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WTI Extern Legisl.

WTI Extern Federal Drug Legislation

Act What It Did
Food and Drug Act of 1906 Pharmaceuticals had to comply with their stated standards of strength, purity, and quality.
Federal Food, Drug, & Cosmetic Act of 1938 Pharmaceutical products have to be safe for human use.
Durham-Humphrey Amendment of 1952 Regulated the refilling of prescription drugs.
Kefauver-Harris Amendment of 1962 Required drugs to be safe and efficacious.
Comprehensive Drug Abuse Prevention and Control Act of 1970 Created five drug “schedules”, I through V, for the classification and control of drugs that might be abused.
Occupational Safety and Health Act of 1970 Part of the U.S. Department of Labor. The mission is to ensure workplace safety and a healthy environment within the workplace.
Poison Prevention Packaging Act of 1970 Requires that most OTC and legend drugs be packaged in child-resistant containers.
Drug Listing Act of 1972 Under this act, each new drug is assigned a unique, permanent product code known as a National Drug Code (NDC) that identifies the manufacturer or distributor, the drug formulation, and the size and type of its packaging.
Omnibus Budget Reconciliation Act of 1990 Requires pharmacists to discuss information about new and refill prescriptions with Medicare and Medicaid recipients
Prescription Drug Marketing Act of 1987 Deals with safety and competition issues raised by secondary markets for drugs, and it prohibits the reimportation of a drug into the U.S. by anyone but the manufacturer.
Orphan Drug Act of 1983 Offers federal financial incentives to commercial and nonprofit organizations to develop and market drugs previously unavailable in the U.S.
Dietary Supplement Health and Education Act of 1994 Clarified the regulatory framework applicable to nutritional supplements and created specific labeling requirements.
Health Insurance Portability and Accountability Act of 1996 A federal legislation that requires all healthcare providers, including pharmacies, to protect patient information from unauthorized use and disclosure. It is referred to as the Privacy Rule.
Combat Methamphetamine Epidemic Act of 2005 Designed to stop illegal use of drugs such as methamphetamine, crack cocaine and others. It is an extension of the Patriot Act.
Created by: lrhamyWTI



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