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LEGAL ASPECTS OF PHARMACOLOGY

LEGAL ASPECTS OF PHARMACOLOGY. HISTORICAL PERSPECTIVE. First writings on drug therapy observations from the Egyptians in 1550 BC. Galen initiated use of prescriptions in Rome around 170 AD 1240 AD Arabs formated 1 st drug standards and measurements. CURRENT U.S. REGULATIONS.

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LEGAL ASPECTS OF PHARMACOLOGY

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  1. LEGAL ASPECTS OF PHARMACOLOGY

  2. HISTORICAL PERSPECTIVE • First writings on drug therapy observations from the Egyptians in 1550 BC. • Galen initiated use of prescriptions in Rome around 170 AD • 1240 AD Arabs formated 1st drug standards and measurements

  3. CURRENT U.S. REGULATIONS • U.S. Pharmacopeia National Formulary (USP-NF) • FEDERAL LEGISLATION • 1938 Food Drug and Cosmetic Act • Durham Humphrey Amendment • Kefauver-Harris Act • 1970 Comprehensive Drug Abuse Prevention and Control Act

  4. THREE CATEGORIES OF DRUGS • CONTROLLED SUBSTANCES • NARCOTICS AND SEDATIVES • PRESCRIPTION OR LEGEND DRUGS • ANTIBIOTICS AND OTHER MEDICATIONS • OVER THE COUNTER DRUGS • MAY BE PURCHASED WITHOUT A PRESCRIPTION

  5. CONTROLLED SUBSTANCES ACT • I – High risk for abuse: no medical use • II – High risk for abuse; may lead to dependence. Some medical use • III – High but less than I or II; moderate physical dependence but high psychological dependence • IV – Low compared to III; Limited dependence • V – Low compared to IV; Limited dependence

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