New Indiana EMS Controlled Substances Registration
April 11, 2022 | Implementing Stricter Drug Disposal Codes on EMS Providers
The Indiana Department of Homeland Security’s enforcement of controlled substances registration (CSR) is currently in a transition period with the implementation of stricter drug disposal codes that took effect on August 25, 2021.
The new policy states all destroyed or disposed of products must be recorded and be irretrievable in accordance with proper disposal practice for EMS providers in the state of Indiana. Historically, these medications have been provided to EMS by hospitals under written affiliation agreements or by the agencies EMS Medical Director using a practitioner DEA registration. In 2017 the Protecting Patient Access to Emergency Medications Act of 2017 passed. Now adding EMS agencies as a new category of DEA registrants. This allowed EMS agencies to register with the state as one registration per state in lieu of how many locations they operate in within the state. Public Law No: 115-83 also authorizes EMS professionals to administer controlled substances without having a medical director physically present as well as a variety of other new requirements of documentation, storage, and other operational features.
To become compliant with Public Law No: 115-83 there are many aspects that need to be changed in current practices. First, the Indiana Board of Pharmacy had to ultimately reverse the exemption of EMS provides from obtaining a state Controlled Substance Registration. The controlled registration is needed to apply for a DEA registration. On July 30th 2021, the Indiana Board of Pharmacy signed a law to allow issuance of State CSR for EMS providers. The only providers that will now be exempt from needing a State CSR is EMS providers who are owned and operated by a hospital. These entities will be allowed to operate under the Hospitals CSR and DEA licenses. This rule went into effect on 8/25/2021.
NEXT STEPS:
- Discuss with your current DEA registrant what your process should be going forward.
- Discuss the new process with your Team
- Review your teams’ policies and procedures for controlled substance handling and administration including but not limited to: ordering, receiving, handling, storing, distribution of, documentation of controlled substances.
- Determine process for preventing diversion and the disposal of expiration of controlled substances
- Apply for State CSR
- Once State CSR is granted, apply for your Federal DEA Registration by selecting “Hospital/Clinic” and following further instructions
The state of Indiana is ahead of where the federal ruling stands. The proposed rule of controlled substances pertaining to EMS providers are still pending final ruling. The pending rule will set out guidelines for day-to-day operations in relation to controlled substances.
Indiana is in a grace period while EMS organizations transition to implementing the new legal requirements for drug disposal. This grace period will end on June 30th, 2022. On July 1st, 2022, you must follow your controlled substance registration (CSR) and use a proper disposal method for disposal of any controlled substance. Once the controlled substance registration (CSR) for ambulances has been issued, you will be liable to comply with the disposal of controlled substances. As a DEA registrant, you are subject to fines for any violation of improper disposal of any controlled substance.
In addition to the new federal laws and rules, EMS providers in the state of Indiana are still required to continue compliance with Indiana 836 administrative code article 2. This includes storing medications in a locked container within a locked compartment and will have written approval of storage by a medical director or issuing pharmacy. It is still required for Advanced EMT and paramedic providers to list approved controlled substances for certification while also complying with the approved list for daily operations. Before the enforcement, disposal of drugs in a Sharps container, sink and/or trash was a commonly used method of disposal. Proper disposal of any controlled substance will eliminate diversion along with harm to the environment. To avoid additional steps, wages, and transportation of controlled substances to hospitals, you have the option to dispose of controlled substances on site.
Rx Destroyer ™is a DEA and EPA approved method of destruction and ready-to-use. We recognize EMS industries must have an effective, user-friendly, safe, and affordable drug disposal system. Our product comes in a variety of sizes including an all-purpose and liquid solution for any drug disposal need.
