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Term | Definition |
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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. |