Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-140).

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: August 7, 2019.

Effective Date: August 22, 2019.

Agency Contact: Caroline Juran, 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 caroline.juran@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which provides the Board of Pharmacy the authority to promulgate regulations to administer the regulatory system. The statutory authority for the board to regulate the security and integrity of drugs and devices is found in § 54.1-3307 of the Code of Virginia.

Purpose: The purpose of the amended regulation is to prevent an entity from using a pharmacy permit without the intent of actually offering pharmacy services. In recent months, inspectors have identified three or four incidents in which a permit has been issued but the pharmacy remains closed indefinitely The concern is that there could be unscrupulous activity (e.g., ordering drugs) using the permit number. To address these concerns and to protect public health and safety, the board proposes to amend the section on issuance of a permit to require a pharmacy to be fully operational within 90 days, unless there are circumstances beyond the control of the permit holder.

Rationale for Using Fast-Track Rulemaking Process: While there are real concerns about public health and safety, there is no evidence that an emergency exists, so an emergency action is not warranted. However, the action should not be controversial and a fast-track rulemaking process is appropriate.

Substance: 18VAC110-20-140 is amended to authorize the board to require a pharmacy to be operational within 90 days of issuance of a permit. If the pharmacy is in violation of the regulation, it would be subject to disciplinary action, including rescission of the permit. The board may grant an extension for circumstances beyond the control of the permit holder.

Issues: The advantage to the public is less risk of a pharmacy permit being used for purposes other than to provide pharmacy services to the public. There are no disadvantages. There are no advantages or disadvantages to this agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy (Board) proposes to require that once a permit has been issued, the pharmacy shall be fully operational within 90 days of issuance.

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

Estimated Economic Impact. Department of Health Professions (DHP) inspectors have been concerned that a pharmacy permit may be used to order drugs for some purpose other than operating a pharmacy. To hinder that possibility, the proposed new text would authorize the Board to take action against the permit upon evidence that the pharmacy has not actually opened within 90 days of being issued a permit. The proposed language also states that for good cause shown, such as circumstances beyond the control of the permit holder, the Board could grant an extension. The proposed amendment would likely produce a net benefit since it should not significantly affect those who intend to use pharmacy permits for legitimate purposes, and may decrease the likelihood that drugs are illegally diverted.

Businesses and Entities Affected. The proposed amendment potentially affects newly permitted pharmacies. Between December 1, 2017, and November 30, 2018, the Department of Health Professions issued 57 pharmacy permits. Currently 1,850 pharmacies in the Commonwealth hold permits.¹

Localities Particularly Affected. The proposed amendment does not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendment is unlikely to significantly affect total employment.

Effects on the Use and Value of Private Property. The proposed amendment is unlikely to significantly affect the legitimate use and value of private property. It may impede illegal use of property.

Real Estate Development Costs. The proposed amendments do not 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 amendments are unlikely to significantly affect costs for small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendments do not adversely affect legitimate small businesses.

Adverse Impacts: 

Businesses. The proposed amendments do not adversely affect legitimate businesses.

Localities. The proposed amendments do not adversely affect localities.

Other Entities. The proposed amendments do not adversely affect other entities.

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¹Data source: Department of Health Professions

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

 

Summary:

The amendments authorize the board to (i) require a pharmacy to be operational within 90 days of issuance of a permit and (ii) grant an extension for circumstances beyond the control of the permit holder for failing to meet the 90-day requirement.

18VAC110-20-140. New pharmacies, acquisitions, and changes to existing pharmacies.

A. Any person wishing to open a new pharmacy, engage in the acquisition of an existing pharmacy, change the location of an existing pharmacy, move the location or make structural changes to an existing prescription department, or make changes to a previously approved security system shall file an application with the board.

B. In the acquisition of an existing pharmacy, if prescription records are to be accessible to anyone for purposes other than for continuity of pharmacy services at substantially the same level offered by the previous owner or for the necessary transfer of prescription records, the owner of the pharmacy acquiring the records shall disclose such information in writing to each patient 14 days prior to the acquisition. Such release of prescription records shall be allowed only to the extent authorized by § 32.1-127.1:03 of the Code of Virginia.

C. The proposed location or structural changes shall be inspected by an authorized agent of the board prior to issuance of a permit.

1. Pharmacy permit applications which that indicate a requested inspection date, or requests which that are received after the application is filed, shall be honored provided a 14-day notice is allowed prior to the requested inspection date.

2. Requested inspection dates which that do not allow a 14-day notice to the board may be adjusted by the board to provide 14 days for the scheduling of the inspection.

3. At the time of the inspection, the dispensing area shall comply with 18VAC110-20-150, 18VAC110-20-160, 18VAC110-20-170, 18VAC110-20-180, and 18VAC110-20-190.

4. If an applicant substantially fails to meet the requirements for issuance of a permit and a reinspection is required, or if the applicant is not ready for the inspection on the established date and fails to notify the inspector or the board at least 24 hours prior to the inspection, the applicant shall pay a reinspection fee as specified in 18VAC110-20-20 prior to a reinspection being conducted.

D. Drugs shall not be stocked within the proposed pharmacy or moved to a new location until approval is granted by the inspector or board staff.

E. Once the permit is issued, prescription drugs may not be stocked earlier than two weeks prior to the designated opening date. Once prescription drugs have been placed in the pharmacy, a pharmacist shall be present on a daily basis to ensure the safety and integrity of the drugs. If there is a change in the designated opening date, the pharmacy shall notify the board office, and a pharmacist shall continue to be on site on a daily basis.

F. Once a permit has been issued, the pharmacy shall be fully operational within 90 days of issuance. For good cause shown, such as circumstances beyond the control of the permit holder, the board may grant an extension.