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PTCB Laws to Know

Federal Laws to be familiar with for the PTCB exam.

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.
Created by: pt_wcc



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