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

Agency Contact: Leslie L. Knachel, Executive Director, Board of Veterinary Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4468, FAX (804) 527-4471, or email leslie.knachel@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia establishes the responsibility of the Board of Veterinary Medicine to promulgate regulations and administer a licensure and renewal program.

Chapter 38 (§ 54.1-3800 et seq.) of Title 54.1 of the Code of Virginia grants the board the following specific powers and duties:

1. Establish essential requirements and standards for approval of veterinary programs.

2. Establish and monitor programs for the practical training of qualified students of veterinary medicine or veterinary technology in college or university programs of veterinary medicine or veterinary technology.

3. Regulate, inspect and register all establishments and premises where veterinary medicine is practiced.

Purpose: The purpose of the amended regulation is to update requirements for drug destruction consistent with current U.S. Drug Enforcement Administration (DEA) policies and rules. Proper destruction of drugs is essential to protect the health and safety of citizens who may be affected by improper flushing, incineration, or disposal in a landfill. Use of expired drugs that may be ineffective could affect the health and welfare of the animals that are patients of veterinarians.

Rationale for Using Fast-Track Process: This regulation is appropriate for the fast-track process because the agency does not have the option of continuing the current regulation, which calls for following instructions in a DEA package that no longer exists. The amendment states the guidance of the DEA for drug destruction and is identical to the regulation for drug destruction by other entities that stock drugs.

Substance: The amendments delete the requirement that Schedule II through V drugs be destroyed by following the instructions contained in the drug destruction packet available from the board office, which provides the latest U.S. Drug Enforcement Administration approved drug destruction guidelines. The amendments specify that the drugs can 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 by burning in an incinerator that is in compliance with applicable local, state, and federal laws and regulations. Regulations further provide that if Schedule 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.

Issues: The primary advantage to the public would be the timely and effective destruction of stocks of unused, expired, or adulterated prescription drugs that could find their way into illegal distribution or abuse. For those reasons, the DEA has a drug destruction form that should be completed by any entity that has the legal authority to maintain a stock of controlled substances. There are no disadvantages to the public, which is better protected by the proper destruction of prescription drugs. There are no advantages or disadvantages to the agency.

Summary of the Proposed Amendments to Regulation. The Board of Veterinary Medicine proposes to specify the drug destruction procedures in the regulations instead of requiring compliance with the drug destruction instructions contained in the packet available from the board office which provides the latest U.S. Drug Enforcement Administration approved drug destruction guidelines.

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

Estimated Economic Impact. Current regulations require destruction of schedule II, III, IV, and V drugs according to the drug destruction instructions contained in the packet available from the board office which provides the latest U.S. Drug Enforcement Administration (DEA) approved drug destruction guidelines. However, DEA no longer has a drug destruction packet. Thus, the proposed regulations spell out the drug destruction procedures in the regulations.

The proposed procedures are the same as the guidelines established by DEA which include transferring drugs to an authorized reverse distributor, destroying by incineration that meets local state, and federal requirements, and completing a drug destruction form. Since the proposed requirements are the same as current requirements followed in practice, no significant economic effect is expected other than improving the clarity of the regulations.

Businesses and Entities Affected. The proposed regulations apply to 709 full service veterinary facilities and 240 restricted service veterinary facilities.

Localities Particularly Affected. The proposed regulations apply throughout the Commonwealth.

Effects on the Use and Value of Private Property. No impact on the use and value of private property is expected.

Small Businesses: Costs and Other Effects. Although most of the 709 full service veterinary facilities and 240 restricted service veterinary facilities are believed to be small businesses, proposed regulations are not expected to have any significant costs or other effects on small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. No adverse impact on small businesses is expected.

Real Estate Development Costs. No effect on real estate development costs is expected.

Legal Mandate. 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 Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Board of Veterinary Medicine concurs with the analysis of the Department of Planning and Budget for the proposed fast-track action on drug destruction in 18VAC150-20, Regulations Governing the Practice of Veterinary Medicine.

The amendments set out the drug destruction procedures that veterinarians must follow in the regulations instead of requiring compliance with the drug destruction instructions contained in the packet available from the board office, which provides the latest U.S. Drug Enforcement Administration approved drug destruction guidelines.

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

A. All drugs shall be maintained, administered, dispensed, prescribed and destroyed in compliance with state and federal laws, which include 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). A client request for nonsafety packaging shall be documented in the patient record.

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

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

D. All drugs shall be maintained in a secured manner with precaution taken to prevent diversion.

1. All Schedule II through V drugs shall be maintained under lock at all times, with access to the veterinarian or veterinary technician only, but not to any unlicensed personnel.

2. Whenever a veterinarian discovers a theft or any unusual loss of Schedule II, III, IV, or V drugs, he shall immediately report such theft or loss to the Board of Veterinary Medicine and to the U.S. Drug Enforcement Administration.

E. Schedule II, III, IV and V drugs shall be destroyed by ~~following the instructions contained in the drug destruction packet available from the board office which provides the latest U.S. Drug Enforcement Administration approved drug destruction guidelines~~ (i) transferring the drugs to another entity authorized to possess or provide for proper disposal of such drugs or (ii) destroying the drugs by burning in an incinerator that is in compliance with applicable local, state, and federal laws and regulations. If Schedule 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, including a refrigerator with the interior thermometer maintained between 36°F and 46°F. Drugs stored at room temperature shall be maintained between 59°F and 86°F. The stock of drugs shall be reviewed frequently and removed from the working stock of drugs at the expiration date.

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

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

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

H. Original invoices for all Schedule II, III, IV and V drugs received shall be maintained in chronological order on the premises where the stock of drugs is held and actual date of receipt is noted. Invoices for Schedule II drugs shall be maintained separately from other records. All drug records shall be maintained for a period of two years from the date of transaction.

I. A complete and accurate inventory of all Schedule II, III, IV and 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 two years from the date of taking the inventory.

J. 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 drug(s) 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.

NOTICE: The following forms used in administering the regulation were filed by the agency. The forms are not being published; however, online users of this issue of the Virginia Register of Regulations may click on the name of the new or amended form to access it. The forms are also available from the agency contact or may be viewed at the Office of the Registrar of Regulations, General Assembly Building, 2nd Floor, Richmond, Virginia 23219.

Instructions to the Applicant for Licensure by Examination as a Veterinary Technician (rev. 4/09).

Applicant Instructions for New, Upgrading to Full Service, or Change of Location Inspections (rev. 8/07).

Application for Registration to Practice as an Equine Dental Technician (eff. 11/07).