It is not just prescribing and dispensing of controlled substances, even research activities require a DEA registration. In fact, this varies with the schedule of drugs being used, while other rules remain the same.
There are certain drugs that are strictly regulated under the Controlled Substances Act because of their tendency to create dependence or cause abuse. Schedule I substances are classified as ‘no currently accepted medical use or treatment’ in the United States and cannot be prescribed or administered to patients. Drugs classified under Schedules II to V can be prescribed, dispensed or administered to patients facing serious medical conditions, but only by those who hold a valid controlled substance license registration.
However, apart from treating patients, controlled substances are also regularly used in research for studying their potential benefits, side effects and so on. Yet, their diversion and abuse still remain a lingering concern.
This is why the Drug Enforcement Administration (DEA) also requires researchers to obtain a DEA registration before dabbling in controlled substances. And the fallout of non-compliance can be severe.
Registration categories for researchers
Here, simply registering with the DEA will not suffice for using any and every of the controlled substances in a study project. There are two separate categories for registration for research. Conducting research using Schedule I drugs requires a separate registration while there is another distinct one for using Schedule II to V substances.
Needless to say, researchers who intend to use drugs from both categories need to obtain two separate registrations from the DEA. Form 225 is used for the registration and can be obtained online or by writing to the DEA Diversion Control Division office. A registration application fee (non-refundable) will be applicable.
A DEA investigator will contact the applicant to finalize the registration. However, the DEA reserves the right to deny, revoke or suspend the research registration just like in regular cases.
Please note that if a person conducts research at more than one location, each place must be separately registered with the DEA. Storage, security, authorization and disposal rules will also apply.
This Certificate of Registration (DEA Form 223) has to be maintained at the registered location in a readily retrievable manner and available for official inspection at all times. A duplicate copy of the certificate can be requested online or from the DEA headquarters.
The researcher registration is valid for 12 months, though some researchers may receive an initial registration period for as low as nine months or even an extended one till 15 months.Renewal has to be done using Form 225a.
Along with this, a state license to conduct research and/or a State controlled substance registration (if applicable) is also mandatory.
Those looking to obtain a DEA new registration, irrespective of the purpose, can reach out to an expert service provider, like the Titan Group. They will take care of all the formalities while ensuring continued compliance at all levels. Peace of mind and security is guaranteed.
