Chapter 1: Consumer Safety & Drug Regulations

controlled substances

drugs controlled by additional prescription requirements because of the danger of addiction or abuse.

Drug Enforcement Administration (DEA)

a bureau of the DOJ that enforces the Controlled Substances Act

drug standards

federally approved requirements for the specified strength, quality, and purity of drugs

Food & Drug Administration (FDA)

an agency within the Department of Health & 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, that is, one affecting fewer than 200k persons in the US, or greater than 200k persons where the cost of developing the drug is probably not recoverable in the US

Over-the-counter (OTC) medication

medication available without a prescription