Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 109 - Prescription Drug Donation Repository Program › Rule 641-109.4 - Standards and Procedures for Accepting Donated Prescription Drugs and Supplies

Current through Register Vol. 47, No. 3, July 24, 2024
(1) Any
			 individual who is 18 years of age or older may donate legally obtained
			 prescription drugs or supplies to the centralized repository or a local
			 repository if the drugs or supplies meet the requirements of this rule, as
			 determined by a pharmacist who is employed by or under contract with a drug
			 repository.
(2) No drugs that
			 require storage temperatures other than normal room temperature as specified by
			 the manufacturer or United States Pharmacopoeia shall be donated or accepted as
			 part of the prescription drug donation repository program. Drugs that require
			 storage temperatures other than normal room temperature as specified by the
			 manufacturer or USP shall not be donated or accepted because of the increased
			 potential for these drugs to become adulterated. Excluded from this restriction
			 are drugs donated directly from a drug manufacturer
(3) Controlled substances shall not be
			 donated or accepted. Pursuant to federal and state laws, a controlled substance
			 cannot be returned or reused once the drug has been dispensed to a
			 patient.
(4) The centralized
			 repository or a local repository 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-dose packaging is imdisturbed;
b. The drug has been stored according to
			 manufacturer or USP 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 will be destroyed in the event of a recall, pursuant to
			 Iowa board of pharmacy rules;
d.
			 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 distributed if the drug is in high demand and
			 can be dispensed for use prior to the drug's expiration date;
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, misbranding, deterioration,
			 compromised integrity or adulteration; and
g. All drugs shall be inventoried at the
			 centralized repository or a local repository. The inventory shall include the
			 name of the drug, strength of the drug, quantity of the drug, and the date of
			 donation if the drug has been continually under the control of a health care
			 professional. If the drug has not been continually under the control of a
			 health care professional, the repository shall collect a donation form provided
			 by the prescription drug donation repository program that is signed by the
			 person making the donation or that person's authorized
			 representative.