It is illegal to prescribe controlled substances without being registered with the DEA. Getting the DEA number is a complex process and maintaining compliance post registration is another tall order!
Drugs that are defined as controlled substances are critical and highly regulated in the United States. Every healthcare provider - including physicians, dentists, veterinarians, physician assistants and nurse practitioners - who prescribes, administers or dispenses these controlled substances (including opioids, morphine and steroids) should have a DEA number.
The federal Drug Enforcement Administration assigns a unique number to each provider after the DEA new registration is complete whichmust thereafter be used by the practitioner in all prescriptions or orders of controlled substances. This becomes a tool for the DEA to authenticate and track provider prescriptions along with the specific quantities prescribed so as to monitor potential fraud and abuse.
Applicants have to submit DEA Form 224 by providing their personal/business details along with information about their business activity, drug schedule and also controlled substances in their background. Providing valid and active state medical and/or controlled substance licenses/registrations is also mandatory.
An application fee also has to be paid which is non-refundable. The fees varies depending on the category and period of registration.
It should be noted that while the DEA issues the DEA number, the licensure and regulation takes place at the state level. Certification and testing is specified by both state and federal law. Processing of new registrations with the DEA takes around four to six weeks. And failure to comply with the requirements can be deemed as cause to declare the application as defective. It will be withdrawn without any refund of the fee.
The initial registration will be valid for a minimum of 28 months to a maximum of 39 months and must be renewed accordingly. After this, the renewal period will be every three years. Then again, the registration has to be modified every time the registrant moves to a new location. It will be handled like a new application and must be approved by the DEA who will issue a new certificate of registration. Moreover, separate DEA registration is required for each state where the registrant prescribes, administers or dispenses controlled substances.
That’s not all either. Following the controlled substance license registration, proper management and oversight of the scheduled drugs is crucial to avoid mishandling, diversion and other illegal activities. Moreover, the registrants will also have to comply with the state and federal procedures and security protocols. They will be subject to regular compliance audits to check whether the operations and policiesare conforming with all the regulations or not.
Fortunately, there are specialized service providers that offer a full suite of compliance-protection and fraud-detection services that mitigates the potential risks. This will ensure peace of mind as getting the DEA registration can be quite complicated in itself. And ensuring compliance after the registration becomes an ongoing challenge! The right assistance will ensure that the registrant does not fail any of the federal or state regulatory inspections.
