Issued by:
Guidance Issuing Office
Office of Regulatory Affairs

The purpose of this Compliance Policy Guide is to provide guidance to FDA staff when considering recommending charges under 21 U.S.C. §331(a) or (d), the Food Drug & Cosmetic Act §301(a) or (d).

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.