Search Results for keywords:"Drug Enforcement Administration"

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Search Results: keywords:"Drug Enforcement Administration"

  • Type:Notice
    Citation:90 FR 10732
    Reading Time:about a minute or two

    S&B Pharma LLC DBA Norac Pharma has submitted an application to the Drug Enforcement Administration (DEA) to register as an importer of certain controlled substances. The company intends to import intermediate forms of Tapentadol for further manufacturing and ANPP for producing other controlled substances. Public comments or objections to this application can be submitted electronically by March 28, 2025. The DEA will only approve import permits if the company's activities comply with specific federal regulations.

    Simple Explanation

    S&B Pharma wants permission from a special U.S. agency to bring in certain powerful medicine ingredients from other countries to make new medicines. People can tell the agency if they think this is okay or not until almost the end of March 2025.

  • Type:Notice
    Citation:89 FR 97070
    Reading Time:about a minute or two

    Navinta LLC has applied to the Drug Enforcement Administration to become a registered bulk manufacturer of certain controlled substances. This registration is part of the process to gain approval for manufacturing these substances for validation purposes, which is a step required by the Food Administration before the substances can be distributed to their customers. The public, including current manufacturers of these substances, can submit comments or objections electronically by February 4, 2025. Comments should be submitted through the Federal eRulemaking Portal to ensure they are properly received.

    Simple Explanation

    Navinta LLC wants to make special kinds of medicines and needs permission first. People have a chance to say if they think this is okay or not by February 4, 2025.

  • Type:Notice
    Citation:90 FR 13782
    Reading Time:about a minute or two

    The Drug Enforcement Administration (DEA) has announced that Sterling Wisconsin, LLC applied to register as a bulk manufacturer of certain controlled substances, specifically synthetic versions of Marihuana Extract, Marihuana, and Tetrahydrocannabinols. Interested parties can submit comments or objections electronically or request a hearing until May 27, 2025. The application was filed on January 30, 2025, and comments should be submitted via the Federal eRulemaking Portal as instructed.

    Simple Explanation

    Imagine a company wants permission to make a special kind of medicine from plants that are usually watched over closely. The people who make the rules asked others to tell them what they think before saying yes or no.

  • Type:Notice
    Citation:90 FR 8158
    Reading Time:about a minute or two

    Veranova, L.P. has applied to become a registered bulk manufacturer of specific controlled substances. The application has been submitted to the Drug Enforcement Administration (DEA) to support their manufacturing and analytical testing needs. Public comments or objections regarding this application can be submitted electronically through the Federal eRulemaking Portal until March 25, 2025. Individuals may also request a hearing about the application by the same date.

    Simple Explanation

    Veranova, L.P. wants to make some special medicines that are carefully controlled because they can be dangerous if not handled right. The government is asking people to say what they think about this plan before it makes a decision.

  • Type:Notice
    Citation:89 FR 106584
    Reading Time:about 7 minutes

    The Drug Enforcement Administration (DEA) issued an Order to Show Cause to Dr. Matthew Okeke, who is based in Nevada. This order proposed revoking his DEA registration because he no longer has a valid state license or authority to handle controlled substances in Nevada. Dr. Okeke did not respond to the order, leading the DEA to proceed with final agency action to revoke his registration. The decision was signed by DEA Administrator Anne Milgram and is set to take effect on January 29, 2025.

    Simple Explanation

    The Drug Enforcement Administration (DEA) is taking back Dr. Matthew Okeke’s permission to handle special medicines because he lost his state license in Nevada, and he didn't reply when they asked why they shouldn't do this.

  • Type:Notice
    Citation:86 FR 9536
    Reading Time:about a minute or two

    Noramco Coventry, LLC has applied to the Drug Enforcement Administration to become an importer of certain controlled substances like raw opium and poppy straw concentrate. These substances will be used to manufacture bulk active pharmaceutical ingredients (APIs) that the company distributes. They will also import other substances for comparison with their own products to ensure quality before exporting their APIs to foreign markets. Public comments or objections to this application, including requests for a hearing, can be submitted until March 18, 2021.

    Simple Explanation

    Noramco Coventry, LLC wants to get permission to bring certain special substances like parts of plants used to make medicine from other countries. They use these substances to make important medicine ingredients and check their quality before sending them to other countries. People can say what they think about this plan until March 18, 2021.

  • Type:Notice
    Citation:90 FR 8534
    Reading Time:about 3 minutes

    The Department of Justice, specifically the Drug Enforcement Administration (DEA), announced a notice for public commentary on its information collection request related to the National Forensics Laboratory Information System. This system gathers drug analysis data from non-federal labs to improve accuracy on drug information. The DEA is seeking approval from the Office of Management and Budget (OMB) for a three-year extension without changes to the existing collection, which involves responses from various agencies and businesses. Public comments on the burden and utility of this data collection are being accepted until March 3, 2025.

    Simple Explanation

    The Department of Justice wants to keep checking how drugs are tested in labs to make sure they get the info right, and they're asking for permission to keep doing this from people who make the rules. They're also asking people to say if they think it's a good idea, but there are some confusing things about how much work it takes and how it helps, so they need better explanations.

  • Type:Proposed Rule
    Citation:86 FR 1030
    Reading Time:about 18 minutes

    The Drug Enforcement Administration (DEA) is proposing a new rule to require that all applications and renewals for DEA registration be submitted online. This change will eliminate the current option to submit paper forms, making the process more efficient and cost-effective. The proposal is expected to save money for both the DEA and applicants by reducing errors and the need for corrections, while nearly all current applicants already use the internet for submissions. The rule change also aligns with federal efforts to streamline and modernize regulatory processes.

    Simple Explanation

    The DEA wants people to apply for or renew their special permission to handle certain drugs, like medicine, using the internet instead of paper forms. They think doing this online will save time and money for everyone, but they haven't checked if everyone has internet to do this.

  • Type:Notice
    Citation:90 FR 13881
    Reading Time:about 6 minutes

    The Drug Enforcement Administration (DEA) decided to revoke the DEA Certificate of Registration for Dr. Willard J. Davis, a doctor in Texas, because he lost his state license to practice medicine, which means he can no longer handle controlled substances legally in Texas. The Texas Medical Board suspended Dr. Davis's medical license on May 16, 2024, and it remained suspended at the time of the decision. Since having a valid state medical license is necessary to maintain DEA registration for dispensing controlled substances, his registration was revoked, and any pending applications related to the registration were denied. This decision will be effective starting April 28, 2025.

    Simple Explanation

    Dr. Willard J. Davis can't be a doctor anymore because his permission to practice medicine was taken away, so he's not allowed to give out special medicine drugs anymore either.

  • Type:Notice
    Citation:90 FR 16554
    Reading Time:about a minute or two

    Scottsdale Research Institute has applied to the Drug Enforcement Administration to become an importer of basic classes of controlled substances for clinical research. Specifically, they plan to bring in synthetic cannabidiol for use by Schedule I researchers. People interested in this application can submit comments or request a hearing by May 19, 2025. The application does not include permission for importing substances for commercial sale.

    Simple Explanation

    Scottsdale Research Institute wants permission from the government to bring in special medicine from other countries to study it in research projects, but they can't sell it. People can say what they think about this plan until May 19, 2025.