Commonly ignored controlled substance regulations that can increase your risk and cost you money when audited by the DEA

Content submitted by SAP Partner Ask Jan For Help.

Disclaimer: The government changes and updates regulations frequently. As of December 2021, the information contained in this article is current. Remember to check with the various governmental agencies, a regulatory consultant, and/or your attorney for changes that may affect your practice.

It’s been said and sadly realized all too late that once the Drug Enforcement Administration (DEA) gets into a practice, it can be difficult getting them out. Here’s a real eye opener: the average DEA fine is $15,040, per citation. Unfortunately, the DEA rarely gives a single citation to a practitioner. So, what’s the best way to minimize the risk of being audited by the DEA? Memorizing and following all state and federal practitioner controlled substance regulations can often seem confusing or contradictory, and what’s more, they are constantly changing.

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.”¹ [Note: The DEA is in the process of updating the DEA Practitioner’s Manual. The information cited in this paragraph is up to date as of December 2021, but may be outdated at a later date.]

With so many regulatory bodies—the federal government (DEA), the state government, the state pharmacy board, and the state veterinary board—it can be difficult to understand which controlled substance regulations take precedence in a practice. The simple answer is: whichever regulation is the most stringent. That means the practice owner must know all the federal DEA regulations found in Title 21 CFR, 1300 to End, plus all their state’s controlled substance regulations, and then follow the most stringent regulation. It can be a challenge even knowing 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 can be unclear. This leads to 2 of the most common violations cited by the DEA and state agencies.

Controlled substance medical waste

How should a practice destroy its controlled substance medical waste? How should it destroy its expired or unwanted controlled substances? Let’s look at their definitions first and then the correct destruction methods per the DEA. Remember that each state’s destruction regulations may differ from Federal DEA destruction regulations, so always follow whichever is more stringent.

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).”²

Controlled substance medical waste destruction is outlined as such: “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 41.²

Unfortunately, this regulation is a bit opaque, but further research provides 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…at this time is incineration.”²

The result, according to US Bio-Clean, is that there is currently a single, 2-step method to meet the DEA destruction requirements³:

• “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.”
• “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 complete regulations for the destruction of expired and unwanted controlled substances should be read in full here, but a relevant portion from section (a)(2) is highlighted below⁴:

“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;”

Please note section (a)(2) is the DEA’s preferred method for destroying unwanted or expired controlled substances. What’s more, the other destruction methods enumerated in the regulation require DEA written approval with destruction in the presence of a DEA Agent or other authorized person. It’s hard to imagine many practices are looking to deal with the headache of deliberately inviting the DEA in when a simpler option exists.

Additionally, a DEA Form 41 must be used when destroying expired or unwanted controlled substances. So, it’s imperative to select a government-approved reverse distributor for the destruction of expired or unwanted controlled substances. The reverse distributor should provide the practice with all the DEA’s required destruction documents. Please ask which forms the reverse distributor provides to ensure having all the necessary documentation in case of a DEA audit.

Again, keep in mind that the only exception to the federal regulations cited here would be more stringent state regulations. Additionally, it’s also important to remember that regulations change frequently, so one should access them frequently to ensure complete compliance. Furthermore, 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.⁵

Key takeaways

Unfortunately, the regulations discussed in this article represent only a fraction of the basic regulations necessary to stay compliant with the DEA and state controlled substance regulations daily. Here are 2 important takeaways from this article to help you reduce 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. Get familiar with all state and federal controlled substance regulations and follow the most stringent regulation.

An easy way to improve controlled substance compliance and reduce risk is to consider buying an automated dispensing cabinet. There are several choices on the market, but as far as I know, Cubex has the longest use history in veterinary practices.

References:

1. United States Department of Justice Drug Enforcement Administration Office of Diversion Control. Practitioner’s Manual: An Informational Outline of the Controlled Substances Act. September 2006. Accessed December 21, 2021. https://www.ca1.uscourts.gov/sites/ca1/files/citations/pract_manual012508.pdf
2. US Department of Justice Drug Enforcement Administration Diversion Control Division. Records and reports of registrants continuing records. §1304.21. Revised December 30, 2016. Accessed December 21, 2021. https://www.ecfr.gov/current/title-21/chapter-II/part-1304
3. How to dispose of controlled substances. US Bio Clean. Accessed December 21, 2021. https://usbioclean.com/how-to-dispose-of-controlled-substances/
4. US Department of Justice Drug Enforcement Administration Diversion Control Division. Disposal of Controlled Substances by Registrants. § 1317.05 Registrant disposal. September 9, 2014. Accessed December 21, 2021. https://www.ecfr.gov/current/title-21/chapter-II/part-1317
5. US Department of Justice Drug Enforcement Administration Diversion Control Division Pharmacist’s Manual: An informational outline of the Controlled Substances Act. 2020.