Current through Register Vol. XLI, No. 50, December 13, 2024
Section 15-20-5 - Eligible Drugs5.1. Any individual who is 18 years of age or older may donate legally obtained prescription drugs or supplies to a drug repository program if the drugs meet the requirements of this rule, as determined by the pharmacist or responsible healthcare provider of the drug repository program. The 18 year or older parent or guardian of a minor may donate the minor's legally obtained drugs or supplies if all requirements are met.5.1.1. The donor shall remove or redact any patient names and prescription numbers on donated drugs or otherwise maintain patient confidentiality by executing a confidentiality agreement with the eligible recipient.5.2. No drugs that require storage temperatures other than normal room temperature as specified by the manufacturer or United States Pharmacopeia shall be donated or accepted as part of the donated drug repository program due to the increased potential for adulteration. Drugs donated directedly from a drug manufacturer, wholesaler, third party logistics provider, or pharmacy are excluded from this provision and may be donated.5.3 Controlled substances shall not be donated or accepted.5.4 Drugs subject to a federal Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to 21 U.S.C. § 355-1 if inventory transfer is prohibited may not be donated or accepted.5.5 Drugs may be dispensed by a donated drug repository program only if all of the following are met:5.5.1 The drug is in unopened, tamper-evident packaging as defined by the United States Pharmacopeia General Chapter 659, Packaging and Storage Requirements, including but not limited to unopened, unit-dose and multiple dose packaging. A drug in a single-unit dose or blister pack with the outside packaging opened may be dispensed if the single unit-dose packaging is undisturbed and meets the labeling requirements of 15 CSR 1-20.2.1;5.5.2 The drug has been stored according to manufacturer's or USP storage conditions;5.5.3 The packaging contains the expiration date;5.5.4 The drug has an expiration date that is more than six months after the date that the drug was donated. However, 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 dispensed if the drug is in high demand and can be dispensed for use prior to the drug's expiration date;5.5.5 The drug does not have any physical signs of tampering or adulteration, and there is no reason the believe that the drug is adulterated;5.5.6 The packaging does not have any physical signs of tampering, misbranding, deterioration, compromised integrity, or adulteration; and5.6 A drop box may not be used to deliver or accept donations.