Current through Register Vol. 47, No. 6, September 18, 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.
(5) A
repository may accept supplies necessary to administer the prescription drugs
donated only if all of the following requirements are met:
a. The supplies are in their original,
unopened, sealed packaging;
b. The
supplies are not adulterated or misbranded; and
c. All supplies shall be inventoried at the
centralized repository or a local repository. The inventory shall include a
description of the supplies and the date donated. Such inventory shall be
recorded on a form provided by the prescription drug donation repository
program.
(6) Drugs and
supplies may be donated on the premises of a participating centralized
repository or a local repository to a person designated by the repository. A
drop box may not be used to deliver or accept donations.
