Search Results for keywords:"controlled substances"

Patheon API Inc. has applied to the Drug Enforcement Administration to register as a bulk manufacturer of several controlled substances. The registration would allow the company to import these substances as reference standards for research and development in its API Manufacturing operations. Interested parties, including current registered bulk manufacturers, can submit comments or objections electronically by April 21, 2025, and may also request a hearing on the application by the same date. Comments submitted will be tracked, and successful submissions will receive a Comment Tracking Number.

The Drug Enforcement Administration (DEA) has announced that Sterling Wisconsin, LLC applied to register as a bulk manufacturer of certain controlled substances, specifically synthetic versions of Marihuana Extract, Marihuana, and Tetrahydrocannabinols. Interested parties can submit comments or objections electronically or request a hearing until May 27, 2025. The application was filed on January 30, 2025, and comments should be submitted via the Federal eRulemaking Portal as instructed.

Sigma Aldrich Research Biochemicals, Inc. has applied to the Drug Enforcement Administration (DEA) to become registered as a bulk manufacturer of controlled substances. The public is invited to submit comments or objections and request a hearing by April 26, 2021. The application was submitted on December 17, 2020, and aims to manufacture reference standards of certain controlled substances. Comments should be sent to the DEA at the address provided in the notice.

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.

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.

IsoSciences, LLC has applied to the Drug Enforcement Administration to become a bulk manufacturer of certain controlled substances. They plan to create synthetic versions of Marihuana and Tetrahydrocannabinols for use in analytical testing, and no other activities for these drugs are permitted with this registration. The public has until March 15, 2021, to submit written comments or objections, or to request a hearing regarding this application.

Lonza Tampa, LLC has applied to the Drug Enforcement Administration to become registered as an importer of controlled substances, specifically focusing on the drug code 7437 (Psilocybin). They plan to use Psilocybin as a bulk active pharmaceutical ingredient for clinical trials, research, and analytical purposes. The DEA is allowing registered bulk manufacturers or applicants to submit electronic comments or objections to this application by March 20, 2025. Requests for a hearing can also be submitted by this date.

In a notice published by the Drug Enforcement Administration (DEA), the agency announced the revocation of registrations for Liberty Pharmacy Inc., Metro Care Pharmacy Inc., RiteCare Pharmacy Inc., and United Pharmacy Upper Darby Inc. The DEA found that these pharmacies, all located in Philadelphia, Pennsylvania, had violated federal and state laws by not maintaining accurate records of controlled substances, resulting in their operations being labeled as a public safety risk. Despite being given an opportunity to respond or request a hearing, none of the pharmacies contested the allegations or provided evidence to dispute the DEA's findings. Consequently, the DEA determined that continuing the registrations would be against the public interest and ordered the revocations to take effect on May 27, 2025.

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.

Groff Hemplex LLC has applied to the Drug Enforcement Administration to be registered as a bulk manufacturer of certain controlled substances. The company plans to use these substances for its own purposes and to sell them to approved research investigators. The public can submit comments or objections electronically by April 28, 2025, and also request a hearing on this application by the same date. This application process follows the regulations set by the DEA under 21 CFR 1301.33(a).