Search Results for keywords:"DEA registration"

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) announced that Mountain Trading LLC has applied to be registered as a bulk manufacturer of marihuana, a controlled substance listed under schedule I. The DEA will evaluate this application, along with others, based on the criteria set out in relevant laws and regulations. Current bulk manufacturers and other applicants can submit comments or objections to this application until April 19, 2021. If registered, the company will produce active pharmaceutical ingredients for research purposes only and must comply with established safeguards against drug diversion.

Navinta LLC has applied to the Drug Enforcement Administration to become a registered bulk manufacturer of certain controlled substances. This registration is part of the process to gain approval for manufacturing these substances for validation purposes, which is a step required by the Food Administration before the substances can be distributed to their customers. The public, including current manufacturers of these substances, can submit comments or objections electronically by February 4, 2025. Comments should be submitted through the Federal eRulemaking Portal to ensure they are properly received.

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.

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.

Royal Emerald Pharmaceuticals has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of controlled substances, specifically Marihuana (Cannabis), at their location in Desert Hot Springs, California. They intend to produce this substance to supply botanical raw materials and active pharmaceutical ingredients to researchers and manufacturers registered with the DEA. Individuals who wish to comment on or object to this application may do so electronically by May 27, 2025, through the Federal eRulemaking Portal. Written requests for a hearing regarding the application are also due by the same date.

Siegfried USA, LLC has applied to the Drug Enforcement Administration (DEA) to become a registered manufacturer of certain controlled substances in bulk. This application was submitted on December 9, 2020. Interested parties can submit comments, objections, or requests for a hearing regarding this application by March 15, 2021. The purpose of this registration is for Siegfried USA, LLC to produce these substances for sale to their customers, and no other activities with these drugs are permitted under this registration.

The Drug Enforcement Administration (DEA) decided to revoke Massoud Amini, M.D.'s DEA Certificate of Registration because he currently lacks the authority to handle controlled substances in California. The DEA issued an Order to Show Cause, notifying Dr. Amini of his right to request a hearing, which he did not do, leading to a default decision. The default means that the DEA's allegations against him are accepted as true, including that his California medical license has been revoked. Consequently, Dr. Amini's DEA registration is revoked, and his pending applications for renewal or new registration are denied.

Scottsdale Research Institute has applied to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of certain controlled substances. This registration will allow them to manufacture these substances for internal research and analytical development purposes only. Comments or objections regarding this application can be submitted electronically until April 21, 2025, via the Federal eRulemaking Portal. A hearing request can also be made by the same date.

Microgenics Corporation, a part of Thermo Fisher Scientific, has applied to the Drug Enforcement Administration (DEA) to become a registered importer of certain controlled substances. These substances are intended for use in feasibility and cross-reactivity studies related to diagnostic products. Comments and objections regarding this application, as well as requests for a hearing, must be submitted to the DEA by March 31, 2021. The DEA will only approve the permit if the company’s activities align with specific legal requirements under U.S. law.