Section 338.3153. Invoices, acquisition, dispensing, administration, and distribution records.

(1) A licensee shall keep and make available for inspection all records for controlled substances, including invoices and other acquisition records, but excluding sales receipts, however a copy of each receipt shall be retained for 90 days. Acquisition records, except for executed DEA 222 order forms, may be kept at a central location, subject to the approval of the administrator. The approval shall specify the nature of the acquisition records to be kept and the exact location where the acquisition records will be kept. All records shall be readily retrievable within 48 hours.

(2)   A licensee shall maintain acquisition records, which may be electronic, as follows:

(a)       Invoices and other acquisition records of all controlled substances listed in schedules 1 and 2 of R 338.3111 to R 338.3119a shall be maintained in a separate file.

(b)       Invoices and other acquisition records of all controlled substances listed in schedules 3, 4, and 5 of R 338.3120 to R 338.3125 shall be maintained in a separate file or in such form so that the information required is readily retrievable from the ordinary acquisition records maintained by the dispenser.

(3)   A licensee shall initial or electronically initial the invoice and indicate the date that the controlled substances are received.

(4)   A licensee shall keep a record, which may be electronic, of all controlled substances dispensed by him or her.

(5)   A prescriber shall keep a record separate from the patient chart which contains all of the following information for controlled substances dispensed or administered by the prescriber:

(a)        Name of patient.

(b)       Name of substance and strength.

(c)        Quantity of substance.

(d)       Date dispensed or administered.

(e)        Name of individual who dispensed or administered.

(6)   Except in medical institutions, patients’ original prescriptions shall be sequentially numbered and maintained in chronological order as follows:

(a)     A separate file shall be maintained for dispensed substances listed in schedule 2 of R 338.3116 to R 338.3119a.

(b)    A separate file shall be maintained for dispensed substances listed in schedules 3, 4, and 5 of R 338.3120 to R 338.3125.

(c)      The original prescription record shall  be kept for 5 years. After 3 years, an electronic duplicate may be made of the original paper prescription which shall become the original prescription. Upon request of an authorized agent of the board, a paper copy of the electronic duplicate prescription shall be presented.

(7)   Records of controlled substances distributed to another licensee, shall include all of the following information and be maintained in the appropriate file described in subrule

(2)   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 controlled substances distributed.

(d)       Date distributed.

A DEA 222 order form shall be used for schedule 2 drugs.

(8)    Complete controlled substances records shall be maintained or controlled by the licensee for 2 years, except for controlled substance prescriptions, which shall be maintained for 5 years from the last date of dispensing. After 3 years, an electronic duplicate may be made of the original paper prescription which shall become the original prescription. Upon request of an authorized agent of the board, a paper copy of the electronic duplicate prescription shall be presented.

History: 1979 AC; 1980 AACS; 1992 AACS; 2002 AACS; 2013 AACS.