Search Results for agency_names:"Drug Enforcement Administration"

Globyz Pharma, LLC has applied to the Drug Enforcement Administration (DEA) for registration as an importer of controlled substances for analytical testing. The application does not authorize any other activities, such as importing FDA-approved finished dosage forms for sale. Interested parties, including registered manufacturers, can submit comments or objections, or request a hearing regarding this application by March 26, 2021. The DEA's decision will be based on alignment with legal requirements under 21 U.S.C. 952(a)(2).

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.

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.

Organic Standards Solutions International, LLC has applied to the Drug Enforcement Administration (DEA) to register as an importer of certain controlled substances. The company aims to import substances like Marihuana Extract, Marihuana, and a synthetic version of Tetrahydrocannabinols to create analytical reference standards for customers. The public can comment or request a hearing on this application by January 6, 2025, through the Federal eRulemaking Portal. Permits will be approved only if the business activities align with legal requirements, and the company is not authorized to import FDA-approved or non-approved finished products for sale.

The Drug Enforcement Administration (DEA) has revoked Rachel Jackson's DEA Certificate of Registration because she is not licensed to handle controlled substances in Maine. Jackson voluntarily surrendered her Maine physician assistant license, making her ineligible to practice or register with the DEA. Despite being alerted about the situation and the chance to request a hearing, Jackson did not respond, leading to a default determination and subsequent action to revoke her registration. The order for revocation is effective from April 21, 2025.

The Drug Enforcement Administration (DEA) has announced that North Star Holdings California, LLC, has applied to become a registered bulk manufacturer of marihuana, a Schedule I controlled substance. This application is part of a DEA program that regulates the cultivation of marihuana for scientific and medical research purposes. The DEA will review this and similar applications to ensure compliance with relevant laws and regulations, ensuring that adequate measures are in place to prevent illegal distribution. Interested parties may submit comments or objections to the DEA regarding this application before April 19, 2021.

The Drug Enforcement Administration (DEA) revoked the registration of Hazem Barmada, M.D., allowing him to handle controlled substances in Mississippi because he no longer has a valid medical license in the state. The Mississippi State Board of Medical Licensure had accepted his voluntary surrender of the license in 2021, making him ineligible to practice medicine and handle controlled substances there. As holding a valid state license is necessary for DEA registration, Dr. Barmada’s registration was revoked, and any pending applications related to it were denied. This decision will take effect on April 21, 2025.

The Drug Enforcement Administration (DEA) has revoked the DEA registration of Xubex Community Pharmacy in Casselberry, Florida. This decision was made because the pharmacy dispensed controlled substances, specifically Schedule II drugs like oxycodone and hydromorphone, without prescriptions. The DEA considered these actions a threat to public health and safety, demonstrating that the pharmacy cannot be trusted to comply with legal requirements. Furthermore, the pharmacy did not request a hearing to dispute these conclusions, leading to the default revocation of its registration.

The Drug Enforcement Administration (DEA) has revoked Samreen Riaz, D.D.S.'s registration to handle controlled substances due to her lack of authority to practice dentistry in California, where her DEA registration was held. The decision was made following the Dental Board of California's revocation of her dental license, effective September 1, 2023. Riaz did not respond to the Order to Show Cause (OSC), resulting in her default and the revocation of her DEA registration. The DEA's action ensures that individuals without the necessary state licenses cannot handle controlled substances, maintaining compliance with federal regulations.

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.