Sec. 14. (a) Except for prescription drugs donated directly from a drug manufacturer, a prescription drug that requires storage temperatures other than normal room temperature as specified by the drug manufacturer or the United States Pharmacopoeia, or its supplements, may not be donated or accepted as part of the program.
(b) The central repository or a local repository may accept or dispense a prescription drug and supplies if the following requirements are met:
(1) The drug is in its original sealed and tamper evident packaging. However, a prescription drug in a single unit dose or blister pack with the outside packaging opened may be accepted if the single unit dose packaging is undisturbed.
(2) The drug has been stored according to manufacturer or United States Pharmacopoeia, or its supplements, storage requirements, unless a United States Pharmacopoeia recognized method to detect improper temperature variations has been used.
(3) The packaging contains the expiration date of the drug and the drug has not expired.
(4) The drug or its packaging does not have any physical signs of tampering, misbranding, deterioration, compromised integrity, or adulteration.
(5) If a prescription drug is subject to risk evaluation and mitigation under 21 U.S.C. 355-1(f)(3), all of the required guidelines for the prescription drug are followed.
(6) The supplies are in its original sealed packaging and are not expired.
(c) The donated prescription drugs and supplies must be inventoried at the central repository or a local repository. If the drug:
(1) has been continually under the control of a practitioner or drug manufacturer, the inventory must include the name of the drug, strength of the drug, quantity of the drug, and date of donation; or
(2) has not been continually under the control of a practitioner or drug manufacturer, the repository shall collect a donation form that is signed by the person making the donation or the person's authorized representative.
(d) The central repository or a local repository shall maintain records of the prescription drugs and supplies that are donated, accepted, distributed, and dispensed under the program. The records must be maintained for two (2) years from the date the prescription drugs or supplies are donated, accepted, distributed, and dispensed under the program.
(e) The central repository or a local repository may repackage donated prescription drugs as necessary for storage, dispensing, administration, or transfers if the repackaged prescription drug is:
(1) labeled with the drug name, strength, and expiration date; and
(2) kept in a separate designated area until inspected and initialed by a practitioner with knowledge or experience with the prescription drug.
If multiple packaged donated prescription drugs with varied expiration dates are repackaged together, the shortest expiration date shall be used. A drug manufacturer's original expiration date may be used in place of a beyond use date.
(f) Donated prescription drugs that do not meet the requirements of this section must be disposed of by:
(1) returning it to the drug donor;
(2) destroying it by an incinerator, medical waste hauler, or other lawful method; or
(3) transferring it to a reverse distributor.
(g) A record of disposed prescription drugs under subsection (f) must contain the following information:
(1) The disposal method that was used.
(2) The date of disposal.
(3) The name, strength, and quantity of each drug disposed.
Any other information concerning the disposal of the prescription drugs is not required.
As added by P.L.208-2023, SEC.5.
