49 Pa. Code § 27.102 - Return to stock of undelivered medication-statement of policy

(a) Background and purpose. Section 5(a)(9)(xi) of the act (63 P. S. § 390-5(a)(9)(xi)) prohibits the return to stock of medication once it has left the premises of the pharmacy. However, many prescriptions do not get delivered to patients and, therefore never leave the control of the pharmacy. These prescriptions may be returned to the active stock of the pharmacy. This section sets forth the guidelines that should be considered when returning undelivered medication to the pharmacy's active stock. This section will insure that the integrity of the drugs is maintained and patient safety is not compromised.

(b) Guidelines. The following guidelines should be considered when returning undelivered medications to stock to assure that the quality of medications is maintained:

(1) Prescriptions that have not been picked up by or delivered to patients should be checked periodically.

(2) Prescriptions not delivered to patients should be assessed by a pharmacist to determine whether they might safely be returned to stock.

(3) Products deemed eligible for redispensing should never be mixed within stock bottles of different lot numbers or with different expiration dates. Manufacturers' stock bottles should never be over-filled. The only safe manner in which drugs can be returned to stock bottles is in those pharmacies in which all medications are tracked by lot numbers and expiration dates.

(4) In those instances in which medication cannot be properly and safely returned to the original stock bottle, the medication may be held in the pharmacy in the container in which it has been repackaged. It is recommended that pharmacies develop an internal manner for so identifying and dating these products.

(5) Medications held for redispensing should be used as soon as possible. Medications held for redispensing, lacking original lot numbers and expiration dates, should only be dispensed to patients up to 6 months from the date the drugs were first prepared for dispensing.

(6) If the manufacturer or the United States Food and Drug Administration orders a recall for a drug product, pharmacists should assume products held in containers without lot numbers are included in the recall and proceed accordingly.

Notes

49 Pa. Code § 27.102

The provisions of this § 27.102 adopted October 17, 2003, effective 10/18/2003, 33 Pa.B. 5202.