TITLE 3. ALCOHOLIC BEVERAGE AND CANNABIS CONTROL

VIRGINIA CANNABIS CONTROL AUTHORITY

Final Regulation

Title of Regulation: 3VAC10-20. Medical Cannabis Program Fees (adding 3VAC10-20-10 through 3VAC10-20-50).

Statutory Authority: §§ 4.1-601, 4.1-604, and 4.1-606 of the Code of Virginia.

Effective Date: January 17, 2024.

Agency Contact: Jake Shuford, Legislative and Regulatory Manager, Virginia Cannabis Control Authority, 333 East Franklin Street, Richmond, VA 23219, telephone (804) 873-9038, or email jake.shuford@cca.virginia.gov.

Background: Chapters 740 and 773 of the 2023 Acts of Assembly transferred regulatory authority for the Medical Cannabis Program from the Board of Pharmacy to the independent agency, the Cannabis Control Authority.

Summary:

Pursuant to Chapters 740 and 773, this action establishes Virginia Medical Cannabis Program Fees (3VAC10-20), which provides registration fees for the Medical Cannabis Program required for (i) a qualifying patient, parent, legal guardian, or registered agent; (ii) a pharmaceutical processor permit; (iii) a cannabis dispensing permit; or (iv) a cannabis cultivation facility permit.

Chapter 20
Medical Cannabis Program Fees

3VAC10-20-10. Definitions.

In addition to words and terms defined in § 4.1-600 of the Code of Virginia, the following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Board" means the Board of Directors of the Virginia Cannabis Control Authority.

"Cannabis cultivation facility" means a location at which the board has authorized a pharmaceutical processor to cultivate cannabis plants pursuant to § 4.1-1602 of the Code of Virginia and the requirements of 3VAC10-30-160.

"Certification" means a written statement, consistent with requirements of § 4.1-1601 of the Code of Virginia, issued by a practitioner for the use of cannabis products for treatment of or to alleviate the symptoms of any diagnosed condition or disease determined by the practitioner to benefit from such use.

"Medical cannabis facility” means a pharmaceutical processor, cannabis dispensing facility, or cannabis cultivation facility.

"PIC" means the pharmacist-in-charge whose name is on the pharmaceutical processor or cannabis dispensing facility application for a permit that has been issued and who shall have oversight of the processor's dispensing area or cannabis dispensing facility.

"Production" or "produce" means the manufacture, planting, preparation, cultivation, growing, harvesting, propagation, conversion, or processing of marijuana for the creation of usable cannabis, botanical cannabis, or a cannabis product derived thereof, (i) directly or indirectly by extraction from substances of natural origin, (ii) independently by means of chemical synthesis, or (iii) by a combination of extraction and chemical synthesis. "Production" or "produce" includes any packaging or repackaging of the substance or labeling or relabeling of its container.

"Qualifying patient" means a Virginia resident who has received from a practitioner, as defined in § 4.1-1600 of the Code of Virginia, a written certification for the use of cannabis products for treatment of or to alleviate the symptoms of any diagnosed condition or disease.

"Registration" means an identification card or other document issued by the board that identifies a person as a qualifying patient, parent, legal guardian, or registered agent that has voluntarily registered with the board.

"Resident" means a person whose principal place of residence is within the Commonwealth as evidenced by a federal or state income tax return or a current Virginia driver's license. If a person is a minor, residency may be established by evidence of Virginia residency by a parent or legal guardian.

"Responsible party" means the person designated on the pharmaceutical processor application who shall have oversight of the cultivation and production areas of the pharmaceutical processor.

3VAC10-20-20. Qualifying patient, parent, legal guardian, or registered agent registration fee.

A. Registration under this section is voluntary.

B. Qualifying patient, parent, legal guardian, or registered agent registration fees are required by the board as specified in this section. Unless otherwise provided, fees listed in this section shall not be refundable.

C. Registration by a qualifying patient, parent, legal guardian, or registered agent.

D. The handling fee for returned check or dishonored credit card or debit card shall be $50.

3VAC10-20-30. Pharmaceutical processor permit fee.

A. Pharmaceutical processor permit fees are required by the board as specified in this section. Unless otherwise provided, fees listed in this section shall not be refundable.

B. Pharmaceutical processor permit.

C. The handling fee for returned check or dishonored credit card or debit card shall be $50.

3VAC10-20-40. Cannabis dispensing facility permit fee.

A. Cannabis dispensing facility permit fees are required by the board as specified in this section. Unless otherwise provided, fees listed in this section shall not be refundable.

B. Cannabis dispensing facility permit.

C. The handling fee for returned check or dishonored credit card or debit card shall be $50.

3VAC10-20-50. Cannabis cultivation facility fee.

A. Cannabis cultivation facility fees are required by the board as specified in this section. Unless otherwise provided, fees listed in this section shall not be refundable.

B. Cannabis cultivation facility.

C. The handling fee for returned check or dishonored credit card or debit card shall be $50.

TITLE 8. EDUCATION

STATE BOARD OF EDUCATION

Fast-Track Regulation

Title of Regulation: 8VAC20-23. Licensure Regulations for School Personnel (amending 8VAC20-23-360).

Statutory Authority: §§ 22.1-298.1 and 22.1-299 of the Code of Virginia.

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: February 28, 2024.

Effective Date: March 14, 2024.

Agency Contact: Maggie Clemmons, Director of Licensure and School Leadership, Department of Education, 101 North 14th Street, Richmond, VA 23219, telephone (804) 371-2471, or email maggie.clemmons@doe.virginia.gov.

Basis: The State Board of Education's overall regulatory authority is found in § 22.1-16 of the Code of Virginia, which authorizes the State Board of Education to adopt bylaws for its own government and promulgate such regulations as may be necessary to carry out its powers and duties and the provisions of Title 22.1 of the Code of Virginia. The board's regulatory authority over licensing requirements for school personnel is found in § 22.1-253.13:2 A of the Code of Virginia, which states that the board shall establish requirements for the licensing of teachers, principals, superintendents, and other professional personnel. Finally, § 22.1-298.1 B of the Code of Virginia requires the board shall prescribe by regulation the requirements for the licensure of teachers and other school personnel required to hold a license.

Purpose: The regulatory action is essential to protect the health, safety, and welfare of citizens because accurate endorsement requirements ensure that properly qualified individuals will be able to teach American Sign Language (ASL) in public schools. The goals of the regulatory action is to maintain accurate requirements for an endorsement in foreign language preK-12 in ASL. The problem that the regulatory action is intended to solve is that the current requirements do not accurately reflect the industry-standard national certifications in ASL.

Rationale for Using Fast-Track Rulemaking Process: This rulemaking is expected to be noncontroversial and therefore appropriate for the fast-track rulemaking process because the board is not making discretionary changes. Rather, the board is seeking to update the current regulatory language in order to align with changes to the industry-standard national certifications.

Substance: The amendments to 8VAC20-23-360 provide the endorsement requirements for foreign language preK-12 in ASL. The regulation is not current as the national certifications prescribed have been changed by the issuing organizations. For instance, American Sign Language Teachers' Association (ASLTA) has changed the names and structure of their certifications, as has Registry Interpreters for the Deaf (RID). In addition, RID has also incorporated National Association of the Deaf (NAD) certifications because the NAD no longer issues certifications. These changes within the national organizations necessitate the amendments to the 8VAC20-23-360.

Issues: The primary advantage of the regulatory action is that the public is informed of the revised national certifications and that the Department of Education is still accepting these certifications for licensure purposes. There are no perceived disadvantages to the public, the agency, or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Code of Virginia and Executive Order 19. The analysis presented below represents DPB's best estimate of these economic impacts.¹

Summary of the Proposed Amendments to Regulation. The Board of Education (board) proposes to amend the requirements for an endorsement in foreign language preK-12 in American Sign Language (ASL) in order to align the requirements with industry-standard national certifications in ASL.

Background. One of the methods to demonstrate competency in ASL in the current regulation is to: "(1) Hold a current, valid Provisional, Qualified, or Professional certification [issued] by the American Sign Language Teachers' Association [(ASLTA)]." The ASLTA formerly issued only Provisional, Qualified, or Professional certifications.² The ASLTA has changed the structure of its national certifications for ASL. The board proposes to strike the obsolete certification names and instead state that one of the methods to demonstrate competency is to "Hold a current, valid certification issued by the American Sign Language Teachers' Association."

Other methods to demonstrate competency in ASL in the current regulation are to:

(2) Hold one of the following current, valid national certificates in interpreting:

(a) Registry of Interpreters for Deaf certification in at least one of the following: Certificate of Interpretation (CI), Certificate of Deaf Interpretation (CDI), Reverse Skills Certification (RSC), or Comprehensive Skills Certificate (CSC);

(b) A current, valid National Association for the Deaf Level IV certification or higher; or

(c) A National Interpreter Certification (NIC);

CI, RSC, CSC, and NIC have all been discontinued.³ The National Association for the Deaf no longer issues certifications.⁴ Thus, the board proposes to amend this text to "(2) Hold a current, valid certification issued by the Registry of Interpreters for the Deaf "

Estimated Benefits and Costs. The proposed text reflects what is being accepted in practice for the endorsement in foreign language preK-12 in ASL.⁵ Thus the requirements in practice would not change, but the proposal would nevertheless be beneficial in that readers of the regulation would be better informed on these requirements.

Businesses and Other Entities Affected. The proposed amendments pertain to teachers seeking the endorsement in foreign language preK-12 in ASL. Over the last six years, the Department of Education has approved approximately eight ASL endorsements per year.⁶

The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.⁷ An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. As the proposal does not introduce costs or affect revenue, no adverse impact is indicated.

Small Businesses⁸ Affected:⁹ The proposed amendments do not adversely affect small businesses.

Localities¹⁰ Affected.¹¹ The proposed amendments do not disproportionately affect any particular localities and do not affect costs for local governments.

Projected Impact on Employment. The proposed amendments do not affect employment.

Effects on the Use and Value of Private Property. The proposed amendments do not affect the use and value of private property or real estate development costs.

_________________________________

¹Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

²Source: Department of Education

³Source: Agency Background Document, page two: https://townhall.virginia.gov/L/GetFile.cfm?File=93\5922\9582\AgencyStatement_DOE_9582_v1.pdf

⁴Ibid

⁵Source: Department of Education

⁶Source: Agency Background Document, page six: https://townhall.virginia.gov/L/GetFile.cfm?File=93\5922\9582\AgencyStatement_DOE_9582_v1.pdf

⁷Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

⁸Pursuant to § 2.2-4007.04, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

⁹If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation. Additionally, pursuant to § 2.2-4007.1 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

¹⁰"Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

¹¹Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency's Response to Economic Impact Analysis: The State Board of Education concurs with the economic impact analysis completed by the Department of Planning and Budget.

Summary:

The amendments change the requirements for an endorsement in foreign language preK-12 in American Sign Language (ASL) to (i) align the requirements with industry-standard national certifications in ASL, (ii) conform with structure of national certifications for ASL, and (iii) accept all certifications issued by American Sign Language Teachers' Association.

8VAC20-23-360. Foreign language preK-12.

A. The specific language of the endorsement will be noted on the license.

B. Endorsement requirements for foreign language preK-12 - languages other than Latin and American Sign Language. The candidate shall have:

1. Earned a baccalaureate degree from a regionally accredited college or university and graduated from an approved teacher preparation program in a foreign language; or

2. Earned a baccalaureate degree from a regionally accredited college or university, and completed a major in the foreign language or 30 semester hours of coursework above the intermediate level in the foreign language distributed in the following areas:

a. Advanced grammar and composition;

b. Conversation, culture and civilization, and literature; and

c. In addition to the 30 semester hours, completed a minimum of 3 three semester hours of methods of teaching foreign languages at the elementary and secondary levels.

3. Endorsement in a second foreign language may be obtained by successfully completing 24 semester hours of coursework above the intermediate level.

4. Candidates who have learned a foreign language without formal academic credit in a regionally accredited college or university shall complete the following requirements:

a. Achieve a qualifying score on a foreign language assessment in the appropriate language as prescribed by the Virginia Board of Education; and

b. Earn a minimum of 3 three semester hours of methods of teaching foreign languages at the elementary and secondary levels from a regionally accredited college or university in the United States or obtain teacher certification in another country with at least 3 three semester hours of methods of teaching foreign languages at the elementary and secondary levels at a foreign institution.

C. Endorsement requirements for foreign language preK-12 - Latin. The candidate shall have:

1. Earned a baccalaureate degree from a regionally accredited college or university and graduated from an approved teacher preparation program in Latin; or

2. Earned a baccalaureate degree from a regionally accredited college or university and completed 24 semester hours of Latin above the intermediate level. A maximum of six semester hours of Roman history, Roman life, Roman mythology, or Roman archaeology may be included in the total hours. A minimum of 3 three semester hours of methods of teaching Latin at the elementary and secondary levels are required.

D. Endorsement requirements for foreign language preK-12 - American Sign Language.

1. The candidate shall have (i) graduated from an approved teacher preparation program in a foreign language - American Sign Language or (ii) earned a baccalaureate degree from a regionally accredited college or university and completed a major in American Sign Language or 24 semester hours above the intermediate level in American Sign Language. The program shall include (i) courses in advanced grammar and syntax, conversation, and culture and (ii) a minimum of 3 three semester hours of methods of teaching foreign languages at the elementary and secondary levels.

2. Native users or candidates who have learned American Sign Language without formal academic credit in a regionally accredited college or university, as explained in subdivision 1 of this subsection, shall complete the following requirements:

a. Competency in American Sign Language demonstrated by written documentation of one of the following:

(1) Hold a current, valid Provisional, Qualified, or Professional certification issued by the American Sign Language Teachers' Association;

(2) Hold one of the following a current, valid national certificates in interpreting: (a) Registry of Interpreters for Deaf certification in at least one of the following: Certificate of Interpretation (CI), Certificate of Deaf Interpretation (CDI), Reverse Skills Certification (RSC), or Comprehensive Skills Certificate (CSC); (b) A current, valid National Association for the Deaf Level IV certification or higher; or (c) A National Interpreter Certification (NIC) certification issued by the Registry of Interpreters for the Deaf; or

(3) Complete requirements by achieving a qualifying score on an assessment demonstrating proficiency in American Sign Language prescribed by the Virginia Board of Education.

b. A minimum of 3 three semester hours of methods of teaching foreign languages at the elementary and secondary levels from a regionally accredited college or university in the United States; and

c. A minimum of 6 six semester hours in coursework, including grammar and syntax of American Sign Language.

TITLE 8. EDUCATION

STATE BOARD OF EDUCATION

Action Withdrawn

Title of Regulation: 8VAC20-131. Regulations Establishing Standards for Accrediting Public Schools in Virginia (amending 8VAC20-131-5).

Statutory Authority: §§ 22.1-16 and 22.1-253.13:3 of the Code of Virginia.

The State Board of Education has WITHDRAWN the regulatory action for 8VAC20-131, Regulations Establishing Standards for Accrediting Public Schools in Virginia, which was published as a Notice of Intended Regulatory Action in 38:1 VA.R. 6 August 30, 2021. The purpose of the proposed action was to establish standards governing public virtual education to maintain a level of student achievement commensurate with high-quality instruction, providing standards for local school boards as they establish virtual public education programs or schools, with all students taking coursework virtually, rather than in a traditional brick and mortar environment. The action was withdrawn by the State Board of Education on December 12, 2023.

Agency Contact: Brendon Albon, Director of Science, Technology, Engineering, and Mathematics and Innovation, Department of Education, 101 North 14th Street, Richmond, VA 23219, telephone (804) 786-2418, or email brendon.albon@doe.virginia.gov.

TITLE 10. FINANCE AND FINANCIAL INSTITUTIONS

STATE CORPORATION COMMISSION

Proposed Regulation

Title of Regulation: 10VAC5-60. Consumer Finance Companies (amending 10VAC5-60-60).

Statutory Authority: §§ 6.2-1535 and 12.1-13 of the Code of Virginia.

Public Hearing Information: A public hearing will be held upon request.

Public Comment Deadline: February 9, 2024.

Agency Contact: Dustin Physioc, Deputy Commissioner, Bureau of Financial Institutions, State Corporation Commission, P.O. Box 640, Richmond, VA 23218, telephone (804) 786-0831, or email dustin.physioc@scc.virginia.gov.

Summary:

The proposed amendments realign the schedule of annual fees to be paid by all licensed consumer finance companies to defray the costs of examination, supervision, and regulation with the costs incurred by the Bureau of Financial Institutions and reduce the total amount of annual fees paid by licensees that are based on net loans receivable, other licensee assets, and the total assets of affiliates that conduct business in any of the licensee's authorized offices.

AT RICHMOND, JANUARY 9, 2024

COMMONWEALTH OF VIRGINIA, ex rel.

STATE CORPORATION COMMISSION

CASE NO. BFI-2024-00001

Ex Parte: In the Matter of Adopting

Amendments to the Regulation

Governing Annual Fees Paid by

Consumer Finance Companies

ORDER TO TAKE NOTICE

Section 6.2-1532 of the Code of Virginia ("Code") requires all licensed consumer finance companies ("licensees") to pay an annual fee that is to be calculated in accordance with a schedule set by the State Corporation Commission ("Commission"). The annual fees defray the costs of examination, supervision, and regulation of licensees by the Bureau of Financial Institutions ("Bureau"), and the Commission's schedule of annual fees is set forth in 10VAC5-60-60 of the Commission's rules governing consumer finance companies, 10VAC5-60-5 et seq.

The Bureau has asserted that as a result of various changes to Chapter 15 of Title 6.2 of the Code that became effective on January 1, 2021, the schedule of annual fees in 10VAC5-60-60 now produces more revenue than is necessary to defray the Bureau's costs of examination, supervision, and regulation of licensees. Accordingly, the Bureau has submitted to the Commission proposed amendments to 10VAC5-60-60 that the Bureau states are designed to realign the schedule with the Bureau's costs and reduce the total amount of annual fees paid by licensees.

NOW THE COMMISSION, having considered the Bureau's proposal and the applicable law, is of the opinion and finds that reasonable notice of the proposed amendments to 10VAC5-60-60 should be given, interested parties should be afforded an opportunity to be heard in accordance with the Commission's Rules of Practice and Procedure, 5VAC5-20-10 et seq., and the proposed amended regulation should be considered for adoption with a proposed effective date of April 1, 2024.

Accordingly, IT IS ORDERED THAT:

(1) The proposed amendments to 10VAC5-60-60 are attached hereto and made a part hereof.

(2) Comments or requests for a hearing on the proposed amended regulation must be submitted in writing to the Clerk of the Commission, State Corporation Commission, c/o Document Control Center, P.O. Box 2118, Richmond, Virginia 23218, on or before February 9, 2024. Requests for a hearing shall state why a hearing is necessary and why the issues cannot be adequately addressed in written comments. All correspondence shall contain a reference to Case No. BFI-2024-00001. Interested persons desiring to submit comments or request a hearing electronically may do so by following the instructions available at the Commission's website: scc.virginia.gov/casecomments/Submit-Public-Comments.

(3) The Bureau shall file its response to any comments filed pursuant to Ordering Paragraph 2 on or before February 29, 2024.

(4) This Order, along with the attached proposal, shall be made available on the Commission's website: scc.virginia.gov/pages/Case-Information.

(5) The Commission's Office of General Counsel shall provide a copy of this Order and the proposed amended regulation to the Virginia Registrar of Regulations for appropriate publication in the Virginia Register of Regulations.

Commissioner James C. Dimitri participated in this matter.

A COPY of this Order, including the proposed amended regulation, shall be sent by the Clerk of the Commission to the Commission's Office of General Counsel and to the Commissioner of Financial Institutions, who shall send by e-mail or U.S. mail a copy of this Order, along with the proposed amended regulation, to all licensed consumer finance companies and such other interested persons as he may designate.

10VAC5-60-60. Schedule prescribing annual fees paid for examination, supervision, and regulation of consumer finance companies.

Pursuant to § 6.2-1532 of the Code of Virginia, the commission sets the following schedule sets the of annual fees to be paid annually by licensees under the Act to defray the costs of examination, supervision, and regulation of licensees by the bureau:.

Minimum Each licensee shall be assessed a minimum annual fee - $300 per of $150 plus $150 for each office open January 1 of the current where the licensee was authorized to engage in business under the Act as of December 31 of the calendar year preceding the date of the assessment. For example, the minimum annual fee due June 1, 2025, for a licensee who maintained a single authorized office as of December 31, 2024, would be $300 ($150 flat fee + $150 office fee) and the minimum annual fee due June 1, 2025, for a licensee who maintained three authorized offices as of December 31, 2024, would be $600 ($150 flat fee + $450 office fee).

In addition to the minimum fee, each licensee shall be assessed the following fee based on total assets fees:

The annual fee for each licensee will be computed on the basis of its total assets combined with the total assets of its affiliates conducting business in any of its authorized offices as of the close of business December 31 of the preceding calendar year.

Fee for net loans receivable:

Fee for other licensee assets (total assets of licensee minus net loans receivable):

Fee for total assets of affiliates that conduct business in any of the licensee's authorized offices:

**The amounts of such total assets Net Loans Receivable, Other Licensee Assets, and Affiliate Assets will be derived obtained from the annual reports that § 6.2-1534 of the Code of Virginia requires licensees to file with the bureau on or before the first day of April of each year. Accordingly, fees will be calculated based on Net Loans Receivable, Other Licensee Assets, and Affiliate Assets as of December 31 of the calendar year preceding the date of the assessment. For purposes of this section, "Net Loans Receivable" means the total outstanding principal balance of all loans made under the Act.

In accordance with § 6.2-1532 of the Code of Virginia, annual fees for any given calendar year will be assessed on or before May 1 of that year and must be paid on or before June 1 of that year.

Notwithstanding any provision of this section, if a licensee was not licensed under the Act as of December 31 of the calendar year preceding the date of the assessment, the annual fee shall be $0.

Fees prescribed and assessed pursuant to this schedule are apart from and do not include the reimbursement for costs authorized by subsection C of § 6.2-1533 of the Code of Virginia.

Sample Annual Fee Calculation:

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Final Regulation

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-322).

Statutory Authority: §§ 54.1-2400 and 54.1-3443 of the Code of Virginia.

Effective Date: February 28, 2024.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4456, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Summary:

The amendments place two compounds into Schedule I of the Drug Control Act. The added compounds will remain in effect for 18 months or until the compounds are placed in Schedule I by action of the General Assembly.

18VAC110-20-322. Placement of chemicals in Schedule I.

A. Pursuant to subsection D of § 54.1-3443 of the Code of Virginia, the Board of Pharmacy places the following in Schedule I of the Drug Control Act:

1. Synthetic opioid. N,N-diethyl-2-[5-nitro-2-(4-propoxybenzyl)-1H-benzimidazol-1-yl]ethanamine (other name: Protonitazene), its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, unless specifically excepted, whenever the existence of these isomers, esters, ethers, and salts is possible within the specific chemical designation.

2. Compounds expected to have hallucinogenic properties. 1-(1,3-benzodioxol-5-yl)-2-(cyclohexylamino)butan-1-one (other names: Cybutylone, N-cyclohexyl Butylone), its salts, isomers (optical, position, and geometric), and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

3. Compounds expected to have depressant properties. 8-bromo-6-(2-chlorophenyl)-1-methyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine (other names: Clobromazolam, Phenazolam), its salts, isomers (optical, position, and geometric), and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

4. Cannabimimetic agents.

a. 5-bromo-N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1H-indazole-3-carboxamide (other name: ADB-5Br-INACA), its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

b. N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-5-bromo-1-butylindazole-3-carboxamide (other name: ADB-5'Br-BUTINACA), its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

The placement of drugs listed in this subsection shall remain in effect until July 31, 2024, unless enacted into law in the Drug Control Act.

B. Pursuant to subsection D of § 54.1-3443 of the Code of Virginia, the Board of Pharmacy places the following in Schedule I of the Drug Control Act:

1. Synthetic opioid. 2-methyl-N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]butanamide (other name: 2-methyl butyryl fentanyl), its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, unless specifically excepted, whenever the existence of these isomers, esters, ethers, and salts is possible within the specific chemical designation.

2. Compounds expected to have hallucinogenic properties.

a. 1-(7-methoxy-1,3-benzodioxol-5-yl)propan-2-amine (other names: 5-methoxy-3,4-methylenedioxyamphetamine, 3-methoxy MDA, MMDA), its salts, isomers (optical, position, and geometric), and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

b. 1-[1-(3-chlorophenyl)cyclohexyl]-piperidine (other names: 3-Chloro Phencyclidine, 3Cl-PCP, 3-chloro PCP), its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

3. Compound expected to have depressant properties. 7-bromo-5-phenyl-1,3-dihydro-1,4-benzodiazepin-2-one (other names: Desalkylgidazepam, Bromonordiazepam), its salts, isomers (optical, position, and geometric), and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

4. Compound classified as a cannabimimetic agent. Methyl N-[(5-bromo-1H-indazol-3-yl)carbonyl]-3-methyl-valinate (other name: MDMB-5Br-INACA), its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

The placement of drugs listed in this subsection shall remain in effect until October 12, 2024, unless enacted into law in the Drug Control Act.

C. Pursuant to subsection D of § 54.1-3443 of the Code of Virginia, the Board of Pharmacy places the following in Schedule I of the Drug Control Act:

1. Synthetic opioids:.

a. 2-(4-isopropoxybenzyl)-5-nitro-1-[2-(pyrrolidin-1-yl)ethyl]-1H-benzo[d]imidazole (other name: N-Pyrrolidino Isotonitazene), its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, unless specifically excepted, whenever the existence of these isomers, esters, ethers, and salts is possible within the specific chemical designation.

b. 5-nitro-2-(4-propoxybenzyl)-1-[2-(pyrrolidin-1-yl)ethyl]-1H-benzo[d]imidazole (other names: N-Pyrrolidino Protonitazene, Protonitazepyne), its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, unless specifically excepted, whenever the existence of these isomers, esters, ethers, and salts is possible within the specific chemical designation.

c. N-phenyl-N-(1-propionyl-4-piperidinyl)-propanamide (other name: N-propionyl Norfentanyl), its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, unless specifically excepted, whenever the existence of these isomers, esters, ethers, and salts is possible within the specific chemical designation.

2. Synthetic compounds.

a. N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)pentanamide (other names: para-fluoro valeryl fentanyl, para-fluoro pentanoyl fentanyl), its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, unless specifically excepted, whenever the existence of these isomers, esters, ethers, and salts is possible within the specific chemical designation.

b. N-(4-fluorophenyl)-N-[1-(2-phenylethyl)piperidin-4-yl]acetamide (other name: para-fluoroacetyl fentanyl), its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, unless specifically excepted, whenever the existence of these isomers, esters, ethers, and salts is possible within the specific chemical designation.

3. Compounds expected to have hallucinogenic properties.

a. 1-[1-(3-fluorophenyl)cyclohexyl]piperidine (other names: 3-fluoro Phencyclidine, 3F-PCP), its salts, isomers (optical, position, and geometric), and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

b. 2-(ethylamino)-2-(2-fluorophenyl)-cyclohexanone (other names: 2-fluoro-2-oxo PCE, 2-fluoro NENDCK), its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

4. Compounds expected to have depressive properties:

a. 6-(4-chlorophenyl)-1-methyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine (other names: 4'-chloro Deschloroalprazolam, 4'Cl-Deschloroalprazolam), its salts, isomers (optical, position, and geometric), and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

b. 7-chloro-5-(2-chlorophenyl)-1-methyl-3H-1,4-benzodiazepin-2-one (other names: Diclazepam, 2-Chlorodiazepam), its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

5. Central nervous system stimulant. 2-(3-chlorophenyl)-3-methylmorpholine (other name: 3-chlorophenmetrazine), its salts, isomers (optical, position, and geometric), and salts of isomers.

The placement of drugs listed in this subsection shall remain in effect until March 27, 2025, unless enacted into law in the Drug Control Act.

D. Pursuant to subsection D of § 54.1-3443 of the Code of Virginia, the Board of Pharmacy places the following compounds expected to have hallucinogenic properties in Schedule I of the Drug Control Act:

1. 1-(3,5-Dimethoxy-4-propoxyphenyl)-2-propanamine (other names: 4-propoxy-3,5-DMA, 3C-P, 1-(3,5-Dimethoxy-4-propoxyphenyl)propan-2-amine), its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

2. 2-(5-methoxy-1H-indol-3-yl)ethanamine (other names: 5-methoxytryptamine, 5-MeOT), its salts, isomers (optical, position, and geometric), and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

The placement of drugs listed in this subsection shall remain in effect until August 28, 2025, unless enacted into law in the Drug Control Act.

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Final Regulation

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-323).

Statutory Authority: §§ 54.1-2400 and 54.1-3443 of the Code of Virginia.

Effective Date: February 28, 2024.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4456, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Summary:

The amendment adds one compound to Schedule IV of the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia) pursuant to § 54.1-3443 of Code of Virginia to conform Virginia scheduled drugs with federal scheduling actions. The amendment represents changes made by the federal government.

18VAC110-20-323. Scheduling for conformity with federal law or rule.

Pursuant to subsection E of § 54.1-3443 of the Code of Virginia and in order to conform the Drug Control Act to recent scheduling changes enacted in federal law or rule, the board:

1. Adds MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine) to Schedule I;

2. Adds Dronabinol ((-)-delta-9-trans tetrahydrocannabinol) in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration to Schedule II;

3. Deletes naldemedine from Schedule II;

4. Deletes naloxegol and 6β-naltrexol from Schedule II;

5. Replaces 4-anilino-N-phenethyl-4-piperidine (CASRN 21409-26-7) in Schedule II with 4-anilino-N-phenethylpiperidine (ANPP);

6. Adds 4-methyl-5-(4-methylphenyl)-4,5-dihydro-1,3-oxazol-2-amine (4,4'-Dimethylaminorex, 4,4'-DMAR) to Schedule I;

7. Adds 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)pyrrolo[2,3-b]pyridine-3-carboxamide (5F-CUMYL-P7AICA) to Schedule I;

8. Adds ethyl N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]carbamate (fentanyl carbamate) to Schedule I;

9. Adds N-(2-fluorophenyl)-N-[1-(2-phenylethyl)piperidin-4-yl]prop-2-enamide (ortho-fluoroacryl fentanyl) to Schedule I;

10. Adds N-(2-fluorophenyl)-2-methyl-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide (ortho-fluoroisobutyryl fentanyl) to Schedule I;

11. Adds N-(4-fluorophenyl)-N-[1-(2-phenylethyl)piperidin-4-yl]furan-2-carboxamide (para-fluoro furanyl fentanyl) to Schedule I;

12. Adds N-(2-fluorophenyl)-N-[1-[2-(2-fluorophenyl)ethyl]piperidin-4-yl]propanamide (2'-fluoro ortho-fluorofentanyl; 2'-fluoro 2-fluorofentanyl) to Schedule I;

13. Adds N-[1-[2-(4-methylphenyl)ethyl]piperidin-4-yl]-N-phenylacetamide (4'-methyl acetyl fentanyl) to Schedule I;

14. Adds N,3-diphenyl-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide (β'-phenyl fentanyl; beta'-phenyl fentanyl; 3-phenylpropanoyl fentanyl) to Schedule I;

15. Adds N-phenyl-N-[1-(2-phenylpropyl)piperidin-4-yl]propanamide (β-methyl fentanyl) to Schedule I;

16. Adds N-(2-fluorophenyl)-N-[1-(2-phenylethyl)piperidin-4-yl]butanamide (ortho-fluorobutyryl fentanyl; 2-fluorobutyryl fentanyl) to Schedule I;

17. Adds N-(2-methylphenyl)-N-[1-(2-phenylethyl)piperidin-4-yl]acetamide (ortho-methyl acetylfentanyl; 2-methyl acetylfentanyl) to Schedule I;

18. Adds 2-methoxy-N-(2-methylphenyl)-N-[1-(2-phenylethyl)piperidin-4-yl]acetamide (ortho-methyl methoxyacetylfentanyl; 2-methyl methoxyacetyl fentanyl) to Schedule I;

19. Adds N-(4-methylphenyl)-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide (para-methylfentanyl; 4-methylfentanyl) to Schedule I;

20. Adds N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]thiophene-2-carboxamide (thiophene fentanyl) to Schedule I;

21. Adds N-(4-chlorophenyl)-2-methyl-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide (para-chloroisobutyryl fentanyl) to Schedule I;

22. Adds 24. 2-[2-[(4-butoxyphenyl)methyl]-5-nitrobenzimidazol-1-yl]-N,N-diethylethanamine (Butonitazene) to Schedule I;

23. Adds N,N-diethyl-2-[2-[(4-fluorophenyl)methyl]-5-nitrobenzimidazol-1-yl] ethanamine (Flunitazene) to Schedule I;

24. Adds Oliceridine to Schedule II;

25. Deletes Samidorphan from Schedule II;

26. Adds Remimazolam to Schedule IV;

27. Adds Serdexmethylphenidate to Schedule IV;

28. Adds Lemborexant to Schedule IV;

29. Adds Daridorexant to Schedule IV;

30. Adds Ganaxolone to Schedule V;

31. Adds N-methyl-1-(thiophen-2-yl)propan-2-amine (other name: methiopropamine) to Schedule I;

32. Adds N-phenyl-N′-(3-(1-phenylpropan-2-yl)-1,2,3-oxadiazol-3-ium-5-yl)carbamimidate (other name: mesocarb) to Schedule I;

33. Adds 1-methoxy-3-[4-(2-methoxy-2-phenylethyl)piperazin-1-yl]-1-phenylpropan-2-ol (other name: zipeprol) to Schedule I;

34. Adds 7-[(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-yl)amino]heptanoic acid (other name: amineptine) to Schedule I; and

35. Deletes Fenfluramine from Schedule IV; and

36. Adds zuranolone to Schedule IV.

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Forms

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy.

Agency Contact: Erin Barrett, Agency Regulatory Coordinator, Department of Health Professions, 9960 Mayland Drive, Suite 300, Henrico, VA 23233, telephone (804) 367-4688, or email erin.barrett@dhp.virginia.gov.

FORMS (18VAC110-20)

Application for a Pharmacy Permit (rev. 10/2020)

Application for a Pharmacy Permit (rev. 1/2024)

Application for a Non-resident Pharmacy Registration (rev. 10/2020)

Application for a Non-Resident Wholesale Distributor Registration (rev. 10/2020)

Application for Registration as Nonresident Manufacturer (rev. 10/2020)

Application for a Non-Resident Third Party Logistics Provider Registration (rev. 10/2020)

Application for Registration as a Nonresident Warehouser (rev. 10/2020)

Application for a Non-resident Outsourcing Facility Registration (rev. 10/2020)

Application for an Outsourcing Facility Permit (rev. 10/2020)

Application for a Medical Equipment Supplier Permit (rev. 10/2020)

Application for a Permit as a Restricted Manufacturer (rev. 10/2020)

Application for a Permit as a Non-Restricted Manufacturer (rev. 10/2020)

Application for a License as a Wholesale Distributor (rev. 10/2020)

Application for a Permit as Warehouser (rev. 10/2020)

Application for a Permit as a Third-Party Logistics Provider (rev. 10/2020)

Application for Registration as a Non-resident Medical Equipment Supplier (rev. 10/2020)

Application for a Controlled Substances Registration Certificate (rev. 10/2020)

Closing of a Pharmacy (rev. 5/2018)

Application for Approval of an Innovative (Pilot) Program (rev. 8/2023)

Registration for a Pharmacy to be a Collection Site for Donated Drugs (rev. 5/2018)

Application for Approval of a Repackaging Training Program (rev. 10/2020)

Registration for a Facility to be an Authorized Collector for Drug Disposal (rev. 5.2018)

Application for Re-inspection of a Facility (rev. 3/2023)

Notification of Distribution Cessation due to Suspicious Orders (rev. 5/2018)