Regulatory Focus™ > News Articles > Legislators, Regulators to Enhance Regulation of Anabolic Steroids

Legislators, Regulators to Enhance Regulation of Anabolic Steroids

Posted 01 August 2012 | By

Legislators and regulatory officials at the Drug Enforcement Administration (DEA) are both proposing to subject anabolic steroids to more stringent controls under the Controlled Substances Act (CSA), according to documents filed in the Federal Register and at the Government Printing Office.

DEA on 30 July released a final regulation classifying two additional anabolic steroids as Schedule II drugs under the CSA: prostanozol and methasterone. Under the definition of schedule III, the drugs are defined as having some potential for abuse leading to a chance of physical or mental dependence despite its accepted medical uses.

The agency started rulemaking proceedings in November 2011 against the two drugs, calling them both chemically and pharmacologically similar to anabolic steroids and being characterized by the same potential side effects as their chemical cousins.

"After evaluation of the statutory factors above and consideration of the comments to the NPRM, DEA concludes that prostanozol and methasterone meet the CSA definition of ``anabolic," DEA explained in its Federal Register posting. "Once a substance is determined to be an anabolic steroid, DEA has no discretion regarding the placement of these substances into Schedule III of the CSA."

Under the new determination, manufacturers will be required to register with and gain approval from DEA before manufacturing or marketing anabolic steroid products containing prostanozol or methasterone.

Legislation Looks to Broaden Scope of Steroid Regulation

DEA isn't the only government entity looking to cut down on the sale of unapproved anabolic steroid products. Legislators, too, have introduced a proposed bill aimed at expediting the process by which the government can go after marketers of the drugs.

The legislation, The Designed Anabolic Steroid Control Act of 2012, was introduced by Sens. Sheldon Whitehouse (D-RI) and Orrin Hatch (R-UT) on 25 July 2012. The bill adds 27 steroids to the CSA's list of "anabolic steroids"-defined as "any drug or hormonal substance, chemically and pharmacologically related to restosterone (other than estrogens, progestins, corticosteroids and dehydroepiandrosterone)"-and seeks to give regulators more leeway under the act by creating a broader, self-updating category of drugs under the Act.

Under the new definition, any chemical "derived from" or having a "chemical structure substantially similar to one or more anabolic steroids listed" under the act "shall be considered to be an anabolic steroid for purposes of this Act." The products will only be regulated as such if they promote muscle growth or cause a "pharmacological effect similar to that of testosterone." Herb-based and botanical-based products will also be exempt from the legislation.

The attorney general would also be allowed to add additional drug products to the list of anabolic steroids if one is found to exist that is not yet regulated yet is being unlawfully imported, manufactured or distributed. This would only be done on a temporary basis until a more permanent regulation could be established, presumably by DEA.

Those found to be marketing unapproved and unlabeled anabolic steroid products will be subject to criminal penalties of up to 10 years in prison and $500,000 in fines, with companies being subject to fines of up to $2.5 million. Additional fines of $25,000 per instance would be assessed for retailers who offer to sell the products.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.