Top 10 DEA Violations

by | Feb 11, 2025 | News

By Kelley Detweiler

Top Ten Lists have become increasingly popular in modern society and are a way to provide measurement and ranking associated with various levels of recognition and importance. As a dental professional, being on the list of Top Ten Best Dentists, the American Dental Association’s 10 Under 10, or being published in one of the top ten dental medical journals are top ten lists you want to be on.

There are top ten lists you want to be on and also ones that you don’t. Being on a list for having committed one of the top ten most common DEA violations should be avoided at all costs. While the DEA does not publish any official “Top Ten List” for violations, having worked with and inspected close to 800 DEA registered practitioners, practices and facilities, we have seen enough to know which violations are commonly cited for areas of noncompliance where DEA registrants get caught off guard.

Associated with violations are fines. Among the DEA registrants I have worked with, an average of 11 violations are typically identified when compliancy is assessed within a facility based on what a U.S. Drug Enforcement Administration Diversion Investigator evaluates and can cite and fine for noncompliance with the requirements set forth in the Title 21 of the Code of Federal Regulations and the Controlled Substances Act. When you consider that the DEA has authority to assess fines a maximum of $15,691 per violation (which when multiplied by 11violations totals over $172,000), making sure that you are not violating DEA requirements suddenly becomes an important priority.

With that in mind, below is a collective “top ten list” of common issues that lead to DEA violations.

1. Inability to Produce a Biennial Inventory

Recordkeeping is a significant part of DEA compliance. Federal regulations require numerous controlled substance records to be maintained, one of which is your DEA biennial inventory. After your initial inventory is established, the DEA requires a biennial inventory of all controlled substances to be conducted every two years, at minimum.1 A biennial inventory is one of the first documents the DEA will ask for during an inspection, and failing to produce will get you off to a bad start with the DEA.

TIPS

  • Do not include any drugs other than DEA-scheduled controlled substances on a DEA biennial inventory.
  • A separate biennial inventory form should be used to document schedule II controlled substances separately from schedules III-V controlled substances.
  • A DEA biennial inventory is an official record that needs to be completed, signed and dated by the DEA registrant and an authorized witness.

2. DEA-Required Records are not “Readily Retrievable”

Controlled substance records that DEA registrants are required to maintain must be kept in a “ready and retrievable” manner, available for inspection upon request at the DEA-registered location for the current two-year period 2. Compliant recordkeeping requires consistency, accuracy and organization. The Controlled Substances Act gives the DEA authority to randomly check registrants for the “correctness of records, reports or other documents required to be kept or made.”3 If you are inspected by the DEA, all required records must be “ready and retrievable”. The last thing you should be doing with the DEA on-site is searching through files and documents.

TIPS

  • If you use an electronic logging system, keep blank USB drives on hand to use for exporting and uploading electronic records if the DEA requests a copy of your logs.
  • Organize required records using a binder divided into sections. Make sure records are organized chronologically within each section for the current two-year period.

3. Licensing and Registration Issues

When it comes to state licensing and DEA registration, remember two main rules: 1) State before Federal; and 2) information on your DEA registration and state license must match.

Every DEA registration is tied to a valid state license. That means all required state licensing must be in place BEFORE you apply for a DEA registration, and the information on both need to match. Before you apply for a DEA registration make sure all required state licenses are in place. If not, your application for a DEA registration will be denied. Similarly, if your registered location changes, the address on your state license needs to be updated before updating the address on your DEA registration. Neglecting these rules can lead to significant problems.

TIPS

  • Make sure your email address on file with the DEA is one that you check so you receive reminders and communications being sent regarding your registration.
  • Don’t wait to renew. The renewal period for a practitioner DEA registration is every three years, and renewals may be submitted online within 60 days of expiration. If you miss the expiration date you only have a grace period of one calendar month, after which you will lose your current DEA number.

4. Poor Logging

Logging is one the most challenging aspects of DEA recordkeeping, which is why many dental professionals having been switching to automated storage and electronic logging systems from manual logbooks which can be time-consuming and hard to stay on top of. Controlled substance logging needs to be conducted in “real-time” at the time that controlled substances are dispensed to patients and should never be “backlogged”. Dispensing logs are a running “register” reflecting every “transaction” that takes place with a controlled substance.4 When logs are not consistently maintained, contain errors and missing information the transactions recorded cannot be relied upon as a true reflection of controlled substance usage.

Equally as important as accurately logging is conducting reconciliations wherein physical inventory counts are compared against what is documented in your logs to check for discrepancies. Discrepancies will inevitably occur; sometimes resulting from innocent mistakes and other times are an indicator of something more nefarious going on. The more consistent you are with conducting reconciliations the easier discrepancy identification, investigation and resolution will be.

TIPS

  • Never remove logbooks from a DEA-registered location.
  • Have two authorized individuals conduct reconciliations weekly, at minimum, in an area covered by security cameras.
  • Implement a process to ensure thorough investigation and resolution of discrepancies and use a form to document the process.

5. Poor Employee Vetting

As a DEA registrant, the people you authorize to work with your controlled substance inventory have the power to make or break you. Guarding controlled substances and preventing drug diversion starts with properly vetting the individuals working with your inventory. At a minimum, vetting an individual as authorized to work with controlled substances should include execution of an Employee Screening Statement per 21 CFR 1301.905 during the initial onboarding process as well as again annually for all authorized employees. Individuals that answer “yes” to any of the questions on the Employee Screening Statement are automatically disqualified from authorization to work with controlled substances.

TIPS

  • Ask for references and when you receive them, actually check them.
  • Conducting background checks and drug testing is not specifically required in regulations but is strongly recommended.

6. Noncompliant Storage

While certain aspects of DEA regulations are vague and open for interpretation, others are clear. The DEA sets forth specific requirements regarding controlled substance storage6:

  • Storage units weighing under 750 pounds must be bolted to the floor, affixed or mounted to a wall or otherwise secured to an immovable object. This applies to safes, lockboxes cabinets, automated units and refrigerated units that controlled substances are stored in.
  • Keys to storage must be secured and access to the storage area must be controlled.
  • Schedule II and schedule III-V controlled substances must be clearly separated out in storage. Automated dispensing machines such as a Zimbis7 make security and separation in storage easier to manage. If you are using a non-automated storage solution such as a lockbox, cabinet or safe, separation may be accomplished using separate shelves and/or bins as long as the separation is clear. This applies to refrigerated and expired controlled substances in inventory as well.

TIPS

  • Do not remove controlled substances from the DEA registered location.
  • Separate schedule II controlled substances out from Schedules III-V in storage and do not “commingle” any non-DEA schedule drugs with controlled substances in storage, even if they are scheduled at the state level.
  • Expired controlled substances must be securely stored and separated out in inventory until undergoing destruction.

7. Poor Physical Security

The Code of Federal Regulations states that all applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances.8

Some of those controls are explicitly laid out, but others are not. Facilities that store and use controlled substances must have an alarm monitoring system and access controls to prevent unauthorized access to controlled substances. Unlocked exterior doors, open windows in areas where controlled substances are used/stored and failing to provide effective access controls between public and authorized areas can put you at risk for drug diversion and result in citations for failure to prevent diversion. Security cameras are not specifically required in regulations, but if something happens and you don’t have them you could be cited for failure to prevent diversion.

TIPS

  • If you have security cameras, make sure to position them correctly and aim for at least 60 to 90 days of CCTV DVR storage.
  • Make sure your alarm is activated during non-operational hours, connected to local law enforcement and tested regularly. Alarm passcodes should not be shared.
  • Make sure keys to the facility indicate “DO NOT DUPLICATE”.

8. Lax Receiving Processes

Controlled substance shipments cannot be left out unsecured, even if they are delivered during a busy workday. Do not leave them unopened on the floor. Do not allow delivery personnel to walk into authorized areas with shipments. An authorized receiving individual should physically “receive” controlled substance shipments from delivery personnel to ensure security and chain of custody. The DEA doesn’t care how busy you are. If a delivery cannot be received into inventory right away it should be placed in temporary secure storage until an authorized individual has time to properly receive those controlled substances into inventory. Poor controls during the controlled substance receiving process will put you at risk diversion.

Properly documenting the receiving process is equally as important from a recordkeeping standpoint. When unpacking controlled substance shipments, retain the inner packing slip and make sure the authorized receiver and a witness sign (not just initial), date and check off what is being received prior to filing the verified receipt of invoice with other required records. When receiving Schedule II controlled substances, make sure that the verified receipt of invoice is stapled to its corresponding DEA Form 222/222e and that the DEA registrant, or their power of attorney designee, complete Part 5 by entering the “date received” and “amount received”.

TIPS

  • Log unopened containers being received into inventory backstock.
  • Use a stapler when attaching documents together instead of a paperclip which is less secure.

9. Improperly Accounting For Hub Loss

When working with liquid controlled substances, the DEA recognizes that hub loss exists when syringes are used; however, the DEA does not set forth a specific amount of “acceptable” hub loss. The DEA also does not allow hub loss to be “predetermined” because depending on the type of controlled substance, needle gauge and syringe used, hub loss amounts will vary. This is particularly true when working with more viscous drugs such as Ketamine.

When accounting for hub loss, make sure to use a consistent formula and have documentation to show how you calculated hub loss. The DEA accepts a “reasonable level” of hub loss, but what is considered a  “reasonable level” is not defined. In the event of any potential or confirmed significant loss, you are required to notify your local DEA divisional office within one business day of discovery.

TIPS

  • If you think a loss may be significant, immediately inform the DEA registrant, document and investigate the matter.
  • Anytime you make notification to the DEA do it via email, so you have documented proof for your records.

10. Non-Compliant Wasting and Disposal and Destruction

Anytime that controlled substances remain after patient administration in a syringe, tubing etc., the DEA requires them to be rendered “non-retrievable”9 prior to disposal into a biohazardous waste unit. Pouring excess controlled substances down a sink, flushing them or tossing them into the trash does not meet the DEA’s “non-retrievable”9 requirement. A DEA-compliant wasting system such as an Rx Destroyer or Cactus Sink must be used for any on-site controlled substance wasting needs. If controlled substance break or spill rendering them “unusable”, they must be properly wasted as well as documented on a DEA Form-41 which must be maintained with other required records. Wasting should always be conducted by an authorized individual and a witness, preferably in an area covered by security cameras.

Expired controlled substances are not the same as administrative waste and breakage/spillage and should be handled differently using a DEA-registered reverse distributor to complete final destruction10. Following final destruction, a reverse distributor will provide you with an official Certificate of Destruction which serves as documented proof completing the “story” for the controlled substances that were destroyed. Until expired controlled substances leave your facility for final destruction, they must be securely stored and included in inventory counts.

TIPS

  • Use a log to document when expired controlled substances are separated out from non-expired inventory in storage.
  • Send expired controlled substances for reverse distribution quarterly as well as before conducting a biennial inventory.

Having a DEA registration is a privilege, not a right. Being granted that privilege comes with a responsibility to provide effective controls and procedures to guard against theft and diversion of controlled substances. If your DEA compliance needs improvement, be proactive and address it before an issue arises. Waiting to act is not worth the risk of being cited for any of the top ten DEA violations on this list.

  1. Code of Federal Regulations website. 21 CFR 1304.11. https:/​/​www.ecfr.gov/​current/​title-21/​part-1304/​section-1304.11#p-1304.11(c).
  2. Code of Federal Regulations website. 21 CFR 1304.04(f)(2). https://www.ecfr.gov/current/title-21/part-1304/section-1304.04#p-1304.04(f)(2).
  3. Govinfo.com website. Title 21 United States Code Controlled Substances Act, Section 880. https://www.govinfo.gov/content/pkg/USCODE-2021-title21/pdf/USCODE-2021-title21-chap13-subchapI-partE-sec880.pdf.
  4. Code of Federal Regulations website. 21 CFR § 1304.22(c). https://www.ecfr.gov/current/title-21/section-1304.22
  5. Code of Federal Regulations website. § 1301.90 Employee screening procedures. https://www.ecfr.gov/current/title-21/chapter-II/part-1301/subject-group-ECFRbf5f8d39b8823bb/section-1301.90
  6. Code of Federal Regulations website. Title 21 CRF §1301.72(b)(3)(i)(ii). Code of Federal Regulations website. 21 CFR 1301.72(b)(3)(i). https:/​/​www.ecfr.gov/​current/​title-21/​part-1301/​section-1301.72#p-1301.72(b)(3)(i)
  7. Zimbis website. https://zimbis.com.
  8. Code of Federal Regulations website. Title 21 CFR 1301.71(a). https:/​/​www.ecfr.gov/​current/​title-21/​part-1301/​section-1301.71#p-1301.71(a)
  9. Code of Federal Regulations website. Title 21 CRF §1300.05. https://www.ecfr.gov/current/title-21/chapter-II/part-1300/section-1300.05
  10. Code of Federal Regulations website. 21 CFR §1317.05. https://www.ecfr.gov/current/title-21/chapter-II/part-1317/subpart-A/section-1317.05

Kelley Detweiler is a DEA and regulatory compliance expert who provides controlled substance risk-management consulting solutions to the health care industry. She is the Founder of DEA360 and can be reached at kelley@dea360.com.