Titles of Regulations: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-20, 18VAC110-20-121).

18VAC110-21. Regulations Governing the Licensure of Pharmacists and Registration of Pharmacy Technicians (amending 18VAC110-21-20).

18VAC110-30. Regulations for Practitioners of the Healing Arts to Sell Controlled Substances (amending 18VAC110-30-15).

18VAC110-50. Regulations Governing Wholesale Distributors, Manufacturers, Third-Party Logistics Providers, and Warehousers (amending 18VAC110-50-20).

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

Effective Date: October 14, 2020.

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.

Summary:

The amendments increase Board of Pharmacy fees to cover expenses for essential functions of reviewing applications, licensing, inspecting, investigating complaints against licensees, and adjudicating and monitoring disciplinary cases. The amendments include a 30% increase in all fees, with the exception of those functions that require an inspection, including an initial pharmacy permit and changes in location or remodeling, which are set at the actual charge to the board by the enforcement division of the Department of Health Professions.

Summary of Public Comments and Agency's Response: No public comments were received by the promulgating agency.

18VAC110-20-20. Fees.

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

B. Initial application fees.

1. Pharmacy permit	$270 $500
2. Permitted physician licensed to dispense drugs	$270 $500
3. Medical equipment supplier permit	$180 $235
4. Outsourcing facility permit	$270 $350
5. Nonresident pharmacy registration	$270 $350
6. Nonresident outsourcing facility registration	$270 $350
7. Controlled substances registrations	$90 $120
8. Innovative program approval.	$250 $325
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.
9. Approval of a repackaging training program	$50 $65

C. Annual renewal fees.

1. Pharmacy permit – due no later than April 30	$270 $350
2. Physician permit to practice pharmacy – due no later than February 28	$270 $350
3. Medical equipment supplier permit – due no later than February 28	$180 $235
4. Outsourcing facility permit – due no later than April 30	$270 $350
5. Nonresident pharmacy registration – due no later than the date of initial registration	$270 $350
6. Nonresident outsourcing facility registration – due no later than the date of initial registration	$270 $350
7. Controlled substances registrations – due no later than February 28	$90 $120
8. Innovative program continued approval based on board order not to exceed $200 $260 per approval period.
9. Repackaging training program	$30 $40 every two years

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

1. Pharmacy permit	$90 $120
2. Physician permit to practice pharmacy	$90 $120
3. Medical equipment supplier permit	$60 $80
4. Outsourcing facility permit	$90 $120
5. Nonresident pharmacy registration	$90 $120
6. Nonresident outsourcing facility registration	$90 $120
7. Controlled substances registrations	$30 $40
8. Repackaging training program	$10 $15

E. Reinstatement fees.

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

2. 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 $315
	b. Physician permit to practice pharmacy	$240 $315
	c. Medical equipment supplier permit	$210 $275
	d. Outsourcing facility permit	$240 $315
	e. Nonresident pharmacy registration	$115 $150
	f. Nonresident outsourcing facility registration	$240 $315
	g. Controlled substances registration	$180 $235
	h. Repackaging training program	$50 $65

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

1. Change of pharmacist-in-charge	$50 $65
2. Change of ownership for any facility	$50 $65
3. Inspection for remodeling or change of location for any facility	$150 $300
4. Reinspection of any facility	$150 $300
5. Board-required inspection for a robotic pharmacy system	$150 $300
6. Board-required inspection of an innovative program location	$150 $300
7. Change of pharmacist responsible for an approved innovative program	$25 $35

G. Miscellaneous fees.

1. Returned check	$35
2. Duplicate permit or registration	$10 $15
3. Verification of permit or registration	$25 $35

18VAC110-20-121. Innovative program approval.

A. An informal conference committee of the board may approve an innovative or pilot program in accordance with § 54.1-3307.2 of the Code of Virginia upon receipt of an application and fee specified in 18VAC110-20-20.

B. If the informal conference committee determines that an inspection is necessary to adequately consider an application, it may require that the applicant pay a fee specified in 18VAC110-20-20 to cover the cost of the inspection.

C. If the informal conference committee determines that a technical consultant is necessary in order for the board to make an informed decision on approval of a program, the applicant shall pay a consultant fee, not to exceed the actual cost of the consultation.

D. In the initial order granting approval of a program, the informal conference committee shall set the approval period with a schedule for submission of required reports and outcome data. The frequency of required reports shall not exceed four times a year.

E. The informal conference committee shall determine the appropriate fee for continued approval of the program based on the requirements for review and monitoring. Such renewal fee shall not exceed $200 $260 per approval period.

18VAC110-21-20. 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 $235
2. Pharmacy intern registration	$15 $20
3. Pharmacy technician registration	$25 $35
4. Approval of a pharmacy technician training program	$150 $200
5. Approval of a continuing education program	$100 $130

D. Annual renewal fees.

1. Pharmacist active license – due no later than December 31	$90 $120
2. Pharmacist inactive license – due no later than December 31	$45 $60
3. Pharmacy technician registration – due no later than December 31	$25 $35
4. Pharmacy technician training program	$75 $100 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 or registration 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 or registration after the expiration date of such license or registration shall be grounds for disciplinary action by the board.

1. Pharmacist license	$30 $40
2. Pharmacist inactive license	$15 $20
3. Pharmacy technician registration	$10 $15
4. Pharmacy technician training program	$15 $20

F. Reinstatement fees. Any person or entity attempting to renew a license 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 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 $275
2. Pharmacist license after revocation or suspension	$500 $650
3. Pharmacy technician registration	$35 $45
4. Pharmacy technician registration after revocation or suspension	$125 $165
5. A pharmacy technician training program 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 a reinstatement fee of $75. A pharmacy technician training program that ceases operation and wishes to resume shall not be eligible for reinstatement but shall apply for a new registration.

G. Miscellaneous fees.

1. Duplicate wall certificate	$25 $50
2. Returned check	$35
3. Duplicate license or registration	$10 $15
4. Verification of licensure or registration	$25 $35

18VAC110-30-15. Fees.

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

B. Initial application fees.

1. License for practitioner of the healing arts to sell controlled substances: $180 $235.

2. Permit for facility in which practitioners of the healing arts sell controlled substances: $240 $315.

C. Annual renewal fees.

1. License for practitioner of the healing arts to sell controlled substances: $90 $120.

2. Permit for facility in which practitioners of the healing arts sell controlled substances: $240 $315.

D. 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.

1. License for practitioner of the healing arts to sell controlled substances: $30 $40.

2. Permit for facility in which practitioners of the healing arts sell controlled substances: $40 $50.

E. Reinstatement fees. Any person or entity attempting to renew a license or permit more than one year after the expiration date shall submit an application for reinstatement with any required fees.

1. License for practitioner of the healing arts to sell controlled substances: $150 $195.

2. Permit for facility in which practitioners of the healing arts sell controlled substances: $240 $315.

3. Application fee for reinstatement of a license or permit that has been revoked or suspended indefinitely: $500 $650.

F. Facilities in which only one practitioner of the healing arts is licensed by the board to sell controlled substances shall be exempt from fees associated with obtaining and renewing a facility permit. Facilities that change from only one practitioner to more than one shall notify the board within 30 days of such change.

G. The fee for reinspection of any facility shall be $150 300.

H. The fee for a returned check shall be $35.

18VAC110-50-20. Fees.

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

B. Initial application fees.

1. Nonrestricted manufacturer permit	$270 $350
2. Restricted manufacturer permit	$180 $235
3. Wholesale distributor license	$270 $350
4. Warehouser permit	$270 $350
5. Nonresident wholesale distributor registration	$270 $350
6. Controlled substances registration	$90 $120
7. Third-party logistics provider permit	$270 $350
8. Nonresident manufacturer registration	$270 $350
9. Nonresident warehouser registration	$270 $350
10. Nonresident third-party logistics provider registration	$270 $350

C. Annual renewal fees shall be due on February 28 of each year.

1. Nonrestricted manufacturer permit	$270 $350
2. Restricted manufacturer permit	$180 $235
3. Wholesale distributor license	$270 $350
4. Warehouser permit	$270 $350
5. Nonresident wholesale distributor registration	$270 $350
6. Controlled substances registration	$90 $120
7. Third-party logistics provider permit	$270 $350
8. Nonresident manufacturer registration	$270 $350
9. Nonresident warehouser registration	$270 $350
10. Nonresident third-party logistics provider registration	$270 $350

D. 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. 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. Nonrestricted manufacturer permit	$90 $120
2. Restricted manufacturer permit	$60 $80
3. Wholesale distributor license	$90 $120
4. Warehouser permit	$90 $120
5. Nonresident wholesale distributor registration	$90 $120
6. Controlled substances registration	$30 $40
7. Third-party logistics provider permit	$90 $120
8. Nonresident manufacturer registration	$90 $120
9. Nonresident warehouser registration	$90 $120
10. Nonresident third-party logistics provider registration	$90 $120

E. Reinstatement fees.

1. Any entity attempting to renew a license, permit, or registration more than one year after the expiration date 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.

2. 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. 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.

3. 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. Nonrestricted manufacturer permit	$240 $315
b. Restricted manufacturer permit	$210 $275
c. Wholesale distributor license	$240 $315
d. Warehouser permit	$240 $315
e. Nonresident wholesale distributor registration	$240 $315
f. Controlled substances registration	$180 $235
g. Third-party logistics provider permit	$240 $315
h. Nonresident manufacturer registration	$240 $315
i. Nonresident warehouser registration	$240 $315
j. Nonresident third-party logistics provider registration	$240 $315

F. Application for change or inspection fees.

1. Reinspection fee	$150 $300
2. Inspection fee for change of location, structural changes, or security system changes	$150 $300
3. Change of ownership fee	$50 $65
4. Change of responsible party	$50 $65

G. The fee for a returned check shall be $35.

H. The fee for verification of license, permit, or registration shall be $25 $35.