Search Results for keywords:"DEA"

Myonex LLC has submitted an application to the Drug Enforcement Administration (DEA) to become a registered importer of certain controlled substances. The company plans to import these substances in dosage forms specifically for use in clinical trials, research, and analytical work, but not for commercial sales. Interested parties, including manufacturers or other applicants, are invited to submit comments or objections to this application by May 19, 2025, and they also have the option to request a hearing. No commercial activities involving the finished dosage forms are allowed under this registration.

The Drug Enforcement Administration (DEA) has revoked the Certificate of Registration of James T. Craig, D.D.S., a dentist from Colorado, meaning he can no longer handle controlled substances. This decision was made because his dental license in Colorado was revoked, and he lacked the necessary state authority to dispense controlled substances. The DEA notified Craig of his right to a hearing, which he opted not to request, resulting in an automatic admission of the allegations against him. Consequently, any pending applications from Craig to renew or modify his registration have also been denied.

Siegfried USA, LLC, located in New Jersey, has submitted an application to become an importer of specific controlled substances, as noted by the Drug Enforcement Administration (DEA). The company plans to import these substances to create active pharmaceutical ingredients for its clients, specifically using Phenylacetone to produce Amphetamine. Comments or objections regarding this application are invited by March 18, 2021, and requests for a hearing can also be made by this date. Final permit approval will align with conditions outlined under the relevant U.S. Code and does not permit the commercial import of drug forms approved or non-approved by the Food and Drug Administration (FDA).

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 announced that GGGYI LLC has applied to be registered as a bulk manufacturer of certain controlled substances, specifically marihuana, for research purposes. This application is part of DEA's program to oversee the cultivation and distribution of marihuana for scientific and medical research under strict regulations. Interested parties, such as existing manufacturers or applicants, can submit comments or objections regarding this application by April 26, 2021. The DEA will evaluate the application based on applicable laws and regulations to ensure proper safeguards against misuse are in place.

Siemens Healthcare Diagnostics Inc. has submitted an application to the Drug Enforcement Administration to become a bulk manufacturer of certain controlled substances. The company intends to use these substances to produce products that are exempt from DEA regulations. Individuals or existing registered manufacturers can express their support or objections in writing by March 15, 2021, or request a hearing regarding this application by the same date.

The Drug Enforcement Administration (DEA) has issued a final order establishing the adjusted 2024 aggregate production quotas for Schedule I and II controlled substances under the Controlled Substances Act, and the annual needs for certain list I chemicals like ephedrine. This decision was made after considering public comments and relevant factors such as production needs, diversion risks, and quotas set in prior years. DEA strives to ensure that these quotas meet lawful medical and scientific needs while preventing drug misuse. Some public suggestions, like changes to the procurement quota processes or addressing opioid shortage concerns, were noted but found to be outside the scope of this specific order.

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.

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 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.