Current through Vol. 24-16, September 15, 2024
Rule 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:
(i) Name of the patient.
(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.
