 10,681 7,072 8,354 9,799 6,116 9,520 10,006 6,206 47,973

Pass Rate 80% 80% 80% 79% 81% 72% 74% 81% 77% 82%

Louisiana Data

No. of Candidates Attempting 308 383 269 324 310 187 327 346 141 514 No. of Candidates Passing 213 269 184 228 227 125 221 271 92 390

Pass Rate 69% 70% 68% 70% 73% 67% 68% 78% 65% 76% Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

New Agenda Items Added During Meeting

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Announcements

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

February 24, 2021

Agenda Item 12: Announcements

February 25 Public Hearing

March 12-15 APhA Annual Meeting (Virtual) March 17-18 Violations Committee March 25 Occupational Licensing Review Commission

April 2 Good Friday – Board office closed April 8 Drug Policy Board April 12 2021 Legislature – Regular Session convenes April 14 Louisiana Pharmacy Congress Pharmacy Benefit Manager Monitoring Advisory Council Prescription Monitoring Program Advisory Council

May 13-14 NABP Annual Meeting (Virtual) May 25 Reinstatement, Impairment & Executive Committees May 26 Board Meeting May 27 Administrative Hearing May 31 Memorial Day – Board office closed

Remaining Board Meeting Sessions for Calendar Year 2021

May 25-27 August 17-19 November 16-18

End of Meeting Binder