(a) Drugs may only be dispensed pursuant to the program if:

1. (1) For prescription drugs, they do not expire before the completion of the medication by the eligible patient based on the prescribing health care professional’s directions for use and, for over-the-counter drugs, they do not expire before use by the eligible patient based on the directions for use on the manufacturer’s label; and
2. (2) The drugs were donated in unopened tamper-evident packaging as defined by United States Pharmacopeia General Chapter 659, Packaging and Storage Requirements, including, but not limited to, unopened unit-dose and multiple-dose packaging.

(b) The following drugs may not be donated to the program:

1. (1) Controlled substances;
2. (2) 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 by such strategy; or
3. (3) Drugs that there is reason to believe are adulterated.