SECTION 291.7. Prescription Drug Recalls by the Manufacturer

(a) 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.

(b) The written procedure shall include, but not be limited to, the following:

(1) 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; and

(2) if the drug that is the subject to a recall is maintained by the pharmacy in a container without a lot number, the pharmacist-in-charge shall consider this drug included in the recall.

Source Note: The provisions of this §291.7 adopted to be effective May 30, 2010, 35 TexReg 4164