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Frequently Asked Questions for Pharmacists on Information Required on Prescription Labels

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.


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