19 CSR 20-50.020 - Standards and Procedures for Donating Prescription Drugs

PURPOSE: This rule contains the criteria by which pharmacies, hospitals and nonprofit clinics will determine a person eligible to donate drugs under the Prescription Drug Repository Program.

(1) The following may donate a prescription drug, pursuant to 19 CSR 30-5.025, to a pharmacy, hospital, or nonprofit clinic that elects to participate in the Prescription Drug Repository Program:
(A) A licensed dispenser of prescription drugs;
(B) A licensed wholesale distributor of prescription drugs; or
(C) A person who was legally dispensed a prescription drug pursuant to a patient-specific prescription or drug order.
(2) An individual electing to donate a prescription drug shall not have taken custody of the drug prior to the donation. The individual may direct the donation through a dispenser of prescription drugs.
(3) A person designated to do so under a durable power of attorney, or acting in their capacity as legal guardian may make the decision to donate a prescription drug on behalf of another person who has lawful possession of the prescription drug.
(4) A person who resides in an institutional facility and was legally dispensed a prescription drug pursuant to a patient-specific prescription or order may elect to sign and date an ownership record prior to donating a drug, which shall state "from this day forward I wish to donate all my remaining unused drugs, pursuant to 19 CSR 20-50.025, to a participating pharmacy, hospital or nonprofit clinic of the Prescription Drug Repository Program. I authorize the institutional facility in which I reside to make the donation on my behalf."
(A) The record shall include the resident's typed or printed name, and the name and address of the institutional facility.
(B) If the institutional facility is a covered entity under the Health Insurance Portability and Accountability Act (HIPAA), the facility shall comply with HIPAA regarding the transfer of any personal health information that may occur as part of the donation.
(5) Each donor must sign an ownership record stating that the donor is the owner of the drug and intends to voluntarily donate the drug to the drug repository program. The ownership record must be completed prior to any donation and include at least the following:
(A) The name of the person to whom the drug was originally dispensed, or the name of the dispenser of prescription drugs or wholesale distributor of prescription drugs that owns the drug;
(B) The signature of the donor or the donor's representative, or the signature of the responsible person or his/her designee from a dispenser of prescription drugs or a wholesale distributor of prescription drugs; and
(C) The date the record was signed.
(6) The following donor information must also be documented on the original signed ownership record or on an alternate donor record that is kept with the ownership record:
(A) The name of the donor of the drug;
(B) The name and address of the institutional facility donor location, when applicable;
(C) The brand name or the generic name of the drug;
(D) Either the name of the manufacturer or the national drug code number (NDC #), if available;
(E) The lot number of the drug, if available;
(F) The strength of the drug;
(G) The quantity of the drug;
(H) The date the drug was donated to a participating pharmacy, hospital or nonprofit clinic;
(I) A statement that the drug has been stored according to manufacturer and/or United States Pharmacopoeia requirements;
(J) A statement that the drug has been examined to determine that no controlled substance or drug that requires storage temperatures other than normal room temperature has been included; and
(K) The name and address of the receiving pharmacy, hospital or nonprofit clinic.
(7) A copy of the ownership record or the alternate donor record that contains the required information shall be maintained by the donor or the institutional facility, when applicable, and the receiving pharmacy, hospital or nonprofit clinic.

Notes

19 CSR 20-50.020
AUTHORITY: section 196.984, RSMo Supp. 2004.* Emergency rule filed Dec. 15, 2004, effective Jan. 1, 2005, expired June 29, 2005. Original rule filed Dec. 15, 2004, effective June 30, 2005.

*Original authority: 196.984, RSMo 2004.

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