18VAC110-60-170: Remove the two-year requirement for pharmacy technicians employed by a pharmaceutical processor

18VAC110-60-220(F,G): Visitors Policy: Remove the requirement that the Board must approve or waive all visitors. Also, allow younger minor children to accompany their parent into the dispensing area and allow visitors to assist someone into the facility that might have mobility issues.

18VAC110-60-230(A)(1), (B): Inventory: Remove requirement that a pharmacist or pharmacy technician must conduct inventory. Change to require a pharmacist or pharmacy technician to verify the inventory, not conduct.

18VAC110-60-290: Product Label: Remove requirements for duplicative information between the product label and patient label.

18VAC110-60-290(B)(2)(e): Expiration Dates: Set a specific expiration date range for products until stability testing is feasible. Specifically consider between 6 and 12 months

18VAC110-60-300(F): Remediation: Allow for remediation if a sample does not pass testing requirements.

18VAC110-60-310(A)(1): VCPRL: Allow non-licensed personnel to access the VCPRL to allow access to the processor.

18VAC110-60-310(C): Patient Labels: Remove requirements for duplicative information between the product label and patient label (same request as product label).

In accordance with Virginia law, the petition has been filed with the Register of Regulations and will be published on August 3, 2020.  Comment on the petition may be sent by email, regular mail or posted on the Virginia Regulatory Townhall at www.townhall.virginia.gov; comment will be requested until August 25, 2020.

Following receipt of all comments on the petition to amend regulations, the Board will decide whether to make any changes to the regulatory language in Regulations Governing Pharmaceutical Processors. This matter will be on the Board’s agenda for its meeting scheduled for September 9, 2020, and the petitioner will be informed of the Board’s decision after that meeting.

The Board voted on September 9, 2020 to proceed with the initiation of rulemaking. After the Notice of Intended Regulatory Action completes executive branch review and is approved by the Governor, it will be published and open for a 30-day comment period.

The Board has referred the requested amendments to the Regulation Committee for further review and recommendation of any regulatory language that will be adopted at the proposed stage.