What CMS has to say aboutdrug security

When I talk about the security of medication, specifically controlled substances, most people immediately think of the DEA. On occasion, I might even be quoting state regulation, especially in states with a CDS (controlled dangerous substance) department.

Believe it or not, CMS regulation actually expands upon the DEA's requirements. While it may not be likely that the DEA inspects your facility anytime soon, you may have a CMS survey coming up.


CMS §416.48(a) States The ASC must provide drugs and biologicals in a safe and effective manner, in accordance with accepted professional practice, and under the direction of an individual designated responsible for pharmaceutical services.

So what does that mean? Interpretive Guidelines for Section 416.48(a) explains what facilities like you should be doing to ensure security of your medication.


  • Do not prepare medications too far in advance. Outside of USP <797> and immediate use regulations, CMS considers advance preparation of a drug to reduce security and increase risk of theft/ diversion

  • Records of receipt and disposition of all scheduled drugs (controlled substances) for schedules II-V must be maintained and readily available. I've been asked whether all controlled drugs must be tracked, or just CII. The answer is ALL controlled substances mustbe tracked.

  • The center must have records to trace the movement of controlled substances throughout the ASC. This means that if controlled drugs are removed from a narcotic cabinet to be brought into the OR and used, there must be record of that movement. If controlled substances are wasted, there must be record of that. For more information on this process, contact Brittney or Madison.

  • An individual must be designated responsible for the ASC's pharmaceutical services. This person is responsible for ensuring records are correct, maintained, and reconciled for all controlled substances.

  • Your tracking system must be capable of identifying loss or diversion, and the extent of such loss or diversion, in a timely manner.


That last bullet point is important. Some JDJ Consulting clients have a backup narcotic cabinet where they keep overflow or bulk stock of controlled substances. These cabinets sometimes go days without being accessed, and in those situations, may not be counted more than once a week. Although that might make sense from an operational standpoint, in the event of diversion, you might go a full week before knowing stock was missing. I caution clients to come up with a workflow that makes sense for your staff, but not at the expense of drug security.

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JDJ Consulting services and availability may vary by state. Contact us to find out what service are available in your area. Pharmacy operational requirements and regulations are governed by Federal, State, Local, and Tribal law, and if applicable, the facility's accrediting agency. JDJ Consulting will provide recommendations based on the regulatory requirements in your area.

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