Drug Definitions and Information Sources

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Official Drug Name

The name listed by the FDA for a medication. This name is standardized and used across different manufacturers.

Brand Name

The name given to a drug by its manufacturer. This name is often catchy and easy to remember.

Generic Name

A name that is not proprietary, meaning it is not owned by a specific manufacturer. It is a more scientific name that describes the drug's chemical structure.

Nonproprietary Name

The official, non-proprietary name for a drug. It is standardized internationally and provides a common language for healthcare professionals.

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Drug Monograph

A document that provides detailed information about a specific drug, including its chemical composition, therapeutic effects, side effects, and dosage guidelines.

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United States Pharmacopoeia/National Formulary (USP NF)

A reliable source of information specific to nutritional supplements, their composition, and potential benefits.

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Drug Facts and Comparisons

A resource that contains drug monographs, organized to compare similar products, brand names, manufacturers, costs, and dosage forms.

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AHFS Drug Information

A comprehensive drug reference that provides detailed information on the therapeutic uses of drugs, including both approved and unapproved uses.

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DailyMed

A readily accessible online tool offering a standardized and up-to-date resource about medicines for healthcare providers and the public.

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Federal Food, Drug, and Cosmetic Act (1938)

The legal framework that enabled the FDA to evaluate and ensure the safety of drugs before they could be marketed.

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Kefauver Harris Drug Amendment (1962)

A legislation requiring drug manufacturers to prove the effectiveness of their products before marketing them.

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Controlled Substances Act (1970)

A piece of legislation that sets rules for the manufacture and distribution of controlled substances

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Schedule II Drug

A controlled substance with a high potential for abuse and the possibility of severe psychological or physical dependence.

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Fast Tracking of Drugs

A process used by the FDA to expedite the development and approval of drugs deemed necessary for public health emergencies, such as pandemics.

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Study Notes

Drug Definitions, Standards, and Information Sources

  • Official drug name: The name listed by the U.S. Food and Drug Administration (FDA)
  • Brand name (trademark): The name given to a drug by its manufacturer.
  • Generic name (nonproprietary name): Provided by the United States Adopted Names Council
  • Nutritional supplements: Information specific to nutritional supplements is found in the United States Pharmacopoeia/National Formulary (USP NF)
  • Drug Interaction Facts: Contains information on drug interactions, not nutritional supplements.
  • Natural Medicines Comprehensive Database: Contains evidence-based information on herbal medicines and herbal combinations, not nutritional supplements.
  • USP Dictionary of USAN & International Drug Names: Compilation of drug names, pronunciations, and possible future FDA-approved drugs, does not include nutritional supplements.
  • Drug monographs: Describe all drugs in a therapeutic class (found in Drug Facts and Comparisons)

Drug References

  • Drug Facts and Comparisons: Contains drug monographs for virtually every single-entity drug available in the US, discussing approved and unapproved therapeutic uses.
  • AHFS Drug Information: Contains drug monographs for virtually every single-entity drug available in the US, describing therapeutic uses, including approved and unapproved
  • DailyMed: A standard, comprehensive, up-to-date online resource for medicine information easily downloadable for both healthcare providers and the public.
  • American Hospital Formulary: Not intended for patient use.
  • American Drug Index: Not suitable for patient use.

Controlled Substances

  • Schedule II drugs: High potential for abuse and lead to severe psychological or physical dependence (e.g., meperidine/Demerol)

Expediting Drug Development

  • Fast-tracking: The FDA's expedited review and approval process for investigational drugs relevant to significant public health needs.

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