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Term

Controlled substances
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TermDefinition
Controlled substances Drugs controlled by additional prescription requirements because of the danger of addiction or abuse.
Drug A substance recognized by an official pharmacopeia or formulary, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease.
Drug Enforcement Administration (DEA) A bureau of the Department of Justice that enforces the Controlled Substances Act.
Drug Standards Federally approved requirements for the specified strength, quality, and purity of drugs.
Food and Drug Administration (FDA) An agency within the Department of Health and Human Services that enforces the provisions of the Federal Food, Drug, and Cosmetic Act and amendments of 1951 and 1962.
National Drug Code (NDC) Directory Provides the FDA with a list of all drugs manufactured for commercial distribution.
Orphan Drugs Drugs or biological products used for the diagnosis, treatment, or prevention of a rare disease or condition affecting fewer than 200,000 persons in the U.S.
Omnibus Budget Reconciliation Act (OBRA) Mandated that all over-the-counter medications a patient is taking must be documented in a medical record.
Over-the-counter (OTC) Medication Medication available without a prescription.
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