Historical Timeline of Drug Regulation and Pharmacy Law

A collection of vocabulary flashcards covering the historical evolution of drug regulations from 1848 to 1994, as well as clinical dispensing and privacy laws such as OBRA ’90 and HIPAA.

Drug Importation Act of 1848

Legislation passed after the Mexican-American War that appointed inspectors at six major ports and empowered the U.S. Customs Service to block adulterated foreign drugs.

Pure Food and Drug Act of 1906

The law that prohibited interstate manufacture and sale of misbranded or adulterated food and drugs, triggered by Upton Sinclair’s novel The Jungle.

Food, Drug, and Cosmetic Act (FD&C Act) of 1938

Legislation prompted by the Elixir Sulfanilamide tragedy that mandated premarketing safety testing and disclosure of active ingredients for all new drug products.

Durham-Humphrey Amendment of 1951

An amendment that formally categorized medications into Legend (Prescription) and Over-the-Counter (OTC) drugs.

Kefauver-Harris Amendments of 1962

Amendments sparked by the thalidomide crisis that required drug manufacturers to prove drug effectiveness (efficacy) through well-controlled clinical studies.

Poison Prevention Packaging Act (PPPA) of 1970

Law requiring child-resistant packaging for prescription drugs and high-risk OTC products to protect children under the age of $5$.

Medical Device Amendments of 1976

Legislation that categorized medical devices into three distinct risk classes to regulate safety and efficacy.

Federal Anti-Tampering Act of 1982

Enacted after the Chicago Tylenol murders, this act made tampering with consumer products a federal offense and mandated tamper-evident packaging.

Orphan Drug Act of 1983

Law providing financial incentives and a $7$-year market exclusivity for therapies targeting rare diseases affecting fewer than $200,000$ individuals.

Hatch-Waxman Act of 1984

Legislation that accelerated the generic market by creating the Abbreviated New Drug Application (ANDA) pathway based on bioequivalence.

Dietary Supplement Health and Education Act (DSHEA) of 1994

Authorized the FDA to regulate dietary supplements as a special category of food, allowing health and structure/function claims without pre-market approval.

Omnibus Budget Reconciliation Act of 1990 (OBRA ’90)

Federal law requiring pharmacies to maintain patient profiles, perform prospective Drug Utilization Reviews (DUR), and offer patient counseling.

Prospective DUR

Evaluation of medication appropriateness before dispensing to identify therapeutic duplication, drug-disease contraindications, and incorrect dosages.

HIPAA Privacy Rule

A regulation that protects all forms of Protected Health Information (PHI), including written, spoken, or electronic communication.

HIPAA Security Rule

A regulation that applies specifically to the protection and safeguarding of electronic forms of Protected Health Information ($ePHI$).

HITECH Act (2009)

Legislation that promoted the adoption of electronic health records (EHR) and strengthened HIPAA privacy penalties and data breach notifications.

Patient Counseling (under OBRA ’90)

The legal requirement for pharmacists to offer to discuss therapeutic factors such as side effects, storage, and self-monitoring techniques with patients.

Practice of Pharmacy (NABP Definition)

A clinical scope of practice that includes medication therapy management (MTM) and active adherence monitoring.