Search Results for keywords:"Director's Order

The Drug Enforcement Administration (DEA) has decided to revoke Joely Keen's DEA registration because she is no longer authorized to handle controlled substances in Texas. Her licenses to practice as an advanced practice registered nurse (APRN) and registered nurse in Texas have been revoked, and she lacks a necessary prescriptive authority agreement with a supervising physician. Without these, she cannot legally prescribe or dispense controlled substances, resulting in the loss of her DEA registration. The order becomes effective on April 28, 2025.

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 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means that the DEA's allegations against him are accepted as true, including that his California medical license has been revoked.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.

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) issued an order to revoke Maria Dewitt's registration to handle controlled substances because she lacks the necessary authorization in Texas. Dewitt did not have a required prescriptive authority delegation agreement with a physician, which is essential for an advanced practice registered nurse in Texas to manage controlled substances. The administrative law judge upheld this decision, noting that without state authorization, Dewitt could not maintain her DEA registration. Consequently, her registration was revoked, and any further applications for registration in Texas were denied.

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 FDA has issued a final debarment order against Alnashir Alibhai Punjani, prohibiting him from importing or attempting to import any drugs into the U.S. for five years. This decision is because Mr. Punjani was found guilty of conspiring to import and sell unapproved drugs. The drugs he imported and resold contained sildenafil, an ingredient used in Viagra, and were not approved by the FDA, raising potential health risks. Mr. Punjani did not respond to the notice of debarment, waiving his right to contest the decision.

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 Food and Drug Administration (FDA) issued an order banning Jonathan Corbett Cosie from importing any drugs into the United States for 10 years. This decision follows his conviction for two federal felonies related to selling misbranded, unapproved drugs, including some that were falsely labeled and sold without a prescription. Mr. Cosie was notified of his debarment and given the opportunity to request a hearing, but he did not respond, waiving his right to contest the decision. The ban is effective as of March 13, 2025.

The Drug Enforcement Administration (DEA) has revoked the DEA registration of Dr. Kim Routh from Grove City, Ohio, because he lost his medical license in Ohio, rendering him unable to legally handle controlled substances. The revocation is based on an Order to Show Cause issued by the DEA, which Dr. Routh did not contest by requesting a hearing. The document states that having a valid state medical license is a crucial requirement for holding a DEA registration, and without it, Dr. Routh cannot continue to administer or prescribe controlled substances. The order also denies any pending applications from Dr. Routh to renew or modify his registration.