Search Results for keywords:"DEA registration"

Patheon API Manufacturing, Inc. has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of certain controlled substances. The company intends to produce these substances as Active Pharmaceutical Ingredients (APIs) for its customers, specifically focusing on synthetic tetrahydrocannabinols. The public, including existing manufacturers and applicants, may submit comments or request a hearing on this application by April 20, 2021.

Restek Corporation has applied to the Drug Enforcement Administration (DEA) to become a registered importer of certain controlled substances. These substances will be imported for use in manufacturing certified reference materials. The public can submit comments or objections to this application by April 28, 2025, through the Federal eRulemaking Portal. Approval will be granted only if the importation activities comply with legal requirements, with no permission for importing finished drug products for commercial sale.

The Drug Enforcement Administration (DEA) has revoked the DEA registration of Dr. Kim Routh from Grove City, Ohio, because he lost his medical license in Ohio, rendering him unable to legally handle controlled substances. The revocation is based on an Order to Show Cause issued by the DEA, which Dr. Routh did not contest by requesting a hearing. The document states that having a valid state medical license is a crucial requirement for holding a DEA registration, and without it, Dr. Routh cannot continue to administer or prescribe controlled substances. The order also denies any pending applications from Dr. Routh to renew or modify his registration.

The Drug Enforcement Administration (DEA) decided to revoke the DEA Certificate of Registration for Dr. Willard J. Davis, a doctor in Texas, because he lost his state license to practice medicine, which means he can no longer handle controlled substances legally in Texas. The Texas Medical Board suspended Dr. Davis's medical license on May 16, 2024, and it remained suspended at the time of the decision. Since having a valid state medical license is necessary to maintain DEA registration for dispensing controlled substances, his registration was revoked, and any pending applications related to the registration were denied. This decision will be effective starting April 28, 2025.

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.

The Drug Enforcement Administration (DEA) has decided to revoke the registration of Dr. Kevin Petersen, meaning he can no longer prescribe or handle controlled substances. This decision came after it was found that his medical license in Nevada, where he practiced, had expired and was then revoked, which automatically made him ineligible to maintain his DEA registration for handling such substances. Dr. Petersen did not contest this action by requesting a hearing, leading the DEA to proceed with its final decision. This order will officially take effect on January 29, 2025.

Janssen Pharmaceuticals, Inc. has applied to the Drug Enforcement Administration to be registered as a bulk manufacturer of certain controlled substances. The DEA has issued a notice inviting public comments or objections to this application and requests for a hearing on the matter, which must be submitted by April 21, 2025. Comments can be made electronically through the Federal eRulemaking Portal. Janssen plans to manufacture these substances for use as intermediates in sales to customers, and no other activities are allowed under this registration.

Catalent Greenville, Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company plans to use these substances for developing bulk dosage formulations for research and clinical trials. People or organizations that have an interest in this matter can submit comments or request a hearing by March 3, 2025. Submissions can be made through the Federal eRulemaking Portal, and hearings request should be sent to the DEA at specified addresses.

The Drug Enforcement Administration (DEA) is proposing a new rule to require that all applications and renewals for DEA registration be submitted online. This change will eliminate the current option to submit paper forms, making the process more efficient and cost-effective. The proposal is expected to save money for both the DEA and applicants by reducing errors and the need for corrections, while nearly all current applicants already use the internet for submissions. The rule change also aligns with federal efforts to streamline and modernize regulatory processes.

Purisys, LLC has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of various controlled substances, including different forms of opium and marihuana extracts, for manufacturing purposes. The company aims to import these substances to create active pharmaceuticals and other controlled substances for its customers. Any comments or objections to this application must be submitted electronically by March 17, 2025. The approval for these imports will only be granted if the business activities align with legal requirements, and the import of finished dosage forms for commercial sale is not authorized.