Regulatory Act or Agency & Measures Enacted Flashcards
State Boards of Pharmacy
- Provides standards for drugs, drug products, herbal products, and supplements
- Provides guidance on safe preparation of sterile product
Pure Food and Drug Act (1906)
- Required drug manufacturers to prove to FDA the safety and effectiveness of their products before they were legally permitted to market them to the public
- Prohibited transportation of adulterated or misbranded food and drugs
- Established the USP and NF as the official book of standards for American pharmaceuticals
Federal Food, Drug, and Cosmetic Act (1938)
- Extended control to cosmetics and therapeutic devices
- Required new drugs to be shown safe before marketing, starting a new system of drug regulation
- Eliminated the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases
- Provided that safe tolerances be set for unavoidable poisonous substances
- Authorized standards of identity, quality, and fill-of-container for foods
- Authorized factory inspections
- Added the remedy of court injunctions to the previous penalties of seizures and prosecutions
- Established the Food and Drug Administration (FDA)
- Regulates approval of new drugs for safety, drug labeling, drug recalls, and pharmaceutical factory inspections
Food and Drug Administration (FDA) (1938)
-Supervises the development, testing, purity, safety, and effectiveness of prescription and over-the-counter medications
Durham-Humphrey Amendment to the Federal Food Drug and Cosmetic Act (1951)
-Established prescription-only (legend) and over-the counter (OTC) classes of drug products
Kefauver-Harris Amendment to the Federal Food Drug and Cosmetic Act (1962)
- Established requirement of human clinical trials to prove safety and efficacy of drugs
- Required Investigational New Drug Application (IND) for phased testing of new drugs
- Required New Drug Application (NDA) to market a new drug in the United States
Comprehensive Drug Abuse Prevention and Control Act (1970) [Enforced by the Bureau of Narcotics and Dangerous Drugs (BNDD); became the Drug Enforcement Agency (DEA) in 1973.]
- Established a single system of control for both narcotic and psychotropic drugs
- Established five schedules that classify controlled substances according to how dangerous they are, their potential for abuse and addiction, and whether or not they possess legitimate medical value
Poison Prevention Packaging Act (PPPA) (1970)
-Established child-resistant containers
Occupational Safety and Health Administration (OSHA) (1971)
- Oversees worker safety for use of chemicals and pharmaceuticals
- Establishes guidelines for blood-borne and airborne pathogens
- Approves Material Safety Data sheets
Drug Listing Act (1972)
- Established the National Drug Code (NDC)
- Established the assignment of National Drug Code (NDC) numbers for reporting to the FDA
Drug Price Competition and Patent-Term Restoration Act (1984)
-Established the Orange book and bioequivalence of brand and generic drugs
Omnibus Budget Reconciliation Act (1990)
-Required pharmacists to counsel Medicare recipients to be eligible for payment
Dietary Supplement Health and Education Act (1994)
-Established that manufacturers of dietary supplements don’t have to prove efficacy or standardization to the FDA
Health Insurance Portability and Accountability Act (1996)
-Required confidentiality of patient records
Medicare Modernization Act (2003)
-Created Medicare Part D that provides prescription drug coverage to eligible Medicare recipients
