VACo recently received letters sent to U.S. Representative Abigail Spanberger and U.S. Representative Bob Good, members of the Virginia Congressional Delegation by the U.S. Food and Drug Administration (FDA), in response to inquiries from those members regarding 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. The letters from the FDA provide additional information and clarity regarding the transition of the program. Of note:
- “FDA’s actions related to the DSCSA do not warrant Virginia EMS agencies and area hospital pharmacies changing their current practice of replenishing/rotating out minimal quantities of product needed for EMS medical kits, based on our understanding of the practice as described in your letter and other relevant correspondence.”
- “FDA has provided guidance to industry that it generally does not intend to take action against a dispenser, such as a hospital pharmacy, who transfers ownership of product directly to a first responder where the dispenser does not provide the first responder with product tracing information, e.g., transaction information”
- “Additionally, apart from FDA’s compliance policy, there are potentially other flexibilities in the statute that may apply; for example, in certain situations an exchange of medication kits between a pharmacy and first responder would not be considered a “transaction” under the DSCSA, and FDA also retains authority to grant waivers from DSCSA requirements in certain situations including for emergency medical reasons.”
Based on this information, VACo encourages members to continue to coordinate with their EMS providers and area hospital pharmacies to seek opportunities to reduce cost burdens in the process of shifting responsibilities for the drug box program to local governments.
As previously reported, 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 this issue.
VACo will continue to provide updates and engage on this issue as they become available. VACo was recently added to the Virignia Regional EMS Medication Kit Transition Workgroup. This workgroup includes representation from the Regional EMS Councils, the Virginia Office of EMS, the Virginia Board of Pharmacy, the EMS Advisory Board Medical Direction Committee, the EMS Advisory Board EMS Next Steps Workgroup, the Virginia Society of Health System Pharmacists, the Virginia Hospital and Healthcare Association, the Virginia Association of Volunteer Rescue Squads, the Virginia Fire Chiefs Association, the Virginia Association of Governmental EMS Administrators, and the Virginia Ambulance Association. The tools and resources developed by the Workgroup and others across the Commonwealth to assist EMS Agencies have been placed on all the Regional Council websites as well as the Virginia Department of Health Office of EMS website.
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