SECTION 95.4. Standards and Procedures for Donating or Accepting Prescription Drugs

(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 be donated.

(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 strategy;

(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 drug;

(B) the donated prescription drug has been properly stored and the tamper-evident packaging has not been opened or tampered with;

(C) the donated prescription drug has not been adulterated or misbranded; and

(D) the donor is voluntarily donating the prescription drug.

(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 drug;

(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.

Source Note: The provisions of this §95.4 adopted to be effective March 1, 2018, 43 TexReg 872