Drug Enforcement Administration 2008 – Federal Register Recent Federal Regulation Documents

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.

DEA is proposing to revise its regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. These regulations would also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These proposed regulations would be an addition to, not a replacement of, the existing rules. These regulations provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances dispensing; additionally, the proposed regulations would reduce paperwork for DEA registrants who dispense or prescribe controlled substances and have the potential to reduce prescription forgery. The proposed regulations would also have the potential to reduce the number of prescription errors caused by illegible handwriting and misunderstood oral prescriptions. Moreover, they would help both pharmacies and hospitals to integrate prescription records into other medical records more directly, which would increase efficiency, and would reduce the amount of time patients spend waiting to have their prescriptions filled.

On September 20, 2007, the Drug Enforcement Administration (DEA) published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (72 FR 53734) proposing to conform its regulations to recent statutory amendments to the Controlled Substances Act that changed certain patient limitations for practitioners who dispense or prescribe certain narcotic drugs for maintenance or detoxification treatment. DEA received one comment in support of this rulemaking. DEA is finalizing the rule as proposed.

This Notice of Proposed Rulemaking (NPRM) proposes to classify the following three steroids as ``anabolic steroids'' under the Controlled Substances Act (CSA): boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione. The Drug Enforcement Administration (DEA) believes that this action is necessary in order to prevent the abuse and trafficking of these steroids. If the regulations are amended, these steroids will be listed as schedule III controlled substances subject to the regulatory control provisions of the CSA.

The Drug Enforcement Administration (DEA) is proposing to designate the precursor chemical, 4-anilino-N-phenethyl-4-piperidine (ANPP) as an immediate precursor for the schedule II controlled substance, fentanyl, under the definition set forth in 21 U.S.C. Sec. 802(23). Furthermore, DEA is proposing to control ANPP as a schedule II substance under the Controlled Substances Act (CSA), pursuant to the authority in 21 U.S.C. 811(e), which states that an immediate precursor may be placed in the same schedule as the controlled substance it produces, without the need of addressing the ``factors determinative of control'' in 21 U.S.C. Sec. 811 or the findings required in 21 U.S.C. 812(b). ANPP is the immediate chemical intermediary in the synthesis process currently used by clandestine laboratory operators for the illicit manufacture of the schedule II controlled substance fentanyl. The distribution of illicitly manufactured fentanyl has caused an unprecedented outbreak of hundreds of fentanyl-related overdoses in the United States in recent months. DEA believes that the control of ANPP as a schedule II controlled substance is necessary to prevent its diversion as an immediate chemical intermediary for the illicit production of fentanyl.