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Frequently Asked Questions for Pharmacists on Generic 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.


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