Search Results for keywords:"DEA"

Leading Pharma LLC has applied to register as an importer of controlled substances. This application is for research and development purposes, aiming toward creating a new pharmaceutical product that is pending approval by the Food and Drug Administration (FDA). Interested parties can submit comments or request a hearing regarding this application, with a deadline of January 17, 2025. The Drug Enforcement Administration (DEA) will approve the application only if it meets specific legal criteria.

Mylan Pharmaceuticals, Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of basic classes of controlled substances. Interested parties, such as registered bulk manufacturers, can submit electronic comments or objections about this application by March 20, 2025, or request a hearing. Comments should be submitted through the Federal eRulemaking Portal, and requests for a hearing should be sent to the DEA's specified addresses. Mylan Pharmaceuticals seeks authorization to import controlled substances in finished dosage form for commercial distribution, with certain restrictions aligning with legal requirements.

The Drug Enforcement Administration (DEA) received an application from Baxter Research Lab to register as a bulk manufacturer of marihuana, a Schedule I controlled substance. This registration would allow Baxter to produce large quantities of active pharmaceutical ingredients (APIs) for research purposes. The DEA will review the application to ensure all legal and safety measures are in place to prevent misuse. Comments or objections regarding this application can be submitted electronically until May 27, 2025.

SpecGx LLC has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances. The company aims to import these substances for the purpose of manufacturing Active Pharmaceutical Ingredients, which will then be distributed to its customers. However, this registration does not automatically allow for permit applications to import these substances to be approved; approval will be granted only if the business activities comply with specific legal requirements. Public comments or requests for a hearing regarding this application are open until April 28, 2025, and can be submitted electronically through the Federal eRulemaking Portal.

The Drug Enforcement Administration (DEA) has proposed a new rule to allow healthcare practitioners to prescribe controlled substances via telemedicine, without needing an in-person exam, through a Special Registration framework. This framework permits three types of special registrations: Telemedicine Prescribing Registration for Schedule III-V drugs, Advanced Telemedicine Prescribing Registration for Schedule II-V drugs for certain specialists, and Telemedicine Platform Registration for online platforms to dispense these drugs. These changes, which aim to expand patient access while safeguarding against drug abuse, also require practitioners to perform additional prescription checks and comply with detailed reporting and recordkeeping. Public comments on this proposal are welcome before final implementation.

Myonex Inc has applied for registration as an importer of specific controlled substances, according to a notice from the Drug Enforcement Administration (DEA). The substances are intended for use in clinical trials, research, and analytical purposes, and not for commercial sale of finished dosage forms. Interested parties have until March 29, 2021, to submit written comments or objections, or to request a hearing regarding this application. Written submissions should be directed to the DEA at their office in Springfield, Virginia.

Catalent Pharma Solutions, LLC has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company plans to import these substances in finished dosage forms for clinical trials, research, and analytical activities. Comments or objections regarding this application can be submitted electronically by March 28, 2025. Any hearing requests should be sent to the DEA at their Springfield, Virginia address.

The Drug Enforcement Administration (DEA) has received an application from AJC Industries, Inc. to become a registered bulk manufacturer of marihuana, a Schedule I controlled substance, for scientific and medical research. This notice allows current registered manufacturers and other applicants to submit comments or objections by April 26, 2021. The DEA will evaluate the application to ensure compliance with legal and regulatory standards and to prevent misuse. Interested parties need to reference Docket No. DEA-797 when submitting their feedback to the DEA's office in Springfield, Virginia.

Vici Health Sciences, LLC has applied to become an importer of specific controlled substances to support their research and clinical trials. The Drug Enforcement Administration (DEA) is accepting public comments and objections to this application until February 27, 2025. Interested parties can submit their comments electronically through the Federal eRulemaking Portal. The DEA has specified that this permit will not authorize the import of finished medication forms for sale.

The Department of Justice, specifically the Drug Enforcement Administration (DEA), is requesting public feedback on a proposed information collection related to emergency medical services and controlled substances. This proposal aims to ensure compliance with the Controlled Substances Act by setting new recordkeeping standards for emergency medical services agencies. These standards involve maintaining records of controlled substances used by these agencies, which include details about administration, disposal, and delivery. The DEA encourages comments on the necessity, burden, and clarity of this information collection until January 13, 2025, as part of their efforts to secure approval for a three-year authorization under the Paperwork Reduction Act.