Pharmacy Law

Pure Food and Drug Act

Prohibited interstate sale of adulterated and misbranded food and drugs.

The Harrison Narcotics Act of 1914

Controlled opium use and required practitioner registration.

The Food, Drug, and Cosmetic Act of 1938

Established FDA, required drug safety and efficacy.

The Durham-Humphrey Amendment of 1951

Differentiated between prescription and OTC drugs.

The Kefauver-Harris Amendment of 1962

Mandated drug products to be effective and safe.

The Comprehensive Drug Abuse Prevention and Control Act of 1970

Regulated controlled substances, classified drugs into Schedules.

The Occupational Safety and Health Act of 1970

Ensured workplace safety, required MSDS for hazardous chemicals.

The Drug Listing Act of 1972

Assigned NDC to all new drugs for unique identification.

The Medical Device Amendments of 1976

Required medical device manufacturers to ensure product safety.

The Orphan Drug Act of 1983

Provided incentives for developing drugs for rare diseases.

The Drug Price Competition and Patent-Term Restoration Act of 1984

Facilitated generic drug approvals to increase competition.

The Prescription Drug Marketing Act of 1987

Prohibited sale of drug samples and importation restrictions.

The Anabolic Steroids Control Act of 1990

Placed anabolic steroids under controlled substances.

The Omnibus Budget Reconciliation Act of 1990 (OBRA '90)

Required pharmacists to counsel Medicare/Medicaid patients.

The Dietary Supplement Health and Education Act of 1994

Set labeling requirements for dietary supplements.

The Health Insurance Portability and Accountability Act of 1996

Enforced patient privacy and standardized health information.

The Drug Addiction Treatment Act of 2000

Allowed DEA-registered physicians to treat opioid addiction.

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003

Provided prescription benefits to seniors, established Medicare Part D.

The Combat Methamphetamine Epidemic Act of 2005

Restricted sales of products used to make methamphetamine.

Accutane iPledge Program of 2006

Restricted distribution of isotretinoin due to birth defect risks.

Patient Protection and Affordable Care Act of 2010

Expanded healthcare access and insurance standards.

Drug Quality and Security Act of 2013

Created "track-and-trace" system for drug supply chain security.