Search Results for agency_names:"Drug Enforcement Administration"

S&B Pharma, Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company intends to import intermediate forms of Tapentadol for manufacturing purposes and ANPP to produce other controlled substances, but they will not import finished products for commercial sale. Interested parties, such as registered manufacturers, can submit comments, objections, or request a hearing regarding this application by March 18, 2021.

Synthcon LLC has applied to be registered as a bulk manufacturer of controlled substances, according to a notice from the Drug Enforcement Administration under the Department of Justice. The company intends to produce these substances for use as reference materials, proficiency tests, and academic research. Interested parties, such as current bulk manufacturers and applicants, are invited to submit comments or objections to this application by April 26, 2021, and may also request a hearing by the same date. Written comments can be sent to the DEA at their address in Springfield, Virginia.

The Drug Enforcement Administration (DEA) has decided to revoke the Certificate of Registration for Dr. Henry-Norbert O. Ndekwe after finding that he no longer has a valid medical license to practice in Oklahoma, where he is registered to handle controlled substances. The DEA issued an Order to Show Cause because Dr. Ndekwe's state medical license expired, and he did not request a hearing to contest the findings. Therefore, the DEA concluded that he is not eligible to maintain his registration to dispense controlled substances. This decision will take effect on May 16, 2025, and any pending applications by Dr. Ndekwe to renew or modify his registration are also denied.

Restek Corporation has applied to be registered as a bulk manufacturer of certain controlled substances. The application was submitted to the Drug Enforcement Administration on February 19, 2025, and the company plans to produce synthetic versions of substances like Marihuana and Tetrahydrocannabinols for specific purposes. Interested parties can file comments or objections, or request a hearing on this registration by June 17, 2025. All submissions must be made through the Federal eRulemaking Portal.

Fisher Clinical Services, Inc. has applied to the Drug Enforcement Administration (DEA) to register as an importer of certain controlled substances. The company intends to import these substances solely for clinical trials. Other types of uses or commercial sales are not allowed under this registration. Interested parties can submit comments or objections electronically by April 16, 2025, and can also request a hearing on the application by the same date.

Sterling Pharma USA LLC has applied to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of controlled substances. This application, filed on February 11, 2025, aims to support the company's internal research and provide substances for pre-clinical trial studies. The public can comment or object to this registration until May 16, 2025, through the Federal eRulemaking Portal.

The Drug Enforcement Administration (DEA) has announced that Siegfried USA, LLC, located in Pennsville, New Jersey, has applied to be registered as a bulk manufacturer of certain controlled substances. Interested parties, including registered manufacturers of these substances, can submit comments or objections electronically by March 24, 2025. They can also request a hearing on the application by the same date. This registration will allow Siegfried USA to produce these substances in bulk for sale.

The Drug Enforcement Administration (DEA) has received an application from Titan Health LLC to become registered to manufacture bulk quantities of marihuana for research purposes. This notice invites current registered bulk manufacturers and applicants to submit comments or objections by April 19, 2021. The DEA will review the application according to regulations to ensure compliance with legal requirements and prevent unlawful distribution. If approved, Titan Health LLC would be authorized to manufacture pharmaceuticals for research but not engage in other activities without additional approval.

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 proposes to make seven fentanyl-related substances permanently controlled under Schedule I of the Controlled Substances Act. These substances, identified as dangerous opioids, are currently regulated under a temporary order due to their potential for abuse and health hazards. If this proposal is finalized, it would enforce permanent restrictions and legal penalties on the handling of these substances, which include para-chlorofentanyl and ortho-chlorofentanyl. The public is encouraged to submit comments on this rule by January 29, 2025.