The Drug Enforcement Administration (“DEA”) published a Final Rule on July 30th (77 Fed. Reg. 44,456 (July 30, 2012) placing prostanozol and methasterone into Schedule III of the federal Controlled Substances Act (“CSA”) as anabolic steroids. DEA’s administrative scheduling of prostanozol and methasterone, along with their salts, esters and ethers, becomes effective August 29, 2012.
According to the CSA, DEA schedules drugs according to statutory procedures set forth in 21 U.S.C. § 811, which mandates a detailed, eight factor scheduling analysis set forth in 21 U.S.C. § 811(b). In the case of anabolic steroids, however, the DEA uses another, simpler process drawn from the Anabolic Steroid Control Act of 1990. The 1990 act establishes and regulates anabolic steroids as Schedule III controlled substances. It also provides that any “new” anabolic steroids are not scheduled according to the multi-step procedures set forth in 21 U.S.C. § 811. Instead, new anabolic steroids are classified through the administrative rulemaking process if the product meets the “regulatory definition of an anabolic steroid” set forth in 21 C.F.R. § 1300.01. Congress defined “anabolic steroid” in the Anabolic Steroid Control Act of 2004, which classifies a drug or a hormonal substance as an anabolic steroid if that substance meets four criteria: (A) The substance is chemically related to testosterone; (B) the substance is pharmacologically related to testosterone; (C) the substance is not an estrogen, progestin, or corticosteroid; and, (D) the substance is not dehydroepiandrosterone ("DHEA"). Any substance that meets the foregoing criteria “is considered an anabolic steroid and must be listed as a Schedule III controlled substance.”
DEA concluded that prostanozol and methasterone are chemically-and pharmacologically-related to testosterone; are not an estrogen, progestin or a corticosteroid; and are not DHEA. Because DEA determined that prostanozol and methasterone met the criteria for anabolic steroids under 21 U.S.C. § 802(41)(A), DEA had no discretion other than to place the substances in Schedule III of the CSA.
DEA stated that the U.S. Food and Drug Administration (“FDA”) issued a Warning Letter in response to adverse health effects associated with methasterone in March 2006. DEA further noted that FDA later issued a warning in July 2009 concerning bodybuilding products containing steroid or steroid-like substances including a product containing the THP ether derivative of prostanozol. DEA also stated that there are no approved medical uses at present for the two substances, and no one can dispense them pursuant to a prescription until such time as a manufacturer applies to FDA and obtains appropriate approvals for products containing such substances. DEA published its Notice of Proposed Rulemaking for classification of these anabolic steroids on November 23, 2011 (76 Fed. Reg. 72355 (Nov. 23, 2011).
DEA’s placement of prostanozol and methasterone in Schedule III subjects manufacturers, distributors, dispensers such as pharmacies and physicians, importers, exporters, and anyone in possession to the applicable provisions of the CSA and its implementing regulations, including administrative, civil and criminal sanctions. DEA registration, recordkeeping and reporting, labeling and packaging, importation and exportation, security and disposal requirements for handlers of prostanozol and methasterone take effect on August 29, 2012.
The scheduling of prostanozol and methasterone is the second major action involving the federal control of anabolic steroids in less than a week. On July 25, 2012, the Designer Anabolic Steroid Control Act of 2012 (S. 3431) was introduced in the Senate and reported here on July 26, 2012. The Act would significantly increase DEA control over anabolic steroids as well as expressly adding twenty-seven additional anabolic steroids to schedule III.