Drug Enforcement Administration March 2010 – Federal Register Recent Federal Regulation Documents
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Electronic Prescriptions for Controlled Substances
The Drug Enforcement Administration (DEA) is revising its regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations will also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These regulations are in addition to, not a replacement of, the existing rules. The 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 regulations will reduce paperwork for DEA registrants who dispense controlled substances and have the potential to reduce prescription forgery. The regulations will also have the potential to reduce the number of prescription errors caused by illegible handwriting and misunderstood oral prescriptions. Moreover, they will help both pharmacies and hospitals to integrate prescription records into other medical records more directly, which may increase efficiency, and potentially reduce the amount of time patients spend waiting to have their prescriptions filled.
Schedules of Controlled Substances: Exempted Prescription Product; River Edge Pharmaceutical, Servira
This Notice of Proposed Rulemaking proposes the amendment of the list of Exempted Prescription Products cited in the Code of Federal Regulations. This action is in response to DEA's review of new applications for exemption. DEA has received one new application for exemption for River Edge Pharmaceutical's Servira[supreg]. Having reviewed this application and relevant information, DEA finds that this preparation has no significant potential for abuse. Therefore, DEA hereby proposes that this product be added to the list of Exempted Prescription Products and exempted from the application of certain provisions of the Controlled Substances Act (CSA).
Schedules of Controlled Substances: Placement of Carisoprodol Into Schedule IV; Announcement of Hearing
This is notice that the Drug Enforcement Administration (DEA) will hold a hearing with respect to the proposed placement of carisoprodol in schedule IV of the Controlled Substances Act (21 U.S.C. 801, et seq.). The control of carisoprodol was initially proposed in a Notice of Proposed Rulemaking published in the Federal Register on November 17, 2009 [74 FR 59108].
Schedules of Controlled Substances; Table of Excluded Nonnarcotic Products: Nasal Decongestant Inhalers Manufactured by Classic Pharmaceuticals, LLC
Under this Final Rule, the Drug Enforcement Administration (DEA) is updating the Table of Excluded Nonnarcotic Products found in 21 CFR 1308.22 to include the Nasal Decongestant Inhaler/Vapor Inhaler (containing 50 mg Levmetamfetamine) manufactured by Classic Pharmaceuticals, LLC and marketed under various private labels (to include the ``Premier Value'' and ``Kroger'' labels). This nonnarcotic drug product, which may be lawfully sold over the counter without a prescription under the Federal Food, Drug, and Cosmetic Act, is excluded from provisions of the Controlled Substances Act (CSA) pursuant to 21 U.S.C. 811(g)(1).
Implementation of the Methamphetamine Production Prevention Act of 2008
In October 2008, the President signed the Methamphetamine Production Prevention Act of 2008, which clarifies the information entry and signature requirements for electronic logbook systems permitted for the retail sale of scheduled listed chemical products. DEA is promulgating this rule to incorporate the statutory provisions and make its regulations consistent with the new requirements. Once finalized, this action will make it easier for regulated sellers to maintain electronic logbooks by allowing greater flexibility as to how information may be captured.
Changes to and Consolidation of DEA Mailing Addresses
DEA is amending Title 21 of the Code of Federal Regulations
Information on Foreign Chain of Distribution for Ephedrine, Pseudoephedrine, and Phenylpropanolamine
The Drug Enforcement Administration (DEA) is finalizing, without change, the Notice of Proposed Rulemaking published in the Federal Register on March 31, 2008 (73 FR 16793). The Combat Methamphetamine Epidemic Act of 2005 (CMEA) requires DEA to collect from importers of ephedrine, pseudoephedrine, and phenylpropanolamine all information known to the importer on the foreign chain of distribution of the chemical from the manufacturer to the importer. This rule amends DEA regulations to incorporate the requirement for this information.
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