|  | Public Health Safety | Medical Research

Government Regulations for Pharmacy Compounding

According to the U.S. Food and Drug Administration (FDA), pharmacy compounding is the "combining or altering of ingredients by a pharmacist in response to a licensed practitioner's prescription." This allows a pharmacist to tailor a medicinal plan to an individual patient's needs.

  1. Federal Food, Drug and Cosmetic Act

    • The Federal Food Drug and Cosmetic Act (FDC Act) makes it illegal to introduce drugs for human consumption without FDA approval. The FDA has always considered compound drugs to fall within the scope of the rule. The FDC Act also prohibits the adulteration or misbranding of drugs. These provisions do not exclude compounded drugs.

    1992 Compliance Policy Guide

    • This policy guide was enacted to provide specific guidance as to the FDA's enforcement policy regarding compounded drugs. It was rescinded when Congress enacted the Food and Drug Modernization Act of 1997 to address the FDA's role in the regulation of pharmacy compounding.

    Food and Drug Administration Modernization Act of 1997

    • The Modernization Act added provisions to the FDC in order to specify the status of compounded drugs. Drugs that met specific requirements would be exempted from the main provisions of the FDC Act. These included the adulteration provision, the misbranding provision and the provision that held compounded drugs to the same standard as new drugs.

Medical Research - Related Articles