Inmate fees for health care services. Final rule

The Bureau of Prisons (Bureau) finalizes rules describing procedures we will follow for charging inmates fees for certain kinds of health services, as required under the Federal Prisoner Health Care Copayment Act of 2000 (Pub. L. 106-294, October 12, 2000, 114 Stat 1038, codified at 18 U.S.C. 4048).     

Control of a chemical precursor used in the illicit manufacture of fentanyl as a List I chemical. Final rule

The Drug Enforcement Administration (DEA) is finalizing the Interim Rule with Request for Comment published in the Federal Register on April 23, 2007. The Interim Rule controlled the chemical N-phenethyl-4- piperidone (NPP) as a List I chemical under the Controlled Substances Act. Clandestine laboratories are using this chemical to illicitly manufacture the schedule II controlled substance fentanyl. No comments to the Interim Rule were received. This Final Rule finalizes the regulations without change.     

Exemption of chemical mixtures. Final rule

On December 15, 2004, the Drug Enforcement Administration (DEA) published a Final Rule corrected January 4, 2005) that implemented new regulations concerning chemical mixtures that contain any of the 27 listed chemicals. The Final Rule added a new provision not previously raised by DEA in any proposed rulemaking. This newly introduced provision exempted domestic and import transactions in chemical mixtures that are regulated solely due to the presence of the List II solvent chemicals acetone, ethyl ether, 2-butanone, or toluene from the Controlled Substances Act (CSA) recordkeeping and reporting requirements. Because this exemption was not previously proposed in any rulemaking, DEA implemented this exemption on an interim basis and requested public comment on this exemption provision. Based upon a review of all comments, DEA is finalizing this exemption. As such, domestic and import transactions in chemical mixtures containing the List II chemicals acetone, ethyl ether, 2-butanone, and toluene shall be exempt from CSA chemical recordkeeping and reporting requirements.     

Clarification of registration requirements for individual practitioners. Final rule

The Drug Enforcement Administration (DEA) is amending its registration regulations to make it clear that when an individual practitioner practices in more than one State, he or she must obtain a separate DEA registration for each State. This amendment will make it easier for practitioners to understand the requirements of the Controlled Substances Act and its implementing regulations.     

Schedules of controlled substances: placement of 5-methoxy-N,N-dimethyltryptamine into Schedule I of the Controlled Substances Act. Final rule

With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), including its salts, isomers and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act (CSA). This action by the DEA Deputy Administrator is based on a scheduling recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and a DEA review indicating that 5-MeO-DMT meets the criteria for placement in schedule I of the CSA. This final rule will impose the criminal sanctions and regulatory controls of schedule I substances under the CSA on the manufacture, distribution, dispensing, importation, exportation, and possession of 5-MeO-DMT.     

Registration and reregistration application fees. Confirmation of final rule,remanded for further notice and comment,and response to comments

DEA is publishing a final rule regarding the registration and reregistration fees charged to controlled substances registrants. DEA is required to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances. To address this mandate, on March 22, 1993 DEA published a final rule in the Federal Register, establishing registration fees for controlled substances registrants (58 FR 15272). Following publication of the final rule, the American Medical Association (AMA) and others filed a complaint in the United States District Court for the District of Columbia objecting to the new fees. The district court issued its final order granting the government's motion for summary judgment and disposing of all claims. The AMA appealed. The United States Court of Appeals for the District of Columbia Circuit found DEA's rulemaking to be inadequate. The appeals court remanded, without vacating, the rule to DEA, requiring the agency to provide an opportunity for meaningful notice and comment on the fee-funded components of the Diversion Control Program. DEA responded to the remand requirement through a document published in the Federal Register on December 30, 1996 (61 FR 68624). This Final Rule supplements the December 30, 1996 Federal Register document and with that document, constitutes the final rule on the Drug Diversion Control Fee Account.     

Schedules of controlled substances: placement of alpha-methyltryptamine and 5-methoxy-N,N-diisopropyltryptamine into schedule I of the Controlled Substances Act. Final rule

This final rulemaking is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place alpha-methyltryptamine (AMT) and 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT) into Schedule I of the Controlled Substances Act (CSA). This action by the DEA Deputy Administrator is based on a scheduling recommendation by the Department of Health and Human Services (DHHS) and a DEA review indicating that AMT and 5-MeO-DIPT meet the criteria for placement in Schedule I of the CSA. This final rule will continue to impose the regulatory controls and criminal sanctions of Schedule I substances on the manufacture, distribution, and possession of AMT and 5-MeO-DIPT.     

Exemption of chemical mixtures containing the List I chemicals ephedrine,N-methylephedrine,N-methylpseudoephedrine,norpseudoephedrine, phenylpropanolamine,and pseudoephedrine. Final rule

On September 16, 1998, the Drug Enforcement Administration (DEA) published a Notice of Proposed Rulemaking (NPRM) to implement provisions of the Controlled Substances Act (CSA) pertaining to the regulation of chemical mixtures which contain any of 34 listed chemicals. The NPRM was published to implement CSA requirements that only those chemical mixtures identified by regulation be exempt from applicable regulatory controls. The NPRM proposed criteria for the determination of whether a chemical mixture shall qualify for automatic exemption from CSA regulatory controls. Additionally, the NPRM defined an application process by which manufacturers may apply for an exemption for chemical mixtures that do not qualify for automatic exemption. Due to concerns regarding the potential illicit use of chemical mixtures which contain ephedrine, N-methylephedrine, N- methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and/or pseudoephedrine (as precursor material for the production of methamphetamine and related amphetamines), DEA is hereby finalizing the portion of the NPRM pertaining to these six chemicals. Final regulations for all remaining listed chemicals will be published under separate rulemaking, upon completion of a thorough review of applicable comments.     

Schedules of controlled substances; exempt anabolic steroid products. Final rule

The Drug Enforcement Administration (DEA) is finalizing an Interim Rule 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.     

Hazardous materials: revision to standards for infectious substances. Final rule

RSPA is revising transportation requirements for infectious substances, including regulated medical waste, to: adopt defining criteria and packaging requirements consistent with international standards; revise the current broad exceptions for diagnostic specimens and biological products; and authorize bulk packaging options for regulated medical waste consistent with requirements in international standards and DOT exemptions. These revisions will assure an acceptable level of safety for the transportation of infectious substances, and facilitate domestic and international transportation.     

Use of ozone-depleting substances; removal of essential-use designations. Final rule

The Food and Drug Administration (FDA) is amending its regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential-use designations for albuterol used in oral pressurized metered-dose inhalers (MDIs). Under the Clean Air Act, FDA, in consultation with the Environmental Protection Agency (EPA), is required to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. Two albuterol MDIs that do not use an ODS have been marketed for more than 3 years. FDA has determined that the two non-ODS MDIs will be satisfactory alternatives to albuterol MDIs containing ODSs and is removing the essential-use designation for albuterol MDIs as of December 31, 2008. Albuterol MDIs containing an ODS cannot be marketed after this date.     

Schedules of controlled substances; placement of 2,5-dimethoxy-4-(n)-propylthiophenethylamine and N-benzylpiperazine into Schedule I of the Controlled Substances Act. Final rule

This final rulemaking is issued by the Acting Deputy Administrator of the Drug Enforcement Administration (DEA) to place 2,5-dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) and N-benzylpiperazine (BZP) into Schedule I of the Controlled Substances Act (CSA). This action by the DEA Acting Deputy Administrator is based on a scheduling recommendation by the Department of Health and Human Services (DHHS) and a DEA review indicating that 2C-T-7 and BZP meet the criteria for placement in Schedule I of the CSA. This final rule will continue to impose the regulatory controls and criminal sanctions of Schedule I substances on the manufacture, distribution, and possession of 2C-T-7 and BZP.     

Placement of gamma-butyrolactone in List I of the Controlled Substances Act (21 U.S.C. 802(34)). Drug Enforcement Administration, Justice. Final rule

Public Law 106-172, signed into law on February 18, 2000, and known as the "Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 1999," amends section 102(34) of the Controlled Substances Act as amended (CSA) by designating gamma-butyrolactone (GBL), the precursor to gamma-hydroxybutyric acid (GHB), as a List I chemical. Reflecting this change in stature, the Drug Enforcement Administration (DEA) is amending its regulation to reflect the status of GBL as a List I chemical subject to the requirements of the CSA and its regulations. Establishment of a threshold for GBL will be the subject of a separate rulemaking. Therefore, unless and until a threshold is established, any distribution of GBL is a regulated transaction as described by 21 CFR 1300.02(b)(28). All handlers of GBL must comply with the CSA regulatory requirements pertaining to List I chemicals as described in the body of this document.     

Schedules of controlled substances: temporary placement of alpha-methyltryptamine and 5-methoxy-N,N-diisopropyltryptamine into Schedule I. Final rule

The Deputy Administrator of the Drug Enforcement Administration (DEA) is issuing this final rule to temporarily place alpha-methyltryptamine (AMT) and 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT) into Schedule I of the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions of the CSA. This final action is based on a finding by the DEA Deputy Administrator that the placement of AMT and 5-MeO-DIPT into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. As a result of this rule, the criminal sanctions and regulatory controls of Schedule I substances under the CSA will be applicable to the manufacture, distribution, and possession of AMT and 5-MeO-DIPT.     

Elimination of exemptions for chemical mixtures containing the list I chemicals ephedrine and/or pseudoephedrine. Final rule

The Drug Enforcement Administration (DEA) is finalizing, without change, the Interim Rule with Request for Comment published in the Federal Register on July 25, 2007 (72 FR 40738). The Interim Rule removed the Controlled Substances Act (CSA) exemptions for chemical mixtures containing ephedrine and/or pseudoephedrine with concentration limits at or below five percent. Upon the effective date of the Interim Rule, all ephedrine and pseudoephedrine chemical mixtures, regardless of concentration and form, became subject to the regulatory provisions of the CSA. DEA regulated the importation, exportation, manufacture, and distribution of these chemical mixtures by requiring persons who handle these chemical mixtures to register with DEA, maintain certain records common to business practice, and file certain reports, regarding these chemical mixtures. No comments to the Interim Rule were received. This Final Rule finalizes the Interim Rule without change.     

Schedules of controlled substances: placement of pregabalin into schedule V. Final rule

This final rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance pregabalin [(S)-3-(aminomethyl)-5-methylhexanoic acid], including its salts, and all products containing pregabalin into Schedule V of the Controlled Substances Act (CSA). As a result of this rule, the regulatory controls and criminal sanctions of Schedule V will be applicable to the manufacture, distribution, dispensing, importation and exportation of pregabalin and products containing pregabalin.     

Definition of "positional isomer" as it pertains to the control of schedule I controlled substances. Final rule

On May 25, 2006, DEA published a Notice of Proposed Rulemaking which proposed the addition of a specific definition for the term "positional isomer" to allow for the systematic determination of which isomers of schedule I substances would be considered to be "positional," and therefore, subject to schedule I control. This rulemaking finalizes that definition. The Controlled Substances Act (CSA) and its implementing regulations specify which hallucinogenic substances are considered schedule I controlled substances. The CSA states that all salts, isomers, and salts of isomers of these substances are also schedule I controlled substances. In non-technical terms, an isomer of a substance is a different compound, but a compound which has the same number and kind of atoms. The terms "optical isomer" and "geometric isomer" are specific scientific terms and it is easy to determine whether one substance is an optical or geometric isomer of another. The term "positional isomer," however, is subject to scientific interpretation. The addition of a definition for the term "positional isomer" will assist legitimate research[ers] and industry in determining the control status of materials that are "positional isomers" of schedule I hallucinogens. While the DEA will remain the authority for ultimately determining the control status of a given material, providing a specific definition for "positional isomer" will ensure consistent criteria are utilized in making these determinations. This rule does not change existing laws, regulations, policies, processes, and procedures regarding the determination of control status for schedule I hallucinogenic substances. This rule merely makes available to the public the longstanding definition of "positional isomer" which DEA has used when making these scheduling determinations. This rule is relevant only to specialized forensic or research chemists. Most of these individuals are existing DEA registrants who are authorized by the DEA to handle schedule I hallucinogenic substances.