© 2006 McGraw-Hill Higher Education. All rights reserved. Chapter 3 Drug Products and Their Regulation

© 2006 McGraw-Hill Higher Education. All rights reserved. Reformism  Race and fear used  Laws came to regulate moral behavior

© 2006 McGraw-Hill Higher Education. All rights reserved. Issues Leading To Legislation  Fraud in patent medicine  Hostetter’s Bitters 44% pure alcohol  Birney’s Catarrh Cure 4% cocaine  Opium  1890 federal act allowed only American citizens to import opium  Morphine  “Morphinism”  Cocaine  Mail order cocaine

© 2006 McGraw-Hill Higher Education. All rights reserved. Two Bureaus, Two Types Of Regulation  The Pure Food and Drug Act  Department of Agriculture  Ensures drugs were pure and honestly labeled  Harrison Act  Treasury Department  Taxing of drug for revenue

© 2006 McGraw-Hill Higher Education. All rights reserved. Regulation 1906 Pure Food And Drugs Act  Purity  The contents of the product must be correct and labeled correctly  1912 Sherley Amendment  Safety  Set up FDA as gatekeeper  Directions must be included  Effectiveness  1962 Kefauver-Harris Amendments

© 2006 McGraw-Hill Higher Education. All rights reserved. Making Of A New Drug  Preclinical research and development  Clinical research and development  Phase I  Phase II  Phase III  Permission to market

© 2006 McGraw-Hill Higher Education. All rights reserved. Making Of A New Drug Exceptions  Fast-track rule  Orphan Drug Law  Dietary Supplements

© 2006 McGraw-Hill Higher Education. All rights reserved. Controlled Substance  Early enforcement of the Harrison Act  18th Amendment  The Narcotic Division  Arresting physicians and pharmacists  Stiffer Penalties  Jones-Miller Act  Prohibited the importing of opium for heroin

© 2006 McGraw-Hill Higher Education. All rights reserved. Controlled Substance  Mandatory Minimum sentences  The Bureau of Narcotics  Drug Czar  Marijuana Tax Act  1956 Narcotic Drug Control Act

© 2006 McGraw-Hill Higher Education. All rights reserved. Drug Abuse Control Act Amendments Of 1965  Comprehensive Drug Abuse Prevention and Control Act 1970  Replaced or updated all laws  Federal vs State  Prevention and treatment  Control, not tax

© 2006 McGraw-Hill Higher Education. All rights reserved. Summary of Controlled Substance Schedules ScheduleCriteriaExamples I a. High potential for abuse b. No medical use c. Lack of accepted safety Heroin, Marijuana II a. High potential for abuse b. Current accepted medical use c. Abuse may lead to psychological or physical dependence MDMA, Morphine, Cocaine III a. Potential for abuse less then I and II b. Current accepted medical use c. Abuse may lead to physical dependence or high psychological dependence Anabolic steroids, most barbiturates IV a. Low Potential for abuse less then III b. Current accepted medical use c. Abuse may lead to limited physical or psychological dependence relative to III Vanax, barbital, Chloral hydrate, fenfluramine V a. Potential for abuse less then I and II b. Current accepted medical use c. Abuse may lead to physical dependence or high psychological dependence Mixture having small amounts of codeine or opium

© 2006 McGraw-Hill Higher Education. All rights reserved. Drug Abuse Control Act Amendments Of 1965  Possession and Selling Penalties  Omnibus Drug Act  Loss of Benefits  Drug precursors  Drug paraphernalia  Office of National Drug Control Policy

© 2006 McGraw-Hill Higher Education. All rights reserved. Americans in Prison

© 2006 McGraw-Hill Higher Education. All rights reserved. State And Local Regulations  Difference in penalties from state to state  Federal law overrides state  Federal Support for Urine Screening  Military led the way  More advanced screening  Transportation and private companies test  Schools test  Testing methods  Different test different results

© 2006 McGraw-Hill Higher Education. All rights reserved. Impact Of Drug Enforcement  People  Budget  International programs  Other costs  Effectiveness of Control