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
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