Drug Enforcement Administration 2005 – Federal Register Recent Federal Regulation Documents

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.

This notice establishes final 2005 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA). The DEA has taken into consideration comments received in response to a notice of the proposed revised aggregate production quotas for 2005 published August 5, 2005 (70 FR 45432).

This notice proposes initial year 2006 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).

On January 18, 2005, DEA published in the Federal Register a solicitation of comments on the subject of dispensing controlled substances for the treatment of pain. Many of the comments that the agency received indicate that there is a need to issue a clarification regarding certain aspects of the prescription requirements for schedule II controlled substances. This document provides such clarification.

DEA is amending its regulations regarding reports by registrants of theft or significant loss of controlled substances. There had been some confusion as to what constitutes a significant loss and when and how initial notice of a theft or loss should be provided to DEA. In this final rule, DEA clarifies the regulations and provides guidance to registrants regarding the theft, significant loss, and unexplained loss of controlled substances.

This notice proposes revised 2005 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).