|(a) Donor Requirements.
(1) No drugs that require storage temperatures other
than normal room temperature as specified by the manufacturer or United
States Pharmacopoeia (USP) shall be donated or accepted as part of
the Prescription Drug Donation 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.
(2) 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.
(3) Drugs previously purchased by Medicaid shall not
(4) All donated drugs must:
(A) be approved by the Food and Drug Administration
(FDA) and not be required to have a risk evaluation or mitigation
(B) be dispensed only by prescription;
(C) bear the federal legend "Rx Only" or "Caution,"
Federal Law Prohibits Dispensing Without Prescription;"
(D) be packaged into unit-dose packages; and
(E) be intended for human use.
(5) The donor must sign a Donor Form prescribed by
the Department stating that:
(A) the donor is the owner of the donated prescription
(B) the donated prescription drug has been properly
stored and the tamper-evident packaging has not been opened or tampered
(C) the donated prescription drug has not been adulterated
or misbranded; and
(D) the donor is voluntarily donating the prescription
(b) Participating Provider Requirements.
(1) Upon the Department’s confirmed receipt of
the Participating Provider Form, a participating provider may accept
legally obtained prescription drugs from a donor in the Program if
the drugs meet the requirements of this rule, as determined by a pharmacist
who is employed by or under contract with the participating provider
and the donor has completed a Donor Form as prescribed by the Department.
(2) The participating provider 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
unit-dose 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 undisturbed;
(B) the drug has been stored according to manufacturer
or USP storage requirements;
(C) the packaging contains the expiration date of the
(D) the drug is not expired;
(E) the drug and the packaging does not have any physical
signs of tampering or adulteration, and there is no reason to believe
that the drug is adulterated; and
(F) all drugs shall be inventoried by the participating
provider. The inventory shall include the name of the drug, strength
of the drug, quantity of the drug, and the date of donation.