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4 Pillars of a DEA Compliance Program
Cathy Gallagher, Sr. Consultant, U.S. Compliance Solutions, IQVIA
Nov 12, 2020

COVID-19 has created a lot of uncertainty for manufactures and distributors of controlled substances.

The chaos caused by the pandemic, coupled with rising opioid addiction rates in the United States, has led to unprecedented times in this industry, and made it clear that having a robust compliance program and strong product stewardship is vital to protecting lives and the business model.

The key to creating an effective compliance program is to use DEA rules as a framework, and meeting all of the requirements for registration, record-keeping, reporting, and security.

Compliance Basics

Regardless of the environment in which a drug is being distributed, a compliant program must adhere to the Controlled Substances Act (CSA). The CSA provides the Drug Enforcement Administration (DEA) with the authority to regulate handling of all controlled substances, including registration, record-keeping, reporting, and security. Failure to adhere to any one of these mechanisms can result in the loss of DEA registration and significant civil fines.

Registration: If you want to legally handle controlled substances, you have to be registered with DEA in the state or jurisdiction where you are based. You also need to have a separate registration for every location where the controlled substances will be stored for distribution to the public.

Record-keeping: Every registrant is required to maintain complete, accurate, and up-to-date records for any controlled substance they manufacture, import, receive, sell, deliver, export, or otherwise dispose of. The record-keeping must include details about every handling step, documenting how the product is created, moved, and sold. This is an area where a lot of inadvertent violations can occur due to incomplete and inaccurate record-keeping.

Reporting: Registrants can now use the Automation of Reports and Consolidated Orders System (ARCOS) system to submit reports related to all thefts, significant loss, and suspicious orders. ARCOS is an automated drug reporting system that monitors the flow of controlled substances from manufacture, through sale and distribution. Registrants can use ARCOS to transmit required monthly or quarterly reports, rather than mailing them, which adds speed and cost savings to the process.

ARCOS accumulates these transactions which are then summarized into reports that can be used to identify the diversion of controlled substances into illicit channels of distribution. It also allows DEA to look at what’s moving through the chain of distribution.

If you experience theft or significant loss, you must report it to the DEA within one business day of discovery via the DEA 106 form. In these situations, record-keeping is key to support and prove an adequate investigation.

Security: The DEA also requires all applicants and registrants provide effective security controls to guard against theft and diversion of controlled substances.

An effective security program includes physical controls – cameras and alarms, locked gates and doors, limited access to storage facilities, and formal monitoring of vehicles entering the plan area.

Operators should also have formal process in place for monitoring the ordering system to identify suspicious orders, and for conducting due diligence on all members in their supply chain – from suppliers to customers. This due diligence review should be updated regularly with all data documented for review.

Maintaining DEA compliance requires a lot of effort and paperwork, but if you make these four pillars the foundation for your controlled substance compliance program, you will have the tools in place to ensure compliance and survive your next inspection.

DEA Compliance for Manufacturers and Distributors in Today’s Virtual Times

Learn more about building a strong foundation for your controlled substance compliance program by viewing this webinar on demand.

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