This guidance is intended to assist manufacturers of prescription drugs approved under section 505 of the Federal Food, Drug, and Cosmetics Act (the Act) (21 U.S.C. 355) that are required to have an FDA-approved Medication Guide. On July 1, 2009, FDA expects affected entities to be in compliance with 21 CFR 208.20(b)(7)(iii), which requires that Medication Guides contain a verbatim statement that includes: (1) FDA’s toll-free MedWatch phone number and (2) a statement that the number is to be used for reporting purposes only, not to receive medical advice (the side effects statement). Manufacturers must also notify the Agency that the side effects statement has been added to their Medication Guides.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.