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Blog
Under Control: How to Meet DEA Security Requirements for 21 CFR 1301.71(a)
May 27, 2022
If an organization is going to produce, ship, or handle a controlled substance, the Drug Enforcement Administration’s (DEA) security requirements must be part of every decision they make.
DEA’s general security requirement is laid out in 21 CFR 1301.71(a), which states that any organization handling controlled substances must provide effective controls and procedures to prevent theft or diversion of these products. Further requirements in this chapter help define what those physical security requirements should include.
It seems like a simple enough directive, but translating this requirement into a security plan that accommodates the unique environment of any manufacturing or distribution environment can be challenging. The security must be rigorous enough to adhere to all DEA requirements, while still enabling safe movement within the environment to meet the needs of staff and customers.
To adapt, organizations need a well-defined security plan that aligns to DEA requirements, along with documentation to demonstrate ongoing compliance.
Everything and the kitchen sink
The overarching expectation of the code is that facilities will create controls and procedures that will “guard against theft and diversion of controlled substances.” It’s a broad expectation that could include any number of safety elements.
For some elements, the requirements laid out in the DEA regulations are extremely precise. For example, in the section discussing structures required to safely store controlled substances, the code goes into great detail about the exact materials, construction, and reinforcements required to meet DEA expectations. The code also offers detailed operational expectations defining where manufacturing activities can be conducted, how product must be stored and handled while in process, and who can have access to that environment. These details draw a specific, tangible roadmap for organizations to follow.
However, other requirements in the code are referenced more generally -- or not at all -- creating potential pitfalls for organizations that lack experience in adhering to DEA security expectations. For example, the regulation never mentions the use of surveillance cameras; however, it’s highly unlikely that DEA would issue a distributor or manufacturer registration to an organization whose security system lacks cameras and associated recording of activities. This lack of specifics gives organizations the flexibility to create a security plan that accommodates their unique facility footprint, workflow, and day-to-day activities.
However, it also introduces risk that their plan won’t be approved by DEA. The agency has a tremendous amount of discretion to determine what each applicant’s facility requires to adhere to its regulations and under what circumstances.
For operations that have no experience creating a security plan that aligns with 21 CFR 1301.71(a), the lack of clarity can leave them uncertain about what they need to do to be compliant.
Best Practices for DEA Compliance
At IQVIA, we’ve helped dozens of clients across the controlled substance supply chain create secure environments that meet DEA goals without hindering the workflow or customer needs. Through these projects, our experts have identified guidelines that can help new facilities think through their own security needs:
- Become very familiar with DEA security regulations. Obtain a paper copy or bookmark the electronic version of the regulations, and refer to it when making any security-related design or operational decision.
- Adopt industry standards. Talk to industry experts about what designs similar facilities have used to achieve compliance and consider adding those to your plans. For example, surveillance cameras and alarms in storage and transit areas are not specifically mentioned in DEA regulations, but are a common tool used to meet DEA goals.
- Conduct a security evaluation prior to DEA review, using internal or third party experts. This evaluation can help you identify potential risk areas and opportunities to close security gaps before DEA audits the site.
- Attempt to engage the local DEA office to the extent allowed. While every office will have its own position about offering feedback or advice, the DEA is still your best source of information. Even if they are unable to provide detailed feedback, the act of reaching out demonstrates your commitment to security, and they may provide valuable advice on what will be expected during the onsite inspection.
- Stay engaged. If after a DEA inspection you find that the inspector is unwilling to put an approval in writing, reach out to your DEA contact by email. Inform them of the installed specifications you’ve completed, share your understanding of the inspector’s input, and request correction if you’ve misunderstood or mischaracterized the results.
Even after your security system is in place and approved by DEA inspectors, don’t assume your facility is permanently compliant. If a diversion event occurs, DEA rules change, or the facility undergoes an upgrade, DEA will need to conduct a new inspection and may deliver new recommendations and/or requirements.
Consider this a constant cycle designed to keep your organization, community, and customers safe. Making 21 CFR 1301.71(a) part of the facility planning, and design decision will help you stay compliant, and ensure your facility is always up to code.
Comprehensive Compliance Services for Life Sciences
If not managed correctly, the regulatory environment can become costly for life sciences and healthcare organizations. IQVIA offers an end-to-end solution for managing compliance risk while driving business value.