All entities that are registered to handle controlled substances have to abide by a set of strict security requirements to ensure that they are not mishandled or misused in any manner whatsoever.
The Controlled Substances Act requires that all DEA registered healthcare providers and other organizations – be it DEA veterinary or others – should institute effective controls and procedures to safeguard against theft and diversion of controlled substances.
The standards for the mandated physical security controls and operating procedures are clearly laid out in the Code of Federal Regulations. There are slight variations in the requirements for practitioners and non-practitioners with certain distinctions in what is expected in case of manufacturing and compounding areas, narcotic treatment programs, freight forwarding facilities, etc.
The security prerequisites are more stringent for Schedule I and II drugs. For instance, these must be stored in a safe or steel cabinet that is equivalent to a U.S. Government Class V security container. For stocks of drugs ranging from Schedule III to V, they can be stored in a securely locked and substantially constructed safe/cabinet. Even the materials and construction to be used have been specified. However, structurally equivalent options are permissible.
In general, the safe/cabinet should be bolted or cemented to a floor or wall. Installing an electronic alarm system is also mandatory.
Then again, the Administrator will determine the level of compliance required with the security requirements while evaluating the overall security system of a registrant/applicant. This will be based on certain factors like:
- The type of activity conducted
- The type and form of controlled substances handled
- The quantity of controlled substances handled
- The location of the premises
- The type of building and office construction
- The type of vault, safe and secure enclosures or other storage system used
- The extent of unsupervised public access to the facility
- The adequacy of supervision and monitoring system
- The availability of local police protection or private security personnel
In case a controlled substance is transferred to a different schedule or there is a significant increase in the quantity of controlled substances, the physical security controls become inadequate and have to be expanded and extended accordingly. Going by the same accord, the physical security controls can be decreased when required – for both veterinary DEA license and otherwise.
Help in executing the security protocols
Any DEA registrant that produces, ships, dispenses or handles controlled substances has to keep the security requirements front and center in all their decisions. In fact, DEA registrants and applicants can choose to get their proposed security system approved by submitting the plans, blueprints, sketches or other materials to the Special Agent in Charge in the region or to the Regulatory Section, Drug Enforcement Administration.
In sum, aligning with the DEA requirements and maintaining documentation to demonstrate ongoing compliance while keeping the needs of staff and customers in mind can get challenging.
A professional compliance provider can help with everything from getting a DEA license veterinary to ensuring full DEA compliance!
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