7/15/2020 11:29 am
Date / Time filed with the Register of Regulations
VA.R. Document Number: R____-______
Virginia Register Publication Information

Transmittal Sheet: Response to Petition for Rulemaking
X
Initial Agency Notice
Agency Decision
Promulgating Board: Board of Pharmacy
Regulatory Coordinator: Elaine J. Yeatts

(804)367-4688

elaine.yeatts@dhp.virginia.gov
Agency Contact: Caroline Juran, RPh

Executive Director

(804)367-4456

caroline.juran@dhp.virginia.gov
Contact Address: Department of Health Professions

9960 Mayland Drive

Suite 300

Richmond, VA 23233
Chapter Affected:
18 vac 110 - 60: Regulations Governing Pharmaceutical Processors
Statutory Authority: State: 54.1-3442.5 et seq.

Federal:
Date Petition Received 07/15/2020
Petitioner Virginia Medical Cannabis Coalition
 Petitioner's Request
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).    
 Agency Plan
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.  
Publication Date 08/03/2020  (comment period will also begin on this date)
Comment End Date 08/25/2020