History
Regulation of therapeutic goods in the United States |
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Prescription drugs Over-the-counter drugs |
Law
Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch-Waxman exemption |
Government agencies
Department of Health and Human Services -Food and Drug Administration- Department of Justice -Drug Enforcement Administration- |
Process
Drug discovery Drug design Drug development New drug application Investigational new drug Clinical trial (Phase I, II, III, IV) Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use |
International coordination
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs |
Non-governmental organizations
Institute of Medicine Research on Adverse Drug events And Reports |
The nation first outlawed addictive drugs in the early 1900s and helped lead international agreements regulating trade.
In 1969, President Richard Nixon announced that the Attorney General, John N. Mitchell, was preparing a comprehensive new measure to more effectively meet the narcotic and dangerous drug problems at the federal level by combining all existing federal laws into a single new statute. The CSA did not merely combine existing federal drug laws but changed the nature of federal drug law and policy, expanded the scope of federal drug laws and expanded federal police power enormously.
Part F of the Comprehensive Drug Abuse Prevention and Control Act of 1970 established the National Commission on Marijuana and Drug Abuse—known as the Shafer Commission after its chairman, Raymond P. Shafer—to study marijuana abuse in the United States. During his presentation of the commission's First Report to Congress, Shafer recommended the decriminalization of marijuana in small amounts, saying,
he criminal law is too harsh a tool to apply to personal possession even in the effort to discourage use. It implies an overwhelming indictment of the behavior which we believe is not appropriate. The actual and potential harm of use of the drug is not great enough to justify intrusion by the criminal law into private behavior, a step which our society takes only with the greatest reluctance.Rufus King notes that this stratagem was similar to that used by Harry Anslinger when he consolidated the previous anti-drug treaties into the Single Convention and took the opportunity to add new provisions that otherwise might have been unpalatable to the international community. According to David T. Courtwright, "the Act was part of an omnibus reform package designed to rationalize, and in some respects to liberalize, American drug policy." (Courtwright noted that the Act became, not libertarian, but instead repressionistic to the point of tyrannical, in its intent.) It eliminated mandatory minimum sentences and provided support for drug treatment and research. King notes that the rehabilitation clauses were added as a compromise to Senator Hughes, who favored a moderate approach. The bill, as introduced by Senator Everett Dirksen, ran to 91 pages. While it was being drafted, the Uniform Controlled Substances Act, to be passed by state legislatures, was also being drafted by the Department of Justice; its wording closely mirrored the Controlled Substances Act.
Since its enactment in 1970, the Act has been amended several times:
- The Psychotropic Substances Act of 1978 added provisions implementing the Convention on Psychotropic Substances.
- The Controlled Substances Penalties Amendments Act of 1984.
- The Chemical Diversion and Trafficking Act of 1988 added provisions implementing the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.
- The Domestic Chemical Diversion and Control Act of 1993.
- The Federal Analog Act.
Read more about this topic: Controlled Substances Act
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