FDA Pharmaceutical Regulations

The U. S. Food and Drug Administration is responsible for ensuring that pharmaceutical products are safe, effective and accurately represented to the public. It regulates drug approvals, over-the-counter (OTC) and prescription drug labeling and drug manufacturing standards using a variety of legislation.
  1. Federal Food, Drug and Cosmetic Act

    • One of the first regulatory steps given to the FDA was the Federal Food, Drug and Cosmetic Act of 1938. This act gave them the ability to demand evidence of safety for new drugs and conduct factory inspections. Of the 20 sections in this Act, section five is devoted specifically to drugs and devices. Each sub-section is devoted to more specific topics such as pharmacy compounding, adulterated drugs and inspections. Many amendments have been added to this act over the years.

    Code of Federal Regulations

    • The Code of Federal Regulations is the set of rules established by the executive department and the agencies under its administration. Of the 50 main sections in the code, Title 21 outlines the rules and regulations governing pharmaceuticals. Sections within this outline areas such as standards of conduct, laboratory practices, drug additives and guidance based on categories of drugs.

    Other Legislation

    • Various other broader legislation help the FDA regulate the process of making drugs available to the public. These laws are not specific to the pharmaceutical industry but help the FDA enforce rules that affect drugs and drug-making. Examples include the Federal Trade Commission Act which helps monitor fair competition and deceptive practices affecting trade and the Federal Anti-Tampering Act which makes tampering with consumer products such as drugs a violation.

Medical Research - Related Articles