Search Results for keywords:"Drug Enforcement Administration"

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Search Results: keywords:"Drug Enforcement Administration"

  • Type:Notice
    Citation:90 FR 13627
    Reading Time:about 3 minutes

    The Drug Enforcement Administration (DEA), part of the Department of Justice, has released a notice regarding an extension of a previously approved information collection related to the registration of those handling controlled substances. This involves DEA Forms 225, 225a, and 225b for businesses and individuals involved in the manufacturing, distribution, or research of controlled substances. The DEA is seeking public comments on the necessity, accuracy, and potential burden of this information collection process, which is estimated to affect 16,560 registrants and require 3,323 hours annually. Comments are welcome until May 27, 2025.

    Simple Explanation

    The DEA wants to keep track of all the people and businesses that work with special medicines known as controlled substances, so they're asking for public help to make sure the process is not too hard for those involved. They're also checking whether they need to change anything about how people sign up and what details they need to share, and they want to hear from everyone by May 27, 2025.

  • Type:Notice
    Citation:89 FR 97071
    Reading Time:about 2 minutes

    Noramco has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances, including Poppy Straw Concentrate and an intermediate form of Tapentadol. They plan to use these substances to manufacture other drugs for their customers. As part of their application, they also intend to import synthetic cannabidiol and synthetic Tetrahydrocannabinol, while noting that they will not import finished drugs for commercial sale. The public can submit comments or request a hearing on this application by January 6, 2025.

    Simple Explanation

    Noramco wants permission to bring certain special materials into the country to make medicine, but they won't sell these materials as final drugs. People have until January 6, 2025, to say what they think about this idea.

  • Type:Notice
    Citation:90 FR 13884
    Reading Time:about a minute or two

    Patheon API Services, Inc. has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances. They intend to use these substances as reference standards in research and development for API Manufacturing, and not for any commercial sales. People affected by this application can submit comments or request a hearing by April 28, 2025. All comments must be submitted electronically through the Federal eRulemaking Portal.

    Simple Explanation

    Patheon API Services, Inc. wants to bring in some special substances for scientific experiments but not to sell them. If people want to say something about this, they have until April 28, 2025, to do so online.

  • 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.

  • Type:Notice
    Citation:90 FR 7173
    Reading Time:about a minute or two

    Invizyne Technologies, Inc. has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of certain controlled substances, including synthetic Tetrahydrocannabinols. Stakeholders, such as current manufacturers and applicants, can submit comments or objections electronically through the Federal eRulemaking Portal by March 24, 2025, and may also request a hearing by the same date. The DEA has provided detailed instructions for submitting comments online and has assured that comments will receive a Comment Tracking Number upon successful submission.

    Simple Explanation

    Invizyne Technologies, Inc. wants to make a special kind of medicine and they're asking permission from a big government team called the DEA. People who have something to say about this can write in their thoughts or ask for a meeting before March 24, 2025.

  • Type:Notice
    Citation:90 FR 13892
    Reading Time:about 7 minutes

    The Drug Enforcement Administration (DEA) issued an order to revoke the registration of Dr. Thomas Andr'e Endicott, a dentist in Utah, due to his lack of authority to handle controlled substances after his state licenses were revoked. The DEA's decision is based on the fact that a practitioner must have state authority to dispense controlled substances to maintain DEA registration. Dr. Endicott did not respond to the order, which was served to him through various means, including email. Consequently, his DEA Certificate of Registration is revoked, and any pending registration applications he has are denied.

    Simple Explanation

    Dr. Thomas Endicott, a dentist in Utah, lost his permission to work with special medicines called "controlled substances" because his state licenses were taken away, and because of that, a government group called the DEA has taken away his permission card to use these medicines.

  • Type:Notice
    Citation:90 FR 15993
    Reading Time:about 12 minutes

    The Drug Enforcement Administration (DEA) issued an Order to Show Cause and Immediate Suspension of Registrations to Empire Pharmacy and Skyline Pharmacy in Philadelphia, claiming their activities posed an imminent danger to public health. Between 2019 and 2023, the pharmacies failed to maintain accurate records of controlled substances, violating federal and state laws. When the pharmacies did not request a hearing to dispute these claims, the DEA moved forward with final actions to revoke their registrations. Due to their failure to comply and their inadequate responses, the DEA decided to revoke both pharmacies' DEA Certificates of Registration.

    Simple Explanation

    Two pharmacies in Philadelphia got into trouble because they didn't keep track of their medicines properly, and this was dangerous, so the government stopped them from being allowed to sell certain drugs anymore.

  • Type:Notice
    Citation:86 FR 10337
    Reading Time:about 88 minutes

    In a decision by the Drug Enforcement Administration (DEA), Dr. Michael W. Carlton's Certificate of Registration was revoked due to inappropriate prescribing practices. The DEA found that Dr. Carlton issued 40 prescriptions for controlled substances without establishing a proper doctor-patient relationship and without conducting necessary physical exams, which violated federal and Arizona state laws. Dr. Carlton argued that his practice was standard at the outpatient treatment center where he worked, but the DEA's investigation and expert testimony showed that his actions fell below the standard of care. Consequently, the revocation was seen as necessary to protect public interest.

    Simple Explanation

    Dr. Michael W. Carlton got in trouble because he gave people medicine without checking them properly like doctors are supposed to, and this was not allowed by the rules. So, the big boss of medicine rules took away his permission to give out medicine to keep everyone safe.

  • Type:Notice
    Citation:86 FR 3197
    Reading Time:less than a minute

    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.

    Simple Explanation

    Siemens Healthcare Diagnostics Inc. wants to make certain special medicines, and they have asked for permission from a group that checks if it's okay. People who have thoughts or worries about this can write to the group or ask to talk with them by March 15, 2021.

  • Type:Notice
    Citation:89 FR 106579
    Reading Time:about a minute or two

    Irvine Labs Inc. has applied to the Drug Enforcement Administration (DEA) for registration as a bulk manufacturer of certain controlled substances. The application aims to facilitate research and development, as well as distribution to their research customers. The public can submit comments or objections about the application until February 28, 2025, via the Federal eRulemaking Portal. This notice was officially filed and noted by the DEA on December 27, 2024.

    Simple Explanation

    Irvine Labs Inc. wants to make and sell certain special medicines, but they need permission first. People can tell the government what they think about this until the end of February next year.