Top 10 DEA Violations

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.

Smart Cabinets in Dental Labs: The Future of Efficient Inventory Management and Compliance

Smart Cabinets in Dental Labs: The Future of Efficient Inventory Management and Compliance

by | Oct 30, 2023 | News

Having been immersed in the world of dental laboratory economics for over three decades, I’ve observed, experienced, and participated in numerous shifts within our industry. Technological advancements have consistently been at the forefront of driving efficiency and quality in our labs. Today, there is a new technology that I firmly believe will be a cornerstone for labs in the coming decade: Automated Dispensing Cabinets (ADCs), also known in our industry as ‘Smart Cabinets.’

Streamlined Compliance with Lot Number Tracking

The FDA’s requirements for tracking lot numbers for implantable medical devices are non-negotiable. With patient safety at stake, the onus on labs to accurately track and report on these numbers is enormous. Traditional manual methods of doing so have proven time and again to be fallible, leading to inaccuracies that can have considerable implications both from a compliance and a patient safety standpoint.

Enter the smart cabinet, which inherently offers electronic and precise lot number tracking with every single dispense. The automation removes the scope for human error, ensuring that each item can be traced back to its source accurately and effortlessly, thus bolstering our adherence to FDA regulations and promoting patient safety.

An End to Tedious Inventory Counts

Inventory management has long been a time-intensive task in our labs. Staff would spend inordinate amounts of time manually counting zirconia disks, dental implants, 3D printer resin, and other essentials, often leading to discrepancies and inefficiencies.

With the ADCs, the need for manual counts vanishes. The system keeps a real-time, accurate track of every item, ensuring that we’re always aware of our inventory levels. This not only saves significant time for our staff but also guarantees the optimal utilization and rotation of stock.

 

Goodbye to Rush Orders and Hello to Cost Savings

One of the most exasperating scenarios in a lab is realizing that a critical item is out of stock, prompting an emergency overnight order, often accompanied by exorbitant shipping charges. ADCs, with their automated re-ordering capability, prevent such scenarios. When inventory levels approach the predetermined minimum, the system automatically generates an order, negating the need for rush orders and thus, ensuring cost-effectiveness.

Addressing the Elephant in the Room: Billing Errors

Billing errors are rife in our industry. Discrepancies in inventory counts, manual entry errors, and mismanagement of order logs all contribute to these issues, negatively impacting both the top line (revenue) and bottom line (profitability) of labs.

A fully integrated automated dispensing system offers a holistic solution. With every item being tracked electronically from the point of dispense to billing, the likelihood of billing errors plummets. This streamlined approach ensures that labs bill accurately for every item, enhancing revenue accuracy and improving profitability.

In Conclusion

The role of technology in the dental laboratory landscape has never been more pivotal. As we advance into a future dominated by precision, efficiency, and compliance, tools like Automated Dispensing Cabinets stand out as beacons of progress. Their ability to automate critical processes, ensure regulatory compliance, and eliminate prevalent challenges like billing errors positions them as invaluable assets in modern dental labs.

For those looking to future-proof their labs and remain at the forefront of quality, efficiency, and profitability, embracing ADCs isn’t just a recommendation—it’s a necessity.

 

Streamlining Dental Lab Operations: How Efficient Inventory Management Boosts Productivity

Streamlining Dental Lab Operations: How Efficient Inventory Management Boosts Productivity

by | Apr 4, 2023 | News

Effective inventory management is crucial for dental labs aiming to improve productivity and maintain a competitive edge in the industry. In this article, we’ll discuss the importance of inventory management in dental labs and how it can positively drive revenue, decrease costs, and improve business valuations.

The Challenges of Inventory Management in Dental Labs

Dental labs face unique challenges when it comes to inventory management. With a wide variety of materials, equipment, and supplies, keeping track of everything can be overwhelming. Additionally, inefficient inventory management can lead to stockouts, waste, high shipping costs and reduced productivity. 

Benefits of Efficient Inventory Management

Implementing an effective inventory management system in your dental lab can offer several benefits:

  • Reduced waste: By keeping track of materials and supplies, dental labs can minimize waste, eliminate shrinkage, and save money.
  • Increased productivity: Efficient inventory management ensures that technicians have the materials they need when they need them, reducing downtime and increasing productivity.
  • Better forecasting: With accurate inventory data, labs can better predict future demand and plan accordingly, reducing overnight shipping needs and saving on costs.
  • Improved customer satisfaction: Streamlined inventory management helps labs fulfill orders more quickly and accurately, resulting in happier clients.

Implementing Efficient Inventory Management in Your Dental Lab

Here are some strategies to improve inventory management in your dental lab: 

  1. Centralize inventory data: Use a centralized inventory management system to store all relevant information, making it easily accessible to everyone in the lab.
  2. Automate inventory tracking: Utilize smart technology to automate the tracking of inventory items, reducing human error and saving time. 
  3. Set reorder points: Determine the optimal reorder points for each item in your inventory to avoid stockouts and overstocking. 
  4. Conduct regular inventory audits: Regularly audit your inventory to identify discrepancies and adjust your processes as needed.

Embracing Technology for Efficient Inventory Management

Leveraging advanced inventory management hardware and software tools is invaluable for dental labs. By embracing technology, labs can streamline their inventory processes, increase productivity, and maintain a competitive advantage in the industry. These best solutions offer real-time inventory tracking, quality control, demand forecasting, and automated reporting, making it easier than ever to manage your lab’s inventory effectively.

In conclusion, efficient inventory management is essential for dental labs aiming to boost productivity and stay ahead in the competitive industry. By implementing effective inventory management strategies and embracing technology, dental labs can streamline their operations and focus on delivering exceptional services to their clients.

ZIMBIS integration with Magic Touch Software is here!

by | Sep 8, 2022 | News

ZIMBIS announces software integration and partnership with Magic Touch Software International, fully integrated smart inventory cabinets now on the horizon for all users of Magic Touch lab management software DLCPM.

Phoenix, Arizona: ZIMBIS, a division of CUBEX LLC and a leading provider of technology enabled healthcare services in the dental lab sector, has developed a bi-directional software integration between their smart cabinet inventory system and the Magic Touch suite of dental lab management products. The two companies have also announced a commercial partnership.

The ZIMBIS system facilitates complete, automated inventory management of critical supplies for any dental lab. ZIMBIS increases profit and efficiency for lab operators by reducing missed revenue and ensuring all critical items are automatically replenished before they run out of stock

“Our Dental Lab placements have really taken off over the past year as lab owners have looked to counter inflation by reducing inventory costs and billing errors. So, we asked, who are the top management software providers that we need to integrate with? And Magic Touch was one of the names at the top of that list.” said Louis Visser, DDS, President of ZIMBIS. “The team at Magic Touch has just been great to work with, and we couldn’t be more thrilled to bring this integration to the dental lab space.”

With this new software integration, Magic Touch users can dispense all desired parts for a case directly from the ZIMBIS smart cabinet without needing to enter the case information themselves – it will seamlessly sync with the ZIMBIS system. The exact costs for all parts will be transmitted back to Magic Touch with no additional input from the tech, ensuring that all charges are correct. FDA lot numbers are also logged for compliance purposes, and once the quantity-on-hand for an individual SKU falls below a pre-set inventory threshold, ZIMBIS will automatically re-order that SKU from the supplier so that costly overnight shipping and the anxiety of ‘stock outs’ become a thing of the past.

ZIMBIS Smart Inventory Cabinets are highly configurable to accommodate almost everything in a dental office or laboratory. Implants, abutments and other associated components are handled within Tower units featuring individually sealed compartments, while larger items such as zirconia discs, cerec blocks, printer resin, etc. are kept in secure Flex cabinets.

About ZIMBIS

ZIMBIS is a leading provider of innovative health care automation and cloud-based business intelligence solutions that enable the dental health providers to improve supply and medication management, cost and patient outcomes while at the same time increasing regulatory compliance. More information can be found at www.ZIMBIS.com.

Media Contact:
Joey Campagna (CUBEX LLC)
(480) 268-7955
jcampagna@cubex.biz

About Magic Touch Software
Magic Touch Software is the leading Dental Lab Software Management System, servicing worldwide dental laboratories. For more than 19 years, Magic Touch has provided customers with end-to-end business management solutions including case management, accounting, sales, marketing, customer service, technician bench, route manager, integrations, and customer portal applications. For more information Visit https://magictouchsoftware.com/

Media Contact
Amir Bagheri
San Marcos, California 92078
amir@magictouchsoftware.com
(800) 714-6490
https://magictouchsoftware.com/

ZIMBIS Announces Partnership with ACE SOUTHERN

by | Aug 19, 2022 | News

PHOENIX, Ariz. – August 18, 2022 – ZIMBIS, a division of CUBEX LLC and provider of medication and supply management technology, announced today the launch of a partnership with ACE SOUTHERN, a leading global provider of surgical products, including biologics, pharmaceuticals, and surgical supplies.

The partnership with ACE SOUTHERN supports ZIMBIS’ mission to provide clients with solutions and workflows that address their specific medication and supply requirements.  This announcement expands ACE SOUTHERN’s order integration to restock inventory with product appearing in a customer’s shopping cart once inventory reorder levels are achieved.

“We very much look forward to our partnership with ZIMBIS,” said Michael Mancini, COO of ACE SOUTHERN. “ACE SOUTHERN looks forward to helping improve operational efficiencies so dental specialists can spend more time delivering quality patient care.”

“Our goal at ZIMBIS is to provide innovative solutions so our partners and clients can provide the best possible patient care,” said Louis Visser, DDS, President of ZIMBIS. “We’re excited to partner with ACE SOUTHERN and bring the benefits of this integration to the dental surgery market.”

For more information about ZIMBIS’ partnership with ACE SOUTHERN and the order integration workflow, please visit https://ZIMBIS.com/acesouthern/

About ZIMBIS

ZIMBIS, a division of CUBEX LLC, is a market leader in developing and delivering innovative health care automation and business intelligence solutions to dentists, dental surgeons and dental laboratories.  ZIMBIS offers a unique ability to meet the demands of a variety of dental environments by offering automated dispensing cabinets, wireless stockroom solutions, cloud-hosted software and more. Additional information can be found at www.ZIMBIS.com

Commonly Ignored Controlled Substance Regulations That Can Increase Your Risk and Cost You Money When Audited by the DEA

by | Nov 1, 2021 | News

Jan Woods, ZIMBIS Regulatory Consultant

Written By Jan Woods

It’s been said and sadly realized all too late that once the DEA (Drug Enforcement Administration) gets into your practice, it can be difficult getting them out! Here’s a real eye opener, did you know that the average DEA fine is $15,040, per citation? Unfortunately, only one citation is rarely given by the DEA to a Practitioner. Yikes! So, what’s the best way to minimize your biggest risk and keep the DEA out of your practice? Should you just memorize and follow all state and federal Practitioner controlled substance regulations? Nope, the regulations are often confusing, contradictory, and constantly changing! 

Did you know that the under the “Controlled Substance Act, the term “practitioner” is defined as a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which the practitioner practices or performs research, to distribute, dispense, conduct research with respect to, administer,        or use in teaching or chemical analysis,  a controlled substance in the professional practice or research. Every person or entity that handles controlled substances must be registered with the DEA or be exempt by regulation from registration.”  Source: Page 7 of the DEA Practitioner’s Manual.

Question: Do you know which controlled substance regulations take precedence in your practice?  Is it the federal government (DEA), the state government, the state pharmacy board or the state dental board? 

Answer: Whichever regulation is the most stringent! 

That means you must know all the federal DEA regulations found in Title 21 CFR, 1300 to End, plus know all your state’s controlled substance regulations and then follow the most stringent regulation! One can get headache just trying to figure out where to start! 

Even the simplest controlled substance regulations can be confusing. For example, knowing the difference between controlled substance medical waste destruction and expired and unwanted controlled substances destruction is often confusing. This leads to two of the most common violations cited by the DEA and state agencies. Read on to learn more.

Controlled Substance Medical Waste

How do you destroy your controlled substance medical waste? How do you destroy your expired or unwanted controlled substances? Let’s look at their definitions first and then the correct destruction methods per the DEA. Remember that your state’s destruction regs may differ from Federal DEA destruction regs, so always follow the most stringent regulations. 

Controlled Substance Medical Waste is defined as “a controlled substance dispensed by a practitioner for immediate administration at the practitioner’s registered location, when the substance is not fully exhausted (e.g., some of the substance remains in a vial, tube, or syringe after administration but cannot or may not be further utilized)”. Source: Title 21 Code of Federal Regulations PART 1304 — RECORDS AND REPORTS OF REGISTRANTS CONTINUING RECORDS §1304.21 General Requirements. 

Controlled Substance Medical Waste destruction is defined as “Destruction of a controlled substance dispensed by a practitioner for immediate administration at the practitioner’s registered location, when the substance is not fully exhausted (e.g., some of the substance remains in a vial, tube, or syringe after administration but cannot or may not be further utilized), shall be properly recorded in accordance with §1304.22(c), and such record need not be maintained on a DEA Form 41. Source: Title 21 Code of Federal Regulations PART 1304 — RECORDS AND REPORTS OF REGISTRANTS CONTINUING RECORDS §1304.21 General Requirements, Excerpted: Unfortunately, this regulation leaves us in a slightly confused state, doesn’t it? But further research provides us with a clearer solution.  

US Bio Clean States: “Although the DEA states that it seeks to determine a variety of destruction methods, the only acceptable method of destruction for pharmaceutical wastage (i.e., drugs dispensed to a patient and not fully used, such as a single syringe with remaining controlled substance) at this time is incineration”. 

“Therefore, the only method that currently meets the DEA requirement for both the non-retrievable and destruction standards involves a two-part process:

  1. Wasting the medication into a suitable neutralizing media, such as a Cactus Smart Sink or an Rx Destroyer. A solidifier can also be used for liquid only waste.
  2. Placing the neutralized container into a non-hazardous pharmaceutical waste container that will be sent out for incineration”.

Expired and Unwanted Controlled Substances

The Definition of Expired and Unwanted Controlled Substances is defined as a controlled substance that has expired or is no longer wanted by the Practitioner.

The Destruction of Expired and Unwanted Controlled Substances can be found in “Regulations for the Destruction of Expired or Unwanted Controlled Substances: Title 21 CFR §1317.05, Registrant Disposal’ Acceptable method are shown below:

(a) “Practitioner inventory. Any registered practitioner in lawful possession of a controlled substance in its inventory that desires to dispose of that substance shall do so in one of the following ways:

(1) Promptly destroy that controlled substance in accordance with subpart C of this part using an on-site method of destruction.

(2) Promptly deliver that controlled substance to a reverse distributor’s registered location by common or contract carrier pick-up or by reverse distributor pick-up at the registrant’s registered location;

(3) For the purpose of return or recall, promptly deliver that controlled substance by common or contract carrier pick-up or pick-up by other registrants at the registrant’s registered location to: The registered person from whom it was obtained, the registered manufacturer of the substance, or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer’s behalf; or

(4) Request assistance from the Special Agent in Charge of the Administration in the area in which the practitioner is located.

(i) The request shall be made by submitting one copy of the DEA Form 41 to the Special Agent in Charge in the practitioner’s area. The DEA Form 41 shall list the controlled substance or substances which the registrant desires to dispose.

(ii) The Special Agent in Charge shall instruct the registrant to dispose of the controlled substance in one of the following manners:

(A) By transfer to a registrant authorized to transport or destroy the substance;

(B) By delivery to an agent of the Administration or to the nearest office of the Administration; or

(C) By destruction in the presence of an agent of the Administration or other authorized person.

(5) In the event that a practitioner is required regularly to dispose of controlled substances, the Special Agent in Charge may authorize the practitioner to dispose of such substances, in accordance with subparagraph (a)(4) of this section, without prior application in each instance, on the condition that the practitioner keep records of such disposals and file periodic reports with the Special Agent in Charge summarizing the disposals. The Special Agent in Charge may place such conditions as he/she deems proper on practitioner procedures regarding the disposal of controlled substances.”

Please note Section (a)(2) is the DEA’s preferred method for destroying unwanted or expired controlled substances. Additionally, the other destruction methods listed above require DEA written approval with destruction in the presence of a DEA Agent or other authorized person. Well, I don’t know about you, but I don’t want to invite the DEA into any practice, do you? 

A DEA Form 41 must be used when destroying expired or unwanted controlled substances. It’s imperative that you select a DEA-registered reverse distributor for the destruction of your expired or unwanted controlled substances.   

Again, keep in mind that the only exception to the federal regulation cited here, would be more stringent state regulations. Additionally, it’s also important to remember regulations change frequently, so doctors (aka practitioners), managers and licensed staff members should access them frequently to ensure complete compliance.

To add further insult to injury, in addition to a DEA citation, the EPA can also fine a Practitioner a minimum of $37,500 per violation, for disposing of your pharmaceutical waste incorrectly! 

Unfortunately, the regulations discussed in this blog represent only a fraction of the basic regulations you need to stay current, complete, and accurate with the DEA and state controlled substance regulations daily! But I hope that you are less confused than when we started. Please stay tuned for more blogs on DEA compliance soon.  

Here are two important takeaways from this blog to help you reduce your risk and improve compliance.   1.) Know the difference between controlled substance medical waste and expired and unwanted controlled substances and follow the correct destruction method for each one.

2.) Familiarize yourself with all state and federal controlled substance regulations and follow the most stringent regulation.

If you would like an easy way to improve your controlled substance compliance and reduce your risk, consider buying an automated dispensing cabinet. ZIMBIS has all sizes of automatic dispensing cabinets to fit your practice size. Contact a ZIMBIS representative at 480.399.3436 for further information.

  Jan Woods is a previous practice owner, seasoned regulatory compliance expert, consultant, author, and frequent speaker at national conferences. She is available to help you and your practice to achieve regulatory compliance with your controlled substances, improve your logs and recordkeeping and perform a mock DEA audit, etc. Contact Ms. Woods today at jan@askjanforhelp.com or via telephone at 913-302-4999.

REFERENCES:

  1. Title 21 of the Code of Federal Regulations (CFR), Sections 1300 to end.
  2. DEA’s Practitioner Manual is available online, but at the time of this writing it is being updated. 
  3. Pharmacist’s Manual: An informational outline of the Controlled Substances Act. US Department of Justice Drug Enforcement Administration Diversion Control Division. 2020. 

DISCLAIMER: The government creates changes and updates regulations frequently. As of August 2021, the information contained in this blog is current. Remember to check with the various governmental agencies or your attorney for changes that may affect your practice.