TITLE 1. ADMINISTRATION
TREASURY BOARD
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the Treasury Board conducted a periodic review and a small business impact review of 1VAC75-20, Virginia Security for Public Deposits Act Regulations, and determined that this regulation should be amended.
The proposed regulatory action to amend 1VAC75-20, which is published in this issue of the Virginia Register, serves as the report of findings.
Contact Information: Kristin A. Reiter, Director of Operations, Department of the Treasury, James Monroe Building, 101 North 14th Street, 3rd Floor, Richmond, VA 23219, telephone (804) 225-3240, FAX (804) 225-3187, or email kristin.reiter@trs.virginia.gov.
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TITLE 4. CONSERVATION AND NATURAL RESOURCES
VIRGINIA SOIL AND WATER CONSERVATION BOARD
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the Virginia Soil and Water Conservation Board conducted a periodic review and a small business impact review of 4VAC50-85, Nutrient Management Training and Certification Regulations, and determined that this regulation should be amended.
The fast-track regulatory action to amend 4VAC50-85, which is published in this issue of the Virginia Register, serves as the report of findings.
Contact Information: Lisa McGee, Policy and Planning Director, Department of Conservation and Recreation, 600 East Main Street, 24th Floor, Richmond, VA 23219, telephone (804) 786-4378, FAX (804) 786-6141, or email lisa.mcgee@dcr.virginia.gov.
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TITLE 6. CRIMINAL JUSTICE AND CORRECTIONS
STATE BOARD OF LOCAL AND REGIONAL JAILS
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the State Board of Local and Regional Jails conducted a periodic review and a small business impact review of 6VAC15-20, Regulations Governing Certification and Inspection, and determined that this regulation should be amended. The department is publishing its report of findings dated January 6, 2022, to support this decision.
Regulations Governing Certification and Inspection (6VAC15-20) meets the criteria set out in Executive Order 14 (as amended, July 16, 2018) in that it is necessary for the protection of the health, safety, and welfare of staff, defendants, and inmates within local, regional, and community correctional facilities. This regulation has proven effective in meeting this need and is deemed to be easily understandable. Due to changes in the Code of Virginia, technical and clarifying amendments are necessary to reflect changes in the name of the board and other technical and clarification amendments to reflect similar changes.
There have been no complaints or comments received from the public concerning the regulation. The regulation is not deemed to be overly complex, nor does it overlap, duplicate, or conflict with federal or state law or regulation. Technology, economic conditions, or other factors have not significantly changed in the area affected by the regulation since it was last updated. The regulation was last reviewed in 2015 and last updated in 2011. Small businesses do not operate the facilities that are covered by the Code of Virginia and subject to this regulation as they are all public facilities; therefore, the regulation has no impact on small businesses.
Contact Information: Ryan McCord, Executive Director, State Board of Local and Regional Jails, 6900 Atmore Drive, Richmond, VA 23225, telephone (804) 887-8340.
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the State Board of Local and Regional Jails conducted a periodic review and a small business impact review of 6VAC15-28, Regulations for Public/Private Joint Venture Work Programs Operated in a State Correctional Facility, and determined that this regulation should be repealed.
The final regulatory action to repeal 6VAC15-28, which is published in this issue of the Virginia Register, serves as the report of findings.
Contact Information: Ryan McCord, Executive Director, State Board of Local and Regional Jails, 6900 Atmore Drive, Richmond, VA 23225, telephone (804) 887-8340, or email ryan.mccord@vadoc.virginia.gov.
BOARD OF JUVENILE JUSTICE
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the Board of Juvenile Justice conducted a periodic review and a small business impact review of 6VAC35-180, Regulations Governing Mental Health Services Transition Plans for Incarcerated Juveniles, and determined that this regulation should be amended.
The notice of intended regulatory action to amend 6VAC35-180, which is published in this issue of the Virginia Register, serves as the report of findings.
Contact Information: Ken Davis, Regulatory Affairs Coordinator, Department of Juvenile Justice, 600 East Main Street, 20th Floor, Richmond, VA 23219, telephone (804) 807-0486, FAX (804) 371-6490, or email kenneth.davis@djj.virginia.gov.
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TITLE 9. ENVIRONMENT
VIRGINIA WASTE MANAGEMENT BOARD
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the Virginia Waste Management Board conducted a periodic review and a small business impact review of 9VAC20-81, Solid Waste Management Regulations, and determined that this regulation should be amended.
The proposed regulatory action to amend 9VAC20-81, which is published in this issue of the Virginia Register, serves as the report of findings.
Contact Information: Priscilla Rohrer, Department of Environmental Quality, 4411 Early Road, P.O. Box 3000, Harrisonburg, VA 22801, telephone (540) 574-7852, FAX (804) 698-4178, or email priscilla.rohrer@deq.virginia.gov.
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TITLE 12. HEALTH
STATE BOARD OF BEHAVIORAL HEALTH AND DEVELOPMENTAL SERVICES
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the State Board of Behavioral Health and Developmental Services conducted a periodic review and a small business impact review of 12VAC35-12, Public Participation Guidelines, and determined that this regulation should be retained as is. The department is publishing its report of findings dated January 14, 2022, to support this decision.
This regulation is required per § 2.2-4007.02 of the Code of Virginia and meets the requirements of Executive Order 14 (as amended, July 16, 2018) in that it lays out a structure for the agency to actively seek input for proposed regulations from interested parties, stakeholders, citizens, and members of the General Assembly. Regulations function best when citizen input is gained and balanced with state and federal requirements, which should be kept to a minimum while helping to ensure the health, safety, and welfare of citizens.
There are no necessary changes at this time as the regulation meets the requirements in the Administrative Process Act and Executive Order 14 for public participation regarding regulatory activity. The regulation is needed to comply with § 2.2-4007.02 of the Code of Virginia. No comments were received concerning the regulation. The regulation is straightforward and minimal while meeting requirements for notification to the public. The regulation does not overlap, duplicate, or conflict with federal or state law or regulation. It has been four years since the regulation was; technology, economic conditions, or other factors have not changed in the area affected by the regulation.
The agency's decision will minimize the economic impact of regulations on small businesses as the requirements on the agency will help to keep regulants informed of proposed changes to regulations and how to comment on them in a timely manner.
Contact Information: Ruth Anne Walker, Director of Regulatory Affairs, Department of Behavioral Health and Developmental Services, Jefferson Building, 1220 Bank Street, 4th Floor, Richmond, VA 23219, telephone (804) 225-2252.
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the State Board of Behavioral Health and Developmental Services conducted a periodic review and a small business impact review of 12VAC35-240, Eugenics Sterilization Compensation Program, and determined that this regulation should be retained as is. The department is publishing its report of findings dated January 20, 2022, to support this decision.
This regulation is necessary to carry out the requirements mandated by the General Assembly (2021 Appropriation Act, Item 320.T.1-2. and meets the requirements of Executive Order 14 in that the regulation helps to protect the welfare of individuals who were victims of forced sterilization pursuant to the Virginia Eugenical Sterilization Act through the provision of compensation to victims. This regulation clearly articulates administrative guidelines for filing appropriate documentation and verification of any claim of individuals who were victims.
The regulation will be retained as is as nothing has changed regarding the application and review processes.
The regulation is needed to carry out the requirements of Item 320.T.1-2. of the Appropriation Act. No comments were received concerning the regulation. The regulation is straightforward and minimal while meeting requirements for filing and verifying applications for compensation. The regulation does not overlap, duplicate, or conflict with federal or state law or regulation. It has been four years since the regulation was reviewed; technology, economic conditions, or other factors have not changed in the area affected by the regulation.
The agency's decision will have no economic impact on small businesses.
Contact Information: Ruth Anne Walker, Director of Regulatory Affairs, Department of Behavioral Health and Developmental Services, Jefferson Building, 1220 Bank Street, 4th Floor, Richmond, VA 23219, telephone (804) 225-2252.
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TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
BOARD OF PHARMACY
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the Board of Pharmacy conducted a periodic review and a small business impact review of 18VAC110-20, Regulations Governing the Practice of Pharmacy, and determined that this regulation should be amended. The department is publishing its report of findings dated December 8, 2021, to support this decision.
This chapter was in effect as VR530-01-1 before the creation of the Virginia Administrative Code. It has been amended 40 times in the past five years. It continues to be effective in protecting the public by scheduling dangerous chemicals in Schedule I; by setting rules for the safety, efficacy, and integrity of prescription medications; and by updating rules as new technologies and techniques are introduced in the practice of pharmacy. Whenever amendments are promulgated, language is reviewed to ensure that it is clearly written and easily understandable
The board will amend the regulation. The board has identified several sections that it will consider for amendments:
• 18VAC110-20-10, amend definition of "personal supervision" to allow audio-visual technology by pharmacist on premises for supervision of compounding in retail pharmacies.
• 18VAC110-20-25, amend the unprofessional conduct section to add the following language:
- Acting in a manner that causes an individual to feel threatened or intimidated so that such individual is discouraged from reporting a public safety concern in good faith or is discouraged from cooperating with an employee of the Department of Health Professions in the conduct of an investigation or inspection.
- Failure to provide a working environment for all pharmacy personnel that protects the health, safety, and welfare of a patient including:
- Sufficient personnel to prevent fatigue, distraction, or other conditions that interfere with a pharmacist's ability to practice with competency and safety or creates an environment that jeopardizes patient care;
- Appropriate opportunities for uninterrupted rest periods and meal breaks;
- Adequate time for a pharmacist to complete professional duties and responsibilities including:
- Drug utilization review;
- Immunization;
- Counseling; and
- Verification of the accuracy of a prescription.
- Introducing external factors such as productivity or production quotas or other programs to the extent that they interfere with the ability to provide appropriate professional services to the public; and
- Incenting or inducing the transfer of a prescription absent professional rationale.
• 18VAC110-20-110, amend to address appropriate opportunities for uninterrupted rest periods and meal breaks which may or may not require the pharmacy to close.
• 18VAC110-20-110, amend to include additional information to be required on a pharmacy permit or nonresident pharmacy registration application and include a requirement to notify board of any changes within timeframe consistent with current laws.
• 18VAC110-20-110 J, amend to require an applicant for a pharmacy permit to report to the board any prior disciplinary action by a regulatory authority, prior criminal convictions, or ongoing investigations related to the practice of pharmacy
• 18VAC110-20-110, extending timeframe beyond 14 days for notification of a change in the pharmacist-in-charge (PIC)
• 18VAC110-20-270, allow a pharmacist to use the pharmacist's professional judgment to alter or adapt a prescription; to change dosage, dosage form, or directions; to complete missing information; or to extend a maintenance drug.
• Including a requirement for an e-profile identification number for facilities
• Extending timeframe beyond 14 days for notification of a change in the PIC
• 18VAC110-20-275 B, C, and F, consider including exemption to requirement for returning to initiating pharmacy any prescriptions not delivered to the patient if prohibited under federal law.
• 18VAC110-20-275, amend to include record requirement for an alternate delivery site further delivering the drug to a patient’s home.
• 18VAC110-20-290, consider amendment to provision that allows dispensing of a Schedule II drug for up to six months after the date on which the prescription was issued
• 18VAC110-20-550, amend to remove the restriction that a stat-drug box contain no more than 20 solid dosage units per schedule of Schedules II through V drugs
• 18VAC110-20-690, prohibit controlled substance registration from being issued to private dwelling or residence just as there is a current prohibition on such issuance of a pharmacy permit.
• Clarifying expectation regarding administration records, particularly if drug administered by someone other than the pharmacist whose initials are captured on the dispensing record.
• Including a requirement for an e-profile identification number for facilities.
After further opportunity for comment and recommendations for amendments, the board will publish a Notice of Intended Regulatory Action.
There is a continued need for the regulation since the Code of Virginia requires pharmacies and other entities to be permitted, registered, or licensed by the board. The board has not received any of complaints or comments concerning the regulation. Practitioners do not find the regulation to be overly complex, but the board will consider whether requirements could be simplified or clarified. There is no overlap, duplication, or conflict with federal or state law or regulation.
As stated, the chapter has been amended 40 times in the last five years and has five additional regulatory actions in process, including amendments to incorporate allowances for newer technology in hospital pharmacies. The last periodic review began in 2016 but was only finalized in 2019, so the board has continually updated regulations while protecting the safety, integrity, and efficacy of dispensing medications.
In its review, the board will consider any additional amendments that are recommended that will streamline or clarify the regulation in order to minimize the economic impact on small businesses. The Board of Pharmacy is seeking public comment on its Decisions decisions or any other topics that should be included in a Notice of Intended Regulatory Action to be adopted at the board's March meeting.
Contact Information: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4456.
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the Board of Pharmacy conducted a periodic review and a small business impact review of 18VAC110-21, Regulations Governing the Licensure of Pharmacists and Registration of Pharmacy Technicians, and determined that this regulation should be amended. The department is publishing its report of findings dated December 8, 2021, to support this decision.
This chapter was carved out of Regulations Governing the Practice of Pharmacy (18VAC110-20) as a result of a periodic review begun in 2016 and completed in 2019. All of the provisions of 18VAC110-21 were included in 18VAC110-20, which has been in effect as VR530-01-1 before the creation of the Virginia Administrative Code. It has been amended 40 times in the past five years. It continues to be effective in protecting the public by setting rules for qualifications and practice of pharmacists and pharmacy technicians. Whenever amendments are promulgated, language is reviewed to ensure that it is clearly written and easily understandable.
The board will amend the regulation. The board has identified at least two sections that it will consider for amendments:
• 18VAC110-21-80, to include a prohibition on taking the board-approved integrated pharmacy examination when the candidate fails to pass on five occasions.
• 18VAC110-21-80, to authorize the board to delegate to the National Association of Boards of Pharmacy the review and granting of testing accommodations for either examination based on a physical or mental impairment that substantially limits one or more major life activities, subject to the Americans with Disabilities Act (42 USC § 12101).
• 18VAC110-21-90 to require FPGEC prior to obtaining pharmacist license through endorsement or score transfer and delete exemption from FPGEC in 18VAC110-21-90 D. A FPGEC is the certificate given by the Foreign Pharmacy Equivalency Committee of the National Association of Boards of Pharmacy that certifies that the holder of such certificate has passed the Foreign Pharmacy Graduate Equivalency Examination and Test of English as a Foreign Language Internet-Based Test, and that a foreign pharmacist's education meets comparable requirements to pharmacists educated from United States pharmacy colleges.
After further opportunity for comment and recommendations for amendments, the board will publish a Notice of Intended Regulatory Action.
There is a continued need for the regulation since Chapter 33 of Title 54.1 (§ 54.1-3300 et seq.) of the Code of Virginia requires pharmacist to be licensed and pharmacy technicians to be registered by the board. The board has not received any of complaints or comments concerning the regulation. Practitioners do not find the regulation to be overly complex, but the board will consider whether requirements could be simplified or clarified. There is no overlap, duplication, or conflict with federal or state law or regulation. The provisions of this chapter were part of 18VAC110-20, which has been amended 40 times in the last five years. The last periodic review began in 2016 but was only finalized in 2019, so the board has continually updated regulations while protecting the safety, integrity, and efficacy of dispensing medications.
In its review, the board will consider any additional amendments that are recommended that will streamline or clarify the regulation in order to minimize the economic impact on small businesses. The Board of Pharmacy is seeking public comment on its Decisions decisions or any other topics that should be included in a Notice of Intended Regulatory Action to be adopted at the board's March meeting.
Contact Information: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4456.
Report of Findings
Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the Board of Pharmacy conducted a periodic review and a small business impact review of 18VAC110-30, Regulations for Practitioners of the Healing Arts to Sell Controlled Substances, and determined that this regulation should be amended. The department is publishing its report of findings dated December 8, 2021, to support this decision.
All of the provisions of 18VAC110-30 were included as VR530-01-2 before the creation of the Virginia Administrative Code. The regulation has been amended 12 times since 2001 as changes in practice and statutory authority have changed. The regulation continues to be effective in protecting the public by setting rules for the security and integrity of drugs being sold by practitioners of the healing arts in their practices. Whenever amendments are promulgated, language is reviewed to ensure that it is clearly written and easily understandable.
The board will amend the regulation. While there was no public comment on this chapter resulting from the Notice of Periodic Review, the board has identified at least two sections that the board will consider for amendments:
• Insertion of requirements, similar to other facilities permitted by the Board of Pharmacy, to declare hours of operation the location will be open to service the public and report changes in the hours of operation expected to last for more than one week to the board and the public at least 14 days prior to the anticipated change. Include exemptions for emergency circumstances beyond control of the owner or responsible party or expansion of hours.
• 18VAC110-30-80 to prohibit license and permit from being issued to private dwelling or residence.
After further opportunity for comment and recommendations for amendments, the board will publish a Notice of Intended Regulatory Action.
There is a continued need for the regulation since § 54.1-3302 of the Code of Virginia provides that a practitioner of the healing arts shall not sell or dispense controlled substances except as provided in §§ 54.1-2914 and 54.1-3304.1. Section 54.1-3302 specifically authorizes the board "authority to license and regulate the dispensing of controlled substances by practitioners of the healing arts." Such regulation can only occur through the continuation of 18VAC110-30. The board has not received any of complaints or comments concerning the regulation. Practitioners do not find the regulation to be overly complex, but the board will consider whether requirements could be simplified or clarified. There is no overlap, duplication, or conflict with federal or state law or regulation. The board has continually updated regulations while protecting the safety, integrity, and efficacy of dispensing medications. There is a current regulatory action (replacing emergency regulations) expanding the authority for nurse practitioners and physician assistants in free clinics to dispense Schedule VI medications.
In its review, the board will consider any additional amendments that are recommended that will streamline or clarify the regulation in order to minimize the economic impact on small businesses. The Board of Pharmacy is seeking public comment on its Decisions decisions or any other topics that should be included in a Notice of Intended Regulatory Action to be adopted at the board's March meeting.
Contact Information: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4456.