Public Meeting Binder
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Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected] Board Meeting May 26, 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; h&[email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; s&[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. Invocation & Pledge of Allegiance 3. Quorum Call 4. Call for Additional Agenda Items & Adoption of Agenda 5. Consideration of Draft Minutes from Previous Meetings ~ February 24, 2021 012 6. Report on Action Items 044 7. Confirmation of Acts 8. Opportunity for Public Comment 9 Special Orders of the Day 10. Committee Reports A. Finance 060 (1) Review of Interim Report for Fiscal Year 2020-2021 061 B. Application Review 068 C. Reciprocity 069 (1) List of Pharmacists Licensed by Reciprocity 070 D. Violations 071 E. Impairment 072 F. Reinstatement 074 (1) List of Credential Reinstatements 075 G. Tripartite 081 H. Regulation Revision 082 (1) Consideration of Comments & Testimony from February 25, 2021 Public Hearing (a) Regulatory Project 2020-10 ~ CDS License for Hemp Facility 083 (b) Regulatory Project 2021-1 ~ Pharmacists, Pharmacies & Prescriptions 102 I. Executive 135 (1) Reconsideration of PPM.I.A.20 ~ Recording Patient Address on Prescriptions for Controlled Substances 136 (2) Reconsideration of PPM.I.A.23 ~ Recordkeeping Requirements for Written Prescription Forms Received in Pharmacies by Facsimile or Electronic Images (Advisory Opinion) 137 (3) Reconsideration of PPM.I.A.29 ~ Reporting Transactions in Marijuana Pharmacies 138 (4) Proposed Revision of PPM.I.D.28 ~ Guidance to Licensees re PREP Act Declaration by HHS 139 (5) Proposed Revision of PPM.III.J ~ Criminal Background Check 150 (6) Consideration of Interim Policies (PPM.I.D.1 – 28) 156 (7) Consideration of Continuing Approval of Policy & Procedure Manual 158 (8) Consideration of Continuing Approval of Loss Prevention Manual 169 (9) Consideration of Continuing Approval of Roster of Colleges of Pharmacy 173 (10) Consideration of Request for Approval of Pharmacy Technician Training Program at Delta Community College [Monroe, LA] 179 (11) Consideration of Continuing Approval of Updated Roster of Pharmacy Technician Training Programs 181 (12) Consideration of Resolutions for Professional Legal Services (a) Ms. Celia R. Cangelosi 182 (b) Shows, Cali & Walsh, LLP 183 (13) Summary Chart of Contracts 184 (14) Consideration of Implementation Plan for 10th Marijuana Pharmacy Permit 185 11. Staff Reports J. Assistant Executive Director – Mr. Fontenot 188 (1) Quarterly Report from Prescription Monitoring Program (PMP) 189 (2) Consideration of Requests for Waivers from PMP Reporting Rule 200 K. General Counsel – Mr. Finalet 202 L. Executive Director – Mr. Broussard 203 (1) Narrative Report 204 (2) Internal Reports Credentials Div. – Census Report 210 Credentials Div. – Licensure Activity Report 222 Credentials Div. – Pending Application Report 223 Credentials Div. – Exceptions Report 224 Compliance Div. – Census Report 226 Compliance Div. – Complaint Investigation Policy Monitor 227 (3) Examination Reports Technicians – ExCPT 228 (4) Interim Legislative Report 230 12. New Agenda Items Added During Meeting 248 13. Announcements 250 14. Recess 251 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