S.D. Admin. R. 20:51:35:03

Current through Register Vol. 50, page 162, June 24, 2024

Section 20:51:35:03 - Criteria for accepting donated prescription drugs and supplies

Participating pharmacies shall only accept the following donations:

(1) A donor who is 18 years of age or older may donate legally obtained prescriptions drugs or supplies to a participating pharmacy if they meet the requirements of this rule as determined by the PIC;

(2) The participating pharmacy may accept a prescription drug only if all of the following requirements are met:

(a) The drug is in its original sealed and tamper-evident packaging. However, a drug in a single-unit dose or blister pack with the outside packaging opened may be accepted if the single-unit package is not opened;

(b) The packaging contains the lot number and expiration date of the drug. If the lot number is not retrievable, all specified medications will be destroyed in the event of a recall;

(c) The drug has an expiration date that is more than six months after the date that the drug was donated. A donated prescription drug bearing an expiration date that is six months or less after the date the prescription drug was donated, may be accepted and distributed if the drug is in high demand and can be dispensed for use prior to the drug's expiration date;

(d) Neither the drug nor the packaging has any physical signs of tampering, misbranding, deterioration or adulteration, and there is no reason to believe that the drug is adulterated;

(e) All donated eligible drugs received by the participating pharmacy shall be documented in the board's electronic database of drugs and supplies and shall be accompanied by a donor form with an agreement to donate; and

(f) If the drug has not been continually under the control of a health care professional, a pharmacy, or other legally authorized entity allowed to possess prescription drugs, the participating pharmacy must collect a donation form that is signed by the donor or that person's authorized representative attesting to proper storage.

(6) A participating pharmacy may accept supplies necessary to administer prescription drugs only if all of the following requirements are met:

(a) The supplies are in their original, unopened, sealed packaging;

(b) The supplies are not adulterated or misbranded; and

(c) All supplies shall be inventoried at the participating pharmacy and documented in the board repository database. The documentation shall be provided on a form provided by the board and shall include a description of the supplies and the date donated.

(7) Drugs and supplies may be donated on the premises of a participating pharmacy to a person designated by the pharmacy. A drop box may not be used to deliver or accept donations.

S.D. Admin. R. 20:51:35:03

49 SDR 051, effective 11/27/2022

General Authority: SDCL 34-20H-7(2)(3).

Law Implemented: SDCL 34-20H-2, 34-20H-7(2)(3)(5), 34-20H-9.