Federal Legislation for Pharmacy and Healthcare

Flashcards covering key federal legislation, acts, and amendments regulating the pharmaceutical and healthcare industries.

Pure Food and Drug Act of 1906

Requires manufacturers to properly label drugs with truthful information and prove effectiveness; prohibits adulteration and misbranding of food and drugs in interstate commerce.

Harrison Narcotics Tax Act of 1914

An act created to stop the recreational use of opium that requires practitioners to be registered, taxes controlled substance distribution, and mandates documentation for dispensing narcotics.

Food, Drug, and Cosmetic Act of 1938

Bans false product claims, requires package inserts with directions, mandates the labeling 'Warning: May be habit forming,' and gave legal status to the FDA, USP, and National Formulary.

Durham-Humphrey Amendment of 1951

Added labeling requirements including 'Caution: Federal law prohibits dispensing without a prescription' and established the distinction between prescription and OTC drugs.

Kefauver-Harris Amendment of 1962

A reaction to the Thalidomide Tragedy that requires manufacturers to provide proof of drug effectiveness and safety before approval and disclose accurate side effect information.

Comprehensive Drug Abuse and Prevention Act of 1970

Also known as the Controlled Substances Act (CSA); it requires strict record keeping and divides controlled substances into five classes (schedules) based on accepted use and abuse potential.

Poison Prevention Packaging Act of 1970

Requires manufacturers and pharmacies to secure medications (both prescription and OTC) in containers with childproof caps/packaging.

Occupational Safety and Health Act (OSHA) of 1970

Aims to ensure worker and workplace safety, preventing exposure to toxic chemicals, excessive noise, mechanical dangers, unsanitary conditions, and extreme temperature stress.

Medical Device Amendment of 1976

Establishes three regulatory classes for medical devices based on risk: Class I (low risk), Class II (moderate risk), and Class III (high risk requiring premarket approval).

Resource Conservation and Recovery Act of 1976

Gives the Environmental Protection Agency (EPA) complete authority in the disposal of hazardous substances, including their generation, transportation, treatment, and storage.

Orphan Drug Act of 1983

Regulates pharmaceuticals developed specifically for rare diseases such as Huntington's disease, Tourette's syndrome, muscular dystrophy, and ALS.

Drug Price Competition and Patent Term Restoration Act of 1984

Encourages the manufacture of generic drugs and outlines the process for drug companies to file an abbreviated new drug application (ANDA) for FDA approval.

Prescription Drug Marketing Act of 1987

Helps prevent counterfeit, discontinued, or expired drugs by providing legal safeguards in the pharmaceutical chain of distribution.

Omnibus Budget Reconciliation Act of 1990

Related to COBRA; it allows for continuing coverage and group health care plan benefits for employees and families during qualifying events when benefits would otherwise terminate.

FDA Safe Medical Devices Act (1990)

Implemented medical device reporting (MDR) of serious incidents and serves as a post-market surveillance tool for the FDA to monitor performance and safety issues.

Anabolic Steroids Control Act of 1990

Amended the CSA to categorize anabolic steroids as a Schedule III drug and established penalties for trainers and advisors who recommend their use.

Americans with Disabilities Act of 1990

A civil rights law that protects against discrimination based on disability and requires employers to make reasonable accommodations for employees.

Dietary Supplement Health and Education Act of 1994

Defines and regulates dietary supplements under the FDA's Good Manufacturing Practices.

FDA Modernization Act (1997)

Updated the Food, Drug, and Cosmetic Act to include technological, trade, and public health issues relevant to the twenty-first century.

Medicare Prescription Drug Improvement and Modernization Act of 2003

Provides low-income patients with prescription drug discount cards and aims to increase treatment access to reduce unnecessary hospitalizations.

Dietary Supplement and Nonprescription Drug Act of 2006

Amends the Food, Drug, and Cosmetic Act to require the reporting of adverse events, abuse, withdrawals, and overdoses caused by dietary supplements and OTC drugs.

Patient Protection and Affordable Care Act of 2010

Also known as Obamacare; it aims to increase healthcare quality and affordability by requiring insurance companies to cover all individuals regardless of pre-existing conditions.

Drug Quality and Security Act of 2013

Modifies the Food, Drug, and Cosmetic Act to build an electronic tracking system to identify and trace specific prescription drugs distributed in the US.