This post was written by Erin Janssen.
The FDA has published a Small Entity Compliance Guide entitled “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 understand and comply with the requirements of the October 28, 2008 final rule on labeling of drugs with a toll-free number for adverse event reporting. The guidance describes certain requirements of the final rule in plain language and provides answers to common questions on how to comply with the rule.