TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Notice of Intended Regulatory Action

Notice is hereby given in accordance with § 2.2-4007.01 of the Code of Virginia that the Board of Pharmacy intends to consider amending 18VAC110-20, Regulations Governing the Practice of Pharmacy. The purpose of the proposed action is to align regulations with new federal requirements of the Drug Supply Chain Security Act (21 USC § 351 et seq.) and the Protecting Patient Access to Emergency Medications Act (21 USC § 823) that ensures emergency medical services (EMS) providers can provide drugs to patients as needed. The amendments being considered (i) allow EMS agencies and regional EMS councils to apply for a controlled substance registration (CSR) and use a hub-and-spoke model to service designated locations of the entity holding the CSR and federal Drug Enforcement Administration registration; (ii) establish requirements for required health care practitioners needed to maintain, audit, and dispense drug stock and requirements for prescribers connected to the CSR holder; (iii) provide certain allowances for EMS agencies and regional EMS councils regarding drug storage, alarm systems, and audits of drugs; and (iv) permit transfer of drugs between locations controlled by a hub CSR and between CSR holders.

The agency intends to hold a public hearing on the proposed action after publication in the Virginia Register.

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Public Comment Deadline: October 9, 2024.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4456, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.