N.J. Admin. Code § 13:39-7.16

Current through Register Vol. 56, No. 21, November 4, 2024

Section 13:39-7.16 - Return of prescription medication

(a) Prescription medication correctly dispensed to a patient may be accepted for return by the pharmacist but shall not be placed in stock for reuse or resale, except as provided in 13:39-9.18(a)2.

(b) Prescription medication incorrectly dispensed to a patient shall be accepted for return by the pharmacist and shall not be placed back in stock for reuse or resale.

(c) For purposes of this subsection, a prescription medication shall be considered to be abandoned when a prescription is prepared and made available for dispensing by the pharmacy but is not dispensed to the patient for whom it was prepared within two weeks. Prescription medication that has been prepared for a patient and that is abandoned by a patient, or that has not been dispensed by a long-term care pharmacy to a patient in a long-term care facility, may be placed back in stock for reuse or resale provided that:

1. In the professional judgment of the pharmacist, the prescription medication is eligible for re-dispensing. Eligible medications are those medications that are able to be consumed by a patient within the original time frame established for the medication's stability and expiration, were maintained under proper storage conditions to ensure their integrity, and have remained under the exclusive control and custody of the pharmacy or the patient's long-term care facility, as applicable, at all times. Products that have a limited shelf life and/or that have not been stored consistent with manufacturers' storage requirements may not be re-dispensed;

2. The prescription medication shall not be placed in manufacturers' stock containers of different lot numbers and/or with different expiration dates;

3. Manufacturers' stock containers shall not be over-filled;

4. In those circumstances in which prescription medications cannot be properly returned to the original manufacturers' stock containers, the medication shall be held in the pharmacy in the labeled container in which it has been repackaged. Prior to redispensing, such medications shall be placed in a new container with a new label or the original label shall be removed and the container shall be relabeled;

5. If the manufacturer or the FDA orders a recall of a drug product, the pharmacist shall assume products held in labeled containers without lot numbers are included in the recall and proceed accordingly; and

6. Medications held for re-dispensing shall be used as soon as possible. Such medications, lacking original lot numbers and expiration dates, shall not be dispensed to patients later than one year from the date the medications were originally prepared for dispensing. Re-dispensed medications shall be marked with the same use by date as the medication which was originally prepared for dispensing.

N.J. Admin. Code § 13:39-7.16

Amended by 49 N.J.R. 3761(a), effective 12/4/2017