Section 338.3609. Donated prescription drugs; participating pharmacy or charitable clinic requirements.

(1) A participating pharmacy or charitable clinic 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, unit of issue package, or blister pack with the outside packaging opened may be accepted if the single-unit-dose packaging or unit of issue packaging is unopened.

(b)  The drug has been stored according to manufacturer or usp-nf storage requirements.

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

(d)    The drug has an expiration date that is more than 6 months after the date that the drug was donated.

(e)     The drug does not have any physical signs of tampering or adulteration, and there is no reason to believe that the drug is adulterated.

(f)        The packaging does not have any physical signs of tampering, deterioration, compromised integrity, or adulteration.

(2) A participating pharmacy or charitable clinic may accept donated prescription drugs from more than 1 eligible facility, provided that the donating is done pursuant to the terms of the program.

History: 2014 AACS.