Over-the-Counter [OTC]


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

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