Search Results for keywords:"Drug Enforcement Administration"

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 decided to revoke William Needham's Certificate of Registration to handle controlled substances in Mississippi. This decision was made because Needham is no longer authorized to practice nursing in Mississippi after his nursing licenses were revoked. The DEA issued an Order to Show Cause, but Needham did not respond, which led to a default judgment against him. Consequently, without a state license, he cannot legally dispense controlled substances and will not have his DEA registration or any related applications renewed.

The Drug Enforcement Administration (DEA) temporarily placed a substance called brorphine in Schedule I of the Controlled Substances Act due to its high potential for abuse, lack of accepted medical use, and potential danger to public safety. This action means strict regulatory controls are now in place regarding the manufacturing, distribution, and possession of brorphine. The DEA found brorphine on the illicit market in several countries and associated it with several fatalities in the U.S. Brorphine is a synthetic opioid with effects similar to fentanyl, which poses significant health risks and has been linked to the ongoing opioid epidemic. This temporary scheduling will last for two years and can be extended for an additional year.

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.

Noramco Coventry, LLC has applied to the Drug Enforcement Administration to become an importer of certain controlled substances like raw opium and poppy straw concentrate. These substances will be used to manufacture bulk active pharmaceutical ingredients (APIs) that the company distributes. They will also import other substances for comparison with their own products to ensure quality before exporting their APIs to foreign markets. Public comments or objections to this application, including requests for a hearing, can be submitted until March 18, 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.

The Drug Enforcement Administration (DEA) has announced that the Research Triangle Institute has applied to become a bulk manufacturer of certain controlled substances. The institute intends to produce these substances synthetically for research purposes and to provide analytical reference standards. Interested parties can submit electronic comments or objections regarding this registration by June 17, 2025, and can request a hearing by the same date. Comments are to be submitted through the Federal eRulemaking Portal at regulations.gov.

Groff NA Hemplex, LLC has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of controlled substances, specifically for conducting clinical trial studies with Marihuana Extracts. The notice invites written comments or objections to the application by March 31, 2021, and allows requests for a hearing within the same deadline. The DEA has specified that this registration is only for scientific study and not for the commercial import of these substances.

The Drug Enforcement Administration (DEA) is proposing to place the substance 4-chloromethcathinone (4-CMC) in schedule I of the Controlled Substances Act. This move aims to impose strict regulations similar to other highly controlled drugs, as 4-CMC is known to have a high potential for abuse and no accepted medical use in the U.S. The decision also helps the United States comply with international agreements on psychotropic substances. Public comments on this proposal are accepted until January 29, 2025.

The Drug Enforcement Administration has announced that Mylan Inc. applied for registration to import certain controlled substances. These substances will be used as bulk active pharmaceutical ingredients for internal testing, as well as finished dosage forms for analytical testing and distribution for clinical trials in foreign markets. Comments or objections regarding this application can be submitted up to March 17, 2025, and requests for a hearing must follow specific submission guidelines. The approval of these permits will only occur if the activities align with the legal requirements under U.S. law.