Search Results for keywords:"Director's Order

The Food and Drug Administration (FDA) has issued an order permanently banning John Warrington Kosolcharoen from working with companies that have approved or pending drug product applications. This decision resulted from his felony conviction for fraudulently selling an unapproved stem cell product, ReGen, and making misleading claims about its safety and effectiveness. Mr. Kosolcharoen was given the chance to challenge the debarment but did not respond in the provided timeframe, leading to a waiver of his right to a hearing on the decision. During his debarment, any business that employs him for related services could also face penalties.

The Food and Drug Administration (FDA) is issuing a permanent debarment order against Joseph A. Rowan, preventing him from working with any businesses that have drug product applications. This order results from Mr. Rowan's felony conviction related to illegal activities with the drug SUBSYS while at Insys Therapeutics. He was found guilty of racketeering, mail fraud, and wire fraud, including bribing doctors to prescribe SUBSYS to patients without cancer and misleading insurers. Mr. Rowan was notified of this debarment decision and waived his right to contest it by not requesting a hearing.

The Drug Enforcement Administration (DEA) is revoking the registration of Dr. Harvey Leslie, which allowed him to handle controlled substances. This is because his medical license in Georgia has been revoked, and he can no longer practice medicine or legally handle controlled substances there. Since having a valid state license is necessary to maintain DEA registration for handling controlled substances, Dr. Leslie's registration is being revoked, effective April 28, 2025. The decision was signed by the Acting Administrator, Derek Maltz, on March 20, 2025.

The Drug Enforcement Administration (DEA) has decided to revoke William Needham's Certificate of Registration to handle controlled substances in Mississippi. This decision was made because Needham is no longer authorized to practice nursing in Mississippi after his nursing licenses were revoked. The DEA issued an Order to Show Cause, but Needham did not respond, which led to a default judgment against him. Consequently, without a state license, he cannot legally dispense controlled substances and will not have his DEA registration or any related applications renewed.

The Drug Enforcement Administration (DEA) decided to revoke the registration of Neumann's Pharmacy, LLC, after finding that it repeatedly failed to ensure controlled substance prescriptions were issued for legitimate medical purposes and did not document resolutions of red flags like drug interactions and cash payments. The pharmacy also improperly filled prescriptions written by the owner’s father, which violates Louisiana law. Despite given opportunities, the pharmacy did not fully acknowledge its mistakes or demonstrate it corrected them, leading to concerns about its ability to responsibly handle controlled substances in the future. The agency emphasized the importance of deterrence and the severity of the misconduct, ultimately leading to revocation of the pharmacy's DEA registration.

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.

The U.S. Department of Energy has issued a Prohibition Order that restricts the acquisition and use of certain bulk-power system (BPS) electric equipment from China because of national security concerns. This order aims to prevent foreign adversaries from potentially exploiting these equipment vulnerabilities, especially in areas critical to defense facilities. It specifically targets equipment like transformers and circuit breakers operating at 69 kV or higher if they are manufactured or supplied by entities under China's influence. Violation of this order may result in significant civil or criminal penalties.

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.

The Drug Enforcement Administration (DEA) has decided to revoke John Stanton, M.D.'s DEA registration because his medical license in Tennessee was revoked, meaning he can't legally handle controlled substances in the state. An Order to Show Cause was issued previously, suggesting the removal of his DEA Certificate of Registration, as he didn't request a hearing, leading to a default judgment. As a result, the DEA has also denied Dr. Stanton's pending applications for any new registration in Tennessee. This decision was signed by the Acting Administrator of the DEA and will take effect on May 21, 2025.

The U.S. Department of Justice and the Drug Enforcement Administration took action against Dr. David Bockoff, resulting in the revocation of his license to prescribe controlled substances. This decision came after a hearing revealed he had violated standards of care in prescribing powerful drugs without proper medical examinations or documentation. The government's investigation showed that between January 2020 and June 2022, he frequently prescribed these drugs in a manner inconsistent with both federal and California laws. Dr. Bockoff did not successfully challenge these findings or take responsibility, leading to the conclusion that his practices were dangerous to public health.