Search Results for keywords:"Drug Enforcement Administration"

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Search Results: keywords:"Drug Enforcement Administration"

  • Type:Notice
    Citation:86 FR 9538
    Reading Time:about 2 minutes

    The Drug Enforcement Administration (DEA) is notifying the public of an application from JW Colorado, LLC, to be registered as a bulk manufacturer of marihuana, a controlled substance listed under schedule I. The DEA will evaluate the application along with others under regulations meant to ensure that the growth of marihuana is for legitimate scientific and medical research purposes. Written comments or objections to this proposed registration must be submitted by April 19, 2021, and the evaluation will ensure compliance with all relevant laws and safeguards against misuse.

    Simple Explanation

    The DEA is telling everyone that a company wants to grow marijuana for important science and medical studies, but before saying yes, they want to check very carefully that it's safe and legal.

  • Type:Notice
    Citation:89 FR 102649
    Reading Time:about 19 minutes

    The Drug Enforcement Administration (DEA), part of the Department of Justice, has issued a final order establishing the aggregate production quotas for controlled substances in schedules I and II, and the annual needs for chemicals like ephedrine and pseudoephedrine for 2025. The order responds to public comments, particularly concerns about potential drug shortages, emphasizing that DEA aims to balance preventing drug misuse with ensuring adequate supply for medical and scientific needs. The quotas are set to address legitimate needs while considering factors like past usage data and potential diversion risks. Public concerns about opioid shortages were discussed, with the DEA noting that various external factors could affect drug availability and reassured that they are working with other agencies to mitigate such issues.

    Simple Explanation

    The government set rules about how much of certain strong medicines can be made each year to make sure there's enough for people who need them, but they also want to stop people from using them in the wrong way. They listen to people’s worries about not having enough medicine but try to make sure there's a good balance.

  • 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:Rule
    Citation:90 FR 6504
    Reading Time:about 107 minutes

    The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have finalized a rule expanding the ability for practitioners to prescribe certain controlled substances for opioid use disorder (OUD) treatment through telemedicine, including audio-only calls. Under these new rules, practitioners can prescribe a six-month supply of these medications after reviewing the patient's prescription drug monitoring program data, with the possibility of extending prescriptions through telemedicine or after a face-to-face evaluation. Additional safeguards include identity verification by pharmacists before filling prescriptions to prevent misuse. The rule aims to continue the telemedicine flexibilities introduced during the COVID-19 pandemic while addressing the opioid crisis and concerns about substance misuse.

    Simple Explanation

    The government has made a new rule so doctors can help people with medicine for feeling better from bad drugs over the phone. They also made sure people picking up these medicines from the pharmacy show who they are to stop any bad stuff from happening.

  • Type:Notice
    Citation:86 FR 10357
    Reading Time:about a minute or two

    VHG Labs, operating as LGC Standards, has submitted an application to the Drug Enforcement Administration (DEA) to become an importer of specific controlled substances, including synthetic cannabidiol and synthetic tetrahydrocannabinol. The company intends to supply these substances to research facilities for drug testing and analysis. Interested parties, such as existing manufacturers or applicants of these substances, can submit comments or request a hearing regarding this application before March 22, 2021. This notice does not permit the import of finished drugs for commercial sale.

    Simple Explanation

    VHG Labs, a company also known as LGC Standards, wants permission to bring special substances into the country to help scientists with their experiments, and people have until March 22, 2021, to share their thoughts or concerns about this plan.

  • Type:Notice
    Citation:89 FR 102954
    Reading Time:about 3 minutes

    The Drug Enforcement Administration (DEA), part of the Department of Justice, is planning to submit an information collection request to the Office of Management and Budget (OMB) for approval. This collection involves the Leadership Engagement Survey, which is administered annually to federal government employees, contractors, and task force officers working at the DEA. The survey is voluntary and takes about 20 minutes to complete, with an expected response count of around 5,000 people. The DEA is seeking authorization to conduct this survey for three years, which will not incur additional costs since it operates on an existing internal platform.

    Simple Explanation

    The Drug Enforcement Administration (DEA) wants to ask people who work with them some questions about being leaders, but it's not clear what all the terms mean or why only a third of the people might answer. They need approval to ask these questions, but they haven't explained everything clearly, like why it's okay for people to choose not to answer or if this will help them make things better.

  • Type:Notice
    Citation:89 FR 106582
    Reading Time:about 6 minutes

    The Drug Enforcement Administration (DEA) issued an order to revoke the DEA registration of Robert Esser, D.D.S., from Erie, Pennsylvania, because his dental license is suspended, making him unable to legally handle controlled substances in Pennsylvania. Dr. Esser did not request a hearing to contest this, leading to his default according to DEA rules. The DEA has denied any pending applications for Dr. Esser to renew or modify his registration, effective January 29, 2025. Consequently, Dr. Esser is not permitted to dispense controlled substances as he does not meet the legal requirements set by the state and DEA regulations.

    Simple Explanation

    In a simple way, this means that Dr. Esser, a dentist, can't give out special medicines anymore because he lost his permission for that in Pennsylvania. The rules say if he can't do it there, he can't do it anywhere, so he didn't try to change the decision, which means it's final.

  • 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 16556
    Reading Time:about a minute or two

    The Drug Enforcement Administration (DEA) has announced that the Research Triangle Institute has applied to become a bulk manufacturer of certain controlled substances. The institute intends to produce these substances synthetically for research purposes and to provide analytical reference standards. Interested parties can submit electronic comments or objections regarding this registration by June 17, 2025, and can request a hearing by the same date. Comments are to be submitted through the Federal eRulemaking Portal at regulations.gov.

    Simple Explanation

    The Research Triangle Institute wants to make special chemicals used for research, and the government (the DEA) is thinking about giving them permission. People can say what they think about it or ask for a meeting to talk about it before June 17, 2025.

  • Type:Notice
    Citation:86 FR 9535
    Reading Time:about a minute or two

    S&B Pharma, Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company intends to import intermediate forms of Tapentadol for manufacturing purposes and ANPP to produce other controlled substances, but they will not import finished products for commercial sale. Interested parties, such as registered manufacturers, can submit comments, objections, or request a hearing regarding this application by March 18, 2021.

    Simple Explanation

    S&B Pharma, Inc. wants permission to bring in special ingredients that can be used to make certain medicines, but they don't want to sell final medicine products. People who are interested can tell the boss what they think by talking or asking questions before March 18, 2021.