Search Results for keywords:"controlled substances"

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Search Results: keywords:"controlled substances"

  • Type:Notice
    Citation:90 FR 16555
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Myonex LLC wants permission to bring in certain special medicines from outside the country to use for tests and studies, but not to sell. People who might worry about this can say something about it by May 19, 2025.

  • Type:Notice
    Citation:90 FR 9169
    Reading Time:about 6 minutes

    The Drug Enforcement Administration (DEA) has revoked the Certificate of Registration of James T. Craig, D.D.S., a dentist from Colorado, meaning he can no longer handle controlled substances. This decision was made because his dental license in Colorado was revoked, and he lacked the necessary state authority to dispense controlled substances. The DEA notified Craig of his right to a hearing, which he opted not to request, resulting in an automatic admission of the allegations against him. Consequently, any pending applications from Craig to renew or modify his registration have also been denied.

    Simple Explanation

    James can't give out special medicine anymore because he lost his dentist license, and he didn’t ask for a chance to talk about it, so the big bosses said no to his request to get back his special permission.

  • Type:Notice
    Citation:90 FR 9555
    Reading Time:about a minute or two

    Maridose LLC has put in an application to register as a bulk manufacturer of certain controlled substances. This application is directed to the Drug Enforcement Administration (DEA) and aims to supply these substances to DEA-registered researchers for their approved studies. Interested parties, such as other registered manufacturers, have until April 14, 2025, to submit comments or objections electronically through the Federal eRulemaking Portal. They can also request a hearing on the application by this deadline.

    Simple Explanation

    Maridose LLC wants to make certain special medicines for research, and they have asked for permission to do this. People who are interested can say what they think about this plan until April 14, 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:86 FR 9540
    Reading Time:about a minute or two

    Siegfried USA, LLC, located in New Jersey, has submitted an application to become an importer of specific controlled substances, as noted by the Drug Enforcement Administration (DEA). The company plans to import these substances to create active pharmaceutical ingredients for its clients, specifically using Phenylacetone to produce Amphetamine. Comments or objections regarding this application are invited by March 18, 2021, and requests for a hearing can also be made by this date. Final permit approval will align with conditions outlined under the relevant U.S. Code and does not permit the commercial import of drug forms approved or non-approved by the Food and Drug Administration (FDA).

    Simple Explanation

    Siegfried USA, LLC wants permission from the government to bring special ingredients into the country to make medicine for their customers. People can say if they think it's a good or bad idea by a certain date, but it's important that these ingredients are used safely and not for anything bad.

  • Type:Notice
    Citation:86 FR 10335
    Reading Time:about 10 minutes

    The Drug Enforcement Administration (DEA) has revoked the DEA registration of Dr. Milad I. Shaker due to his lack of authority to handle controlled substances in Pennsylvania. This decision followed the suspension of his medical license in Pennsylvania after he was found noncompliant with probation terms and was convicted of unlawfully distributing a controlled substance. Dr. Shaker did not request a hearing or submit a corrective action plan, leading to the automatic waiver of these rights. As a result, his registration has been revoked, and any pending applications to renew or modify this registration have been denied.

    Simple Explanation

    The government took away Dr. Shaker's permission to give out certain medicines because he got into trouble for not following the rules in Pennsylvania, and he also broke the law by giving out drugs wrongly.

  • Type:Notice
    Citation:90 FR 10731
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Catalent Pharma Solutions wants to bring certain special medicines from other countries into the U.S. so they can use them for important tests and studies. People have until March 28, 2025, to say if they have any concerns about this.

  • Type:Notice
    Citation:86 FR 11328
    Reading Time:about 2 minutes

    The Drug Enforcement Administration (DEA) has announced that GGGYI LLC has applied to be registered as a bulk manufacturer of certain controlled substances, specifically marihuana, for research purposes. This application is part of DEA's program to oversee the cultivation and distribution of marihuana for scientific and medical research under strict regulations. Interested parties, such as existing manufacturers or applicants, can submit comments or objections regarding this application by April 26, 2021. The DEA will evaluate the application based on applicable laws and regulations to ensure proper safeguards against misuse are in place.

    Simple Explanation

    The DEA is looking at an application from a company called GGGYI LLC that wants to grow a big amount of marihuana for research to help doctors and scientists. People can say what they think about this idea until April 26, 2021, so the DEA can make sure it’s safe and done the right way.

  • Type:Notice
    Citation:90 FR 11997
    Reading Time:about a minute or two

    Fisher Clinical Services, Inc. has applied to the Drug Enforcement Administration to be registered as an importer of certain controlled substances. The purpose of this registration is solely for use in clinical trials, and not for the commercial sale of the substances. The public can submit comments or request a hearing about this application until April 14, 2025. Comments must be submitted electronically, and hearings can be requested in writing, with specific addresses provided for these submissions.

    Simple Explanation

    Fisher Clinical Services wants permission from the government to bring special medicines into the country, but only to use them for testing, not selling. People have time until April 14, 2025, to tell the government what they think about this or ask for a chat about it.

  • Type:Notice
    Citation:90 FR 16002
    Reading Time:about 15 minutes

    The Drug Enforcement Administration (DEA) has revoked the DEA registration of Dr. Victor Augusto Silva from Tampa, Florida, due to his failure to comply with federal and state laws regarding controlled substances. The DEA found that Dr. Silva allowed an unauthorized individual to use his registration to issue prescriptions for controlled substances, which is against the law. As Dr. Silva did not adequately respond to the charges or demonstrate he can be trusted with prescribing controlled substances, the DEA determined his continued registration would not serve the public interest. As a result, his registration was revoked, and any pending applications for registration in Florida were denied.

    Simple Explanation

    Dr. Victor from Tampa, Florida, got his permission to give out certain medicines taken away because he let someone else use his special permission slip, and that's not allowed by the rules. The people in charge checked and decided that he couldn't be trusted with this responsibility anymore.

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