Understanding Drug Denaturing and Non-Retrievable Strategies

Written by Benjamin Mandel
November 8, 2021
a white bottle with pills spilling out of it, drug denaturing

Expired or unwanted pharmaceutical drugs and unused prescription opioids must be rendered harmless before disposal in order to prevent potential theft or misuse of a drug through inadvertent exposure to children or others. Such practice can also reduce incidents of drug diversion, as well as to prevent those drugs from entering into and damaging groundwater or soil. When it comes to drug denaturing and planning non-retrievable strategies to protect people and the environment, definitions are important.


What is drug denaturing?


Medical dictionaries define drug denaturing as “changing the nature or natural quality of something,” and the process of denaturation involves the modification of a drug’s molecular structure.

The definition of a non-retrievable waste and its disposal is also important to know and understand even though it is similar to the definition of drug denaturing. The term “non-retrievable” implies a permanent alteration of the physical or chemical components or condition of a controlled substance through irreversible means, such as making it unusable or unavailable for its intended purposes.

Every state has its own rules and regulations regarding drug disposal, typically developed through their Departments of Environmental Quality or Protection. When it comes to destruction of controlled substances, opioids, and other pharmaceutical drugs, it is vital to maintain compliance not only with state but federal laws, especially those of the Drug Enforcement Administration (DEA). In these instances, the most stringent rules across local, state, and federal agencies apply.


What does the law say about destruction of controlled substances?


At its essence, the DEA requires that all controlled substances are to be destroyed in compliance with local, tribal, state, and federal laws and regulations, thereby rendering them “non-retrievable.” Refer to §1317.95 (Destruction Procedures) for a listing of requirements that must be followed when it comes to controlled substances destruction to maintain compliance with federal laws.

DEA regulations are overseen by the Diversion Control Division. Title 21 CFR Part 1300 contains information for safe drug disposal processes that includes definitions, labeling, and packaging requirements for controlled substances. Schedules of controlled substances and information regarding disposal (Part 1317) are a must-read. Part C of this section of the law focuses on destruction of controlled substances.

Regardless of what type or product of drug denaturing and non-retrievable strategies used by a healthcare facility, federal regulations must be followed to ensure compliance and to reduce the risk of substantial fines and penalties.


The importance of secure drug disposal


The importance of secure drug disposal is vital for all healthcare and pharmaceutical providers, regardless of the type or size of facility. Unfortunately, hospitals around the country continue to struggle with drug diversion among professional healthcare staff members. Unsafe disposal practices also contribute to unauthorized access by potential patients, visitors, the general public, and even animals if such waste is not properly secured.


Current non-retrievable strategies


A number of disposal options are currently available for unwanted and expired pharmaceuticals in order to reduce diversion and the resulting misuse of controlled substances. Such strategies are employed to prevent illicit drug use and abuse as well as in the prevention of drug overdoses.

Proper disposal methods are also required of such drugs to prevent them from contributing to pharmaceutical pollution in groundwater supplies and in waterways. Formerly common practices of disposal in general trash, for example, leads to greater instances of drug diversion practices, accidental exposure to others, and environmental pollution.

Contemporary medication disposal products used in a non-retrievable drug strategy contain several different active ingredients to absorb and chemically alter pharmaceuticals. For example, some utilize activated carbon to denature narcotics. Another common active ingredient is bentonite clay, which absorbs chemicals and transforms them to clay.

Some contain a combination of activated carbon and other proprietary agents, depending on the manufacturer, while others utilize calcium hypochlorite along with absorbent polymers whose mechanism of action is oxidation and absorption.

Other effective non-retrievable strategies, such as those used by Secure a Drug, include a relatively simple solution of controlled substance disposal that promotes safety for patients, clinicians, and the general public. Secure a Drug utilizes warm water and activated charcoal as its primary source to denature, dissolve, and neutralize pharmaceuticals in three simple steps. The containers are then picked up by the supplying company and disposed of in compliance with state and federal regulations.

Such strategies, in addition to incineration and chemical “digestion” or interactions that render the drug unusable, are in use today. It is important to note that the DEA does not – and will not – officially evaluate, review, or approve these products or processes as long as the “desired result is achieved.”[1]

It should also be noted that patients that use controlled substances in a home environment are not subject to the DEA’s rule regarding disposal requirements. Even so, they are encouraged to follow the recommendations of state and federal agencies and, when possible, utilize national drug take-back programs as preferable over trash disposal.

Finally, DEA regulations require that drug disposal methods that render a substance non-retrievable follow federal regulations for the destruction and disposal of controlled substances. The definition of non-retrievable as noted in 21 CFR 1317.90(a) states that any destruction method used must comply with that regulation and that the DEA requires substances to be rendered to a permanently unusable state (21 CFR 1300.05).


Once a controlled substance has been rendered non-retrievable, standard Department of Transportation (DOT) requirements must be followed for shipping waste off-site, in addition to all other state and federal guidelines. This includes proper shipping documentation as well as following appropriate packaging guidelines. Remember, just because waste is no longer onsite, it does not mean you are no longer responsible for it. The cradle-to-grave approach still applies, meaning it is vital that these regulations are followed. This is where an experienced waste provider can provide assistance.


Secure a Drug for safety


Secure a Drug is dedicated to promoting anti-drug diversion practices in healthcare facilities, keeping patients, healthcare professionals, and clinicians safe. We provide easy-to-use, cost-effective, and compliant processes to denature controlled substances and pharmaceuticals. We focus on enhanced safety and containment procedures that reduce potential threats of theft, misuse, and dangers of unauthorized use of opioids. For more information, contact a Secure a Drug representative today.

[1] https://www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf