FDA ISSUES DRAFT GUIDANCE FOR OTC HUMAN-DRUG LABELING

The FDA has published a draft guidance to provide drugmakers with recommendations on how to convert OTC drug monograph labeling to OTC "Drug Facts" format.

The document is one of a series of guidances intended to facilitate compliance with the Drug Facts format, which the FDA formalized in a final rule (21 CFR 201.66) published March 17, 1999.

Intended to be more user-friendly for consumers than monograph labeling, the Drug Facts format uses standardized headings and subheadings with terms that are familiar to the general public. The Drug Facts labeling requirements apply to all OTC drugs and drug-cosmetic products.

The FDA's latest guidance on the subject, titled "Labeling OTC Human Drug Products: Questions and Answers," contains a lengthy question and answer section addressing the topics of content labeling requirements, format labeling requirements, and exemption and deferrals to Drug Facts labeling requirements. The majority of the questions were submitted to the FDA by manufacturers, packers and distributors, the agency said.

To view the draft guidance, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0549-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0549-gdl0001.pdf).