July 26, 2012
Designer Anabolic Steroid Control Act of 2012 Introduced; Would Bulk Up Federal Anabolic Steroid Controls
By Larry K. Houck ?
Senators Orrin Hatch (R-UT) and Sheldon Whitehorse (D-RI) introduced legislation on July 25, 2012, that would amend the definition of ?anabolic steroid? under the Federal Controlled Substances Act (?CSA?) and expressly add twenty-seven additional anabolic steroids to schedule III. The proposed ?Designer Anabolic Steroid Control Act of 2012? (S. 3431) (?2012 Act?) would significantly increase Drug Enforcement Administration (?DEA?) control over drugs and substances that meet anabolic steroid criteria. If enacted, the 2012 Act would be the third major federal legislative action impacting anabolic steroids since 1990. Congress passed the Anabolic Steroid Control Acts of 1990 and 2004 that placed certain anabolic steroids into schedule III of the CSA, expanding DEA?s authority to regulate such substances.
Passage of the 2012 Act would similarly add twenty-seven anabolic steroids, their salts and esters, to schedule III of the CSA. Placement of anabolic steroids in schedule III subjects manufacturers, distributors, dispensers such as pharmacies and physicians, importers, exporters, and anyone in possession of the scheduled anabolic steroids to the applicable provisions of the CSA and its implementing regulations that establish registration, recordkeeping/reporting and security requirements as well as administrative, civil and criminal sanctions.
The 2012 Act would expand the definition of anabolic steroids to include a drug or hormonal substance (other than estrogens, progestins, corticosteroids and dehydroepiandrosterone) ?derived from, or has a chemical structure substantially similar to? anabolic steroids listed under the CSA if: the drug or substance has been created or manufactured with the intent of producing a drug or other substance that promotes muscle growth or causes a pharmacological effect similar to that of testosterone; or the drug or substance has been, or is intended to be marketed or otherwise promoted in a manner suggesting that consumption will promote muscle growth or any pharmacological effect similar to that of testosterone. The 2012 Act would exclude herbs and other botanicals, ?a concentrate, metabolite, or extract of, or a constituent isolated directly from? herbs or botanicals that are dietary ingredients for purposes of the Federal Food, Drug and Cosmetic Act.
The 2012 Act would also authorize DEA to issue a temporary order for up to two years (that could be extended six additional months) adding a drug or other substance to the list of anabolic steroids in schedule III if it finds that the drug or substance satisfies the Act?s criteria as an anabolic steroid. Adding the drug or substance to the list of anabolic steroids ?will assist in preventing the unlawful importation, manufacture, distribution, or dispensing of such drug or other substance.? The Act would also consider a drug or other substance not temporarily or permanently listed as an anabolic steroid in any criminal, civil or administrative proceeding arising under the CSA that satisfies the anabolic steroid criteria. This could occur if, for example, such product was promoted for muscle growth. The Act would also require anabolic steroids and products containing anabolic steroids to bear a label identifying such contents. Lastly, the Act would also subject violators to specific civil and/or criminal penalties including up to $500,000 per violation and imprisonment of up to ten years.
DEA Deputy Assistant Administrator Joseph Rannazzisi, stated in testimony before the Senate Judiciary Committee Subcommittee on Crime and Drugs, ?[t]he use of anabolic steroids or dietary supplements that contain anabolic steroids or designer steroids, in high doses that boost, alter or derive from testosterone may trigger numerous adverse health effects in the human body including liver toxicity, baldness, uncontrolled rage and heart attacks.?
The Council for Responsible Nutrition and American Herbal Products Association have issued statements endorsing the measure (here and here).
The 2012 Act has been referred to the Senate Committee on the Judiciary.
http://www.fdalawblog.net/fda_law_bl...roid-cont.html Compounds to be added to the banned list;
5α-Androstan-3,6,17-trione;
Androst-4-ene-3,6,17-trione;
Androsta-1,4,6-triene-3,17-dione;
6-bromo-androstan-3,17-dione;
6-bromo-androsta-1,4-diene-3,17-dione;
4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;
4-chloro-17α-methyl-androst-4-ene-3β,17β-diol;
4-chloro-17α-methyl-17β-hydroxy-androst-4-en-3-one;
4-chloro-17α-methyl-17β-hydroxy-androst-4-ene-3,11-dione;
4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;
2α,17α-dimethyl-17β-hydroxy-5α-androstan-3-one;
2α,17α-dimethyl-17β-hydroxy-5β-androstan-3-one;
2α,3α-epithio-17α-methyl-5α-androstan-17β-ol;
[3,2-c]-furazan-5α-androstan-17β-ol;
3β-hydroxy-estra-4,9,11-trien-17-one;
17α-methyl-androst-2-ene-3,17β-diol;
17α-methyl-androsta-1,4-diene-3,17β-diol;
Estra-4,9,11-triene-3,17-dione;
18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one;
6α-Methyl-androst-4-ene-3,17-dione;
17α-Methyl-androstan-3-hydroxyimine-17β-ol;
17α-Methyl-5α-androstan-17β-ol;
17β-Hydroxy-androstano[2,3-d]isoxazole;
17β-Hydroxy-androstano[3,2-c]isoxazole;
4-Hydroxy-androst-4-ene-3,17-dione
[3,2-c]pyrazole-5α-androstan-17β-ol;
[3,2-c]pyrazole-androst-4-en-17β-ol;
[3,2-c]pyrazole-5α-androstan-17β-ol;
http://www.hpm.com/pdf/blog/s3431.pdf 
