Opening a new pharmacy or navigating a change of ownership has always involved significant planning, documentation, and coordination. Recently, many pharmacies are encountering an additional layer of review from the Drug Enforcement Administration (DEA) during the registration process.
Across the industry, the DEA appears to be taking a more hands-on approach to reviewing new pharmacy applications and Change of Ownership (CHOW) situations before issuing or transferring DEA registrations.
Please know this does not necessarily indicate a problem with an application. Instead, it reflects a broader effort to strengthen oversight surrounding controlled substances, ownership verification, and pharmacy security.
What Are Pharmacies Experiencing?
Pharmacies applying for a new DEA registration, or submitting information related to a CHOW, are receiving requests for supplemental documentation and photographs before approval is granted.
These requests often include:
In many cases, applications are being placed into manual review while the DEA evaluates the information provided.
Why is the DEA Requesting More Information?
While the DEA has always maintained authority to review pharmacy applications, the level of detail being requested appears to be expanding.
The goal is likely tied to several key areas of concern, including:
This shift reflects an emphasis on documentation, transparency, and security before registrations are approved.
Common Documentation Requests
Based on recent experiences within the industry, pharmacies should be prepared to provide information such as:
Business Information
Ownership Information
CHOW Documentation
For Change of Ownership situations, pharmacies may also need:
Pharmacist-in-Charge and Staff Information
Business and Facility Documentation
Security and Facility Photos
Many pharmacies are also being asked to provide photographs showing:
Buildout Timing Matters
Pharmacies should be aware of timing.
The DEA may delay approval if the pharmacy is still under active construction or appears incomplete. Pharmacies should expect that the facility will need to be substantially completed or near completion before registration is finalized.
Incomplete shelving, unfinished workspaces, or uninstalled security measures may contribute to additional review time and delays in achieving a DEA #.
Planning Ahead Can Help Reduce Delays
Because these enhanced reviews can require substantial documentation, pharmacies should begin organizing materials early in the application or CHOW process.
A few best practices include:
Setting realistic expectations early may also help reduce frustration during the approval process.
A Growing Industry Trend
These additional DEA requests appear to be becoming more common rather than isolated events. Pharmacies planning a new location, acquisition, or ownership transition should be aware that additional verification steps may now be part of the standard registration process.
As regulatory expectations continue to evolve, preparation and proactive documentation can help pharmacies navigate the process more efficiently while minimizing unnecessary delays.
Disclaimer: This article is intended for informational purposes only and should not be considered legal advice or regulatory guidance. Pharmacies should consult appropriate legal counsel and regulatory agencies regarding their specific situation.