New Jersey News: Labeling Requirements for Dispensed Retail Prescription Drug Containers

January 1, 2006 2:51 PM Topics: Prescription label

Reprinted from the January 2006 New Jersey Board of Pharmacy Newsletter.

The affixed label for any dispensed retail drug container must contain the following information, as detailed in N.J.A.C. 13:39-7.12: (1) name and address of the dispensing pharmacy; (2) telephone number of the dispensing pharmacy; (3) brand name or generic name of the drug dispensed (manufacturer name must be included if the generic name is used); (4) medication strength; (5) quantity dispensed; (6) date dispensed; (7) CDS cautionary statement where appropriate; (8) name of the patient; (9) initials of the dispensing pharmacist;  (10) name of the prescriber; (11) prescription number; adequate directions for use; (12) “use by” date if dispensed in any package other than the manufacturer’s original package (the “use by” date is one year from the dispensing date or one year from the expiration date on the manufacturer’s original package, whichever comes first);  (13) all auxiliary labeling as required by the manufacturer; and (14) additional patient directions or cautionary labels that, in the professional judgement of the dispensing pharmacist, should be added to ensure appropriate medication administration, storage, or use by the patient. Larger, bolded, or different color type must be used for the patient name, brand or generic medication name, and directions for use.