FDA Issues Final Guidance on OTC Drug Labeling - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Issues Final Guidance on OTC Drug Labeling


ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration last week issued the final draft of its guidance for industry titled Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers. The guidance is intended to help manufacturers, packers, and distributors of such drug products comply with the new section 502(x) of the Federal Food, Drug, and Cosmetic Act.

Section 502(x) states that the label of an over-the-counter (OTC) drug marketed in the United States without an approved application must include “a domestic address or domestic phone number through which the responsible person … may receive a report of a serious adverse event.” The guidance document clarifies the meaning of “domestic address” as the complete mailing address, so as not to be confused with the term “place of business” often used by Congress.

The guidance describes FDA’s recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label. Several examples of such a statement are listed in the document. According to the guidance, the product label can include an email address or website to which reports can be made, “provided that such email address or Web site is in addition to the domestic phone number or domestic address ….”

Section 502(x) of the Act became effective on Dec. 22, 2007, and the labeling requirements are already in effect. FDA intends to “exercise enforcement discretion for the new labeling requirements until September 30, 2010.” Enforcement will begin immediately after this date.

See related PharmTech articles:
FDA Releases Draft Guidance for OTC Labeling (ePT article)

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
35%
Breakthrough designations
12%
Protecting the supply chain
35%
Expedited reviews of drug submissions
12%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here