Frequently Asked Questions for Pharmacists on Prescription Labeling
Q: Must a prescription label state the drug's generic name?
A: Rule .1818 provides that prescription labels shall contain the generic name of the drug even if the brand name is in the container. The purpose of this rule is to make it possible for hospital personnel to easily identify products from the labels on prescription containers that may arrive with the patient in the emergency department. For example, a prescription for Cordarone could be labeled as "Cordarone (Amiodarone)" if the brand name was dispensed. If the generic was dispensed the label would only need to contain the word "Amiodarone".
Compounded products should contain a list of active ingredients. Exceptions could be made for standard items such as "Duke’s Mouthwash" or "Compounded Cafergot".
This rule is intended to meet a health need and is not meant as a punitive measure. Board staff does expect pharmacies to be in compliance within a reasonable time.
Some patients have expressed confusion over the rule. A consumer-friendly explanatory FAQ is available here.
Q. What information is required to be on the prescription label?
A. The following information must be on every prescription label:
1. Name and address of the dispensing pharmacy.
2. Serial number of the prescription.
3. Date of the prescription.
4. Name of the prescriber.
5. Name of the patient.
6. Name and strength of the drug.
7. The generic name of the drug, even if the generic drug is unavailable to dispense or even if the substitution of a generic drug is not authorized.
8. Directions for use.
9. Appropriate cautionary statements.
10. “Filled by” or “dispensed by” with the name of the dispensing pharmacist. The name must include, at a minimum, the first initial and full last name of the dispensing pharmacist.
11. If the dispensed drug is a “tranquilizer or sedative,” it should bear the warning “The consumption of alcoholic beverages while on this medication can be harmful to your health” if the prescriber so directs on the prescription.
12. If the prescription is dispensed in a container other than the manufacturer’s original container, a discard date, which shall be the earlier of one year from the date dispensed or the manufacturer’s expiration date, whichever is earlier.
13. If the prescription is dispensed in the manufacturer’s original container, the label must not obscure the expiration date and storage statement when the product is dispensed in the manufacturer's original container.
21 U.S.C. § 353(b)(2); N.C.G.S. §§ 90-85.29, 106-134.1(b); 21 N.C.A.C. 46.1818.
These requirements do not prohibit pharmacists from including additional information on the label. For example, no federal or North Carolina statute requires that the label indicate the number of refills remaining, but such information is, for good reasons, typically included on the prescription label.