Implementation of the Anabolic Steroid Control Act of 2004

The purpose of this rulemaking is to conform the Drug Enforcement Administration's (DEA) regulations to the provisions of the Anabolic Steroid Control Act of 2004. Effective January 20, 2005, the Act amended the Controlled Substances Act (CSA) and replaced the existing definition of "anabolic steroid" with a new definition. This new definition altered the basis for all future administrative scheduling actions relating to the control of anabolic steroids as Schedule III controlled substances by eliminating the requirement to prove muscle growth. Additionally, the Act lists 59 specific substances as being anabolic steroids. As such, these substances and their salts, esters and ethers are Schedule III controlled substances. This rulemaking amends 21 CFR Parts 1300 and 1308 to reflect these changes. The Act also amends the CSA by revising the language requiring exclusion of certain over the counter products from regulation as controlled substances. The Act clarifies that the exclusionary language in 21 U.S.C. 811(g)(1) pertains only to non-narcotic "drugs" that may, under the Federal Food, Drug, and Cosmetic Act (FDCA), be lawfully sold over the counter without a prescription. The statute is self-implementing with the changes that became effective on January 20, 2005. DEA has no authority to revise the changes and is simply modifying its regulations to conform to the statute. Consequently, public comments are not being solicited since they could not alter this rule.