Federal Pharmacy Law and Legal Structure

Vaccine Act of 1813

First federal law concerning drugs; enacted in response to smallpox vaccine fraud to ensure authenticity and availability.

Drug Importation Act of 1848

Prohibited the importation of low-quality, adulterated, or substandard drugs from foreign countries.

Biologics Control Act of 1902

Triggered by a tetanus outbreak from contaminated diphtheria vaccine; required manufacturers of biologics to be licensed and inspected.

Pure Food and Drug Act of 1906

Prohibited the interstate commerce of adulterated or misbranded food and drugs; defined drugs based on USP and NF standards.

Harrison Anti-Narcotic Act of 1914

Established control over the manufacturing, distribution, and dispensing of opiates and cocaine through taxation and registration.

Food, Drug, and Cosmetic Act (FDCA) of 1938

Triggered by the sulfanilamide elixir tragedy; required new drugs to be proven safe before marketing and empowered the FDA.

Durham-Humphrey Amendment of 1951

Established two distinct classes of drugs: prescription (legend) and over-the-counter (OTC).

Kefauver-Harris Amendment of 1962

Triggered by the thalidomide tragedy; required new drugs to prove efficacy in addition to safety and established GMPs.

Poison Prevention Packaging Act of 1970

Required child-resistant packaging for most prescription drugs, OTC products, and hazardous household substances.

Orphan Drug Act of 1983

Provided tax and exclusive licensing incentives to develop drugs for rare diseases affecting fewer than 200,000 Americans.

Waxman-Hatch Act of 1984

Created the Abbreviated New Drug Application (ANDA) process for generics and extended patent terms for brand-name drugs.

Prescription Drug Marketing Act of 1987

Banned the reimportation of U.S.-made drugs from abroad and regulated the distribution and storage of drug samples.

OBRA '90 (Omnibus Budget Reconciliation Act)

Required pharmacists to offer counseling to Medicaid patients on new and refilled prescriptions and established DUR programs.

Dietary Supplement Health and Education Act (DSHEA) of 1994

Defined dietary supplements as a special category and allowed four types of substantiated structure/function claims with disclaimers.

HIPAA of 1996

Established national standards for protecting the privacy and confidentiality of patients' health information in pharmacies.

FDAMA (FDA Modernization Act of 1997)

Streamlined regulatory processes, renewed PDUFA, created fast-track review for life-threatening diseases, and added compounding rules.

Drug Quality and Security Act (DQSA) of 2013

Triggered by the NECC meningitis tragedy; created federal licensing and regulation for human compounding outsourcing facilities.

Commerce Clause (Article I, Section 8)

The constitutional provision granting Congress the authority to regulate interstate commerce, serving as the basis for federal drug laws.

10th Amendment

Reserves powers not delegated to the federal government to the states, providing the basis for state 'police powers' over public health and safety.

Legal Hierarchy of Federal Law

U.S. Constitution > Federal Statutes > Federal Regulations > Common Law > Executive Orders and Policies.