REGULATIONS
Vol. 35 Iss. 26 - August 19, 2019

TITLE 3. ALCOHOLIC BEVERAGES
ALCOHOLIC BEVERAGE CONTROL AUTHORITY
Final Regulation

Title of Regulation: 3VAC5-70. Other Provisions (amending 3VAC5-70-210).

Statutory Authority: §§ 4.1-111 and 4.1-227 of the Code of Virginia.

Effective Date: September 21, 2019.

Agency Contact: LaTonya D. Hucks-Watkins, Legal Liaison, Virginia Alcoholic Beverage Control Authority, 2901 Hermitage Road, Richmond, VA 23220, telephone (804) 213-4698, FAX (804) 213-4574, or email latonya.hucks-watkins@abc.virginia.gov.

Summary:

The amendments increase the civil penalty amounts charged in lieu of suspension for first-offense violations for a licensee that has no other pending charges, has not had a violation in three years, and enters a written waiver of hearing. The increases reflect maximums effective July 2017 in § 4.1-227 of the Code of Virginia.

Summary of Public Comments and Agency's Response: No public comments were received by the promulgating agency.

3VAC5-70-210. Schedule of penalties for first-offense violations.

A. Any licensee charged with any violation of board regulations or statutes listed below in this subsection, if the licensee has no other pending charges and has not had any substantiated violations of regulation or statute within the three years immediately preceding the date of the violation, may enter a written waiver of hearing and (i) accept the period of license suspension set forth below in this subsection for the violation, or (ii) pay the civil charge set forth [ below in this subsection ] for the violation in lieu of suspension. In the case of a violation involving the sale of beer, wine, or mixed beverages to a person at least 18 but under younger than 21 years of age, or to an intoxicated person, or allowing consumption of such beverages by such person, any retail licensee that can demonstrate that it provided alcohol seller/server seller or server training certified in advance by the board to the employee responsible for such violation within the 12 months immediately preceding the alleged violation may accept the lesser period of license suspension or pay the lesser civil charge listed below for the violation in lieu of suspension. Any notice of hearing served on a licensee for a violation covered by this section shall contain a notice of the licensee's options under this section. Any licensee who fails to notify the board of its intent to exercise one of the options provided for under this section within 20 days after the date of mailing of the notice of hearing shall be deemed to have waived the right to exercise such options, and the case shall proceed to hearing. For good cause shown, the board may, in its discretion, allow a licensee to exercise the options provided for under this section beyond the 20-day period.

VIOLATION

SUSPENSION

CIVIL CHARGE

SUSPENSION WITH CERTIFIED TRAINING

CIVIL CHARGE WITH CERTIFIED TRAINING

Sale of beer, wine, or mixed beverages to a person at least 18 butunderyounger than 21 years of age.

25 days

$2,000$2,500

5 days

$1,000$1,500

Allowing consumption of beer, wine, or mixed beverages by a person at least 18 butunderyounger than 21 years of age.

25 days

$2,000$2,500

5 days

$1,000$1,500

Aiding and abetting the purchase of alcoholic beverages by a person at least 18 butunderyounger than 21 years of age.

10 days

$1,000$1,250

 

 

Keeping unauthorized alcoholic beverages on the premises, upon which appropriate taxes have been paid.

7 days

$500$750

 

 

Allow an intoxicated person to loiter on the premises.

7 days

$500$750

 

 

Sale to an intoxicated person.

25 days

$2,000$2,500

5 days

$1,000$1,500

Allow consumption by an intoxicated person.

25 days

$2,000$2,500

5 days

$1,000$1,500

After hours sales or consumption of alcoholic beverages.

10 days

$1,000$1,250

 

 

No designated manager on premises.

7 days

$500$750

 

 

Invalid check to wholesaler or board.

7 days

$250$500

 

 

Inadequate illumination.

7 days

$500$750

 

 

ABC license not posted.

7 days

$500$750

 

 

Not timely submitting report required by statute or regulation.

7 days

$500$750

 

 

Designated manager not posted.

7 days

$500$750

 

 

Personlessyounger than 18years of age serving alcoholic beverages;lessyounger than 21years of age acting as bartender.

7 days

$500$750

 

 

Sale of alcoholic beverages in unauthorized place or manner.

10 days

$1,000$1,250

 

 

Consumption of alcoholic beverages in unauthorized area.

7 days

$500$750

 

 

Removal of alcoholic beverages from authorized area.

7 days

$500$750

 

 

Failure to obliterate mixed beverage stamps.

7 days

$500$750

 

 

Employee on duty consuming alcoholic beverages.

7 days

$500$750

 

 

Conducting illegal happy hour.

7 days

$500$750

 

 

Illegally advertising happy hour.

7 days

$500$750

 

 

Unauthorized advertising.

7 days

$500$750

 

 

Failure to remit statebeer/winebeer or wine tax (if deficiency has been corrected).

10 days

$1,000$1,250

 

 

Wholesaler sale ofwine/beerbeer or wine in unauthorized manner.

10 days

$1,000$1,250

 

 

Wholesaler sale ofwine/beerbeer or wine to unauthorized person.

10 days

$1,000$1,250

 

 

B. For purposes of this section, the Virginia Department of Alcoholic Beverage Control Authority will certify alcohol seller/server seller or server training courses that provide instruction on all the topics listed on the Seller/Server Training Evaluation form. The following steps should be completed to submit a training program for approval:

1. Complete the Alcohol Seller/Server Training Data Sheet and review the Seller/Server Training Evaluation form to make sure the program will meet the listed criteria; and

2. Submit the Alcohol Seller/Server Training Data Sheet and a copy of the proposed training program materials for review. Materials submitted should include copies of any lesson plans and instructional materials used in the training program.

Requests for certification of training courses should be sent to:

VirginiaDepartment of Alcoholic Beverage ControlAuthority

Education Section

P.O. Box 27491

Richmond, VA 23261

Emailcorrespondences: education@abc.virginia.gov

Persons in charge of any certified alcohol server training course shall maintain complete records of all training classes conducted, including the date and location of each class, and the identity of all those successfully completing the course.

C. For a licensee that operates more than one retail establishment, each such establishment shall be considered a separate licensee for the purpose of this section.

VA.R. Doc. No. R18-5365; Filed July 26, 2019, 9:00 a.m.
TITLE 8. EDUCATION
STATE BOARD OF EDUCATION
Final Regulation

Title of Regulation: 8VAC20-760. Regulations Governing the Designation of School Divisions of Innovation (adding 8VAC20-760-10 through 8VAC20-760-50).

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

Effective Date: September 19, 2019.

Agency Contact: Emily V. Webb, Director for Board Relations, Department of Education, James Monroe Building, 101 North 14th Street, 25th Floor, Richmond, VA 23219, telephone (804) 225-2924, FAX (804) 225-2524, or email emily.webb@doe.virginia.gov.

Summary:

The regulation establishes the School Division of Innovation (SDI) designation process and timeline, expectations for a plan of innovation, procedures for ongoing evaluation of an SDI, and regulations that may be waived in conjunction with an SDI application.

Summary of Public Comments and Agency's Response: No public comments were received by the promulgating agency.

CHAPTER 760
REGULATIONS GOVERNING THE DESIGNATION OF SCHOOL DIVISIONS OF INNOVATION

8VAC20-760-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Board of Education" or "board" means the board responsible for the general supervision of the public school system in Virginia as prescribed in Section 4 of Article VIII of the Constitution of Virginia and § 22.1-8 of the Code of Virginia.

"Innovation" means a new or creative alternative to existing instructional or administrative practices or school structures that evidence-based practice suggests will be effective in improving student learning and educational performance.

"School Division of Innovation" or "SDI" means a school division in which the local school board has developed and for which the board has approved a plan of innovation to improve student learning; educational performance; and college, career, and citizenship readiness skills in one or more schools, for the benefit of all schools in the school division.

8VAC20-760-20. School Division of Innovation designation.

A. Any local school board may apply to the board for the local school division to be designated as an SDI.

B. Pursuant to a plan of innovation, an SDI shall be exempted from selected regulatory provisions and permitted to adopt alternative policies for school administrators, teachers, and staff to meet the diverse needs of students.

C. An application for an SDI designation shall consist of a plan of innovation for the local school division, following a format prescribed by the Superintendent of Public Instruction. The plan of innovation shall include:

1. Goals and performance targets that may include:

a. Reducing achievement and opportunity gaps among groups of public school students by expanding the range of engaging and relevant learning experiences for students who are identified as academically low-achieving;

b. Increasing student learning through the implementation of high, rigorous standards for student performance and balanced assessments that measure both student growth and achievement;

c. Creating opportunities for students to demonstrate mastery of learning at different points in the learning process based on readiness;

d. Increasing student participation in opportunities that enhance students' preparation for college, career, and citizenship;

e. Increasing the number of students who are college, career, and citizenship ready;

f. Increasing opportunities for students to learn from content experts through integrated course opportunities; or

g. Motivating students at all levels by offering additional curricular choices, personalized learning opportunities, and relevant student learning experiences such as community service projects, internship opportunities, and job shadowing;

2. Divisionwide and school-level policies that will lead students to be better prepared for success in work and life;

3. A description of the ways in which designated schools will incorporate innovative practices;

4. A description of how schools in the division will benefit from innovative practices and share experiences and practices for application in other schools;

5. The incorporation of relevant professional development;

6. Evidence of collaboration, support, and shared leadership among teachers in the school division;

7. Evidence of the support and engagement of educators, parents, the local community, and the local business community in the development of the plan of innovation and of the capacity of such individuals and entities to support the implementation of innovation;

8. Any requests for exemptions from regulatory provisions as provided in 8VAC20-760-30, including the rationale for such exemptions and alternative policies; and

9. Specific measures of student success that may include alternate assessments or approved substitute tests that will be used to determine if students have met graduation requirements, as applicable.

D. Applications for SDI designation shall conform to a format and timeline prescribed by the Superintendent of Public Instruction. The timeline shall include deadlines for (i) a preapplication conference to be held with staff if any exemptions are requested and (ii) submission for consideration by the board.

8VAC20-760-30. Exemption from regulatory provisions.

A. In conjunction with the designation of an SDI, the board may exempt a local school board from board regulations as requested in a school division's plan of innovation. However, the board shall not grant exemptions from the following provisions:

1. Regulations mandated by state or federal law;

2. Regulations designed to promote health or safety;

3. Regulations Governing Special Education Programs for Children with Disabilities in Virginia (8VAC20-81);

4. Student achievement expectations (8VAC20-131-30);

5. Requirements for graduation (8VAC20-131-50 and 8VAC20-131-51);

6. Program of instruction and learning objectives (8VAC20-131-70); or

7. Part VIII of the Regulations Establishing Standards for Accrediting Public Schools in Virginia, School Accreditation (8VAC20-131-370 through 8VAC20-131-430).

B. The board may grant all or a portion of any request for such an exemption and designate conditions as appropriate.

8VAC20-760-40. Approval, amendment, and renewal.

A. The designation of an SDI shall be for a five-year period beginning with the school year following the board's approval.

B. SDI designations may be renewed for subsequent periods not to exceed five years each.

C. School boards seeking to amend a plan of innovation shall be required to seek board approval following the same procedure as provided in 8VAC20-760-20.

8VAC20-760-50. Evaluation.

A. Each SDI shall annually submit to the Department of Education, prior to a date designated by the Superintendent of Public Instruction, information demonstrating progress toward meeting the goals and performance targets included in the approved plan of innovation.

B. Such information shall be considered by the board when possible SDI designation renewals are being reviewed.

C. The board may revoke an SDI designation prior to the end of the five-year approval period in circumstances where it deems appropriate, including:

1. Continued failure to meet goals and performance targets established in the plan of innovation.

2. Continued failure to maintain accredited status for any school subject to the SDI designation.

VA.R. Doc. No. R18-5324; Filed July 26, 2019, 9:52 a.m.
TITLE 12. HEALTH
STATE BOARD OF HEALTH
Fast-Track Regulation

Title of Regulation: 12VAC5-135. Recreational Advisories (adding 12VAC5-135-10 through 12VAC5-135-40).

Statutory Authority: § 32.1-12 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: September 18, 2019.

Effective Date: October 3, 2019.

Agency Contact: Joseph Hilbert, Deputy Commissioner, Governmental and Regulatory Affairs, Virginia Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7001, FAX (804) 864-7022, or email joe.hilbert@vdh.virginia.gov.

Basis: Statutory authority to promulgate this regulation is granted to the State Board of Health pursuant to §§ 32.1-2, 32.1-12, and 32.1-23 of the Code of Virginia.

Purpose: This regulation is necessary to ensure continued public notification whenever there is a higher risk of illness when swimming in public beach water. The Virginia Department of Health (VDH) participated in a regulatory advisory panel (RAP) with the Department of Environmental Quality (DEQ) to amend regulations in 9VAC25-260-170. The RAP participants came to the consensus that DEQ would eliminate regulatory language related to issuing beach advisories and closures, given this is a primary function of VDH's Beach Monitoring and Notification Program. In order for VDH to continue to manage beach advisories in recreational water, promulgation of a new VDH regulation is necessary.

Rationale for Using Fast-Track Rulemaking Process: This regulatory action was initiated as the result of a board decision in response to an action by DEQ. The DEQ RAP, which included representatives of VDH, other local and state agencies, and nonprofit organizations, reached consensus on the removal of the beach advisory and closure language from DEQ regulation provided VDH promulgates a regulation to manage beach advisories in recreational water. VDH does not expect this rulemaking to be controversial. Further, promulgation of this regulation will not result in any changes to the current practice of issuing and lifting recreational water advisories. This regulatory action moves requirements from one title of the Virginia Administrative Code to another and adds procedures for issuing and lifting beach advisories.

Substance: DEQ is repealing 9VAC25-260-170 A 5, which reads: "For beach advisories or closures, a single sample maximum of 235 E. coli cfu/100 ml in freshwater and a single sample maximum of 104 enterococci cfu/100 ml in saltwater and transition zones shall apply." For VDH to continue to manage beach advisories in recreational water, a new VDH regulation with these provisions is necessary. While VDH is maintaining the principle of the DEQ regulation, there are some minor differences. Substantive changes include the removal of individual reference values for the single sample maximum (235 E. coli cfu/100 ml in freshwater and 104 enterococci cfu/100 ml in saltwater and transition zones). The VDH regulation uses a beach action value (BAV). The BAV is set at 104 enterococci mpn/100 mL in saltwater and transition zones. There is no established VDH monitoring protocol for E. coli in recreational freshwater for the issuance of advisories. Further, through this regulation, VDH establishes procedures for issuing and lifting beach advisories. The VDH Beach Monitoring and Notification Program, funded by the U.S. Environmental Protection Agency BEACH Act Grant, requires the use of a BAV. The BAV is contained within the VDH Beach Monitoring and Notification Protocol. The proposed regulation directs readers to the protocol.

Issues: The primary advantage to the public is that VDH currently has this authority through 9VAC25-260-170 A 5 and therefore, there will be no additional impact to the management of recreational water advisories. There are no known disadvantages to the public or agency to promulgating this regulation.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) proposes to promulgate a new regulation concerning the issuance and lifting of beach advisories and beach warnings for public beaches.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The Virginia Department of Health (VDH) Beach Monitoring and Notification Program is funded by the United States Environmental Protection Agency (EPA)'s BEACH Act Grant.1 Under the program, staff from VDH regional offices collect public beach water samples on a weekly basis from mid-May through September at the various public beaches2 in the Commonwealth. The samples are tested for the presence of enterococci.3 If the concentration of enterococci is equal to or above 104 colony forming units per 100 milliliter (beach action value), VDH issues a beach advisory for the tested beach. A beach advisory is a public announcement that the beach action value of enterococci has been met or exceeded, and that there is a higher risk of illness when swimming. After the issuing of the beach advisory, if the results of subsequent testing of samples are below the beach action value, the agency lifts the beach advisory.

VDH issues beach warnings whenever it is not possible for agency staff to collect samples of the public beach water on the scheduled day as a result of practical or safety concerns, or if the proximity of other imminent hazards, such as those of a chemical spill, pose a health risk to public beach water users. A beach warning is a public announcement issued as a result of VDH suspecting a public beach water hazard to be present, such as during extreme weather events or chemical spills, or when the agency staff have been unable to test public beach water as scheduled. When the event or imminent health hazard has passed or public beach water sampling has resumed, the warning is lifted.

Currently, these specifications and other details of the program are in neither statute nor regulation. The Board proposes to put these specifications, procedures for monitoring, definitions, and other information in regulation. According to VDH, promulgation of this regulation would not result in any changes to the current practice of issuing and lifting advisories and warnings. Further, the proposed regulation contains no requirements for local governments, private entities, or anyone else outside of VDH. Thus, the proposed regulation is beneficial in that it provides clarity to the public, but otherwise would not likely have a significant effect.

Businesses and Entities Affected. Beach advisories and beach warnings affect businesses that are dependent on beach attendance, such as nearby restaurants and retail stores. Placing specifications and other details of the VDH Beach Monitoring and Notification Program in regulation, but not changing the actual practice of issuing and lifting advisories and warning, does not significantly affect these entities, though.

Localities Particularly Affected. The proposed regulation particularly applies to Gloucester, Mathews, Hampton, Newport News, York, Norfolk, Virginia Beach, Northumberland, and Accomack.4

Projected Impact on Employment. The proposed regulation would not likely affect employment.

Effects on the Use and Value of Private Property. The proposed regulation would not likely significantly affect the use and value of private property.

Real Estate Development Costs. The proposed regulation would not likely affect real estate development costs.

Small Businesses.

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, 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."

Costs and Other Effects. The proposed regulation would not likely significantly affect costs for small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed regulation does not adversely affect small businesses.

Adverse Impacts:

Businesses. The proposed regulation does not adversely affect businesses.

Localities. The proposed regulation does not adversely affect localities.

Other Entities. The proposed regulation does not adversely affect other entities.

________________________________

1https://www.epa.gov/beach-tech/about-beach-act

2"Public Beach" is defined as "a sandy beach located on a tidal shoreline adjacent to water that is suitable for swimming and that remains open and accessible for public use."

3See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3510518/

4Source: Virginia Department of Health

Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs with the findings of the economic impact analysis.

Summary:

The regulation establishes the Virginia Department of Health's role in issuing and lifting recreational water advisories based on the beach action value, including procedures for issuing and lifting beach advisories.

CHAPTER 135
RECREATIONAL ADVISORIES

12VAC5-135-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Beach action value" or "BAV" means the concentration of an indicator organism that shall determine whether a beach advisory is issued or lifted.

"Beach advisory" means a public announcement that the beach action value has been met or exceeded and informing the public of a higher risk of illness when swimming.

"Beach warning" means a public announcement issued as a result of the department suspecting a public beach water hazard to be present, such as during extreme weather events or chemical spills or when the department has been unable to test public beach water as scheduled.

"Commissioner" means the State Health Commissioner or the commissioner's designee.

"Department" means the Virginia Department of Health.

"Public beach" means a sandy beach located on a tidal shoreline adjacent to water that is suitable for swimming and that remains open and accessible for public use.

"Public beach water" means the water adjacent to a public beach.

12VAC5-135-20. Beach Monitoring and Notification Program.

Through the Virginia Department of Health Beach Monitoring and Notification Program, funded by the U.S. Environmental Protection Agency BEACH Act Grant, the commissioner issues and lifts beach advisories and beach warnings for public beach water.

12VAC5-135-30. Issuance and lifting of beach advisories and beach warnings.

A. The BAV value that determines issuance or lifting of a beach advisory equals 104 most probable number (MPN) per 100 mL enterococci.

B. The commissioner shall issue beach advisories whenever public beach water samples are equal to or greater than the BAV. After the issuing of the beach advisory, if the results of subsequent testing of public beach water samples are less than the BAV, the commissioner shall lift the beach advisory.

C. The commissioner shall issue beach warnings whenever it is not possible for department staff to collect samples of the public beach water on the scheduled day as a result of practical or safety concerns, or if the proximity of other imminent hazards, such as those of a chemical spill, pose a health risk to public beach water users. The commissioner shall lift beach warnings when the event or imminent health hazard has passed or public beach water sampling has resumed. The appropriate laboratory analysis for the hazard shall be used when available to demonstrate public beach water conditions are safe for public use.

D. Acceptable means of public notification of beach advisories and beach warnings include public beach signage, press releases, contacting of local government officials, social media posts, and other forms of communication to convey a beach advisory or beach warning.

12VAC5-135-40. Procedures for beach monitoring.

The procedures for beach monitoring are as follows:

1. The department shall collect public beach water samples on a weekly basis from the middle of May through September or as otherwise determined by the department based on factors such as the size of the beach-going population and the climate at any particular public beach.

2. The department shall analyze public beach water samples using methods approved by the U.S. Environmental Protection Agency.

3. If the department does not collect and test a public beach water sample as scheduled, the commissioner shall issue a beach warning, or if there is an existing beach advisory, the commissioner shall continue the beach advisory.

4. If multiple public beach water samples are taken at several sites within public beach water, the department may average and compare the samples with the BAV. If the average result of the public beach water samples is equal to or greater than the BAV, then the commissioner shall issue a beach advisory.

5. If a public beach water sample is equal to or greater than the BAV, the commissioner-issued beach advisory shall remain in effect until follow-up samples can be taken that demonstrate that levels are less than the BAV.

6. In the event of the issuance of a beach advisory, the department shall collect and analyze follow-up public beach water samples as soon as reasonably possible. Follow-up public beach water samples that are equal to or greater than the BAV shall result in a continuation of the beach advisory.

VA.R. Doc. No. R19-5588; Filed July 26, 2019, 10:03 a.m.
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
BOARD OF VETERINARY MEDICINE
Final Regulation

REGISTRAR'S NOTICE: The Board of Veterinary Medicine is claiming an exemption from Article 2 of the Administrative Process Act in accordance with § 2.2-4006 A 4 a of the Code of Virginia, which excludes regulations that are necessary to conform to changes in Virginia statutory law or the appropriation act where no agency discretion is involved. The board will receive, consider, and respond to petitions by any interested person at any time with respect to reconsideration or revision.

Title of Regulation: 18VAC150-20. Regulations Governing the Practice of Veterinary Medicine (amending 18VAC150-20-190).

Statutory Authority: §§ 54.1-2400 and 54.1-3804 of the Code of Virginia.

Effective Date: September 18, 2019.

Agency Contact: Leslie L. Knachel, Executive Director, Board of Veterinary Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 597-4130, FAX (804) 527-4471, or email leslie.knachel@dhp.virginia.gov.

Summary:

The amendment adds requirements mandated by Chapter 686 of the 2019 Acts of Assembly that every veterinary establishment licensed by the Board of Veterinary Medicine (i) maintain records of the dispensing of feline buprenorphine and canine butorphanol, (ii) reconcile such records monthly, and (iii) make such records available for inspection upon request.

18VAC150-20-190. Requirements for drug storage, dispensing, destruction, and records for all establishments.

A. All drugs shall be maintained, administered, dispensed, prescribed, and destroyed in compliance with state and federal laws, which include § 54.1-3303 of the Code of Virginia, the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia), applicable parts of the federal Food, Drug, and Cosmetic Control Act (21 USC § 301 et seq.), the Prescription Drug Marketing Act (21 USC § 301 et seq.), and the Controlled Substances Act (21 USC § 801 et seq.), as well as applicable portions of Title 21 of the Code of Federal Regulations.

B. All repackaged tablets and capsules dispensed for companion animals shall be in approved safety closure containers, except safety caps shall not be required when any person who requests that the medication not have a safety cap, or in such cases in which the medication is of such form or size that it cannot be reasonably dispensed in such containers (e.g., topical medications, ophthalmic, or otic). An owner request for nonsafety packaging shall be documented in the patient record.

C. All drugs dispensed for companion animals shall be labeled with the following:

1. Name and address of the facility;

2. First and last name of owner;

3. Animal identification and species;

4. Date dispensed;

5. Directions for use;

6. Name, strength (if more than one dosage form exists), and quantity of the drug; and

7. Name of the prescribing veterinarian.

D. All veterinary establishments shall maintain drugs in a secure manner with precaution taken to prevent theft or diversion. Only the veterinarian, veterinary technician, pharmacist, or pharmacy technician shall have access to Schedules II through V drugs, with the exception provided in subdivision 6 of this subsection.

1. In a stationary establishment, the general stock of Schedules II through V drugs shall be stored in a securely locked cabinet or safe that is not easily movable.

2. The establishment may also have a working stock of Schedules II through V drugs that shall be kept in (i) a securely locked container, cabinet, or safe when not in use or (ii) direct possession of a veterinarian or veterinary technician. A working stock shall consist of only those drugs that are necessary for use during a normal business day or 24 hours, whichever is less.

3. Whenever the establishment is closed, all general and working stock of Schedules II through V drugs and any dispensed prescriptions that were not delivered during normal business hours shall be securely stored as required for the general stock.

4. Prescriptions that have been dispensed and prepared for delivery shall be maintained under lock or in an area that is not readily accessible to the public and may be delivered to an owner by an unlicensed person, as designated by the veterinarian.

5. Whenever a theft or any unusual loss of Schedules II through V drugs is discovered, the veterinarian-in-charge, or in his absence, his designee, shall immediately report such theft or loss to the Board of Veterinary Medicine and the Board of Pharmacy and to the DEA. The report to the boards shall be in writing and sent electronically or by regular mail. The report to the DEA shall be in accordance with 21 CFR 1301.76(b). If the veterinarian-in-charge is unable to determine the exact kind and quantity of the drug loss, he shall immediately take a complete inventory of all Schedules II through V drugs.

6. Access to drugs by unlicensed persons shall be allowed only under the following conditions:

a. An animal is being kept at the establishment outside of the normal hours of operation, and a licensed practitioner is not present in the facility;

b. The drugs are limited to those dispensed to a specific patient; and

c. The drugs are maintained separately from the establishment's general drug stock and kept in such a manner so they are not readily available to the public.

E. Schedules II through V drugs shall be destroyed by (i) transferring the drugs to another entity authorized to possess or provide for proper disposal of such drugs or (ii) destroying the drugs in compliance with applicable local, state, and federal laws and regulations. If Schedules II through V drugs are to be destroyed, a DEA drug destruction form shall be fully completed and used as the record of all drugs to be destroyed. A copy of the destruction form shall be retained at the veterinarian practice site with other inventory records.

F. The drug storage area shall have appropriate provision for temperature control for all drugs and biologics. If drugs requiring refrigeration are maintained at the facility, they the drugs shall be kept in a refrigerator with the interior thermometer maintained between 36°F and 46°F. If a refrigerated drug is in Schedules II through V, the drug shall be kept in a locked container secured to the refrigerator, or the refrigerator shall be locked. Drugs stored at room temperature shall be maintained between 59°F and 86°F.

G. The stock of drugs shall be reviewed frequently, and expired drugs shall be removed from the working stock of drugs at the expiration date and shall not be administered or dispensed.

H. A distribution record shall be maintained in addition to the patient's record, in chronological order, for the administration and dispensing of all Schedules II through V drugs.

This record is to be maintained for a period of three years from the date of transaction. This distribution record shall include the following:

1. Date of transaction;

2. Drug name, strength, and the amount dispensed, administered, and wasted;

3. Owner and animal identification; and

4. Identification of the veterinarian authorizing the administration or dispensing of the drug.

I. Original invoices for all Schedules II through V drugs received shall be maintained in chronological order on the premises where the stock of drugs is held, and the actual date of receipt shall be noted. All drug records shall be maintained for a period of three years from the date of transaction.

J. A complete and accurate inventory of all Schedules II through V drugs shall be taken, dated, and signed on any date that is within two years of the previous biennial inventory. Drug strength must be specified. This inventory shall indicate if it was made at the opening or closing of business and shall be maintained on the premises where the drugs are held for three years from the date of taking the inventory.

K. Inventories and records, including original invoices, of Schedule II drugs shall be maintained separately from all other records, and the establishment shall maintain a continuous inventory of all Schedule II drugs received, administered, or dispensed, with reconciliation at least monthly. Reconciliation requires an explanation noted on the inventory for any difference between the actual physical count and the theoretical count indicated by the distribution record. A continuous inventory shall accurately indicate the physical count of each Schedule II drug in the general and working stocks at the time of performing the inventory.

L. Veterinary establishments shall (i) maintain records of the dispensing of feline buprenorphine and canine butorphanol, (ii) reconcile such records monthly, and (iii) make such records available for inspection upon request.

L. M. Veterinary establishments in which bulk reconstitution of injectable, bulk compounding, or the prepackaging of drugs is performed shall maintain adequate control records for a period of one year or until the expiration, whichever is greater. The records shall show the name of the drugs used; strength, if any; date repackaged; quantity prepared; initials of the veterinarian verifying the process; the assigned lot or control number; the manufacturer's or distributor's name and lot or control number; and an expiration date.

M. N. If a limited stationary or ambulatory practice uses the facilities of another veterinary establishment, the drug distribution log shall clearly reveal whose Schedules II through V drugs were used. If the establishment's drug stock is used, the distribution record shall show that the procedure was performed by a visiting veterinarian who has the patient record. If the visiting veterinarian uses his own stock of drugs, he shall make entries in his own distribution record and in the patient record and shall leave a copy of the patient record at the other establishment.

VA.R. Doc. No. R19-6065; Filed July 29, 2019, 7:59 p.m.
TITLE 24. TRANSPORTATION AND MOTOR VEHICLES
COMMONWEALTH TRANSPORTATION BOARD
Final Regulation

REGISTRAR'S NOTICE: The Commonwealth Transportation Board is claiming an exemption from the Administrative Process Act in accordance with § 2.2-4002 B 11 of the Code of Virginia, which exempts regulations relating to traffic signs, markers, or control devices.

Title of Regulation: 24VAC30-610. List of Differentiated Speed Limits (repealing 24VAC30-610-10).

Statutory Authority: § 33.2-210 of the Code of Virginia.

Effective Date: September 18, 2019.

Agency Contact: Vanloan Nguyen, Assistant Division Administrator, Traffic Engineering Division, Department of Transportation, 1401 East Broad Street, 2nd Floor, Richmond, VA 23219, telephone (804) 786-2918, FAX (804) 225-4978, or email vanloan.nguyen@vdot.virginia.gov.

Summary:

The action repeals List of Differentiated Speed Limits (24VAC30-610) because the chapter is duplicative of the requirements in § 46.2-878 of the Code of Virginia.

VA.R. Doc. No. R19-6089; Filed August 5, 2019, 11:49 a.m.