Commonly ignored controlled substances regulations that can increase your risk and cost you money when audited by the DEA
An expert describes the critical steps to ensure compliance with DEA regulations.
Disclaimer: The government changes and updates regulations frequently. As of December 2021, the information in this article is up to date. Remember to check with various government agencies, a regulatory consultant and / or your lawyer for changes that may affect your practice..
It has been said and unfortunately realized too late that once the Drug Enforcement Administration (DEA) gets into a practice, it can be difficult to get 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? Remembering and complying with all state and federal regulations for substances controlled by practitioners 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, research scientist, pharmacy, hospital or other person authorized, registered or otherwise authorized by the United States or the jurisdiction in which the practitioner practices or conducts research, to distribute, dispense, conduct research relating to, administer or use in teaching or chemical analysis, a controlled substance in professional practice or research. Any 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 The information cited in this paragraph is up to date as of December 2021, but may be outdated at a later date.]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), State Government, State Board of Pharmacy, and State Veterinary Board – it can be difficult to understand what regulations on substances controlled take precedence in a practice. The answer is simple: whatever the strictest regulations. This means that the practice owner should be aware of all federal DEA regulations found in Title 21 CFR, 1300 at the end, along with any of their state’s controlled substance regulations, then follow the more stringent regulations. It can be a challenge even to know where to start.
Even the simplest of controlled substances regulations can be confusing. For example, it can be difficult to know the difference between the destruction of medical waste of controlled substances and the destruction of obsolete and unwanted controlled substances. This leads to 2 of the most common violations cited by the DEA and state agencies.
Medical waste of controlled substances
How should a practice destroy its medical waste of controlled substances? How should he destroy his obsolete or unwanted controlled substances? Let’s take a look at their definitions first, and then the correct destruction methods according to the DEA. Keep in mind that each state’s destruction regulations may differ from federal DEA destruction regulations, so always follow whichever is more stringent.
Medical waste of controlled substances is defined as “a controlled substance dispensed by a practitioner for immediate administration to the practitioner’s registered location, when the substance is not completely depleted (for example, part of the substance remains in a vial, tube or syringe after administration but cannot or cannot be further used).2
The destruction of medical waste of controlled substances is described as follows: or the syringe after administration but cannot or cannot be reused), must be properly recorded in accordance with §1304.22(c), and this record does not need to be kept on a DEA 41 form.2
Unfortunately, this regulation is a bit opaque, but other research provides a clearer solution. US Bio-Clean states, “Although the DEA says it is looking to determine a variety of destruction methods, the only acceptable method of destruction for pharmaceutical waste… at this time is incineration.2
The result, according to US Bio-Clean, is that there is currently a unique 2-step method to meet the DEA destruction requirements.3:
- “Drug wastage in an appropriate neutralization medium, such as a Cactus Smart Sink or an Rx Destroyer. A solidifier can also be used for liquid waste only.
- “Place the neutralized container in a container of non-hazardous pharmaceutical waste which will be sent for cremation.
Obsolete 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 sought by the practitioner. The complete regulations for the destruction of obsolete and unwanted controlled substances should be read in their entirety here, but a relevant part of section (a) (2) is highlighted below4:
“Promptly deliver this controlled substance to the registered location of a reverse dispenser by common or contract carrier pickup or by pickup by a reverse dispenser at the registrant’s registered location; “
Please note that section (a) (2) is the DEA’s preferred method of destroying unwanted or expired controlled substances. In addition, the other destruction methods listed in the regulations require the written approval of the DEA with destruction in the presence of a DEA officer or other authorized person. It’s hard to imagine that many practices seek to deal with the headache of deliberately inviting the DEA when a simpler option exists.
In addition, a DEA 41 form must be used when destroying obsolete or unwanted controlled substances. It is therefore imperative to select a government approved reverse dispenser for the destruction of obsolete or unwanted controlled substances. The reverse distributor must provide the firm with all destruction documents required by the DEA. Please ask what forms the reverse distributor provides to ensure you have all the necessary documentation in the event of a DEA audit.
Again, keep in mind that the only exception to the federal regulations listed here would be more stringent state regulations. Additionally, it’s also important to remember that regulations change frequently, so they need to be accessed frequently to ensure full compliance. Additionally, in addition to a DEA citation, the EPA can also fine a practitioner at least $ 37,500 per violation for improperly disposing of your pharmaceutical waste.5
Key points to remember
Unfortunately, the regulations discussed in this article are only a fraction of the basic regulations needed to stay in daily compliance with DEA and state controlled substances regulations. Here are 2 important takeaways from this article to help you reduce risk and improve compliance:
- Know the difference between medical waste of controlled substances and obsolete and unwanted controlled substances, and follow the appropriate disposal method for each.
- Familiarize yourself with all state and federal regulations on controlled substances and follow the most stringent regulations.
A simple way to improve controlled substance compliance and reduce risk is to consider purchasing an automated dispensing cabinet. There are several choices on the market, but to my knowledge Cubex has the longest history of use in veterinary practices.
- Office of Diversion Control of the Drug Enforcement Administration of the United States Department of Justice. Practitioner’s Manual: An Informative Overview of Controlled Substances Law. September 2006. Accessed December 21, 2021. https://www.ca1.uscourts.gov/sites/ca1/files/citations/pract_manual012508.pdf
- United States Department of Justice Drug Enforcement Administration Diversion Control Division. Records and reports of registrants of domain names. §1304.21. Revised December 30, 2016. Accessed December 21, 2021. https://www.ecfr.gov/current/title-21/chapter-II/part-1304
- How to get rid of controlled substances. US Bio Clean. Accessed December 21, 2021. https://usbioclean.com/how-to-dispose-of-Controlled-substances/
- United States Department of Justice Drug Enforcement Administration Diversion Control Division. Elimination of substances controlled by reporters. § 1317.05 Elimination of the holder. September 9, 2014. Accessed December 21, 2021. https://www.ecfr.gov/current/title-21/chapter-II/part-1317
- US Department of Justice Drug Enforcement Administration Diversion Control Division Pharmacist’s Manual: An Informative Overview of the Controlled Substances Act. 2020.