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   What is the FDA definition of a drug?

   • The FDA defines a drug, in part, as “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Refer to section 201 (g) of the Federal Food Drug and Cosmetic Act (FD&C Act).

   Importing Human Drugs | FDA - U.S. Food and Drug Administration

   www.fda.gov/industry/importing-fda-regulated-products/importing-human-drugs

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   What is a drug in pharmacology?

   • Drug A drug is defined as: A substance recognized by an official pharmacopoeia or formulary. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance (other than food) intended to affect the structure or any function of the body.

   Drugs@FDA Glossary of Terms | FDA

   www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-glossary-terms

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   Do all FDA-regulated medical products meet the definition of a drug?

   • Conceptually, all FDA-regulated medical products meet the definition of “drug” under section 201 (g) of the FD&C Act, due to the broader scope of the drug definition.

   Classification of Products as Drugs and Devices and Additional Issues

   www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-product-classification-issues

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   What does FDA approved label mean?

   • Label The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging.

   Drugs@FDA Glossary of Terms | FDA

   www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-glossary-terms

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2. www.fda.gov › regulatory-information › search-fdaClassification of Products as Drugs and Devices and ...

   www.fda.gov › regulatory-information › search-fda

   • Cached

   Conceptually, all FDA-regulated medical products meet the definition of “drug” under section 201(g) of the FD&C Act, due to the broader scope of the drug definition.

   • Guidance for Industry - Food and Drug Administration

     FDA’s determination of whether to classify a product as a...

   • Drugs@FDA Glossary of Terms | FDA - U.S. Food and Drug ...

     A substance recognized by an official pharmacopoeia or...

   • Definition of a Drug (April 2017) | FDA

     Whether a product is regulated as a drug, a cosmetic, or...

   • CFR - Code of Federal Regulations Title 21 - Food and Drug ...

     Authorized generic drug is a listed drug, as defined in this...

   • Transcript: Definition of a Drug (April 2017) | FDA

     Drugs are defined as articles intended for use in the...

   • Importing Human Drugs | FDA - U.S. Food and Drug Administration

     What is a drug? The FDA defines a drug, in part, as...

   • Is My Product a Medical Device? - U.S. Food and Drug ...

     Define what is a medical device. Discuss special...