Retail Sales of Scheduled Listed Chemical Products; Self-Certification of Regulated Sellers of Scheduled Listed Chemical Products
In March 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005, which establishes new requirements for retail sales of over-the-counter (nonprescription) products containing the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The three chemicals can be used to manufacture methamphetamine illegally. DEA is promulgating this rule to incorporate the statutory provisions and make its regulations consistent with the new requirements. This action establishes daily and 30-day limits on the sales of scheduled listed chemical products to individuals and requires recordkeeping on most sales.
Issuance of Multiple Prescriptions for Schedule II Controlled Substances
DEA is hereby proposing to amend its regulations to allow practitioners to provide individual patients with multiple prescriptions, to be filled sequentially, for the same schedule II controlled substance, with such multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90- day supply of that controlled substance. DEA is requesting public comment on this proposed rule.
Dispensing Controlled Substances for the Treatment of Pain
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 DEA received asked the agency to elaborate on the legal requirements and agency policy relating to this subject. This document provides such information.
Schedules of Controlled Substances: Exempt Anabolic Steroid Products
The Drug Enforcement Administration (DEA) is designating six pharmaceutical preparations as exempt anabolic steroid products under the Controlled Substances Act. This action is part of the ongoing implementation of the Anabolic Steroids Control Act of 1990.
Schedules of Controlled Substances: Placement of Embutramide Into Schedule III
With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance embutramide, including its salts, into Schedule III of the Controlled Substances Act (CSA). As a result of this rule, the regulatory controls and criminal sanctions of Schedule III will be applicable to the manufacture, distribution, dispensing, importation and exportation of embutramide and products containing embutramide.
Controlled Substances and List I Chemical Registration and Reregistration Application Fees
This final rule establishes the fee schedule for DEA registration and reregistration 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 for the conduct of activities as mandated by 21 U.S.C. 822 and 958. Specifically, this final rule revises 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. In doing so, this rule implements clarifications to the Diversion Control Program and the Diversion Control Fee Account made by Congress in the Consolidated Appropriations Act of 2005 (Pub. L. 108-447) that amended 21 U.S.C. 886a.
Controlled Substances: Proposed Aggregate Production Quotas for 2007
This notice proposes initial year 2007 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).
Changes in the Regulation of Iodine Crystals and Chemical Mixtures Containing Over 2.2 Percent Iodine
This Notice of Proposed Rulemaking (NPRM) proposes changes in the regulation of the listed chemical iodine pursuant to the chemical regulatory provisions of the Controlled Substances Act (CSA). The Drug Enforcement Administration (DEA) believes that this action is necessary in order to remove deficiencies in the current regulatory controls, which are being exploited by drug traffickers who divert iodine (in the form of iodine crystals and iodine tincture) for the illicit production of methamphetamine in clandestine drug laboratories. This NPRM proposes (1) the movement of iodine from List II to List I; (2) a reduction in the iodine threshold from 0.4 kilograms to zero kilograms; (3) the addition of import and export regulatory controls; and (4) the control of chemical mixtures containing greater than 2.2 percent iodine. This NPRM proposes regulatory controls that will apply to iodine crystals and iodine chemical mixtures that contain greater than 2.2 percent iodine. This regulation will therefore control iodine crystals and strong iodine tinctures/solutions (e.g., 7 percent iodine) that do not have common household uses and instead have limited application in livestock, horses and for disinfection of equipment. Household products such as 2 percent iodine tincture/solution and household disinfectants containing iodine complexes will not be adversely impacted by this regulation. If finalized as proposed, persons conducting regulated transactions involving iodine would need to be registered with the DEA, would be subject to import/export notification requirements of the CSA, and would be required to maintain records of all regulated transactions involving iodine regardless of size.
Solicitation of Information on the Use of Tryptamine-Related Compounds
The DEA is soliciting information on substances that are related in chemical structure to tryptamine (see SUPPLEMENTARY INFORMATION). The Controlled Substances Act (CSA), in Title 21 of the United States Code (U.S.C. 812(c) Schedule I (Title 21 of the Code of Federal Regulations (CFR 1308.11(d)), lists certain tryptamines as Schedule I controlled substances. Some tryptamines that are not controlled under the CSA produce central nervous system effects that are similar to tryptamines that are controlled under the CSA. DEA is requesting information to help determine the impact on business if these substances were to be placed under control in the CSA.