FEDERAL & STATE GUIDELINES

Definitions | Links
FED & STATE GUIDELEINES

FEDERAL & STATE GUIDELINES

Always follow recommended guidelines of your facility, local, state, tribal and federal regulatory agencies for proper disposal of pharmaceutical waste. If your facility requires and does not have a pharmaceutical waste service provider, Rx Destroyer™ can recommend a service provider. Below are links to education and various regulatory agencies and organizations that address pharmaceutical waste disposal. We will continue to update this information.

► DEA 21 CFR Parts 1300, 1301, 1304, et al. - Effective September 9th 2014

21 CFR FINAL RULE DOCUMENT

BRIEF: DEA Disposal of Controlled Substances – Final Rule:

“Existing DEA regulations do not specify a standard to which controlled substances must be destroyed. With this final rule, the DEA is implementing a standard of destruction—non-retrievable—for registrants that destroy controlled substances, and procedures for the destruction of controlled substances. 21 CFR 1300.05 (‘‘non-retrievable’’), 1317.90, and 1317.95. The DEA is not requiring a particular method of destruction, so long as the desired result is achieved.”

“This standard is intended to allow public and private entities to develop a variety of destruction methods that are secure, convenient, and responsible, consistent with preventing the diversion of such substances.” Destruction of controlled substances must also meet all other applicable Federal, State, tribal, and local laws and regulations. Once a controlled substance is rendered ‘‘non-retrievable’’, it is no longer subject to the requirements of the DEA regulations.”

  • Key Aspects to 21 CFR and use of Rx Destroyer™
    • “Methods of Destruction” See Page 53522: “Existing DEA regulations do not specify a standard to which controlled substances must be destroyed. With this final rule, the DEA is implementing a standard of destruction–non-retrievable–for registrants that destroy controlled substances…”
    • “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. 21 CFR 1317.19
  • Maintaining Records and Reports:    Title 21 Code of Federal Regulation §1304.22
  • Disposal of Controlled Substances:   Disposal Part 1317
  • Practitioner Disposal Clarification Letter:   Dear Practitioner Letter October 17, 2014
  • DEA Definitions Relating to the Disposal of Controlled Substances: §1300.05:   Definitions

► DEA 40 CFR PROTECTION OF ENVIRONMENT

40 CFR Protection of Environment – Parts 1-49 Entire Document

40 CFR Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P1075 Listing for Nicotine – Effective Aug 21st 2019

BRIEF Final Rule:

“Some pharmaceuticals are regulated as hazardous waste under the Resource Conservation and Recovery Act (RCRA) when discarded. This final rule adds regulations for the
management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. Healthcare facilities (for both humans and animals) and reverse distributors will manage their hazardous waste pharmaceuticals under this new set of sector-specific standards in lieu of the existing hazardous waste generator regulations. Among other things, these new regulations prohibit the disposal of hazardous waste pharmaceuticals down the drain and eliminates the dual regulation of RCRA hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances.”

State Reference Guide to Incineration* – The following states or districts require DEA Registrants and Generators to incinerate pharmaceutical waste:

California | Washington | Maryland | Washington D.C. | New York | Missouri | Louisiana | New Mexico | Colorado | Minnesota

*Ultimate Users may continue to dispose Rx Destroyer™ into common trash. Please visit state for specifics and or improvements to rules and regulations.

The above quick reference guide and state links are dynamic and maintained to the best of our ability. Information is made available as a convenience to future and current Rx Destroyer™ customers. Reader understands information, links, rules, processes may change without notice. Users of Rx Destroyer™ products agree to perform due diligence in understanding and abide by specific process, rules and laws by which they are governed. 

To assist in your search on state websites, consider the following terms:

  • Non-Hazardous Waste | Pharmaceutical Waste | Medication Disposal
  • Destruction of Collected Pharmaceuticals | Landfill non-RCRA Waste

We appreciate any updates to your state’s guidelines link, please forward information to cs@rxdestroyer.com.

Thank you.

Have questions?