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Laws and Regulations


The Association of Food and Drug Officials (AFDO), established in 1896, is an international non-profit organization that successfully fosters uniformity in the adoption and enforcement of food, drug, medical devices, cosmetics and product safety laws, rules, and regulations by either drafting regulatory rules or by commenting on government proposals.

The Drug Policy Information Clearinghouse is a component of the National Criminal Justice Reference Service, within the Office of Justice Programs at the United States Department of Justice. The Drug Policy Information Clearinghouse is staffed by subject matter specialists and serves as a resource for statistics, research data, and referrals useful for developing and implementing drug policy.

The Food and Drug Law Institute (FDLI), founded in 1949, is a non-profit organization that provides a marketplace for discussing food and drug law issues through conferences, publications and member interaction.

The Generic Pharmaceutical Association (GPhA) represents the manufacturers and distributors of finished generic pharmaceutical products; manufacturers and distributors of bulk active pharmaceutical chemicals; and suppliers of other goods and services to the generic pharmaceutical industry.

The National Association of Boards of Pharmacy (NABP) is the independent, international association that assists its member boards and jurisdictions in developing, implementing, and enforcing uniform standards for the purpose of protecting the public health.

The National Community Pharmacists Association (NCPA) represents the pharmacist owners, managers, and employees of independent community pharmacies across the United States.

The United States Drug Enforcement Administration (DEA), of the United States Department of Justice strives: 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.

The United States Pharmacopeia (USP) is the non-governmental official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States.

Other Resources

Abood RR, Burns KA, editors. Pharmacy Practice and the Law. 8th ed. Burlington (MA): Jones & Bartlett Learning; 2017.

FOI Services. Drugs Under Patent 2010. Rockville, MD: FOI Services; 2010.

Lynch HG, Cohen IG, editors. FDA in the Twenty-First Century: the challenges of regulating drugs and new technologies. New York: Columbia University Press; 2015.

Nusim SH, editor. Active Pharmaceutical Ingredients: development, manufacturing, and regulation. 2nd ed. New York: Informa Healthcare, 2010.

Mantus D, Pisano DJ, editors. FDA Regulatory Affairs. 3rd ed. Boca Raton (FL): Taylor & Francis; 2014. 387 p.

O’Donnell J, editor. O’Donnell’s Drug Injury. 4th ed. Tucson (AZ): Lawyers & Judges Publishing; 2016. Regulatory Affairs Professionals Society. Fundamentals of International Regulatory Affairs. 1st ed. Rockville, MD: Regulatory Affairs Professionals Society; 2010.

United States Office of the Federal Register. Code of Federal Regulations. 21: Food and Drugs. Washington, DC: U.S. Office of the Federal Register, National Archives and Records Service; 2013. Available in print and online.

Weisman F. Pharmacy Practice and Tort Law. New York: McGraw-Hill; 2016.

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