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.
Controlled Substances: Established Initial Aggregate Production Quotas for 2006
This notice establishes initial 2006 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).
Controlled Substances and List I Chemical Registration and Reregistration Application Fees
DEA is proposing to adjust the fee schedule for DEA registration and reregistration application fees relating to the registration and control of the manufacture, distribution and dispensing of controlled substances and listed chemicals to appropriately reflect all costs associated with its Diversion Control Program as mandated by 21 U.S.C. 822. Specifically, DEA proposes to revise the fee schedule for controlled substances and List I chemical handlers so that all manufacturers, distributors, importers, exporters, and dispensers of controlled substances and of List I chemicals pay an annual fee, by registrant category, irrespective of whether they handle controlled substances or List I chemicals. This action responds to recent amendments to the Diversion Control Fee Account provisions in the Controlled Substances Act (CSA) and will bring DEA's fee collections into line with the new requirements.
Controlled Substances: Final Revised Aggregate Production Quotas for 2005
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).
Controlled Substances: Proposed Aggregate Production Quotas for 2006
This notice proposes initial year 2006 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).
Schedules of Controlled Substances: Placement of Embutramide Into Schedule III; Extension of Comment Period
The Drug Enforcement Administration (DEA) is extending the comment period and time to request a hearing on the Federal Register Notice of proposed rulemaking entitled ``Schedules of Controlled Substances: Placement of Embutramide into Schedule III'' published on July 29, 2005 (70 FR 43809).
Clarification of Existing Requirements Under the Controlled Substances Act for Prescribing Schedule II Controlled Substances
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.
Reports by Registrants of Theft or Significant Loss of Controlled Substances
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.
Controlled Substances: Proposed Revised Aggregate Production Quotas for 2005
This notice proposes revised 2005 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).
Schedules of Controlled Substances: Placement of Embutramide Into Schedule III
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance embutramide, including its salts, into Schedule III of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Acting Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and on an evaluation of the relevant data by DEA. If finalized, this action will impose the regulatory controls and criminal sanctions applicable to Schedule III on those who handle embutramide and products containing embutramide.