Drug Disposal Laws & Regulations

Solutions that Meet Regulations

Drug Disposal requirements can feel complicated. And truth be told, they are. Regulations vary by industry, facility type, location, whether you are a DEA registrant or an end user, and more.

Rx Destroyer is here to help simplify the process with clear guidance and disposal solutions design to support safe and compliant controlled substance disposal.

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There Isn’t One Size-Fits-All for Drug Disposal

Hospitals, pharmacies, veterinary clinics, law enforcement, and households all follow different rules for controlled substance disposal.

DEA regulations under 21 CFR Part 1317 outline the disposal requirements for controlled substances held by DEA registrants.

EPA rules also apply when pharmaceuticals are considered hazardous. This is especially important for healthcare facilities and reverse distributors. You can learn more about the EPA ruling under 40 CFR Part 266 Subpart P.

However, these rules do not apply for non-registrants and ultimate users (aka end users).

What does the DEA require?

21 CFR Part 1317 – Compliance for Medication Disposal

The Drug Enforcement Administration, DEA, under the Department of Justice, outlines the rules to govern the secure disposal of controlled substances by registrants and ultimate users in 21 CFR Parts 1300, 1301, 1304, 1305,1307, and 1317, effective September 9, 2014. These regulations implement the Secure and Responsible Drug Disposal Act of 2010 by expanding the available options for collecting and disposing of controlled substances, allowing public and private entities to develop a variety of destruction methods which are convenient, secure and responsible to prevent drug diversion. Once a controlled substance has met the standard of ‘‘non-retrievable’’, it now meets the requirements of DEA chemical digestion medication disposal.

  • 21 CFR 1300 includes 1300.01 definitions relating to controlled substances and 1300.05, definitions relating to the disposal of controlled substances.
  • This final ruling implements a standard for destruction, non-retrievable, and the procedures for the destruction of controlled substances.
  • 21 CFR 1317 covers the disposal of controlled substances including 1317.90, Methods of Destruction and 1317.95, Destruction Procedures
  • 21 CFR 1317.19, Incineration and Chemical Digestion Destruction Methods, see page 53548: The DEA is specifying a required result, non-retrievable, rather than a required method for achieving that result.
  • The DEA does not require a particular method of destruction as long as the desired result is achieved.
  • Rx Destroyer can help you decipher the key aspects of medication disposal that meets 21 CFR DEA chemical digestion methods. For more information, see page 53522, Methods of Destruction.
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DEA Compliance

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What environmental regulations apply?

40 CFR – Protection of Environment

The Resource Conservation and Recovery Act, RCRA, regulates the storage, treatment, transportation, generation and disposal of hazardous waste and gives the EPA authority to control hazardous waste from “cradle to grave”.

This includes pharmaceuticals deemed as hazardous waste, outlined in 40 CFR Regulations, parts 261, 262, 264, 265, 266, 268, 270, and 273, the Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine. This final ruling adds regulations for pharmaceutical waste disposal by healthcare facilities and reverse distributors.

Healthcare facilities, including animal clinics, and reverse distributors must manage their hazardous pharmaceutical waste under these new sets of standards. States may operate under their own hazardous waste program, although it must be at least as stringent as federal regulations.

This final ruling in 40 CFR eliminates the dual regulation of RCRA hazardous pharmaceutical waste which is also a DEA controlled substance. New DEA compliant medication disposal method requirements prohibit disposing of pharmaceutical hazardous waste down the drain. Rx Destroyer can help you decipher the regulations applicable to your state as we work together to prevent water contamination and drug diversion.

 

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EPA Compliance

Components of the Drug Diversion Prevention Program

Maintaining a proper “Chain of Custody” of controlled substances is critical for drug diversion prevention and detection in healthcare facilities. A chain of custody refers to a documented trail with either paper witness logs or electronic witness log systems which track the custody, control, transfer and disposition of drugs maintained in hospitals and healthcare settings. Ideally, prescriptions should be tracked from “cradle to grave” with clear documentation of where the pharmaceutical is in the chain of custody.

Most hospitals typically use an electronic system such as Omnicell or BD Pyxis™ PARx™ with barcode scanning technology which requires input into an electronic form of a witness log. Rx Destroyer offers a reference Witness Log Form for download which provides a DEA compliant disposal method of controlled substance with witness destruction.

Activated carbon is a form of chemical destruction. Chemical destruction is recognized in DEA regulations. Rx Destroyer uses activated carbon. According to the most recent DEA ruling in the Disposal Act, a supplement to the Controlled Substance Act, DEA registrants which includes hospitals must not dispose of controlled substances in collection receptacles, they must be destroyed. See this supplement to the 2014 ruling with additional information for healthcare practitioners.

Drug Diversion Prevention in Healthcare Solutions

Rx Destroyer provides proven solutions with high quality products and services, assisting customers with drug diversion prevention strategies. We provide free compliance consultation to qualified customers as well as free samples, education, on-site training and phone support. Our customers have come to trust and rely upon our industry insights, education based philosophy and best practices for quick and effective drug disposal compliance requirements.

Our products are convenient and easy to use with no need to add water and no batteries required. We offer an All-Purpose product list in various sizes to accommodate any healthcare setting which neutralizes pills, capsules, tables, lozenges, liquids, suppositories, transdermal patches and fentanyl lollipops. Our product list for liquid pharmaceuticals including syringe injectables also offers various sizes for the most convenient and economical drug disposal solution especially effective in surgical environments.

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“I use Rx Destroyer in all my departments in my hospital, and several other facilities in our corporation use it as well. We’ve found it to be the perfect product for smaller hospitals. Since the COVID outbreak, having access to Rx Destroyer has become even more important because it gives us the ability to just dedicate an Rx Destroyer jug to the COVID area for medication waste, then discard of the jug without it ever leaving the COVID area.”

JOE DEMATTEI, PHARM.D., MBA, DIRECTOR OF PHARMACY – CROSSROADS COMMUNITY HOSPITAL

Other Related Resources

For more resources visit our downloads page

All Downloads

  • DEA Form 41

    Registrant Record of Controlled Substances Destroyed

    Download

  • EPA Effluent Guidelines

    The National regulatory standards for wastewater discharged to surface waters

    Learn More

  • P and U Lists

    Classifications of hazardous wastes established by the U.S. Environmental Protection Agency (EPA)

    See List

  • “The Orange Book” – DEA Controlled Substance List

    Master reference list of DEA regulated controlled substances

    Download

Regulations By State

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