Accreditation & Regulatory Journal
November 2022


Controlled Substance Wasting Regulations

By: Ann Martin
How can your organization assure it meets these requirements? When disposing of controlled substances, DEA requirement (§1300.05) requires that the drug must be rendered non-retrievable. This means to permanently alter the controlled substance’s physical or chemical condition through irreversible means and make it unavailable or unusable for all purposes. During survey activity, it is often found that staff are either disposing of controlled substance waste in a general sharps’ container, squirting it down the sink, disposing pills or liquids in the trash, or placing them into a non-hazardous pharmaceutical waste bin with an open lid. This type of disposal would trigger a citation to be issued. None of these methods would render the medication unavailable or unusable.
It is not acceptable to release a controlled substance down the drain or dispose of it in a manner that it would eventually land in a landfill disposal. Additionally, placing controlled substances in a sharps’ container or non-hazardous pharmaceutical waste container is not considered non-retrievable and therefore, not acceptable. These containers have an open lid and can easily be poured out and collected, making the medication retrievable. The two-part process described below is the only currently acceptable means of disposal to meet the DEA (§1300.05) regulatory/legal requirements within your organization.
  • Wasting of the controlled substance in a neutralizing media. Examples: Cactus smart sink, CsRx, or an RX destroyer. Research which system works best for your facility.
  • Placing a neutralizer container into a non-hazardous pharmaceutical waste container that would be sent out for incineration. Currently, incineration is the only final method that is accepted by the DEA for final disposal.
Thus, all organizations must comply with DEA regulations and must use a product or method that renders the drugs non-retrievable. Regardless of whether products claim to render controlled substances non-retrievable, assure that the product meets the defined DEA requirements.
CMS requires that organizations have policies and procedures in place to minimize scheduled drug diversion. In addition, CMS requires the hospital system to have the capability to identify loss or diversion of all controlled substances to minimize the time frame between the loss or diversion to time of detection and then determine the extent of loss or diversion.
Having the correct controlled substance waste container is a one great step to assist your organization in compliance with preventing diversion and meeting the DEA requirements.
Federal Register/Vol. 79 Tuesday, No. 174 September 9, 2014
CMS Conditions of Participation for Acute Care Hospitals, §42 CFR 482.25(a)(3).