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Applying or Renewing a DEA Registration

DEA registration and renewal is smooth sailing in most instances. However, challenges and hurdles can crop up when the DEA chooses to deny the application which can result in a legal hearing.

Healthcare professionals like physicians, nurses, physician assistants, dentists, veterinarians and even pharmacists that prescribe, administer or dispense controlled substances are required to possess a valid controlled substance license registration issued by the Drug Enforcement Agency (DEA).

New applicants for the Certificate of Registration are required to submit the DEA Form 224 along with the valid documents and it can take four to six weeks for the federal agency to process the registration. The registration has to be renewed at periodic intervals through the DEA Form 224a which can take up to four weeks.
 

In reality, the DEA takes much longer to issue the registration and applicants are often left waiting for months to even hear from the DEA. While the process usually proceeds smoothly and in good faith, the agency has the right to deny the registration (or renewal) under special circumstances. Such as:


  • Providing false information on the application
  • Applicant being convicted for felony under state or federal laws related to controlled substances
  • Suspension, revocation or denial of a state license or registration
  • Applicant has lost provider status and is excluded from participating in Medicare, Medicaid or other insurance programs
  • Failing to maintain effective controls against drug diversion
  • Cases of failure to comply with applicable state and local laws
  • Previous state or federal convictions related to the manufacture, distribution or dispensing of controlled substances
  • Lack of experience in handling or distributing controlled substances
  • Any other factors that can affect public safety and health

In case the DEA is considering denying a registration or renewal of registration, it will first issue a formal ‘Show Cause’ order to the applicant. It will contain a statement of the legal basis for the hearing, the reason(s) for denial and a summary of the matters of fact and law asserted.

This is the applicant’s chance to explain why the application should be approved instead. He/she can file a request for a DEA administrative hearing or submit a written statement in lieu of the same. Either action should be taken within 30 days from the receipt of the order. Failure to do so will waive the rights to a hearing and can lead to the final denial of the registration application or renewal.

During the hearing, both sides can present their arguments and evidence to an Administrative Law Judge (ALJ). After reviewing the case, the ALJ will issue a recommendation as to whether the DEA registration should be granted or denied. In case of dissatisfaction, the applicant can appeal in a federal court with appellate jurisdiction.

Therefore, it is always better to have DEA compliance experts guide and oversee the process of applying for DEA controlled substance licenses. The professionals will ensure that everything is in order. They will also know how to proceed in case the application is rejected for some reason.
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