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Public Meeting Binder Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected] Board Meeting August 13, 2020 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 – C. Acronyms 004 0 – D. Agenda 010 1. Call to Order 2. Quorum Call 3. Call for Additional Agenda Items & Adoption of Agenda 4. Consideration of Draft Minutes from Previous Meetings ~ July 28, 2020 015 5. Report on Action Items 022 6. Confirmation of Acts 7. Opportunity for Public Comment 8 Special Orders of the Day 9. Committee Reports A. Finance (1) Review of Final Report for Fiscal Year 2019-2020 040 (2) Consideration of Proposed Budget Amendment No. 1 for FY 20-21 056 B. Application Review C. Reciprocity (1) List of Pharmacists Licensed by Reciprocity 066 D. Violations (1) Consideration of Proposed Voluntary Consent Agreements (2) Consideration of Proposed Revision of PPM-I.C.7.a ~ Publication of Final Adverse Actions 068 E. Impairment F. Reinstatement (1) List of Credential Reinstatements G. Tripartite H. Regulation Revision (1) Consideration of Renewal of Pilot Projects 074 (2) Consideration of Regulatory Proposals and Projects (a) Regulatory Proposal 454-2019-03 ~ Medication Administration (Draft 3) and 075 Proposed Emergency Rule re Medication Administration 079 (b) Regulatory Proposal 454-2019-13 ~ Staffing Ratios for Pharmacy Technicians (Draft #2) 082 (c) Regulatory Proposal 454-2019-34 ~ Telepharmacy Dispensing Sites (Draft #3) 083 (d) Regulatory Proposal 2020-G ~ Delivery of Dispensed Marijuana Products (Draft #1) 085 (e) Regulatory Proposal 2020-H ~ Marijuana Product Labeling (Draft #2) 086 (f) Regulatory Proposal 2020-J ~ Emergency Dispensing (Draft #2) 088 (g) Regulatory Proposal 2020-K ~ Veterinary Drug Reference (Draft #1) 089 (h) Regulatory Proposal 2020-M ~ Occupational Licensing for Military Families (Draft #1) 090 (i) Regulatory Project 2020-2 ~ Automated Medication Systems (Draft #8) 097 I. Executive (1) Consideration of Compliance Questionnaire for 2020 Financial Audit 111 (2) Consideration of 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 118 (3) Consideration of Regulatory Proposal 2020-D ~ CDS License for Hemp Facility (Draft #3) 130 (4) Consideration of Renewal of Agreement with Metrc for Board Access to Louisiana Medical Marijuana Tracking System (LMMTS) 132 10. Staff Reports J. Assistant Executive Director – Mr. Fontenot (1) Quarterly Report from Prescription Monitoring Program (PMP) 137 (2) Consideration of Requests for Waivers from PMP Reporting Rule 147 K. General Counsel – Mr. Finalet (1) Consideration of Proposed Voluntary Consent Agreements and Voluntary Surrenders L. Executive Director – Mr. Broussard (1) Narrative Report 152 (2) Internal Reports Credentials Div. – Census Report 158 Credentials Div. – Licensure Activity Report 170 Credentials Div. – Pending Application Report 171 Credentials Div. – Exceptions Report 172 Compliance Div. – Census Report 174 Compliance Div. – Complaint Investigation Policy Monitor 175 Compliance Div. – Annual Statistical Report 176 External Reports Annual Report for Fiscal Year 2019-2020 182 Roster & Inventory of Agency Publications 199 (3) Examination Reports Pharmacists – MPJE 203 Pharmacists – NAPLEX 209 Technicians – ExCPT 215 Technicians – PTCB 218 11. Request for Opinion A. Delivery of Dispensed Prescriptions to Lockers for Employees 227 12. New Agenda Items Added During Meeting 13. Announcements 231 14. Adjourn 232 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
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