This is a story that will leave many of you without words. Soma has changed from Muscle Relaxers Over the Counter to controlled medication.

[box type=”bio”] by Larry K. Houck

Mr. Houck’s practice area encompasses controlled substances and regulated chemicals as well as state licensing/registration compliance issues. Mr. Houck worked in the Drug Enforcement Administration’s Office of Diversion Control for 15 years prior to joining the firm in 2001. As staff coordinator with the DEA Office of Diversion Control’s Liaison and Policy Section, Mr. Houck counseled DEA and other government officials, and pharmaceutical industry and healthcare professionals, about the federal Controlled Substances Act and DEA regulations, policies and practices, in addition to other federal and state criminal and civil statutes and regulations that pertain to controlled substances and regulated chemicals. As a diversion investigator in DEA’s Washington, D.C., and Portland, Oregon, field offices, Mr. Houck conducted a full-range of regulatory and criminal investigations and inspections of controlled substance and chemical registrants. He earned his Juries Doctorate degree from the Northwestern School of Law of Lewis and Clark College in 1995, and is admitted to practice law in Oregon and the District of Columbia. He received his Bachelor and Master of Arts degrees from George Mason University in 1980 and 1983, respectively.[/box]

The Drug Enforcement Administration (“DEA”) published its long awaited final rule in the Federal Register today (76 Fed. Reg. 77,330 (Dec. 12, 2011)) placing carisoprodol into schedule IV of the federal Controlled Substances Act (“CSA”).  Federal scheduling of carisoprodol follows control of the drug by eighteen states around the country.  Effective January 12, 2012, DEA’s placement pertains to carisoprodol (widely distributed under the trade name of Soma®), and its salts, isomers and salts of isomers.

DEA’s placement of carisoprodol in schedule IV subjects manufacturers, distributors, dispensers such as pharmacies and physicians, importers, exporters, and anyone in possession of the drug to the applicable provisions of the CSA and its implementing regulations, including administrative, civil and criminal sanctions.

Soma has changed from Muscle Relaxers Over the Counter to controlled medication

DEA’s final rule establishes the following timetable:

a.  Manufacturers, distributors, dispensers, importers, exporters, researchers, and persons conducting instructional and chemical analysis must submit an application for registration to DEA by January 11, 2012.  Entities currently conducting these activities may continue until DEA has approved or denied their application for registration;

b.  Entities electing not to obtain a DEA registration, or who cannot obtain a registration, must surrender all stocks of carisoprodol pursuant to 21 C.F.R. § 1307.21 on or before January 11, 2012.  Entities may, in the alternative, transfer all carisoprodol to a DEA resistant who is authorized to possess schedule IV controlled substances on or before January 11, 2012;

c.  Carisoprodol will generally be subject to the security requirements applicable to schedule IV controlled substances as of January 11, 2012.  However, certain storage, manufacturing and freight forwarding security requirements under 21 C.F.R. §§ 1301.72(b) and (c), 1301.73 and 1301.77 are not applicable until April 10, 2012;

d.  Commercial containers of carisoprodol packaged on or after April 10, 2012 must be labeled as “C-IV” and packaged in accordance with 21 C.F.R. §§ 1302.03-.07.  Registrants may distribute commercial containers packaged before April 10, 2012 that do not comply with 21 C.F.R. §§ 1302.03-.07 until June 11, 2012.  All commercial containers of carisoprodol must be labeled as “C-IV” and comply with 21 C.F.R. §§ 1302.03-.07 on or after June 11, 2012;

e.  Registrants who possess any quantity of carisoprodol must take an initial inventory of all stocks on-hand on or before January 11, 2012 and then include carisoprodol in its biennial inventory thereafter;

f.  Registrants who possess any quantity of carisoprodol must maintain all records required for schedule IV controlled substances after January 11, 2012;

g.  All prescriptions for carisoprodol or prescriptions containing carisoprodol must comply with DEA’s controlled substance prescription requirements after January 11, 2012;

h.  Carisoprodol is subject to importation and exportation requirements after January 11, 2012; and

i.  Any activity with carisoprodol that is not authorized by, or that is conducted in violation of, the CSA on or after January 12, 2012, is unlawful.

Article Source from www.fdalawblog.net

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