Did you know that the United States currently has over 2 million Drug Enforcement Administration (DEA) registrants engaging in activities with controlled substances? Whether you’re a student in residency, a healthcare provider, or a business aiming to enter the controlled substance space, understanding the process to obtain federal licensing is crucial. If you’re uncertain about where to begin, enlisting the services of a third-party consultant can be beneficial; specifically, consultants who have experience in completing the DEA Registration application process.

Types of DEA Registration Applications

There are four primary application types:

• Practitioners – including pharmacies, hospitals/clinics, doctors, teaching institutions, and mid-level practitioners (DEA Form 224).
• Non-practitioners – business entities interested in importing, exporting, manufacturing, distributing, researching, or conducting chemical analysis with controlled substances (DEA Form 225).
• Narcotic Treatment Programs (NTPs) – facilities offering maintenance and detoxification services for Substance Use Disorder (SUD), requiring a specific application distinct from other business entities (DEA Form 363).
• Domestic Chemical – companies engaged in the import, export, manufacture, and distribution of List 1 chemicals (DEA Form 510).

Electronic submission of applications and other information is mandatory; applications forms can be accessed on the DEA Diversion Control Division website. Applicants should ensure the proper application type as described above so that the approval process is not delayed.

Requirements

The applicant must meet specific requirements to have an application approved. Though not an all-inclusive list, some minimal requirements include:

• Use of a computer and a valid email address.
• Payment of non-refundable registration fees at the time of application submission.
• Proper state licensing for business type, including state-controlled substance licensing if required.

Expectations

It is important to note that sometimes, especially for non-practitioners, the pre-registration process may take some time before a decision is made. Thus, it is imperative to diligently prepare before submitting your DEA Registration application, ensure that all pre-requisites have been met, and that all information is accurate and complete:

• State authority: Depending on the applicant’s business activity, this can cause some applications to be in pending status until proper state authority is confirmed. DEA investigators verify reported state information, especially state board issues, through various background searches.
• Liability questions: Each application asks four different liability questions. These questions must be answered and are crucial to advance the application in a timely manner.
• Preparation for on-site pre-registration inspections: For non-practitioners, NTPs, and Domestic Chemical applicants, an on-site visit by the local DEA office is almost a certainty to confirm compliance with procedures and security measures. Reporting and recordkeeping responsibilities are also discussed, emphasizing the prevention of controlled substance diversion. Ensuring not only that all regulatory requirements are met but that personnel are prepared for the inspection are important components of readiness.

Common Pitfalls

Recognizing common pitfalls can expedite the registration process and help guarantee a smooth and streamlined application process. The following are a few examples of such missteps:

• Providing incomplete or inaccurate information on the application.
• Not properly satisfying state and local licensing requirements.
• Not disclosing proper historical information in response to the liability questions.
• Not having policies and procedures related to controlled substances in place.
• Lack of physical security or control measures to guard against diversion.

When navigating the intricate details of the application process, seeking the assistance of a third-party consultant such as the DEA experts at Guidepost can be invaluable. Common scenarios where a consultant can help include:

• Preparing for a DEA on-site inspection, including compiling a DEA Binder.
• Establishing standard operating procedures for handling, hiring, and training employees, and security of controlled substances.
• Determining the necessity for multiple registrations, if warranted.
• Interpreting DEA expectations related to non-practitioners’ security features.
• Addressing complexities like the usage of third-party logistic companies and applying for manufacturing or procurement quotas.

The Takeaway

Partnering with experienced professionals during the application process can save you and your organization time and resources that can be better spent towards growing your business or practice. Since obtaining a DEA registration is the first step in the process, collaborating with experts from the beginning of your venture helps to set the registrant up for future compliance success.