7/15/2020 11:29 am Date / Time filed with the Register of Regulations | VA.R. Document Number: R____-______ |
Virginia Register Publication Information
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Transmittal Sheet: Response to Petition for Rulemaking
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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 |
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 |