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Vici Health Sciences, LLC has applied to become an importer of specific controlled substances to support their research and clinical trials. The Drug Enforcement Administration (DEA) is accepting public comments and objections to this application until February 27, 2025. Interested parties can submit their comments electronically through the Federal eRulemaking Portal. The DEA has specified that this permit will not authorize the import of finished medication forms for sale.

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.

The Drug Enforcement Administration (DEA) is extending the temporary Schedule I classification for seven specific fentanyl-related substances. This extension lasts for one year or until a permanent decision is made. These substances are considered a public safety hazard, and the DEA is working on permanently scheduling them. The temporary classification does not require the normal rulemaking processes, as the DEA needs to act quickly to prevent potential dangers.

VHG Labs, doing business as LGC Standards, has applied to the Drug Enforcement Administration (DEA) to register as an importer of specific controlled substances for analytical testing purposes. The DEA has announced this in the Federal Register and is accepting comments or objections from registered bulk manufacturers and other interested parties until February 24, 2025. Requests for a hearing related to this application must also be sent to the DEA by this date. The authorization sought does not include the importation of finished dosage forms approved by the Food and Drug Administration for commercial sale.

Myonex Inc has applied for registration as an importer of specific controlled substances, according to a notice from the Drug Enforcement Administration (DEA). The substances are intended for use in clinical trials, research, and analytical purposes, and not for commercial sale of finished dosage forms. Interested parties have until March 29, 2021, to submit written comments or objections, or to request a hearing regarding this application. Written submissions should be directed to the DEA at their office in Springfield, Virginia.

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.

SpecGx LLC has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances. The company aims to import these substances for the purpose of manufacturing Active Pharmaceutical Ingredients, which will then be distributed to its customers. However, this registration does not automatically allow for permit applications to import these substances to be approved; approval will be granted only if the business activities comply with specific legal requirements. Public comments or requests for a hearing regarding this application are open until April 28, 2025, and can be submitted electronically through the Federal eRulemaking Portal.

Catalent Pharma Solutions, LLC has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company plans to import these substances in finished dosage forms for clinical trials, research, and analytical activities. Comments or objections regarding this application can be submitted electronically by March 28, 2025. Any hearing requests should be sent to the DEA at their Springfield, Virginia address.

The Drug Enforcement Administration (DEA) of the Department of Justice is asking for public comments on proposed changes to rules about suspicious orders of controlled substances. They had initially asked for comments by January 4, 2021, but due to challenges posed by the COVID-19 pandemic, they have reopened the comment period from February 25, 2021, to March 29, 2021. The new rules would require registrants dealing with controlled substances to report any suspicious orders to a central DEA database. This change aims to improve monitoring and decision-making regarding these substances' distribution.

The Drug Enforcement Administration (DEA) has announced that Ohana Bio Pharma, LLC has applied to be registered as a bulk manufacturer of controlled substances in schedule I, specifically for marihuana. This application is part of a program to grow marihuana for scientific and medical research. The DEA will evaluate the application according to its regulations to ensure legal compliance and prevent any misuse. Interested parties can submit their comments or objections by May 27, 2025, through the Federal eRulemaking Portal.