Search Results for keywords:"DEA"

Pharmaron Manufacturing Services (US) LLC has applied to be registered as an importer of certain controlled substances. The Drug Enforcement Administration (DEA) announced this application and is inviting comments and requests for hearings from other registered bulk manufacturers and applicants until April 25, 2025. The company aims to use the imported substances for analytical purposes and production processes but is not authorized for commercial sale of finished dosage forms. The submission of comments should be done electronically through the Federal eRulemaking Portal.

Organix, Inc. has applied to the Drug Enforcement Administration (DEA) to become a registered producer of certain controlled substances, specifically synthetic versions of Marihuana and Tetrahydrocannabinol. The notice invites comments or objections from existing registered manufacturers and applicants by March 15, 2021. Requests for a hearing on the application must also be submitted by this date. Written feedback should be directed to the DEA in Springfield, Virginia.

The Drug Enforcement Administration (DEA) issued an order to revoke the registration of Dr. Thomas Andr'e Endicott, a dentist in Utah, due to his lack of authority to handle controlled substances after his state licenses were revoked. The DEA's decision is based on the fact that a practitioner must have state authority to dispense controlled substances to maintain DEA registration. Dr. Endicott did not respond to the order, which was served to him through various means, including email. Consequently, his DEA Certificate of Registration is revoked, and any pending registration applications he has are denied.

PCI Synthesis has applied to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of controlled substances. They plan to use these substances for developing manufacturing processes and conducting tests. The application has been filed under notice by the DEA, and comments or objections to this application can be submitted by April 19, 2021. Additionally, PCI Synthesis has patents for the synthesis process of amphetamines.

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.

The Drug Enforcement Administration (DEA) temporarily placed a substance called brorphine in Schedule I of the Controlled Substances Act due to its high potential for abuse, lack of accepted medical use, and potential danger to public safety. This action means strict regulatory controls are now in place regarding the manufacturing, distribution, and possession of brorphine. The DEA found brorphine on the illicit market in several countries and associated it with several fatalities in the U.S. Brorphine is a synthetic opioid with effects similar to fentanyl, which poses significant health risks and has been linked to the ongoing opioid epidemic. This temporary scheduling will last for two years and can be extended for an additional year.

The Drug Enforcement Administration (DEA) has announced that Royal Beverages, LLC has applied to become a registered bulk manufacturer of marijuana, which is a Schedule I controlled substance. This registration would allow Royal Beverages, LLC, located in Harrisburg, Pennsylvania, to produce bulk active pharmaceutical ingredients (APIs) for research purposes. Comments or objections about this application can be submitted electronically through the Federal eRulemaking Portal before May 27, 2025. The DEA will evaluate the application based on certain legal regulations to ensure it complies with all laws and safeguards against illegal distribution.

Patheon API Services, Inc. has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances. They intend to use these substances as reference standards in research and development for API Manufacturing, and not for any commercial sales. People affected by this application can submit comments or request a hearing by April 28, 2025. All comments must be submitted electronically through the Federal eRulemaking Portal.

The Drug Enforcement Administration has announced that Mylan Inc. applied for registration to import certain controlled substances. These substances will be used as bulk active pharmaceutical ingredients for internal testing, as well as finished dosage forms for analytical testing and distribution for clinical trials in foreign markets. Comments or objections regarding this application can be submitted up to March 17, 2025, and requests for a hearing must follow specific submission guidelines. The approval of these permits will only occur if the activities align with the legal requirements under U.S. law.

VHG Labs, doing business as LGC Standards, has applied to the Drug Enforcement Administration (DEA) to register as an importer of specific controlled substances for analytical testing purposes. The DEA has announced this in the Federal Register and is accepting comments or objections from registered bulk manufacturers and other interested parties until February 24, 2025. Requests for a hearing related to this application must also be sent to the DEA by this date. The authorization sought does not include the importation of finished dosage forms approved by the Food and Drug Administration for commercial sale.