Law | Year | Summary |
HIPAA | | |
Durham-Humphrey Amendment | 1951 | AKA "the Prescription Drug Amendment" - required Rx drugs bear the legend, "Caution: Federal law prohibits dispensing without a prescription." This is why Rx-only drugs are called "legend drugs" |
Comprehensive Drug Abuse Prevention and Control Act | 1970 | AKA "the Controlled Substances Act" - Established the DEA and CI-CV control schedules. Required DEA registration to prescribe, manufacture, dispense, import, compound, distribute, or do research with controlled substances. |
Pure Food & Drug Act | 1906 | Law providing for federal inspection of products, banning the sale/manufacture of "adulterated food products or poisonous patent medicines." (Failed to cover cosmetics, labeling of products, prohibit making false claims about products, or ban drugs) |
The Food, Drug and Cosmetic Act | 1938 | Required manufacturers to prove (clinical trials) that drugs were safe before selling, list warnings and directions. Established Rx only and OTC status and who could prescribe. Required ingredients label. |
The Kefauver-Harris Amendment | 1962 | AKA the "Drug Efficacy Amendment" - Established GMP for manufacturing, required clinical trials to prove effectiveness and safety, established NDA and IND procedures. Placed Rx advertising under FDA authority. |
The Poison Prevention Packaging Act | 1970 | Required all legend and controlled drugs to be dispensed in a childproof container unless a documented request for easy-open is obtained. Exceptions include: SL NTG, hospital meds, certain emergency meds. |
OSHA | 1970 | The Occupational Safety and Health Act - Ensures worker and workplace safety. Established NIOSH (National Institute for Occupational Safety and Health). |
The Drug Listing Act | 1972 | Requires all human and veterinary drugs to be labeled clearly with unique, permanent NDC product code which identifies the manufactuerer, formulation, and the size/type of product packaging. |
The Medical Device Amendment | 1976 | Required for the 1st time that safety and effectiveness of life-sustaining and support devices have premarket approval from FDA. |
The Orphan Drug Act | 1983 | Tax and patent incentive for drug manufacturers designed to encourage development of drugs for rare conditions: 7 years of market exclusivity, 50% of cost of clinical trial tax credit, and grants for research into certain diseases. |
Drug Price Competition and Patent Term Restoration Act | 1984 | AKA Hatch-Waxman Act. established modern system of generic drugs and ANDA's (abbreviated new drug applications) for FDA approval of generic drugs. |
The Prescription Drug Marketing Act | 1987 | governs distribution of free Rx samples, drug coupons, and other price incentive Rx drug programs. |
The Anabolic Steroid Control Act | 1990 | Placed anabolic steroids in CIII to address abuse of testosterone products. |
DSHEA | 1994 | Dietary Supplement Health and Education Act - vaguely defined dietary supplements, established framework for labeling, GMP and how to address safety issues. |
HIPAA | 1996 | Health Insurance Portability and Accountability Act - Established rules governing privacy of PHA (protected health information). Covers written, auditory and electronic information that includes payment information or could be used to identify a patient. |
CMEA | 2005 | Combat Methamphetamine Epidemic Act - regulates OTC sale of pseudoephedrine and ephedrine-containing products. Limits qty that can be purchased, requires ID to be shown. |
OBRA | 1990 | Omnibus Budget Reconciliation Act - , mandated that the pharmacist perform DUR's and provide medication counseling to their patients. |