Source: http://wiki-offline.jakearchibald.com/wiki/Controlled_Substances_Act
Timestamp: 2019-04-19 03:07:44+00:00

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The Drug Enforcement Administration was established in 1973, combining the Bureau of Narcotics and Dangerous Drugs (BNDD) and Customs' drug agents. Proceedings to add, delete, or change the schedule of a drug or other substance may be initiated by the DEA, the Department of Health and Human Services (HHS), or by petition from any interested party, including the manufacturer of a drug, a medical society or association, a pharmacy association, a public interest group concerned with drug abuse, a state or local government agency, or an individual citizen. When a petition is received by the DEA, the agency begins its own investigation of the drug.
The HHS recommendation on scheduling is binding to the extent that if HHS recommends, based on its medical and scientific evaluation, that the substance not be controlled, then the DEA may not control the substance. Once the DEA has received the scientific and medical evaluation from HHS, the DEA Administrator evaluates all available data and makes a final decision whether to propose that a drug or other substance be controlled and into which schedule it should be placed. Under certain circumstances, the Government may temporarily schedule a drug without following the normal procedure. An example is when international treaties require control of a substance. In addition, 21 U.S.C. § 811(h) allows the Attorney General to temporarily place a substance in Schedule I "to avoid an imminent hazard to the public safety". Thirty days' notice is required before the order can be issued, and the scheduling expires after a year; however, the period may be extended six months if rulemaking proceedings to permanently schedule the drug are in progress. In any case, once these proceedings are complete, the temporary order is automatically vacated. Unlike ordinary scheduling proceedings, such temporary orders are not subject to judicial review.
The Congressional findings in 21 USC §§ 801(7), 801a(2), and 801a(3) state that a major purpose of the CSA is to "enable the United States to meet all of its obligations" under international treaties. The CSA bears many resemblances to these Conventions. Both the CSA and the treaties set out a system for classifying controlled substances in several schedules in accordance with the binding scientific and medical findings of a public health authority. Under 21 U.S.C. § 811 of the CSA, that authority is the Secretary of Health and Human Services (HHS). Under Article 3 of the Single Convention and Article 2 of the Convention on Psychotropic Substances, the World Health Organization is that authority.
According to the Cato Institute, these treaties only bind (legally obligate) the United States to comply with them as long as that nation agrees to remain a state party to these treaties. The U.S. Congress and the President of the United States have the absolute sovereign right to withdraw from or abrogate at any time these two instruments, in accordance with said nation's Constitution, at which point these treaties will cease to bind that nation in any way, shape, or form.
A provision for automatic compliance with treaty obligations is found at 21 U.S.C. § 811(d), which also establishes mechanisms for amending international drug control regulations to correspond with HHS findings on scientific and medical issues. If control of a substance is mandated by the Single Convention, the Attorney General is required to "issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations," without regard to the normal scheduling procedure or the findings of the HHS Secretary. However, the Secretary has great influence over any drug scheduling proposal under the Single Convention, because 21 U.S.C. § 811(d)(2)(B) requires the Secretary the power to "evaluate the proposal and furnish a recommendation to the Secretary of State which shall be binding on the representative of the United States in discussions and negotiations relating to the proposal."
Placing a drug or other substance in a certain schedule or removing it from a certain schedule is primarily based on 21 USC §§ 801, 801a, 802, 811, 812, 813, and 814. Every schedule otherwise requires finding and specifying the "potential for abuse" before a substance can be placed in that schedule. The specific classification of any given drug or other substance is usually a source of controversy, as is the purpose and effectiveness of the entire regulatory scheme.
Except when dispensed directly to an ultimate user by a practitioner other than a pharmacist, no controlled substance in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.), may be dispensed without the written prescription of a practitioner, except that in emergency situations, as prescribed by the Secretary by regulation after consultation with the Attorney General, such drug may be dispensed upon oral prescription in accordance with section 503(b) of that Act (21 USC 353 (b)). With exceptions, an original prescription is always required even though faxing in a prescription in advance to a pharmacy by a prescriber is allowed. Prescriptions shall be retained in conformity with the requirements of section 827 of this title. No prescription for a controlled substance in Schedule II may be refilled. Notably no emergency situation provisions exist outside the Controlled Substances Act's "closed system" although this closed system may be unavailable or nonfunctioning in the event of accidents in remote areas or disasters such as hurricanes and earthquakes. Acts which would widely be considered morally imperative remain offenses subject to heavy penalties.
In addition to the CSA, due to pseudoephedrine (PSE) and ephedrine being widely used in the manufacture of methamphetamine, the U.S. Congress passed the Methamphetamine Precursor Control Act which places restrictions on the sale of any medicine containing pseudoephedrine. That bill was then superseded by the Combat Methamphetamine Epidemic Act of 2005, which was passed as an amendment to the Patriot Act renewal and included wider and more comprehensive restrictions on the sale of PSE-containing products. This law requires customer signature of a "log-book" and presentation of valid photo ID in order to purchase PSE-containing products from all retailers.
There has been criticism against the schedule classifications of the listed drugs and substances in the CSA, citing undefined terms. Some criticism has arisen due to research that has found several substances on the list of Schedule I substances to have actual accepted medical uses and low abuse potential, despite the requirement for a Schedule I listing mandating that any substance so scheduled have both a high potential for abuse and no accepted medical use. One such example is the legalization of marijuana in some capacity in over 29 states.
^ a b Government Regulations Docket ID: DEA-2009-0013 in BASIS FOR THE RECOMMENDATION TO CONTROL 5-METHOXY-DIMETHYLTRYPTAMINE (5-MeO-DMT) IN SCHEDULE I OF THE CONTROLLED SUBSTANCES ACT The term "abuse" is not defined in the CSA.
^ "Illegal Drugs in America: A Modern History". DEA Museum & Visitors Center. Archived from the original on 4 December 2004.
^ "The 1912 Hague International Opium Convention". Public Policy Options. Canadian Senate Special Committee on Illegal Drugs. 3. Schaffer Library of Drug Policy.
^ Musto, David F. "History of Legislative Control Over Opium, Cocaine, and Their Derivatives". Schaffer Library of Drug Policy.
^ "Legislation". U.S. Food and Drug Administration. 2 July 2015.
^ "Medical Device Amendments". Rx-wiki. Parsons Printing Press. Retrieved 2012-12-30.
^ "50 Years: The Kefauver-Harris Amendment". FDA. Retrieved 7 July 2016.
^ "NORML - Working to Reform Marijuana Laws". norml.org. Retrieved 2018-05-15.
^ a b King, Rufus. "The 1970 Act: Don't Sit There, Amend Something". The Drug Hang Up, America's Fifty-Year Folly. Schaffer Library of Drug Policy.
^ Courtwright, David T. (5 October 2004). "The Controlled Substances Act: how a "big tent" reform became a punitive drug law". Drug and Alcohol Dependence. 76 (1): 9–15. doi:10.1016/j.drugalcdep.2004.04.012. PMID 15380284.
^ "S.510 - An Act to amend the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and for other purposes". Congress.Gov. Library of Congress. Retrieved 31 August 2016.
^ "S.2399 - Psychotropic Substances Act". Congress.Gov. Library of Congress. Retrieved 31 August 2016.
^ "S.3397 - 111th Congress (2009-2010): Secure and Responsible Drug Disposal Act of 2010". Congress.Gov. Library of Congress. Retrieved 26 March 2019.
^ "Title 21 United States Code (USC) Controlled Substances Act". Drug Enforcement Administration: Office of Diversion Control. United States Department of Justice.
^ "State and Local Task Forces". Drug Enforcement Administration. United States Department of Justice. Retrieved 2012-12-30.
^ "Final Order: Temporary Placement of Five Synthetic Cannabinoids Into Schedule I". Drug Enforcement Administration: Office of Diversion Control. United States Department of Justice. Retrieved 2012-12-30.
^ Abood, Richard R. (21 November 2012). "The Closed System of Controlled Substance Distribution". Pharmacy Practice and the Law. Jones & Bartlett. p. 184. ISBN 978-1-4496-8691-8. Retrieved 2012-12-30.
^ a b "The War on Drugs" (PDF). Cato Handbook for Congress: Policy Recommendations for the 108th Congress. Cato Institute. 2003. pp. 171–178. Retrieved 2012-10-20.
^ "21 U.S. Code Chapter 13 - Drug Abuse Prevention and Control". LII / Legal Information Institute.
^ "21 U.S. Code § 802 - Definitions". LII / Legal Information Institute.
^ "Appendix C: Measurement of Dependence, Abuse, Treatment, and Treatment Need – 2000 NHSDA – Substance Dependence, Abuse, and Treatment". National Household Survey on Drug Abuse. SAMHSA, Office of Applied Studies. 2000. Archived from the original on 2013-02-21.
^ a b Marshall, Donnie (20 March 2001). "Notice of denial of petition to reschedule marijuana". Federal Register. Drug Enforcement Administration. 66 (75): 20038–20076. Retrieved 13 June 2013.
^ Gee, Paul; Gilbert, Mark; Richardson, Sandra; Moore, Grant; Paterson, Sharon; Graham, Patrick (2008). "Toxicity from the Recreational Use of 1-benzylpiperazine". Clinical Toxicology. 46 (9): 802–07. doi:10.1080/15563650802307602. PMID 18821145.
^ Brennan, K.; Johnstone, A.; Fitzmaurice, P.; Lea, R.; Schenk, S. (2007). "Chronic Benzylpiperazine (BZP) Exposure Produces Behavioral Sensitization and Cross-sensitization to Methamphetamine (MA)". Drug and Alcohol Dependence. 88 (2–3): 204–13. doi:10.1016/j.drugalcdep.2006.10.016. PMID 17125936.
^ Tunnicliff, G. (1997). "Sites of action of gamma hydroxybutyrate (GHB)--A neuroactive drug with abuse potential". Clinical Toxicology. 35 (6): 581–590. doi:10.3109/15563659709001236.
^ Okun, M. S.; Boothy, L. A.; Bartfield, R. B.; Doering, P. L. (2001). "GHB: An important pharmacologic and clinical update". Journal of Pharmacy and Pharmacological Science. 4 (=2): 167–175.
^ a b c "21 U.S. Code § 829 - Prescriptions". LII / Legal Information Institute.
^ "21 U.S. Code Part D - Offenses and Penalties". LII / Legal Information Institute.
^ "Issuance of Multiple Prescriptions for Schedule II Controlled Substances". U.S. DEA, U.S. DOJ. November 2007. Retrieved 3 September 2014.
^ Halpern, J.H. (2004). "Hallucinogens and dissociative agents naturally growing in the United States". Pharmacology & Therapeutics. 102 (2): 131–138. doi:10.1016/j.pharmthera.2004.03.003. PMID 15163594.
^ Mitchell, Thomas (28 September 2018). "Why This Colorado Law Firm Is Upset Over DEA's Rescheduling of CBD Medication". Westword.
^ "Federal Pseudoephedrine Law" (PDF). doh.state.fl.us. Florida Department of Health, Division of Medical Quality Assurance. October 5, 2006. Archived from the original (PDF) on July 30, 2012. Retrieved 2012-10-20.
^ "Drug Scheduling". Drug Enforcement Administration, United States Department of Justice.
^ Nutt, David J.; King, Leslie A.; Phillips, Lawrence D.; Independent Scientific Committee on Drugs (6 November 2010). "Drug harms in the UK: A multicriteria decision analysis". The Lancet. 376 (9752): 1558–1565. CiteSeerX 10.1.1.690.1283. doi:10.1016/S0140-6736(10)61462-6. PMID 21036393.
^ "DrugFacts: Is Marijuana Medicine?". National Institute on Drug Abuse. National Institutes of Health; U.S. Department of Health and Human Services. July 2015.
^ "State Marijuana Laws in 2018 Map". www.governing.com.

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