Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-220; repealing 18VAC110-20-230).

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

Public Hearing Information: No public hearings are scheduled.

Public Comments: Public comments may be submitted until 5 p.m. on November 26, 2008.

Effective Date: December 11, 2008.

Agency Contact: Elizabeth Scott Russell, 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 scotti.russell@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Pharmacy the authority to promulgate regulations to administer the regulatory process.

Purpose: Proposed amendments modifying the requirements for nuclear pharmacies eliminate conflicting or overlapping regulations for entities and persons that are already tightly regulated by the federal government and the Virginia Department of Health, the state agency that has oversight responsibility for radiological health programs. Some of the board’s regulations were not consistent with current requirements and qualifications for nuclear pharmacists; others were no longer necessary. By streamlining the regulation and addressing only those aspects of pharmacy practice that are not regulated by other agencies, the board’s requirements focus on the transmission of orders, labeling of containers and packaging as necessary for public health and safety.

Rationale for Using Fast-Track Process: The board has determined that a fast-track process is appropriate because there is no controversy with this action. It will eliminate conflicting or overlapping regulations for pharmacies and pharmacists who are already subject to state and federal requirements for other agencies. The amendments have been developed with the Director of the Radioactive Materials Program at the Virginia Department of Health and are consistent with the request from that department for amendments.

Substance: The board’s amendments eliminate conflicting language and unnecessary provisions. A subsection is amended to reference compliance with the U.S. Nuclear Regulatory Commission (NRC) and VDH requirements for staffing and operation of a nuclear facility. Another subsection is amended to use correct terminology – prescriber rather than practitioner. 18VAC110-20-230, which sets out the qualifications of a nuclear pharmacist, is repealed as unnecessary since those agencies have more stringent qualifications.

Issues: There are no particular advantages or disadvantages to the public since regulations have been clarified and made consistent with requirements of other agencies that are already in place.

There are no advantages or disadvantages to the agency or the Commonwealth. There are less than 10 nuclear pharmacies in Virginia, so oversight has not been problematic.

There is no other pertinent matter of interest related to this action

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy proposes to repeal language that is either duplicative or in conflict with U.S. Nuclear Regulatory Commission (NRC) and Virginia Department of Health provisions.

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

Estimated Economic Impact. The proposal to repeal duplicative language will have no effect since requirements remain in the NRC and VDH provisions. According to the Department of Health Professions language that is not consistent with NRC and VDH rules has not been enforced. Thus repealing this language will have no impact beyond presenting clearer information to the public concerning the law as applied. Thus the proposed changes produce benefit and no cost.

Businesses and Entities Affected. The proposed amendments affect the fewer than ten¹ pharmacies which provide radiopharmaceutical services in the Commonwealth.

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposal amendments do not significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments do not significantly affect the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed amendments do not significantly affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments do not significantly affect small businesses.

Real Estate Development Costs. The proposed amendments do not significantly affect real estate development costs.

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 36 (06). 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.

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¹ Data Source: Department of Health Professions

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The Board of Pharmacy concurs with the analysis of the Department of Planning and Budget on proposed amended regulations for 18VAC110-20, Regulations Governing the Pharmacy, relating to requirements for nuclear pharmacies.

Summary:

The board has amended its regulations pertaining to the general requirements for pharmacies providing radiopharmaceutical services and repealed the section of regulations that establishes the qualifications for a nuclear pharmacist. Amendments will refer to standards and requirements of the U. S. Nuclear Regulatory Commission (NRC) and the Virginia Department of Health (VDH) related to the staffing and operation of a nuclear pharmacy.

Part V
Nuclear Pharmacies

18VAC110-20-220. General requirements for pharmacies providing radiopharmaceutical services.

A. A permit to operate a pharmacy providing radiopharmaceutical services shall be issued only to a qualified nuclear pharmacist as defined in 18VAC110-20-230. In emergency situations, in the absence of the nuclear pharmacist, he may designate one or more other qualified pharmacists to have access to the licensed area. These individuals may obtain single doses of radiopharmaceuticals for the immediate emergency and shall document such withdrawals in the control system.

B. Pharmacies providing ordinary pharmacy services in addition to radiopharmaceutical services shall comply with all regulations applicable to pharmacies in general. Pharmacies providing only radiopharmaceutical services shall comply with all regulations related to physical standards, sanitary conditions and security.

C. A. Nuclear pharmacies shall have adequate space and equipment, commensurate with the scope of services required and provided and in compliance comply with standards and requirements of the Nuclear Regulatory Commission (NRC) and the Virginia Department of Health related to the staffing and operation of the facility.

D. B. Radiopharmaceuticals are to be dispensed only upon an order from a practitioner prescriber authorized to possess, use and administer radiopharmaceuticals.

1. Orders shall originate at an institution or healthcare facility licensed to receive and possess radiopharmaceuticals, and must contain all necessary information relative to the radiopharmaceutical, activity, time of calibration, and any special preparation or delivery instructions.

2. Orders for radiopharmaceuticals may be transmitted orally, by fax, or by electronic transmission by an authorized agent of the prescriber. If the fax or electronic transmission of the authorized agent is pursuant to an oral order from the prescriber, the transmitted document need not include the prescriber's signature, but must include the name of the agent.

E. C. The immediate outside container of a radioactive drug to be dispensed shall also be labeled in accordance with requirements of § 54.1-3410.1 B of the Code of Virginia.

F. D. The immediate inner container shall be labeled with: (i) the standard radiation symbol; (ii) the words "Caution--Radioactive Material"; and (iii) the serial number assigned to the order.

G. The amount of radioactivity shall be determined by radiometric methods for each individual dose immediately prior to dispensing.

H. E. Nuclear pharmacies may redistribute approved radioactive drugs if the pharmacy does not process the radioactive drugs in any manner nor violate the product packaging.

18VAC110-20-230. Qualification as a nuclear pharmacist. (Repealed.)

In order to practice as a nuclear pharmacist, a pharmacist shall possess the following qualifications:

1. Meet Nuclear Regulatory Commission (NRC) standards of training for medically used or radioactive by-product material.

2. Have received a minimum of 200 contact hours of didactic instruction in nuclear pharmacy.

3. Attain a minimum of 500 hours of clinical nuclear pharmacy training under the supervision of a qualified nuclear pharmacist in a nuclear pharmacy providing nuclear pharmacy services, or in a structured clinical nuclear pharmacy training program in an approved school of pharmacy.

4. Submit to the board an affidavit of experience and training meeting the requirements of subdivisions 1, 2 and 3 of this section; documentation of NRC approval as an authorized nuclear pharmacist; or documentation of certification as a nuclear pharmacist by the American Pharmaceutical Association Board of Pharmaceutical Specialties.