Search Results for agency_names:"Drug Enforcement Administration"

The Drug Enforcement Administration (DEA) has proposed a new rule to allow healthcare practitioners to prescribe controlled substances via telemedicine, without needing an in-person exam, through a Special Registration framework. This framework permits three types of special registrations: Telemedicine Prescribing Registration for Schedule III-V drugs, Advanced Telemedicine Prescribing Registration for Schedule II-V drugs for certain specialists, and Telemedicine Platform Registration for online platforms to dispense these drugs. These changes, which aim to expand patient access while safeguarding against drug abuse, also require practitioners to perform additional prescription checks and comply with detailed reporting and recordkeeping. Public comments on this proposal are welcome before final implementation.

The Drug Enforcement Administration (DEA) announced that Mountain Trading LLC has applied to be registered as a bulk manufacturer of marihuana, a controlled substance listed under schedule I. The DEA will evaluate this application, along with others, based on the criteria set out in relevant laws and regulations. Current bulk manufacturers and other applicants can submit comments or objections to this application until April 19, 2021. If registered, the company will produce active pharmaceutical ingredients for research purposes only and must comply with established safeguards against drug diversion.

Kinetochem LLC has filed an application to be registered as a bulk manufacturer of certain controlled substances. The company plans to manufacture these substances, including synthetic versions of Marihuana and Tetrahydrocannabinols, for use as Active Pharmaceutical Ingredients in research and clinical trials. The public or other manufacturers may submit comments or objections electronically by February 4, 2025, through the Federal eRulemaking Portal.

Siegfried USA, LLC has applied to the Drug Enforcement Administration (DEA) to become a registered manufacturer of certain controlled substances in bulk. This application was submitted on December 9, 2020. Interested parties can submit comments, objections, or requests for a hearing regarding this application by March 15, 2021. The purpose of this registration is for Siegfried USA, LLC to produce these substances for sale to their customers, and no other activities with these drugs are permitted under this registration.

The Drug Enforcement Administration (DEA) has revoked the DEA Certificate of Registration for Dr. Shiva Akula after finding that he is not authorized to handle controlled substances in Louisiana, as his medical license is suspended and his controlled substances license is lapsed. The decision follows a Motion for Summary Disposition by the DEA, which Dr. Akula did not respond to, and a recommendation from the Administrative Law Judge supporting the revocation. Consequently, Dr. Akula is also denied any pending applications to renew or modify the registration. This decision was signed by DEA Administrator Anne Milgram and will take effect on January 29, 2025.

The Drug Enforcement Administration (DEA) has decided to revoke the registration of Jeffrey W. Young, Jr., a nurse practitioner from Tennessee, due to his lack of state authorization to handle controlled substances. Young's Tennessee nurse and advanced practice nurse licenses were both revoked, making him ineligible to dispense medications under state laws. Despite being given a chance, Young did not request a hearing to challenge this decision, leading the DEA to proceed with the revocation of his Certificate of Registration. This order will be effective from January 29, 2025.

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.

The Drug Enforcement Administration (DEA) has decided to revoke Dr. Yogesh Patel's DEA registration because he is not permitted to handle controlled substances as he lacks the authority to practice medicine in Colorado. The DEA's Order to Show Cause indicated that Dr. Patel's Colorado medical license is restricted, preventing him from practicing medicine, which is a critical requirement for maintaining his DEA registration. Dr. Patel did not request a hearing or dispute these allegations, leading to the revocation of his registration and denial of any pending applications. This decision was finalized by Acting Administrator Derek Maltz and will take effect on March 17, 2025.

The Drug Enforcement Administration (DEA) issued a decision to revoke Dr. Robert L. Carter's registration to handle controlled substances. This decision was due to his repeated material falsifications on DEA applications by misrepresenting his disciplinary history, as well as improperly prescribing controlled substances from a New Jersey address without the necessary registration. Despite being given multiple opportunities to comply with prehearing procedures, Dr. Carter failed to do so, which led to the termination of his hearing request. The DEA determined that Carter's actions were inconsistent with the public interest and could not trust him with a registration.

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.