U.S. Food and Drug Administration
Protecting and Promoting Your Health
Congratulations! You have completed the Requirements for the All OTC Products module.
Let's take a minute to review the key points about what you have learned.
- All OTC products have the same requirements for drug establishment registration, drug product listing,
and adherence to good manufacturing practice (GMP) regulations. For more information on these topics,
please select the Resources tab.
- "Labeling" means all labels and other written, printed, or graphic matters upon any article or
any of its containers or wrappers, or accompanying such article. Depending on the circumstances,
this may include packaging, product inserts, Web sites, and other promotional materials.
- In addition to labeling requirements specified in final monographs and the Drug Facts labeling requirements in
(21 CFR § 201.66), there are many other regulations in Part 201 of the CFR that pertain to OTC drug labeling.
For more information on these very important requirements, please select the Resources tab.
Click the MENU tab once to return to the Topic List for this lesson. Click it a second time to return to the Course Menu and select another module.