§ 431.323 Circumstances Under Which Donated Drugs May be Accepted and Dispensed
§ 431.323. Circumstances Under Which Donated Drugs May be Accepted and Dispensed
(a) A charitable medical clinic may accept and dispense or administer donated drugs only in accordance with this subchapter.
(b) The donated drugs must be drugs that require a prescription. A donated drug may not be a controlled substance under Chapter 481.
(c) The donated drugs must be approved by the federal Food and Drug Administration and:
(1) be sealed in the manufacturer's unopened original tamper-evident packaging and either:
(A) individually packaged; or
(B) packaged in unit-dose packaging;
(2) be oral or parenteral medication in sealed single-dose containers approved by the federal Food and Drug Administration;
(3) be topical or inhalant drugs in sealed units-of-use containers approved by the federal Food and Drug Administration; or
(4) be parenteral medication in sealed multiple-dose containers approved by the federal Food and Drug Administration from which no doses have been withdrawn; and
(5) must not be the subject of a mandatory recall by a state or federal agency or a voluntary recall by a drug seller or manufacturer.
(d) The charitable medical clinic may dispense or administer the donated drugs only:
(1) before the expiration date or within the recommended shelf life of the donated drugs, as applicable; and
(2) after a licensed pharmacist has determined that the drugs are of an acceptable integrity.
(e) The donated drugs may be accepted and dispensed or administered by the charitable medical clinic only in accordance with rules adopted by the department.