Search Results for keywords:"DEA registration"

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Search Results: keywords:"DEA registration"

  • Type:Notice
    Citation:86 FR 10353
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Patheon API Manufacturing, Inc. wants permission to make certain special medicines called controlled substances, and people can say if they think this is okay by April 20, 2021.

  • Type:Notice
    Citation:86 FR 9537
    Reading Time:about 2 minutes

    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.

    Simple Explanation

    The DEA is letting everyone know that a company named Mountain Trading LLC has asked for permission to grow and make medicine from marihuana for research. They will check if it's safe and follows the rules, but haven't said exactly what all those rules are.

  • Type:Notice
    Citation:90 FR 13887
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Restek Corporation wants permission from a government agency to bring special kinds of medicine materials into the country for testing and not for selling as regular medicines. People can say if they think this is okay or not by sending their thoughts online before the end of April 2025.

  • Type:Notice
    Citation:90 FR 9554
    Reading Time:about 2 minutes

    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.

    Simple Explanation

    Purisys, LLC wants to bring certain plant parts and chemicals from other countries so they can make medicine, but they must follow all the rules, and they can't sell the medicine directly in stores. People can share their thoughts or concerns about this plan by March 17, 2025.

  • Type:Notice
    Citation:90 FR 2028
    Reading Time:about 6 minutes

    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.

    Simple Explanation

    Dr. Kim Routh lost his permission to handle certain medicines because he doesn't have his doctor license anymore, and that means he can't give out or prescribe these medicines.

  • Type:Notice
    Citation:90 FR 9166
    Reading Time:about 7 minutes

    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.

    Simple Explanation

    When a doctor named Massoud Amini couldn't legally give out certain medicines in California anymore, a group called the DEA said he couldn't have their special permission to do so either, because he didn't ask for a meeting to discuss it.

  • Type:Notice
    Citation:89 FR 106585
    Reading Time:about 8 minutes

    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.

    Simple Explanation

    Dr. Kevin Petersen can't give out medicines that need special permission because he lost his doctor's license in Nevada, and since he didn't say he disagreed with this, the decision will start on January 29, 2025.

  • Type:Notice
    Citation:86 FR 2458
    Reading Time:less than a minute

    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.

    Simple Explanation

    Siegfried USA, LLC asked the government for permission to make certain special medicines in big batches, and people can tell the government if they think it's a good or bad idea.

  • Type:Notice
    Citation:90 FR 9732
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Scottsdale Research Institute wants permission to make special medicines for research, and people can say what they think about it by April 21, 2025.

  • Type:Notice
    Citation:86 FR 9537
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Sigma Aldrich Co. wants to bring in special ingredients to help scientists study drugs, but they promise not to sell these as medicines. If people have opinions or worries about this, they need to let the helpers in charge know before March 18, 2021.

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