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:
- 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 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:
- Title 21 of the Code of Federal Regulations (CFR), Sections 1300 to end.
- DEA’s Practitioner Manual is available online, but at the time of this writing it is being updated.
- 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.