Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 20 - Division of Community and Public Health › Chapter 50 - Prescription Drug Repository Program › Section 19 CSR 20-50.030 - Standards and Procedures for Inspecting and Storing Donated Prescription Drugs

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule contains the criteria by which
				  pharmacies, hospitals and nonprofit clinics will determine drugs to be
				  acceptable for dispensing under the Prescription Drug Repository Program. This
				  rule also establishes documentation of receipt of donated
				  drugs.
(1) A pharmacy,
				hospital or nonprofit clinic shall inspect donated prescription drugs to
				determine that they are safe and suitable for dispensing, the drug and the
				packaging are in compliance with
				19
				CSR 20-50.025, and there are no controlled substances
				or drugs that require storage temperatures other than normal room temperature
				as specified by the manufacturer and/or
United States
				Pharmacopoeia
. The person who inspects the drugs shall sign an
				inspection record stating the above and attach it to the copy of the ownership
				record or alternate donor record provided with the drugs.
(2) Donated drugs shall be stored in the
				pharmacy, hospital or nonprofit clinic in a location separate from other
				drugs.
(3) When donated drugs are
				not inspected immediately upon receipt, they shall not be placed in the
				dispensing area until they have been inspected.
(4) Donated non-controlled substances that
				are not suitable for dispensing, shall be destroyed and a record made of such
				destruction.
(5) Controlled
				substances found upon inspection shall not be accepted for donation.
(A) Controlled substances submitted for
				donation shall be documented and returned immediately to the donor or the
				donor's representative that provided the drugs.
(B) In the event that it is not possible to
				return the controlled substances to the donor or donor's representative due to
				inability to identify the donor or donor's representative or due to refusal by
				the donor or donor's representative to receive them, abandoned controlled
				substances shall be documented, quarantined and destroyed as required in this
				subsection.
1. Abandoned controlled substances
				shall be documented as required in subsection (C) of this section.
2. Abandoned controlled substances shall be
				quarantined separate from other controlled substances in a location that meets
				requirements of 19 CSR 30-1.
3.
				Abandoned controlled substances shall be destroyed beyond reclamation. Such
				destruction shall be performed by a pharmacist or other person that has
				authority to dispense controlled substances and witnessed by another
				responsible employee of the pharmacy, hospital or nonprofit clinic according to
				19 CSR
				30-1.078 and
				21 CFR
				1307.21.
(C) A controlled substance donor return or
				destruction record shall be prepared and retained by the pharmacy, hospital or
				nonprofit clinic. The controlled substance donor return or destruction record
				shall include the following when applicable:
1. The name and address of the pharmacy,
				hospital or nonprofit clinic;
2.
				The date the drug was received by the pharmacy, hospital or nonprofit
				clinic;
3. The brand name of the
				drug; or the generic name and either the name of the manufacturer or the
				national drug code number (NDC #) when available;
4. The strength of the drug;
5. The quantity of the drug;
6. The lot number of the drug when
				available;
7. The expiration date
				of the drug;
8. The name and
				address of the donor;
9. The name
				and address of the donor's representative;
10. The circumstances under which the drug
				was abandoned;
11. The signature of
				the donor or donor's representative when the drug is returned to the
				donor;
12. The signature of the
				representative of the pharmacy, hospital or nonprofit clinic when the drug is
				returned to the donor;
13. The
				signature of the individual performing the destruction of the drug;
14. The signature of the individual
				witnessing the destruction of the drug; and
15. The date the drug was returned or
				destroyed.