Section 431.454. Circumstances Under Which Donated Drugs May Be Accepted

TX Health & Safety Code § 431.454 (2019) (N/A)
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Sec. 431.454. CIRCUMSTANCES UNDER WHICH DONATED DRUGS MAY BE ACCEPTED. (a) The department may accept donated drugs only in accordance with this subchapter.

(b) The donated drugs must be:

(1) prescription drugs; and

(2) approved by the federal Food and Drug Administration and:

(A) sealed in unopened tamper-evident unit dose packaging;

(B) be oral medication in sealed single-dose containers approved by the federal Food and Drug Administration; or

(C) be topical or inhalant drugs in sealed units-of-use containers approved by the federal Food and Drug Administration.

(c) A drug packaged in single unit doses may be accepted and distributed if the outside packaging is opened but the single unit dose packaging is unopened.

(d) Donated drugs may not:

(1) be the subject of a mandatory recall by a state or federal agency or a voluntary recall by a drug seller or manufacturer;

(2) be adulterated or misbranded;

(3) be a controlled substance under Chapter 481;

(4) be a parenteral or injectable medication;

(5) require refrigeration;

(6) expire less than 60 days after the date of the donation; or

(7) be a drug that is prohibited from being dispensed to a patient other than a patient who is registered with the drug's manufacturer in accordance with federal Food and Drug Administration requirements.

(e) The department may distribute the donated drugs only after a licensed pharmacist has determined that the drugs are of an acceptable integrity.

(f) The department may not charge a fee for the drugs donated under the pilot program other than a nominal handling fee to defray the costs incurred in implementing the pilot program under this subchapter.

(g) The department may not resell the drugs donated under the pilot program.

Added by Acts 2015, 84th Leg., R.S., Ch. 1191 (S.B. 1243), Sec. 1, eff. September 1, 2015.