Editing Controlled Substances Act (section)

==Enforcement authority==
[[File:FDA and the International Mail Facilities (IMFs) (27057043228).jpg|thumb|U.S. Food and Drug Administration agents inspect packages for illegal drug shipments at an international mail facility in New York.]]
The [[Drug Enforcement Administration]] was established in 1973, combining the Bureau of Narcotics and Dangerous Drugs (BNDD) and Customs' drug agents.<ref>{{cite web |title=State and Local Task Forces |website=Drug Enforcement Administration |publisher=United States Department of Justice |url=https://www.justice.gov/dea/ops/taskforces.shtml |access-date=December 30, 2012 |archive-date=November 4, 2014 |archive-url=https://web.archive.org/web/20141104002834/http://www.justice.gov/dea/ops/taskforces.shtml |url-status=dead}}</ref> 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 DEA may begin an investigation of a drug at any time based upon information received from laboratories, state and local law enforcement and regulatory agencies, or other sources of information. Once the DEA has collected the necessary data, the Deputy Administrator of DEA,<ref>{{cite journal |title=Schedules of Controlled Substances: Placement of 5-Methoxy-N,N-Dimethyltryptamine Into Schedule I of the Controlled Substances Act |author=Drug Enforcement Administration |journal=[[Federal Register]] |date=August 21, 2009 |volume=74 |issue=161 |pages=42217–42220 |quote=Under the authority vested in the [[United States Attorney General|Attorney General]] by section 201(a) of the CSA (21 USC 811(a)), and delegated to the Administrator of DEA by Department of Justice regulations (28 CFR 0.100), and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104...}} {{Federal Register|74|42217}}</ref>{{rp|42220}} requests from HHS a scientific and medical evaluation and recommendation as to whether the drug or other substance should be controlled or removed from control.

This request is sent to the Assistant Secretary of Health of HHS. Then, HHS solicits information from the Commissioner of the [[Food and Drug Administration]] and evaluations and recommendations from the [[National Institute on Drug Abuse]] and, on occasion, from the scientific and medical community at large. The Assistant Secretary, by authority of the Secretary, compiles the information and transmits back to the DEA a medical and scientific evaluation regarding the drug or other substance, a recommendation as to whether the drug should be controlled, and in what schedule it should be placed.

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<ref>{{cite web |title=Final Order: Temporary Placement of Five Synthetic Cannabinoids Into Schedule I |website=Drug Enforcement Administration: Office of Diversion Control |publisher=United States Department of Justice |url=http://www.deadiversion.usdoj.gov/fed_regs/rules/2011/fr0301.htm |access-date=December 30, 2012 |archive-date=April 9, 2016 |archive-url=https://web.archive.org/web/20160409154145/http://www.deadiversion.usdoj.gov/fed_regs/rules/2011/fr0301.htm |url-status=dead}}</ref> a drug without following the normal procedure.

An example is when international treaties require control of a substance. {{uscsub|21|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. 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 CSA creates a closed system of distribution<ref>{{cite book |chapter=The Closed System of Controlled Substance Distribution |title=Pharmacy Practice and the Law |page=184 |first=Richard R. |last=Abood |date=November 21, 2012 |publisher=Jones & Bartlett |isbn=978-1-4496-8691-8 |chapter-url=https://books.google.com/books?id=c9gp80lkqXMC&pg=PA184 |access-date=December 30, 2012 }}</ref> for those authorized to handle controlled substances. The cornerstone of this system is the registration of all those authorized by the DEA to handle controlled substances. All individuals and firms that are registered are required to maintain complete and accurate inventories and records of all transactions involving controlled substances, as well as security for the storage of controlled substances.