posted on February 11, 2021 21:27
The Bureau of Professional Licensing (BPL) within the Department of Licensing and Regulatory Affairs (LARA) would like to inform you that new Pharmacy – Continuing Education and Pharmacy – General Rules were effective as of December 22, 2020.
Summaries of the notable changes are below. The summaries are not intended to provide a comprehensive listing of all changes or current requirements. Licensees should review the rules and statute for a complete understanding of all applicable requirements.
The Board of Pharmacy – Pharmacist Continuing Education rule modifications will:
- Clarify the CE requirements for a special retired volunteer pharmacist licensee.
- Require a one-time training for identifying victims of human trafficking and a one-time training in opioids and other controlled substances awareness before renewal of the license.
- Clarify that CE is only required if a licensee has been licensed for a full 2-year cycle.
- Require 1 hour of CE in pharmacy ethics and jurisprudence.
- Limit CE credit for taking the same CE course or program twice during 1 renewal period.
- Require documentation of meeting CE requirements.
- Require a waiver request prior to the expiration date of the license.
- Modify CE approval standards.
- Organize CE activities in a table and expand CE options.
- Require specific proof for CE.
- Require all requests for approval of courses or programs that relate to emergency situations to relate to the health of a patient.
- Allow a pharmacist who resides or practices in another state to renew a license in this state by showing he or she has accumulated CE substantially equivalent to the requirements in this state by earning 30 CE credits consistent with the rules.
- A continuing education sponsor must submit to the department a completed continuing education program application to request approval of their continuing education program at least 70 days prior to the date the continuing education course or program is conducted and 70 days prior to the next regularly scheduled board meeting for the proposed continuing education to be considered for approval by the board. A continuing education course or program conducted prior to board consideration will not be approved.
The Board of Pharmacy – General Rules were substantially rewritten and reorganized to provide for rules that encompass all the necessary requirements for licensing and regulating the practice for pharmacists, interns, preceptors, pharmacies, manufacturers, and wholesale distributors. The revisions modify the parts pertaining to general provisions, pharmacist licenses, pharmacy licenses, manufacturer licenses, wholesale distributor licenses, and the practice of pharmacy.
Part 1 of the proposed pharmacy rules pertains to pharmacy services in medical institutions, definitions, resale of drugs and devices, and inspections of applicants and licensees.
Part 2 of the proposed pharmacy rules pertains to licensure of pharmacists. This part includes the rules pertaining to training for identifying victims of human trafficking, educational limited licenses, internship requirements, preceptor licenses, examinations, pharmacist licensure by examination and endorsement, and relicensure. Key changes in this part include:
- Pharmacist intern licenses issued to individuals who graduated from a non-accredited college or school of pharmacy and have successfully passed the foreign pharmacy graduate equivalency examination administered by the National Association of Boards of Pharmacy Foreign Pharmacy Graduate Examination Committee will be valid for one year and limited to one renewal. Existing licensees in this circumstance will be able to renew their intern license one more time.
- Individuals may be eligible for a pharmacist intern license who are actively enrolled in a school of pharmacy, or are within 180 days of having graduated, from an approved program accredited by the American Council of Pharmaceutical Education.
- Applicants must have held a Michigan pharmacist license in good standing for the past year and have been engaged in the practice of pharmacy in Michigan for at least one year to be eligible for a pharmacist preceptor license.
- Pharmacists applying for relicensure may now show proof of licensure in another state in lieu of earning practical experience hours.
Part 3 of the proposed pharmacy rules pertains to pharmacy licenses. This part includes the application requirements for pharmacies, compounding services and the adoption by reference of standards that apply to these services, inspections, discontinuance and resumption of sterile compounding services, housing of a pharmacy, professional and technical equipment and supplies, closure of a pharmacy, and relicensure. Key changes in this part include:
- Applicants for a new pharmacy license located outside of this state that will not be shipping compounded sterile pharmaceutical products into this state shall submit to the department a copy of its most recent pharmacy inspection that was performed within the last 2 years.
- Applicants for a new pharmacy license or applicants renewing an existing pharmacy license that will be shipping compounded sterile pharmaceutical products into this state shall obtain a physical inspection and corresponding report from a board approved accrediting organization every 18 months.
- Pharmacies that no longer wish to perform sterile compounding must provide notice to the department within 30 days of ceasing to provide those services.
Part 4 of the proposed pharmacy rules pertains to manufacturer licenses. This part includes licensure requirements for manufacturers, persons to whom drugs or devices may be sold, adoption by reference of a federal regulation on good manufacturing practices for finished pharmaceuticals, closure of a manufacturer, and relicensure. Key changes in this part include:
- Manufacturers of biologicals applying for initial licensure must provide their FDA certification information.
- Manufacturers applying for initial licensure must provide an inspection report from its resident state board of pharmacy or evidence of verified-accredited wholesale distributors (VAWD) accreditation.
Part 5 of the proposed pharmacy rules pertains to wholesale distributor licenses. This part includes the determination of a pharmacy as a wholesale distributor, the licensure requirements for wholesale distributors, persons to whom drugs or devices may be sold, wholesale distributor practices, recordkeeping and policy requirements for wholesale distributors, facility requirements, examination of drugs and devices, closure of a wholesale distributor, and relicensure. Key changes in this part include:
- Distributors of biologicals applying for initial licensure must provide their FDA certification information.
- A wholesale distributor applying for initial licensure that will be utilizing a facility manager must complete an affidavit regarding the education, experience, and training of the facility manager.
- Exceptions have been added to the requirement that a pharmacy obtain a wholesale distributor license if it distributes more than 5% of the total dosage units of prescription drugs dispensed during any consecutive 12-month period.
Part 6 of the proposed pharmacy rules pertains to the practice of pharmacy. This part includes prescription drug labeling and dispensing, prescription drug receipts, noncontrolled prescriptions, a customized patient medication package, prescription records, prescription refill records, automated devices, professional responsibility of a pharmacist, and hospice emergency drug boxes.
A complete copy of the new rules can be found on our website at www.michigan.gov/bpl.