Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-20, 18VAC110-20-190).

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: July 1, 2015.

Effective Date: July 16, 2015.

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 of the Code of Virginia establishes the general powers and duties of health regulatory boards, including the responsibility to promulgate regulations that are reasonable and necessary to administer effectively the regulatory system 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 purpose of the regulatory action to amend 18VAC110-20-20 is to facilitate the work of the board in renewing the permits of nonresident pharmacies. A prerequisite for renewing a nonresident pharmacy is submission of a copy of a current inspection report from the state in which the pharmacy is located or from a duly authorized agency. Therefore, the renewal process for nonresident pharmacies is a labor-intensive, hands-on task. By tying the renewal to the date of initial registration rather than a set date on the calendar, the task can be spread throughout the year and handled more expeditiously by staff of the board. If there are any issues with the inspection report, staff will have more time to work with the nonresident pharmacies to resolve and meet the statutory requirements. Therefore, the change will facilitate renewals and avoid possible delays that could impact pharmacies that dispense prescriptions to patients in Virginia.

The purpose of the regulatory action in 18VAC110-20-190 is to protect the security of the drugs in the prescription department. If a pharmacist, pharmacy technician, or pharmacy intern has had his license or registration suspended or revoked, he represents a risk to the dispensing work of the prescription department. There is opportunity for diversion or adulteration that could threaten the health and safety of a community. Therefore, the amendment would prohibit the pharmacist-in-charge (PIC) or pharmacist on duty from permitting such a person to have access to the prescription department or controlled substances.

Rationale for Using Fast-Track Process: The amendments are very straightforward and proposed to address specific problems recently encountered by the board. The board does not expect the rulemaking to be controversial so it adopted the proposed changes by a fast-track rulemaking action.

Substance: An amendment to 18VAC110-20-20 on fees will change the renewal date for nonresident pharmacy from "no later than April 30" to no later than "the date of initial registration."

An amendment to 18VAC110-20-190 on prescription departments will add a rule that a PIC or pharmacist on duty shall not permit access to the prescription department or controlled substances by a pharmacist, pharmacy intern, or pharmacy technician whose license or registration is currently suspended or revoked.

Issues: The primary advantage to the public is facilitation of renewal of nonresident pharmacy permits to avoid disruptions in dispensing of prescriptions for patients in Virginia. There is an advantage to the public if persons whose license or registration has been suspended or revoked are prohibited from access to controlled substances and the prescription department to avoid a risk of diversion or adulteration of drugs. There are no disadvantages to the public.

The advantage to the agency is the ability to space out renewal of nonresident pharmacy permits, which are time-consuming and labor-intensive. There are no 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 (Board) proposes to: 1) change the annual permit renewal date for nonresident pharmacies from April 30th of each year to the date of the initial registration, and 2) clarify that pharmacists-in-charge and pharmacists on duty are prohibited from allowing access to the prescription department by a pharmacist, pharmacy intern, or pharmacy technician whose license or registration is currently suspended or revoked.

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

Estimated Economic Impact. A prerequisite for renewing a nonresident pharmacy permit is submission of a copy of a current inspection report from the state in which the pharmacy is located or from a duly authorized agency. Reviewing these out-of-state inspection reports is time consuming for Board staff. Under the current April 30th due date requirement, the Board labor for this task is concentrated around this one time a year. By tying the renewal to the anniversary date of initial registration rather than one date for all nonresident pharmacies, the task can be spread throughout the year and handled more expeditiously by Board staff. If there are any issues with the inspection report, staff will have more time to work with the nonresident pharmacies to resolve and meet the statutory requirements. Therefore, the change will facilitate renewals and avoid possible delays which could impact pharmacies that dispense prescriptions to patients in Virginia.

According to the Department of Health Professions, once this proposed amendment is promulgated, the next permit renewal due date will be the anniversary of initial registration after the next April 30th. This will benefit nonresident pharmacies by giving them a fraction of a second year for their one-year permit fee during this time of transition. For example, if a nonresident pharmacy permit currently is due to be renewed on April 30, 2015, but its date of initial registration was January 30th, the next renewal for that pharmacy would be January 30, 2016. The pharmacy would therefore have an additional nine months on its permit.

If we assume that the initial registration dates for the nonresident pharmacies are approximately randomly distributed throughout the year, then on average nonresident pharmacies will receive an extra six months of permit time without paying extra. The annual renewal fee for nonresident pharmacies is $270. So the value of six months extra time will be half of that, i.e. $135. So the proposed change of annual permit renewal date for nonresident pharmacies will on average produce a one-time benefit worth approximately $135 for each nonresident pharmacy.

In April of 2014, the Board revoked the license of a pharmacist who was found to be in violation of numerous laws and regulations. Subsequently he was continued to be allowed in the prescription department, which the Board believes created a potential danger to public health and safety. Specifying in these regulations that pharmacists, pharmacy interns, and pharmacy technicians whose license or registration has been suspended or revoked are prohibited from accessing the prescription department may reduce the likelihood that pharmacists-in-charge and pharmacists on duty allow such access.

Businesses and Entities Affected. The proposed amendments particularly affect the 505 nonresident pharmacies permitted to do business in the Commonwealth.¹

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

Projected Impact on Employment. The proposed amendments are unlikely to significantly affect employment.

Effects on the Use and Value of Private Property. The proposal to change the annual permit renewal date for nonresident pharmacies from April 30th of each year to the date of the initial registration will on average save each nonresident pharmacy $135.

Small Businesses: Costs and Other Effects. The proposal to change the annual permit renewal date for nonresident pharmacies from April 30th of each year to the date of the initial registration will on average save each small nonresident pharmacy $135.

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

Real Estate Development Costs. The proposed amendments are unlikely to affect real estate development costs.

Legal Mandate. General: 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 Code of Virginia and Executive Order Number 17 (2014). Section 2.2-4007.04 requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the report should include but not be limited to:

• the projected number of businesses or other entities to whom the proposed regulatory action would apply,

• he 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.

Small Businesses: If the proposed regulatory action will have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include:

• an identification and estimate of the number of small businesses subject to the proposed regulation,

• the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents,

• a statement of the probable effect of the proposed regulation on affected small businesses, and

• a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation.

Additionally, pursuant to § 2.2-4007.1, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules is notified at the time the proposed regulation is submitted to the Virginia Register of Regulations for publication. This analysis shall represent DPB's best estimate for the purposes of public review and comment on the proposed regulation.

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¹ Data 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 (i) prohibit a pharmacist-in-charge or a pharmacist on duty from allowing access to the prescription department or controlled substances by a pharmacist, pharmacy intern, or pharmacy technician whose license or registration is currently suspended or revoked and (ii) change the renewal schedule for a nonresident pharmacy permit to annually at the date of initial registration.

18VAC110-20-20. Fees.

A. Unless otherwise provided, fees listed in this section shall not be refundable.

B. Unless otherwise provided, any fees for taking required examinations shall be paid directly to the examination service as specified by the board.

C. Initial application fees.

1. Pharmacist license	$180
2. Pharmacy intern registration	$15
3. Pharmacy technician registration	$25
4. Pharmacy permit	$270
5. Permitted physician licensed to dispense drugs	$270
6. Medical equipment supplier permit	$180
7. Humane society permit	$20
8. Nonresident pharmacy	$270
9. Controlled substances registrations	$90
10. Innovative program approval. If the board determines that a technical consultant is required in order to make a decision on approval, any consultant fee, not to exceed the actual cost, shall also be paid by the applicant in addition to the application fee.	$250
11. Approval of a pharmacy technician training program	$150
12. Approval of a continuing education program	$100
13. Approval of a repackaging training program	$50

D. Annual renewal fees.

1. Pharmacist active license – due no later than December 31	$90
2. Pharmacist inactive license – due no later than December 31	$45
3. Pharmacy technician registration – due no later than December 31	$25
4. Pharmacy permit – due no later than April 30	$270
5. Physician permit to practice pharmacy – due no later than February 28	$270
6. Medical equipment supplier permit – due no later than February 28	$180
7. Humane society permit – due no later than February 28	$20
8. Nonresident pharmacy – due no later than April 30 the date of initial registration	$270
9. Controlled substances registrations – due no later than February 28	$90
10. Innovative program continued approval based on board order not to exceed $200 per approval period.
11. Approval of a pharmacy technician training program	$75 every two years
12. Approval of a repackaging training program	$30 every two years

E. Late fees. The following late fees shall be paid in addition to the current renewal fee to renew an expired license within one year of the expiration date or within two years in the case of a pharmacy technician training program. In addition, engaging in activities requiring a license, permit, or registration after the expiration date of such license, permit, or registration shall be grounds for disciplinary action by the board.

1. Pharmacist license	$30
2. Pharmacist inactive license	$15
3. Pharmacy technician registration	$10
4. Pharmacy permit	$90
5. Physician permit to practice pharmacy	$90
6. Medical equipment supplier permit	$60
7. Humane society permit	$5
8. Nonresident pharmacy	$90
9. Controlled substances registrations	$30
10. Approval of a pharmacy technician training program	$15
11. Approval of a repackaging training program	$10

F. Reinstatement fees. Any person or entity attempting to renew a license, permit, or registration more than one year after the expiration date, or more than two years after the expiration date in the case of a pharmacy technician training program, shall submit an application for reinstatement with any required fees. Reinstatement is at the discretion of the board and, except for reinstatement following license revocation or suspension, may be granted by the executive director of the board upon completion of an application and payment of any required fees.

1. Pharmacist license	$210
2. Pharmacist license after revocation or suspension	$500
3. Pharmacy technician registration	$35
4. Pharmacy technician registration after revocation or suspension	$125
5. Facilities or entities that cease operation and wish to resume shall not be eligible for reinstatement but shall apply for a new permit or registration. Facilities or entities that failed to renew and continued to operate for more than one renewal cycle shall pay the current and all back renewal fees for the years in which they were operating plus the following reinstatement fees:
a. Pharmacy permit	$240
b. Physician permit to practice pharmacy	$240
c. Medical equipment supplier permit	$210
d. Humane society permit	$30
e. Nonresident pharmacy	$115
f. Controlled substances registration	$180
g. Approval of a pharmacy technician training program	$75
h. Approval of a repackaging training program	$50

G. Application for change or inspection fees for facilities or other entities.

1. Change of pharmacist-in-charge	$50
2. Change of ownership for any facility	$50
3. Inspection for remodeling or change of location for any facility	$150
4. Reinspection of any facility	$150
5. Board-required inspection for a robotic pharmacy system	$150
6. Board-required inspection of an innovative program location	$150
7. Change of pharmacist responsible for an approved innovative program	$25

H. Miscellaneous fees.

1. Duplicate wall certificate	$25
2. Returned check	$35

18VAC110-20-190. Prescription department enclosures; access to prescription department.

A. The prescription department of each pharmacy shall be provided with enclosures subject to the following conditions:

1. The enclosure shall be constructed in such a manner that it protects the prescription drugs from unauthorized entry and from pilferage at all times whether or not a pharmacist is on duty.

2. The enclosure shall be locked and alarmed at all times when a pharmacist is not on duty.

3. The enclosure shall be capable of being locked in a secure manner at any time the pharmacist on duty is not present in the prescription department.

B. The keys or other means of entry into a locked prescription department and the alarm access code shall be restricted to pharmacists practicing at the pharmacy and authorized by the PIC with the following exceptions:

1. The PIC or a pharmacist on duty, for emergency access, may place a key or other means of unlocking the prescription department and the alarm access code in a sealed envelope or other container with the pharmacist's signature across the seal in a safe or vault or other secured place within the pharmacy. This means of emergency access shall only be used to allow entrance to the prescription department by other pharmacists, or by a pharmacy technician in accordance with subsection D of this section. In lieu of the pharmacist's signature across a seal, the executive director for the board may approve other methods of securing the emergency access to the prescription department.

2. Pharmacy interns, pharmacy technicians, and other persons authorized by the PIC or pharmacist on duty may possess a key or other means of entry into a locked prescription department only when a pharmacist is on duty. Such key or other means of entry shall not allow entry when a pharmacist is not on duty.

C. The prescription department is restricted to pharmacists who are practicing at the pharmacy. Pharmacy interns, pharmacy technicians, and other persons designated by the pharmacist on duty may be allowed access by the pharmacist but only when the pharmacist is on duty. Each pharmacist while on duty shall be responsible for the security of the pharmacy, including provisions for effective control against theft or diversion of prescription drugs and devices.

D. A PIC or pharmacist on duty shall not permit access to the prescription department or controlled substances by a pharmacist, pharmacy intern, or pharmacy technician whose license or registration is currently suspended or revoked.

D. E. Upon a request by a patient to obtain an already-dispensed prescription, a pharmacy technician may enter the pharmacy for the sole purpose of retrieving filled prescriptions that have already been reviewed and certified for accuracy by a pharmacist and deemed ready for delivery to the patient if:

1. There is an unforeseen, unplanned absence of a pharmacist scheduled to work during regular prescription department hours;

2. Alternate pharmacist coverage cannot immediately be obtained;

3. The technician is accompanied by a member of the pharmacy's management or administration; and

4. All requirements of subsection E F of this section are met.

E. F. Requirements for entry into the prescription department in the absence of a pharmacist.

1. The requirements for prescriptions awaiting delivery in subsection A of 18VAC110-20-200 are followed.

2. Prior to entry into the prescription department, the pharmacy technician shall obtain verbal permission from the PIC or another pharmacist regularly employed by that pharmacy to obtain and use the emergency key or other access and alarm access code and enter the pharmacy.

3. A record shall be made by the pharmacy technician of the entry to include the date and time of entry; the name and signature of the pharmacy technician; the name, title, and signature of the person accompanying the pharmacy technician; the pharmacist's name granting permission to enter and telephone number where the pharmacist was reached; the name of the patient initially requesting needed medication and the nature of the emergency; a listing of all prescriptions retrieved during that entry; and the time of exit and re-securing of the prescription department.

4. The pharmacy technician shall reseal the key and alarm access code after the pharmacy is re-secured, and the PIC shall have the alarm access code changed within 48 hours of such an entry and shall document that this has been accomplished on the record of entry.

5. All records related to entry by a pharmacy technician shall be maintained for a period of one year on premises.