By J. Kathleen Marcus, Esq.
On any given day, a sedation dentist may be faced with one or all of the following scenarios:
- A check of inventory uncovers that there are pills that are now past their expiration date.
- During a procedure, a sedative pill accidentally falls on the floor.
- A patient responds adequately to half of a sedative pill, leaving an unused half pill.
I will quickly respond to the first thought–NO; none of these pills can be used on future patients. The dentist is, however, left with controlled substances they cannot use on future patients. What now, and why can’t the sedation dentist destroy the unusable pills in the office? Because federal law has limited permissible destruction of controlled substances to a requirement beyond the abilities of the average dentist office. Under the DEA Final Rule for the Disposal of Controlled Substances (2014), which implements the Secure and Responsible Drug Disposal Act of 2010, to destroy a controlled substance it must be made “non-retrievable.”
“Non-retrievable means, for the purpose of destruction, the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance's physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes. The process to achieve a non-retrievable condition or state may be unique to a substance's chemical or physical properties. A controlled substance is considered "non-retrievable" when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. The purpose of destruction is to render the controlled substance(s) to a non-retrievable state and thus prevent diversion of any such substance to illicit purposes.”
Until 2010, acceptable destruction included crushing the pills and mixing the powder with kitty litter. This result is, however, no longer considered “non-retrievable.” Flushing controlled substances (and other pharmaceuticals) down the toilet has been outlawed by environmental protection legislation. When asked for more guidance about what “non-retrievable” meant, the DEA released the following clarification:
“To comply with the DEA regulations when disposing of a controlled substance, registrants must use a method which renders the substance "non-retrievable" (21 CFR 1317.90(a)) and otherwise complies with relevant law and regulations. The term "non-retrievable" is defined in a results-oriented manner as DEA requires the substance to be permanently rendered to an unusable state. 21 CFR 1300.05. The performance standard is that the method irreversibly renders the substance such that it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. Thus, regardless of whether the product claims to render controlled substances non-retrievable, to comply with the DEA regulations, a registrant that disposes of a controlled substance must use a product or method that actually does render the controlled substance non-retrievable within the meaning of the DEA regulations. Much like DEA does not evaluate, review, or approve the specific processes or methods utilized to produce, synthesize or propagate a controlled substance, DEA will not evaluate, review, or approve the processes or methods utilized to render a controlled substance "non-retrievable," as long as the desired result is achieved. EO-DEA178, October 5, 2020”
As helpful as United States Supreme Court Justice Potter Stewart’s famous definition of pornography, "I know it when I see it," the only method of destruction to which the DEA has given an approving nod is incineration. A dentist may incinerate controlled substances on-premises but must maintain a record of precisely what was incinerated with Form 41; when, where, why, by whom–AND it’s strongly recommended this is done in front of at least two witnesses, must be done with the full knowledge of the local DEA office.
While companies advertise liquids into which pills might be dropped and rendered compliantly destroyed, no product has ever been approved by the DEA as capable of rendering controlled substances “non-retrievable.”
Ultimately for most DEA registrant dentists, there are two methods to legally disposing of expired or otherwise unusable inventory:
- REVERSE DISTRIBUTOR: A company authorized by the DEA to collect and destroy medication which for any reason you cannot use it. There are many reasons why some of your drug inventory must be destroyed: a recall by the manufacturer, the drug expires, the drug is damaged (dropped on the floor, for example). Reverse distributors handle all the paperwork, collection, storage, return, or destruction of the drug, depending on what is legally required.
- FORM 41: You can use Form 41 if you want to ask for the help of the local DEA field office each time you have drugs in your inventory that, for whatever reason, cannot be used. The direction you get from your field office varies depending upon the field office and the reason the drug cannot be used (expired, recalled, damaged). This process is much more time-consuming than using a reverse distributor.
A reverse distributor is a company with which you contract for the destruction of controlled substances that are expired or otherwise unusable. A contract with a reverse distributor eliminates the need to file a Form 41 or to deal directly with the DEA each time you wish to dispose of inventory.
While the DEA does not recommend a particular reverse distributor, it does issue a list of approved reverse distributors.
However, reverse distributors charge for their services, and for dentists who have a “small” quantity of drugs to dispose, a DEA Form 41 may be the most cost-effective route. First, inform your regional DEA Field Division that you are in possession of expired Schedule IV Controlled Substances that you wish to dispose. Upon review of your completed form by your local field office, the DEA will send you instructions on how to destroy the controlled substances. The instruction may be to surrender the drugs to your local police department, to a particular drug take-back program, or to surrender them to the DEA Officer in Charge. Once the controlled substance has been destroyed, the remainder of Form 41 needs to be completed and returned to your local DEA Field Division.
Keep in mind that in some states, dentists are required to use reverse distributors either because state law requires it or because the local DEA office does not have the capacity to assist individual practitioners with drug destruction. The choice of whether to use a reverse distributor or Form 41 to dispose of controlled substances is (mostly) yours. Regardless of how you dispose of controlled substances, record keeping for sedation dentists is easier and more streamlined by using the DOCS DEA Drug Log Book, free to DOCS members.
Jacobellis v. State of Ohio, 378 U.S. 184 (Potter, J. concurring) (1964). https://www.law.cornell.edu/supremecourt/text/378/184
In Iowa, the regulations of the Iowa Board of Pharmacy requires that: “Any person or business registered to handle controlled substances in Iowa shall dispose of such drugs as follows: The responsible person shall contact and utilize the services of a DEA-registered and Iowa-licensed disposal firm (reverse distributor) OR The responsible person may contact the assigned compliance officer for their county for assistance or direction regarding the disposal of the drugs.” https://pharmacy.iowa.gov/controlled-substance-disposal-0
Author: J. Kathleen Marcus, Esq., is Strategic Dentistry’s General Counsel and DOCS Education's Regulatory Counsel. Uniquely qualified to advise and advocate for sedation dentistry, she draws on a healthcare law background that started over three decades ago. A 1988 graduate of Temple University School of Law, she was Research Editor of the Temple Law Review; she previously attended Bennington College and has a B.A. in Philosophy. Pennsylvania licensed, Kate spends her free time practicing sustainability in her suburban Philadelphia garden and on her land in the Guatemalan highlands around Lake Atitlan.