“Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications”

Issue Date: June 15, 2012
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final

“Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications”

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.

Download the Guidance Document