Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: The board is amending section (3) of this
rule to address return and reuse of medication to an automated filling
system.
(1) Pharmacists and
pharmacies shall not accept from patients or their agents for reuse or resale
any drugs, prescribed medications, chemicals, poisons or medical devices unless
otherwise provided for in this regulation.
(2) A pharmacist or pharmacy may receive and
reuse drugs from long-term care facilities, hospitals, and hospice facilities
(as regulated by the Department of Health and Senior Services, in
19 CSR
30-35.020 Hospices Providing Direct Care in a Hospice
Facility), provided that the following conditions are met:
(A) The pharmacist has assurance from a
person in responsible charge of the drugs at a facility delineated in this
section that the drugs being returned have been stored in accordance with the
manufacturer's recommendations and meet U.S.P. standards;
(B) The drugs were originally dispensed by
the pharmacist or pharmacy to the facility delineated in section (2);
(C) There is an established mechanism to
trace the expiration date and the manufacturer's lot number of the drugs being
returned;
(D) Only drug products
dispensed by a licensed pharmacy utilizing one (1) of the following sources may
be reused and no drug products for reuse shall be in any way subject to further
repackaging:
1. Drug products in the original
manufacturer's packaging that remains sealed in tamper-evident
packaging;
2. Drug products
repackaged by facilities that are federally registered as a repackager of
medications and the packaging remains sealed in tamper-evident
packaging;
3. Drug products that
have been repackaged by a licensed pharmacy and are returned unused by the
facility and remain sealed in tamper-evident packaging;
4. Drug products that have been repackaged by
a licensed pharmacy and are provided in unit of use packaging whereby unused
portions can be separated and reused without any further repackaging processes
necessary on the returned product; and
(E) Any products that are accepted for return
and can be reused based on standards provided in this rule shall be re-labeled
to provide accurate information concerning patient and prescription
information. Original lot numbers, expiration or beyond-use-dates assigned to a
product that is reused by a pharmacy shall not be altered or in any way
updated.
(3) Pharmacists
and pharmacies may return to stock prescriptions that have not been received by
or delivered to the patient and shall delete the dispensing from the pharmacy's
records and reverse the claim with the third party payor, if applicable. In
order for a product to be returned to stock, it must have been stored at all
times at the manufacturer's labeled storage requirements.
(A) Except as otherwise authorized by
subsection (3)(B), all drugs returned to stock that are not in the original
manufacturer container must be maintained in the patient container with the
dispensing date, prescription number, and name of drug visible. The expiration
date of the drug shall become the lesser of one (1) year from the dispensing
date on the label or the manufacturer's original expiration date, if
known.
(B) Return-to-stock
medication may be returned to an automated filling system unit, cell, or
cartridge containing the same medication, if-
1. The prescription/medication order is
returned to the automated filling system that originally dispensed
it;
2. A pharmacist verifies the
return-to-stock drug is properly stocked and loaded in the automated filling
system;
3. The expiration date for
all drugs in the unit, cell, or cartridge where medication is returned must
become the shortest expiration of any drug contained in the same unit, cell, or
cartridge, including, any return-to-stock medication; and
4. Drugs from different manufacturers may not
be commingled in the same unit, cell, or cartridge.
*Original authority: 338.280, RSMo 1951, amended 1971,
1981.
