Solutions That Meet Regulations
C2R Global Manufacturing, Inc. offers medication disposal that is compliant with DEA chemical digestion methods consultations and solutions which meet the Code of Federal Regulations (CFR) 21, 40 and 42 for regulated medical waste disposal. It is the responsibility of each distributor, reverse distributor, facility and end user to meet the guidelines of their facility, local, state, tribal and federal regulatory agencies for proper drug disposal. We offer the following resources for education and links to various regulatory agencies and organizations that address pharmaceutical waste disposal.
DEA 21 CFR 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.
C2R Global Manufacturing, Inc. can help you decipher the key aspects of medication disposal that meets 21 CFR DEA chemical digestion requirements. For more information, see page 53522, Methods of Destruction.
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
EPA 40 CFR Regulations 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.
Federal Specific and DEA Compliant Links
DEA Form 41, Registrant Record of Controlled Substances Destroyed
EPA Effluent Guidelines, the national regulatory standards for wastewater discharged to surface waters.
Registrant Fact Sheet – Quick reference guide for DEA Medication Disposal Regulations including definition of the “ultimate user”. Ultimate Users may continue to dispose of Rx Destroyer™ into common trash. Please visit each state for specifics and or improvements to rules and regulations.
42 USC 256b, Title 42 Public Health and Welfare, Limitation on prices of drugs purchased by covered entities
42 USC 2651, Title 42 Public Health and Welfare, Federal Medical Care Recovery Act (FMCRA)
State Specific Links
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
State Reference Guide to Incineration* – The following states or districts require DEA Registrants and Generators to incinerate pharmaceutical waste:
- Washington D.C.
- New York
- New Mexico
We appreciate any updates to your state’s guidelines link, please forward information to firstname.lastname@example.org.
The above quick reference guides and state links are dynamic and maintained to the best of our ability. Information is made available as a convenience to future and current C2R Global Manufacturing, Inc. 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.
C2R Global Manufacturing, Inc. differs from other pharmaceutical waste management companies in our commitment and exceptional support to our customers and distributors. We offer free compliance consultations, no contracts and no hidden fees. We are dedicated to our mission of saving water, saving lives, one prescription at a time with medication disposal that meets DEA chemical digestion requirements.
C2R Global Manufacturing, Inc. offers quick and seamless facility implementation for DEA and EPA compliance. We are committed to saving water, saving lives…one prescription at a time with compliance made easy. Learn more about our proven solutions on drug diversion prevention in healthcare.