Search Results for keywords:"controlled substances"

Sharp Clinical Services, LLC has submitted an application to register as an importer of certain controlled substances. The purpose of this registration is to import these substances for distribution and clinical trials, but not for commercial sales of finished products. The public can submit comments or objections electronically until March 28, 2025, and requests for a hearing on the application must be sent to the Drug Enforcement Administration by the same date.

The Indigenous Peyote Conservation Initiative has applied to the Drug Enforcement Administration (DEA) to become registered as an importer of certain controlled substances, specifically Peyote plants. They aim to use the imported Peyote for research, analysis, and conservation efforts related to South Texas Cacti. Public comments or objections to this application can be submitted until March 1, 2021, and requests for a hearing must also be made by then. The DEA will grant the registration only if the applicant's activities comply with authorized guidelines, and it does not include commercial importation of finished drug forms.

The Drug Enforcement Administration (DEA) issued an order to revoke Maria Dewitt's registration to handle controlled substances because she lacks the necessary authorization in Texas. Dewitt did not have a required prescriptive authority delegation agreement with a physician, which is essential for an advanced practice registered nurse in Texas to manage controlled substances. The administrative law judge upheld this decision, noting that without state authorization, Dewitt could not maintain her DEA registration. Consequently, her registration was revoked, and any further applications for registration in Texas were denied.

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.

Kinetochem LLC has filed an application to be registered as a bulk manufacturer of certain controlled substances. The company plans to manufacture these substances, including synthetic versions of Marihuana and Tetrahydrocannabinols, for use as Active Pharmaceutical Ingredients in research and clinical trials. The public or other manufacturers may submit comments or objections electronically by February 4, 2025, through the Federal eRulemaking Portal.

The Drug Enforcement Administration (DEA) has announced that Livwell Michigan, LLC has applied to be registered as a bulk manufacturer of controlled substances, specifically marihuana, listed under Schedule I. The DEA will evaluate this application based on specific regulations and guidelines to ensure it complies with laws and has measures in place to prevent misuse. The public and other manufacturers have until April 26, 2021, to submit comments or objections regarding this application. If approved, Livwell Michigan, LLC would be allowed to produce marihuana for use in scientific and medical research, but not for other purposes.

Sigma Aldrich Co. LLC. has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances, specifically for drug testing and analysis in research facilities. The application was submitted on January 15, 2021. Public comments or objections regarding this proposed registration are invited until March 18, 2021. The company plans to import synthetic Tetrahydrocannabinols; however, their registration does not authorize them to import finished drug products for commercial sale.

Meridian Medical Technologies, LLC has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances. The company plans to import these substances solely for analytical purposes and has no authorization for other activities involving these drugs. The DEA is accepting public comments or objections to this application until April 14, 2025, and has outlined procedures for submitting these electronically via regulations.gov. Requests for a hearing regarding the application must also be submitted by the same date to designated DEA offices in Springfield, Virginia.

Maridose, LLC has applied to the Drug Enforcement Administration (DEA) to become registered as an importer of certain controlled substances. This registration will allow the company to import specific synthetic cannabinoids, like synthetic cannabidiol and synthetic tetrahydrocannabinol, for research and analysis purposes. Public comments or objections regarding this application can be submitted until April 25, 2025, through the Federal eRulemaking Portal. The DEA will only approve the permit if it aligns with the specific business activities authorized under federal law.

The Drug Enforcement Administration (DEA) has announced that the University of Kentucky Cannabis Center has applied to become a registered bulk manufacturer of controlled substances, specifically marihuana. This application, filed on July 1, 2024, aims to allow the center to produce bulk active pharmaceutical ingredients for research purposes. Interested parties can comment on or object to this application until April 14, 2025, through the Federal eRulemaking Portal. DEA will review the application to ensure it complies with laws and regulations, focusing on preventing the potential diversion of the controlled substance.