How do you Ensure Compliance in Drug Disposal?

Written by Benjamin Mandel
October 4, 2023
a hand holding a pen over a paper, compliance and drug disposal

When it comes to safe and compliant drug disposal, it’s important to know the laws and regulations for containment and safe disposal of pharmaceuticals. There are many subcategories of pharmaceutical waste, all with their own unique set of disposal requirements.. How do you ensure compliance?

One of the first steps is to create a checklist or a list of questions to ask yourself when reviewing your facility’s disposal policies and processes.

Where do you start? The laws.


Who makes drug disposal laws and regulations?


Find, review, and adhere to the laws of your state and the federal government. It is important to understand that the state agency has the authority to impose more stringent requirements, but never less stringent requirements. Several agencies are involved in drug disposal compliance, including the Drug Enforcement Administration (DEA) and Environmental Protection Agency (EPA).

Other organizations such as the Department of Transportation have detailed guidelines for the proper packaging and shipment of pharmaceutical waste during transportation. Together, these agencies provide a robust outline for management of all pharmaceutical wastes to ensure the protection of human health and the environment.

  • Some specific regulations for pharmaceutical disposal include:Controlled Substances Act (CSA)
  • Secure and Responsible Drug Disposal Act of 2010
  • Resource Conservation and Recovery Act (RCRA)

Note that RCRA only regulates hazardous pharmaceuticals. However, any facility dealing with controlled substances ­– especially with disposal – must follow DEA guidelines that can be found here.


How to create a checklist for drug disposal compliance – start with the basics


Policies and procedures for compliance in handling and disposal of pharmaceuticals are essential for safety in any facility. Implementation and best practices will differ slightly among facilities depending on geographic location, size, and type of facility, but certain topics are common for all.

Topics that need to be included in any drug disposal compliance policy should include but is not limited to:

  • Process for evaluation pharmaceutical waste and identification of “Hazardous Waste Pharmaceuticals” and DEA Controlled SubstancesClearly outlined process for disposal of pharmaceutical wastes broken out by category (i.e. hazardous waste, DEA controlled waste, non-hazardous waste)
  • Potential for exposure to healthcare personnel, waste handlers/waste transfer personnel, and the environment
  • Safe handling of hazardous drugs
  • Personnel training
  • Compliant labeling and packaging
  • Ensuring that any off-site transportation and disposal processes are also compliant

A critical component to waste management is the understanding that every waste generator is responsible for the waste from “Cradle – to – Grave.” You are the one responsible for making sure that any transport or disposal facility you use is appropriately licensed to handle your drug waste and is in compliance with both state and federal regulations.


How to store waste pharmaceuticals?


According to the EPA, waste pharmaceuticals should be placed into a container that is structurally sound, compatible with contents, and lacks evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions. The agency also states that these containers must be kept closed and secured in a manner that prevents unauthorized access to its contents.

When evaluating how to properly store DEA controlled substances for disposal, please refer to DEA requirements found in 21 CFR.

What about drug disposal compliance standards for effective training?


Standards for effective training in regard to controlled substances and drug disposal processes in facilities must be included in policy and procedures of the facility. This will ensure that all employees who come into contact with such substances are aware of proper labeling and storage guidelines of the state and federal government.

Adherence to such practices also ensures that drugs are disposed of properly and safely, regardless of facility size, specialty, or function.

Employees are to be provided with information as well as training before they are exposed to any hazardous chemical or drug, as well as informed of any potential for risk to health in handling. Each employee must be able to demonstrate competency in understanding hazardous wastes and substances, and documentation needs to confirm this.

How should controlled or hazardous drugs be labeled, packaged, and transported?


Do your healthcare employees understand the importance of accuracy when it comes to labeling and packaging controlled substances or hazardous drugs for transport and disposal? They should be or your facility might risk fines and penalties for non-compliant drug disposal practices.

Important aspects of drug disposal or contact with controlled substances and hazardous drugs should be reviewed and added to policies and procedures. For example:

  • Standard operating procedures require that every employee must be trained in prevention of accidental spills or exposure as well as how to respond to such an event.
  • Containers of waste pharmaceuticals should be managed in a way that prevents release, and is appropriately labeled for the hazards of the contents.
  • When storing waste pharmaceuticals, containers should be appropriately marked and labeled in accordance with state and federal guidelines.
  • Care should be taken by personnel to avoid the mixing of pharmaceutical waste types. In the event that mixing occurs, the resulting waste should be evaluated against state and federal guidelines for proper disposal.
  • Compliant packaging standards or use of containers that are appropriately marked must adhere to state and federal guidelines that will prevent drugs from leaking, contaminating, or otherwise damaging those containers and potentially increasing the risk of exposure when handling.

Standards for labeling, packaging, transportation and compliance and drug disposal must be followed in accordance with the local, state, and federal regulations. The EPA and DOT clearly outline the requirements.

How to prevent drug diversion


Reducing the risk for drug diversion is of primary concern to the DEA. As such, policies and procedures for any facility in possession of controlled substances needs to:

  • Install systems for accountability and accuracy for record-keeping and documentation
  • Create drug diversion-specific policies for medication security (during receipt, storage, dispensing, inventory, and disposal of unused drugs)
  • Develop a zero-tolerance policy for drug theft of any kind
  • Ensure that destruction methods are consistent with local, state, and federal laws and regulations
  • Create a waste retrieval system, waste processes, and/or use of secure drug diversion containers that enable denaturing or destruction of drugs by chemical or other formulas. Containers of denatured drugs, after being rendered useless, can then be picked up and transported off-site by a licensed healthcare/hazardous waste company.

Do your part


Secure a Drug is dedicated to preventing drug diversion in healthcare facilities regardless of size or type. Drug diversion in medical care scenarios has the potential to endanger not only professional healthcare providers, but their patients. Do your part to ensure compliance in drug disposal. For more information about Secure a Drug or denaturing drugs in healthcare facilities, contact one of our knowledgeable representatives today.