Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-710).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: December 7, 2011.

Effective Date: December 22, 2011.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4416, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: Section 54.1-2400 established the general powers and duties of health regulatory boards, including the Board of Pharmacy's responsibility to promulgate regulations and establish renewal schedules.

The specific authority to control prescription drugs in the Commonwealth is found in Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.

Purpose: The elimination of a requirement for a security system for certain emergency medical services (EMS) agencies will make it less burdensome for a few small agencies to carry fluids that may be essential for the stabilization of a patient being transporting to the hospital. Any reduction in regulation that makes maintenance of an EMS agency less costly is beneficial and contributes to the health and safety of the people in its community.

Rationale for Using Fast Track Process: The amendments are proposed to eliminate an unnecessary security requirement for EMS agencies. The change is not expected to be controversial.

Substance: The substance of the amended regulation is to eliminate the requirement for a security system for EMS agencies that only stock IV fluids without added drugs.

Issues: The primary advantage to the public is the elimination of an expense for EMS agencies, particularly those who provide limited but essential services in many communities. 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 Pharmacy proposes to no longer require a security system for Emergency Medical Services agencies that only stock intravenous fluids with no drug additives.

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

Estimated Economic Impact. The Board of Pharmacy proposes to eliminate the requirement for a security system for Emergency Medical Services (EMS) agencies that only stock intravenous fluids without added drugs. The security system is required to deter pilferage or diversion of drugs. According to Department of Health Professions (DHP), it is unnecessarily burdensome for EMS agencies that only stock intravenous fluids without added drugs to have an alarm system. DHP estimates that less than 10 EMS agencies would stock only intravenous fluids. While this change has the potential to reduce compliance costs of certain EMS agencies, DHP does not know which agencies may be affected and does not have an estimate for the size of expected savings. Also, EMS agencies may have other incentives to obtain or maintain a security system making it difficult to assess the likely impact.

Businesses and Entities Affected. The proposed changes are expected to affect less than 10 EMS agencies.

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

Projected Impact on Employment. The proposed changes do not seem to be significant enough to have a notable effect on employment.

Effects on the Use and Value of Private Property. The proposed changes do not seem to be significant enough to have a notable effect on the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed regulations do not impose costs on small businesses. Other effects on small businesses are the same as discussed above.

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

Real Estate Development Costs. The proposed regulations are not expected to create any 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 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 DPBs best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis of the Department of Planning and Budget on fast-track regulations to eliminate the security requirement for certain EMS agencies.

Summary:

The amendment eliminates the requirement for an alarm system for emergency medical services agencies that only stock intravenous fluids with no drug additives.

18VAC110-20-710. Requirements for storage and security for controlled substances registrants.

A. Drugs shall be stored under conditions which meet USP-NF specifications or manufacturers' suggested storage for each drug.

B. Any drug which has exceeded the expiration date shall not be administered; it shall be separated from the stock used for administration and maintained in a separate, locked area until properly disposed.

C. If a controlled substances registrant wishes to dispose of unwanted or expired Schedule II through VI drugs, he shall transfer the drugs to another person or entity authorized to possess and to provide for proper disposal of such drugs.

D. Drugs shall be maintained in a lockable cabinet, cart, device or other area which shall be locked at all times when not in use. The keys or access code shall be restricted to the supervising practitioner and persons designated access in accordance with 18VAC110-20-700 C.

E. In a facility not staffed 24 hours a day, the drugs shall be stored in a fixed and secured room, cabinet or area which has a security device for the detection of breaking which meets the following conditions:

1. The device shall be a sound, microwave, photoelectric, ultrasonic, or any other generally accepted and suitable device.

2. The installation and device shall be based on accepted alarm industry standards.

3. The device shall be maintained in operating order, have an auxiliary source of power, be monitored in accordance with accepted industry standards, be maintained in operating order; and shall be capable of sending an alarm signal to the monitoring entity if breached and the communication line is not operational.

4. The device shall fully protect all areas where prescription drugs are stored and shall be capable of detecting breaking by any means when activated.

5. Access to the alarm system shall be restricted to only designated and necessary persons, and the system shall be activated whenever the drug storage areas are closed for business.

6. An alarm system is not required for researchers, animal control officers, humane societies, or alternate delivery sites as provided in 18VAC110-20-275, or emergency medical services agencies stocking only intravenous fluids with no added drug.