Search Results for keywords:"controlled substances"

Found 141 results
Skip to main content

Search Results: keywords:"controlled substances"

  • Type:Notice
    Citation:90 FR 17450
    Reading Time:about a minute or two

    SpecGx LLC is seeking to become a registered bulk manufacturer of certain controlled substances. The Drug Enforcement Administration (DEA) has announced the application and is allowing other existing bulk manufacturers and applicants to submit comments or objections electronically until June 24, 2025. Additionally, there is a provision for requesting a hearing on this application within the same timeframe. SpecGx plans to manufacture these substances mainly for use as Active Pharmaceutical Ingredients and Analytical Research Standards.

    Simple Explanation

    SpecGx LLC wants permission to make large amounts of certain medicines, and people have until June 24, 2025, to say if they think this is a good idea or not.

  • 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 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 15999
    Reading Time:about 16 minutes

    The Drug Enforcement Administration (DEA) has revoked the DEA Certificates of Registration for Lona Bibbs-Walker, D.D.S., after finding that her continued registration would pose an imminent danger to public health and safety. The Georgia Board of Dentistry revoked her authority to practice dentistry, and evidence showed she failed to maintain accurate records and account for controlled substances. Despite these allegations, Dr. Bibbs-Walker did not request a hearing, leading to the default judgment against her and further supporting the DEA's decision to revoke her registrations. The decision highlights the importance of compliance with state and federal regulations for handling controlled substances.

    Simple Explanation

    The DEA took away the special permission for a dentist named Lona Bibbs-Walker to give out certain medicines because she didn't keep careful track of them and is no longer allowed to be a dentist in Georgia. She didn't ask for a chance to explain herself, so they decided she can't have this permission anymore to keep everyone safe.

  • Type:Notice
    Citation:90 FR 13783
    Reading Time:about 2 minutes

    SpecGx LLC has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances. The company intends to import specific drugs, including Tapentadol and Thebaine, for manufacturing purposes to create Active Pharmaceutical Ingredients. This notice allows registered manufacturers and other stakeholders to submit comments or request a hearing about this application by April 25, 2025. Approval for import will be strictly for manufacturing purposes and not for importing finished drug forms for sale.

    Simple Explanation

    SpecGx LLC wants permission from the government to bring in special ingredients from other countries to make medicine, but not to sell the medicine itself. People who make medicine or are interested can say what they think about this by a certain date.

  • Type:Notice
    Citation:90 FR 17626
    Reading Time:about a minute or two

    Siemens Healthcare Diagnostics, Inc. has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of certain classes of controlled substances. The intention behind this registration is to produce these substances in bulk for use in making DEA-exempt products. The public, as well as other registered bulk manufacturers and applicants, can submit comments or objections electronically about this application until June 27, 2025. They can also request a hearing on the matter by the same date through the Federal eRulemaking Portal.

    Simple Explanation

    Siemens Healthcare Diagnostics wants permission from a government group to make lots of special medicines because they have ideas for new products that won't break any rules. People can say if they think this is a good or bad idea until the end of June 2025.

  • Type:Notice
    Citation:90 FR 13200
    Reading Time:about 6 minutes

    The Drug Enforcement Administration (DEA) issued an Order to Show Cause to Dr. Margaret Sprague, proposing to revoke her Certificate of Registration due to her lack of authority to handle controlled substances in California. This decision followed the revocation of her state medical license by the Medical Board of California. Dr. Sprague did not request a hearing and was deemed in default, admitting the allegations against her. Consequently, the DEA revoked her registration and denied any future applications for registration in California.

    Simple Explanation

    Dr. Margaret Sprague lost her permission to give out certain medicines in California because she no longer had a valid doctor's license. Without her license, the rules say she can't continue, so now she can't give out those medicines anymore in California.

  • 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.

  • 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.

  • 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.