25 Tex. Admin. Code § 95.5 - Standards and Procedures for Inspecting and Storing Donated Prescription Drugs

(a) A licensed pharmacist employed by or under contract with the participating provider shall inspect donated prescription drugs to determine, to the extent reasonably possible in the judgement of the pharmacist, that the drugs are not adulterated or misbranded, are safe and suitable for dispensing, and are not ineligible drugs.

(b) Donated drugs may not be stored with non-donated inventory. When donated drugs are not inspected immediately upon receipt, the participating provider shall quarantine the donated drugs separately from all dispensing stock until the donated drugs have been inspected and approved for dispensing.

(c) The participating provider shall destroy donated non-controlled substances that are not suitable for dispensing and make a record of such destruction.

(d) The pharmacist-in-charge shall develop and implement a written procedure for proper management of drug recalls by the manufacturer. Such procedures shall include, where appropriate, contacting patients to whom the recalled drug products have been dispensed.

(e) The pharmacist-in-charge shall reasonably ensure that a recalled drug has been removed from inventory no more than 24 hours after receipt of the recall notice, and quarantined until proper disposal or destruction of the drug.

Notes

25 Tex. Admin. Code § 95.5

Adopted by Texas Register, Volume 43, Number 07, February 16, 2018, TexReg 0872, eff. 3/1/2018