Over-the-Counter [OTC]

« Back to Glossary Index
Synonyms
Non-prescription

OTC drugs are defined as drugs that are determined by FDA to be safe and effective for use by the general public for self-care without obtaining a prescription from a health professional.

There are two bases for the lawful marketing of OTC drugs under the FDCA.

  • An approved application (see “FDA-Approved Medication”.
  • Is a drug which falls outside the FDCA definition of “new drug” and is Generally Recognized as Safe and Effective.

CFR – Code of Federal Regulations Title 21

National Association of Drug Diversion Investigators Federal Tax ID: 52-1660752 / DUNS Number: 073539913

Copyright © 2021 - NADDI. All Rights Reserved. Privacy Policy / Trademark Policy / Copyright Policy / Refund Policy

Log in with your credentials

or    

Forgot your details?

Create Account