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GUIDANCE DOCUMENT

"Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications" June 2012

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2012-D-0544
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to help small businesses better understand and comply with FDA’s final rule regarding labeling of drugs with a toll-free number for adverse event reporting, which was published in the Federal Register on October 28, 2008 (73 FR 63886). The Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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 written comments should be identified with this document's docket number: FDA-2012-D-0544.

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