SB1766: Controlled substance tracking system; Board of Pharmacy to conduct a two-year pilot program.


Offered January 18, 2019
A BILL to direct the Board of Pharmacy to conduct a two-year pilot program for the development, management, use, and evaluation of a controlled substance tracking system; report.
Patron-- Boysko

Referred to Committee on Education and Health

Be it enacted by the General Assembly of Virginia:

1. § 1. The Board of Pharmacy (Board) shall conduct a two-year pilot program (program), beginning September 1, 2019, for the development, management, use, and evaluation of a controlled substance tracking system using dispenser data compliant with the federal Drug Supply Chain Security Act (DSCSA) (21 U.S.C. § 360eee). The purpose of the pilot program is to ensure that all pharmacies permitted in the Commonwealth are compliant with the DSCSA and to develop and evaluate a statewide system that prevents drug counterfeiting and diversion and provides advanced detection of opioid abuse and drug abuse using real-time drug analytics for regulators and law enforcement.

§ 2. Each pharmacy permitted in the Commonwealth shall participate in the program and shall collect and report, in an acceptable electronic format, its DSCSA data to the Board. The Board shall pay the cost of compliance with this section for any pharmacy for which such costs would constitute an undue hardship, as determined by the Board. No physician, dentist, veterinarian, or nurse practitioner dispenser shall be required to participate in the program.

§ 3. The Board shall provide access to the reported information to state and federal law-enforcement agencies having jurisdiction over prescription drug law enforcement, but all data, records, and reports relating to the program that are in the possession of the Board and any material relating to the operation or security of the program shall be confidential and shall be exempt from the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia) pursuant to subdivision 2 of § 2.2-3705.5 of the Code of Virginia.

§ 4. The Board may enter into agreements with the Department of Health and the Department of State Police to manage the program, contract with any vendors, and to apply for, manage, and utilize federal grants to implement the program.

§ 5. The Board shall provide a final report by October 31, 2021, to the Governor's Advisory Commission on Opioids and Addiction and to the Chairmen of the House Committee on Health, Welfare and Institutions and the Senate Committee on Education and Health.

§ 6. The Board shall promulgate regulations to implement the provisions of the program to be effective no later than September 1, 2019. The Board's initial adoption of such regulations shall be exempt from the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia), except that the Board shall provide an opportunity for public comment on the regulations prior to adoption.