VACo recently sent a letter to Administrator Anne Milgram of the U.S. Drug Enforcement Administration (DEA), Commissioner Robert M. Califf of the U.S. Food and Drug Administration (FDA), and members of the Virginia Congressional Delegation expressing concerns over federal regulatory changes association with the Drug Supply Chain Security Act, 21 U.S.C. § 351 et seq. (DSCSA), and the Protecting Patient Access to Emergency Medications Act, 21 U.S.C. § 823, which will cause major changes to the Virginia’s Prescription Drug Program. VACo urges the FDA and DEA to consider the unique circumstances of Virginia’s EMS providers and work collaboratively with state and local agencies to develop a regulatory framework that ensures compliance without imposing undue burdens on local governments. Specifically, we request that federal agencies explore options for maintaining the viability of the Prescription Drug Box Program while aligning with federal law.
As previously reported, hospitals have indicated that they will no longer provide and exchange drug kits with Emergency Medical Service (EMS) providers as of November 27, 2024, the date the FDA has indicated that it will begin enforcing additional requirements of the DSCSA impacting hospital pharmacies. This unique program to Virginia, also known colloquially as prescription drug boxes, has, for years, performed an important part of emergency service provision in Virginia, which is also uniquely reliant upon volunteer EMS providers, as it allows EMS vehicles to ensure they are fully stocked to provide needed drugs to patients in transport or at accident sites. While seemingly condoned by the DEA, the Virginia Board of Pharmacy (BOP) has opined that kit exchange process is not fully compliant with DEA requirements as drugs are not exclusively transferred between DEA registrants or provided to an EMS agency working as an extension of a specific hospital DEA registration. This could upend existing local EMS practices and impose significant financial and/or staffing burdens upon local governments.
Additionally, emergency regulations from the Virginia Department of Health Professions completed their regulatory review process and were published on Virginia Regulatory Town Hall on August 16th. These changes do much to address fundamental challenges EMS providers and local governments face in trying to comply with the federal regulations. However, many localities and EMS providers may still struggle to implement changes.
VACo will provide updates on this issue as they become available. If your county or EMS providers are still struggling to implement changes to the prescription drug box program as a result of the new regulations or are facing delays in the approval of waivers submitted to the FDA, VACo encourages you to contact members of your congressional delegation for assistance. A useful compilation of additional information and resources provided by the Peninsulas EMS Councils can be found here.
VACo Contact: Jeremy R. Bennett