PTCB (Federal Legislation) 2026

Pure Food and Drug Act of 1906

Requires all manufacturers to properly label a drug with truthful information and prove its effectiveness through scientific methods; prohibits the adulteration and misbranding of food and drugs in interstate commerce.

Harrison Narcotic Act of 1914

Created in response to international treaties to stop the recreational use of opium; requires practitioners to be registered and document the use and dispensing of narcotics; restricts and taxes the sale and distribution of products used to prepare controlled substances (e.g., opium and coca leaves)

Food, Drug, and Cosmetic Act of 1938

Bans false product claims and requires all that products include package inserts with directions and labeling; requires addictive substances to be labeled, "Warning: May be habit forming"; gave legal status to the FDA and created the USP and National Formulary.

Durham-Humphrey Amendment of 1951

Added more labeling requirements, including "Caution: Federal law prohibits dispensing without a prescription and OTC drugs to be distinguished.

Kefauver-Harris Amendment of 1962

A reaction to the Thalidomide Tragedy; requires manufacturers to provide proof of a drugs' effectiveness and safely before approval; requires disclosure of accurate side effect information; prevents generic drugs from being marketed under new trade names.

Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA)

Requires strict record keeping and physical security of certain drug types; divides controlled substances into five classes (schedules) based on their accepted use, potential for abuse, and accepted safety under medical supervision.

Poison Prevention Packaging Act of 1970

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

Occupational Safety and Health Administration (OSHA) of 1970

Aims to ensure worker and workplace safety, including an environment that prevents toxic chemical exposure, excessive noise, mechanical dangers, unsanitary conditions and stress from heat or cold.

Medical Device Amendment of 1976

Establishes three regulatory classes for medical devices: Class I (general controlled devices with low risk for human use); Class Il (performance-standard devices with moderate risk for human use); Class Ill (the most regulated -high risks for human use, requires premarket approval applications equivalent to a new drug application)

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, storage, and disposal.

Orphan Drug Act of 1983

Regulates orphan drugs (pharmaceuticals developed specifically for rare diseases); passed to help develop treatments for orphan 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; formed the modern system of generic drug regulation in the US; outlines the process for drug companies to file an abbreviated new drug application (ANDA) to receive approval of a generic drug by the FDA.

Prescription Drug Marketing Act of 1987

Helps prevent counterfeit drugs by providing legal safeguards in the pharmaceutical chain of distribution; designed to prevent the sales of discontinued, counterfeit, misbranded, subpar, and expired prescription drugs.

Omnibus Budget Reconciliation Act of 1990

Related to COBRA, which allows for continuing coverage and group health care plan benefits for employees and families based on qualifying issues and events when benefits would otherwise be terminated.

FDA Safe Medical Devices Act of 1990

Implemented medical device reporting (MDR) of serious incidents that occur from the use of medical devices; a post-market surveillance tool used by the FDA to monitor performance, potential safety issues, and benefit-risk assessments of the devices.

Anabolic Steroids Control Act of 1990

Amended the CSA to require penalties for trainers and advisors who recommend anabolic steroid use; added anabolic steroids as a CIll schedule drug.

American with Disabilities Act of 1990

Civil rights law that protects against discrimination based on a disability; requires employers to make reasonable accommodations to employees with disabilities.

Dietary Supplement Health and Education Act of 1994

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

FDA Modernization Act of 1997

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

Medicare Prescription Drug Improvement and Modernization Act of 2003

Gives low-income patients the option of a prescription drug discount card; helps increase access to medical treatments and reduces unnecessary hospitalizations associated with noncompliance in taking prescription drugs.

Dietary Supplement and Nonprescription Drug Act of 2006

Amends the Food, Drug, and Cosmetic Act by requiring the reporting of adverse events caused by dietary supplements and nonprescription drugs, including abuse of and withdrawals from the drug, overdose of the drug, and failure of the drug's expected pharmacological action.

Patient Protection and Affordable Care Act of 2010

Also known as the Affordable Care Act or Obamacare; aims to increase health care quality and affordability by lowering the costs of insurance and the number of uninsured persons in the US; requires insurance companies to cover all individuals with new minimum standards regardless of pre-existing conditions.

Drug Quality and Security Act of 2013

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

Health Insurance Portability and Accountability Act (HIPAA)

Guarantees health insurance access, portability, and renewal. Also limits the exclusion of some preexisting conditions and prohibits discrimination baes on a person's health status.

Protected Health Information (PHI)

Any information about health status, provision of health care, or payment for health care that can be linked to an individual. This is interpreted rather broadly and includes any part of a patient's medical record or payment history.