Search Results for keywords:"controlled substances"

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Search Results: keywords:"controlled substances"

  • Type:Notice
    Citation:90 FR 13881
    Reading Time:about a minute or two

    Promega Corporation has applied to the Drug Enforcement Administration to register as a bulk manufacturer of certain controlled substances. This notice invites comments or objections to the proposed registration by May 27, 2025. Comments must be submitted electronically through the Federal eRulemaking Portal at regulations.gov. The substances will be manufactured as Active Pharmaceutical Ingredients for sale to customers, with no other uses authorized.

    Simple Explanation

    Promega Corporation wants permission to make certain special medicines in large amounts, and people can say what they think about this by May 27, 2025, on a website called regulations.gov.

  • 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: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: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:90 FR 12367
    Reading Time:about a minute or two

    Sterling Pharma USA LLC has applied to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of controlled substances. This application, filed on February 11, 2025, aims to support the company's internal research and provide substances for pre-clinical trial studies. The public can comment or object to this registration until May 16, 2025, through the Federal eRulemaking Portal.

    Simple Explanation

    Sterling Pharma USA wants permission to make special medicines and asked the DEA to approve this. People can tell the DEA what they think about this until May 16, 2025.

  • Type:Notice
    Citation:90 FR 9733
    Reading Time:about a minute or two

    Patheon API Inc. has applied to the Drug Enforcement Administration to register as a bulk manufacturer of several controlled substances. The registration would allow the company to import these substances as reference standards for research and development in its API Manufacturing operations. Interested parties, including current registered bulk manufacturers, can submit comments or objections electronically by April 21, 2025, and may also request a hearing on the application by the same date. Comments submitted will be tracked, and successful submissions will receive a Comment Tracking Number.

    Simple Explanation

    Patheon API Inc. wants permission to make special medicines, and people can share their thoughts about it until April 21, 2025. They need to let an official group called the Drug Enforcement Administration know what they think and follow some rules to do so.

  • Type:Notice
    Citation:89 FR 106591
    Reading Time:about 6 minutes

    The Drug Enforcement Administration (DEA) has decided to revoke the registration of Jeffrey W. Young, Jr., a nurse practitioner from Tennessee, due to his lack of state authorization to handle controlled substances. Young's Tennessee nurse and advanced practice nurse licenses were both revoked, making him ineligible to dispense medications under state laws. Despite being given a chance, Young did not request a hearing to challenge this decision, leading the DEA to proceed with the revocation of his Certificate of Registration. This order will be effective from January 29, 2025.

    Simple Explanation

    The DEA decided not to let Jeffrey Young, Jr., a nurse from Tennessee, give out certain medicines anymore because his state said he couldn't. He didn't ask to talk to them about it, so they went ahead and made it official; this will start on January 29, 2025.

  • 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:90 FR 9733
    Reading Time:about a minute or two

    Purisys, LLC has applied to become a registered bulk manufacturer of certain controlled substances, as announced by the Drug Enforcement Administration (DEA) under the Justice Department. The company intends to produce these substances for use as active pharmaceutical ingredients and analytical reference standards, and to support clinical trials. People or companies who are already registered bulk manufacturers or applicants of these substances may submit comments or request a hearing on the application by April 21, 2025. Comments must be submitted electronically via the Federal eRulemaking Portal.

    Simple Explanation

    Purisys, LLC wants to make certain special medicines, and this notice tells people how they can say if they think it's a good idea or not. They have until April 21, 2025, to share their thoughts.

  • Type:Notice
    Citation:89 FR 101051
    Reading Time:about a minute or two

    Groff NA Hemplex LLC has applied to the Drug Enforcement Administration to become a registered importer of certain controlled substances. These substances will be imported in bulk to produce research-grade materials for clinical trial studies, specifically involving Marihuana Extract compounds. The application process allows for public comments or objections and requests for a hearing until January 13, 2025. The comments should be submitted electronically through the Federal eRulemaking Portal, while hearing requests must be directed to the DEA's office in Springfield, Virginia.

    Simple Explanation

    Groff NA Hemplex LLC wants permission to bring special plant extracts from outside the country to use for research. People can tell the government what they think about it until January 13, 2025.