Title of Regulation: 18VAC85-20. Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry, and Chiropractic (amending 18VAC85-20-400).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: June 29, 2016.

Effective Date: July 15, 2016.

Agency Contact: William L. Harp, M.D., Executive Director, Board of Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4621, FAX (804) 527-4429, or email william.harp@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of Chapter 24 (§ 54.1-2400 et seq.) of Title 54.1 of the Code of Virginia. Section 54.1-2400 of the Code of Virginia provides the Board of Medicine the authority to promulgate regulations that are reasonable and necessary to administer effectively the regulatory system.

The exemption for mixing, diluting, and reconstituting (MDR) from the requirements of compounding is found in § 54.1-3401 of the Code of Virginia.

Purpose: The purpose of the amended regulation is consistency with the law for compounding by pharmacists under provisions of the Drug Control Act. The amendment is essential to protect the health and safety of citizens for whom drugs are being compounded in a physician's office and to eliminate confusion about the role of a pharmacist in a physician's practice.

Rationale for Using Fast-Track Rulemaking Process: There is no controversy in the adoption of this amendment; it is recommended for consistency with advice by the Office of the Attorney General to the Board of Pharmacy and to the Board of Medicine committee reviewing regulations for MDR.

Substance: The proposed amendment to 18VAC85-20-400 eliminates the pharmacist as a practitioner who can perform a second check of mixing, diluting, or reconstituting drugs in a physician's office by a specifically trained person and also eliminates the pharmacist as a practitioner who can perform mixing, diluting, or reconstituting without a second check. A pharmacist is required by law to follow the United States Pharmacopeia - National Formulary for compounding of drug products and does not fall under the exemption for physicians and persons in physicians' practices.

Issues: The primary advantage to the public is greater protection in the compounding of sterile drug products. There are no disadvantages.

There are no advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Medicine proposes to clarify that pharmacists working in physician offices are not allowed to mix, dilute, and reconstitute drugs or perform a second check on such actions performed by another authorized practitioner.

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

Estimated Economic Impact. Pharmacists are allowed to compound drugs, but mixing, diluting, or reconstitution of drugs for the purpose of administration to a patient is not considered compounding pursuant to § 54.1-3401 of the Code of Virginia. In contrast to the statutory definition, this regulation appears to indicate that pharmacists are allowed to mix, dilute, or reconstitute drugs at physician offices for the purpose of administration to a patient and perform a second check if mixing, diluting, or reconstituting is performed by another authorized practitioner. The proposed change will clarify that pharmacists in physician offices are allowed to compound but are not allowed to mix, dilute, or reconstitute drugs for the purpose of administration to a patient or perform a second check on such actions performed by another authorized practitioner.

The proposed change will eliminate a potential source of confusion as to the scope of pharmacists' functions in a physician office. The Department of Health Professions notes that pharmacists are always advised to follow United States Pharmacopeia-National Formulary for compounding of drugs pursuant to § 54.1-3410.2 of the Code of Virginia and does not believe mixing, diluting, or reconstitution are currently performed by pharmacists in physician offices for the purpose of administration to a patient. Thus, no significant economic effect is expected from this proposed change other than improving the clarity of the regulation and eliminating a potential source of confusion.

Businesses and Entities Affected. The proposed regulation applies to pharmacists employed in physician offices. Currently, there are 13,429 pharmacists licensed to practice in Virginia. Exactly how many of these pharmacists are employed in physician offices is not known, but estimated to be less than 100.

Localities Particularly Affected. The proposed regulation applies statewide.

Projected Impact on Employment. No impact on employment is expected.

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

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

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 does not impose costs or other effects on small businesses.

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

Adverse Impacts:

Businesses. The proposed regulation does not have an impact on non-small businesses.

Localities. The proposed regulation will not adversely affect localities.

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

Agency's Response to Economic Impact Analysis: The Board of Medicine concurs with the analysis of the Department of Planning and Budget.

Summary:

The amendment eliminates the pharmacist as a practitioner who can perform (i) a second check of mixing, diluting, or reconstituting drugs in a physician's office by a specifically trained person and (ii) mixing, diluting, or reconstituting without a second check.

Part IX
Mixing, Diluting, or Reconstituting of Drugs for Administration

18VAC85-20-400. Requirements for immediate-use sterile mixing, diluting, or reconstituting.

A. For the purposes of this chapter, the mixing, diluting, or reconstituting of sterile manufactured drug products when there is no direct contact contamination and administration begins within 10 hours of the completion time of preparation shall be considered immediate-use with the exception of drugs in fat emulsion for which immediate use shall be one hour. If manufacturers' instructions or any other accepted standard specifies or indicates an appropriate time between preparation and administration of less than 10 hours, the mixing, diluting, or reconstituting shall be in accordance with the lesser time. No direct contact contamination means that there is no contamination from touch, gloves, bare skin, or secretions from the mouth or nose. Emergency drugs used in the practice of anesthesiology and administration of allergens may exceed 10 hours after completion of the preparation, provided administration does not exceed the specified expiration date of a multiple use vial and there is compliance with all other requirements of this section.

B. Doctors of medicine or osteopathic medicine who engage in immediate-use mixing, diluting, or reconstituting shall:

1. Utilize the practices and principles of disinfection techniques, aseptic manipulations and solution compatibility in immediate-use mixing, diluting, or reconstituting;

2. Ensure that all personnel under their supervision who are involved in immediate-use mixing, diluting, or reconstituting are appropriately and properly trained in and utilize the practices and principles of disinfection techniques, aseptic manipulations, and solution compatibility;

3. Establish and implement procedures for verification of the accuracy of the product that has been mixed, diluted, or reconstituted to include a second check performed by a doctor of medicine or osteopathic medicine or a pharmacist, or by a physician assistant or a registered nurse who has been specifically trained pursuant to subdivision 2 of this subsection in immediate-use mixing, diluting, or reconstituting. Mixing, diluting, or reconstituting that is performed by a doctor of medicine or osteopathic medicine, a pharmacist, or by a specifically trained physician assistant or registered nurse or mixing, diluting, or reconstituting of vaccines does not require a second check;

4. Provide a designated, sanitary work space and equipment appropriate for aseptic manipulations;

5. Document or ensure that personnel under his supervision documents document in the patient record or other readily retrievable record that identifies the patient; the names of drugs mixed, diluted or reconstituted; and the date of administration; and

6. Develop and maintain written policies and procedures to be followed in mixing, diluting, or reconstituting of sterile products and for the training of personnel.

C. Any mixing, diluting, or reconstituting of drug products that are hazardous to personnel shall be performed consistent with requirements of all applicable federal and state laws and regulations for safety and air quality, to include but not be limited to those of the Occupational Safety and Health Administration (OSHA). For the purposes of this chapter, Appendix A of the National Institute for Occupational Safety and Health publication (NIOSH Publication No. 2004-165), Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings is incorporated by reference for the list of hazardous drug products and can be found at www.cdc.gov/niosh/docs/2004-165.