STATEMENTS OF POLICY
Title 49--PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF PHARMACY
[49 PA. CODE CH. 27]
Return to Stock of Undelivered Medications
[33 Pa.B. 5202] The State Board of Pharmacy (Board) adopts this statement of policy regarding the return to stock of undelivered medication to read as set forth in Annex A.
Section 5(a)(9)(xi) of the Pharmacy Act (63 P. S. § 390-5(a)(9)(xi)) prohibits the return to stock of unused medication once it has left the premises of the pharmacy. However, many prescriptions sit in the pharmacy but are never picked up. These prescriptions never leave the control of the pharmacy and may be returned to the stock of the pharmacy. In addition, many prescriptions are sent out for delivery with a pharmacy staff member but never get delivered to the patient. The Board views the premises of the pharmacy as not only the licensed physical structure, but as extending to delivery services that are provided by pharmacy staff. The drugs are still under the control of the pharmacy while they are being delivered to patients by pharmacy staff. Therefore, the pharmacy is able to ensure that the integrity of the drugs is maintained. The Board has determined that it is appropriate for these medications to be returned to the stock of the pharmacy under certain circumstances.
This statement of policy sets forth the guidelines that should be considered when returning undelivered medication to the pharmacy's stock. These guidelines will insure that the integrity of the drugs is maintained and patient safety is not compromised.
The statement of policy set forth in Annex A is effective upon publication in the Pennsylvania Bulletin and applies to the return to stock of medication that has not been delivered and has not left the control of the pharmacy.
RICHARD R. SMIGA, R.Ph.,
Chairperson(Editor's Note: The regulations of the Board, 49 Pa. Code Chapter 27, are amended by adding a statement of policy in § 27.102 to read as set forth in Annex A.)
Fiscal Note: 16A-5411. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 27. STATE BOARD OF PHARMACY
STATEMENTS OF POLICY § 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.
[Pa.B. Doc. No. 03-2025. Filed for public inspection October 17, 2003, 9:00 a.m.]
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