Federal Regulations

Federal Regulations

• The 1906 Food & Drugs Act & Its Enforcement

  A brief history and explanation of the Food and Drugs Act of 1906.
• The 1938 Food, Drug, & Cosmetic Act

  A brief history and explanation of the 1938 Food, Drug, and Cosmetic Act.
• Controlled Substance Act

  The Controlled Substances Act (CSA) places all substances which were in some manner regulated under existing federal law into one of five schedules. This placement is based upon the substance’s medical use, potential for abuse, and safety or dependence liability.
• Orphan Drug Act

  The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”).

Federal Agencies

• Drug Enforcement Administration (DEA)

  The mission of the Drug Enforcement Administration (DEA) is to enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system of the United States, or any other competent jurisdiction, those organizations and principal members of organizations, involved in the growing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States; and to recommend and support non-enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets.
• Food and Drug Administration (FDA)

  FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and animal drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation.For FDA statistics, type in “statistics” in the search box on FDA’s home page.