Section R. 338.3153 - Invoices, acquisition, dispensing, administration, and distribution recordsRule 53.
(1) For 2 years, a licensee shall maintain in the pharmacy for review by the department, an agency, or the board, all records for controlled substances, including invoices and acquisition records as follows: (a) A licensee may keep acquisition records, except for executed or voided DEA 222 order forms, in an electronic form at a central location with notice to the department.(b) A licensee shall maintain invoices and other acquisition records of all controlled substances listed in schedules 1 and 2 in a separate file from invoices and other acquisition records of controlled substances listed in schedules 3, 4, and 5. The information must be readily retrievable from the ordinary acquisition records maintained by the dispenser.(c) A licensee shall initial or electronically initial the invoice and indicate the date that the controlled substances are received.(2) A licensee shall maintain in the pharmacy for review by the department, an agency, or the board, patient sales receipts and dispensing records as follows:(a) A licensee shall retain patient sales receipts for 90 days in electronic or paper form.(b) A licensee shall keep a record, which may be electronic, of all controlled substances dispensed by the licensee.(c) A licensee that prescribes controlled substances shall keep a record separate from the patient chart that contains all of the following information for controlled substances dispensed or administered by the prescriber: (ii) Name and strength of the controlled substance.(iii) Quantity of the controlled substance.(iv) Date the controlled substance was dispensed or administered.(v) Name of the individual who dispensed or administered the controlled substance.(d) Except in medical institutions, a licensee shall sequentially number and maintain in chronological order the patients' original prescriptions as follows: (i) A licensee shall maintain a separate file for dispensed substances listed in schedule 2.(ii) A licensee shall maintain a separate file for dispensed substances listed in schedules 3, 4, and 5.(3) A licensee shall keep the original prescription record on-site for 5 years after the last date of dispensing. However, 2 years after the last date of dispensing, a licensee may make an electronic duplicate of the original paper prescription, which becomes the original prescription.(4) A licensee shall maintain records of controlled substances distributed to another licensee that must include all of the following information and be maintained in the appropriate file described in subrule (1)(b) of this rule or in a separate record that is available for inspection:(a) Name, address, and DEA number of receiver.(b) Name, address, and DEA number of supplier.(c) Name and quantity of the controlled substances distributed.(d) Date the controlled substances were distributed.(5) A DEA 222 order form must be used for schedule 2 drugs.Mich. Admin. Code R. 338.3153
1979 AC; 1980 AACS; 1992 AACS; 2002 AACS; 2013 AACS; 2022 AACS; 2024 MR 10, Eff. 5/28/2024