18VAC110-50 Regulations Governing Wholesale Distributors, Manufacturers, and Warehousers

REGULATIONS

Vol. 25 Iss. 3 - October 13, 2008

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Chapter 50

Emergency Regulation

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

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

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

Effective Date: September 23, 2008, through September 22, 2009.

Agency Contact: Elizabeth Scott Russell, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone [phone], FAX [phone], or email [e-mail].

Preamble:

Chapter 330 of the 2008 Acts of the Assembly eliminated the specified date of December 31 for renewal of various permits and registrations under the Board of Pharmacy and added that a date must be determined by the board in regulation. The second enactment on Chapter 330 requires that the board promulgate regulations to implement the provisions of the act to be effective within 280 days of its enactment. Therefore, there is an "emergency situation" as defined in § 2.2-4011 of the Administrative Process Act.

All licenses, permits and registrations have expired on December 31 of each year, which has created an exceptional workload for staff during one period of time. The board sought legislation to allow expiration dates for permitted or registered facilities to be set on dates different from those of licensed pharmacists or registered technicians to distribute the renewals.

All facility permits or registrations that currently expire on December 31 will continue to be in effect until the next renewal date as set by the board in regulation. Resident and nonresident pharmacy permits will next expire on April 30, 2009, so they will get an extra four months on their permits. Manufacturers, wholesale distributors, warehousers, physicians permitted to practice pharmacy, medical equipment suppliers, humane societies, and controlled substance registrations will expire on February 28, 2009, so they will get an extra two months. The goal is to distribute the workload for board and department staff and to make it less burdensome for pharmacies, some of which pay the renewal for the pharmacy permit and all licensed or registered staff.

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 (Between November 2, 2005, and December 31, 2006, the application fee for a controlled substance registration shall be $50)	$90
	10. Robotic pharmacy system approval	$150
	11. 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
	12. Approval of a pharmacy technician training program	$150
	13. Approval of a continuing education program	$100

D. Annual renewal fees.

	1. Pharmacist active license – due December 31	$90
	2. Pharmacist inactive license – due December 31	$45
	3. Pharmacy technician registration – due December 31	$25
	4. Pharmacy permit – due April 30	$270
	5. Physician permit to practice pharmacy – due February 28	$270
	6. Medical equipment supplier permit – due February 28	$180
	7. Humane society permit – due February 28	$20
	8. Nonresident pharmacy – due April 30	$270
	9. Controlled substances registrations – due February 28	$90
	10. Innovative program continued approval based on board order not to exceed $200 per approval period.

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. 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

F. Reinstatement fees. Any person or 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.

	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. 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

I. For the annual renewal due on or before December 31, 2006, the following fees shall be imposed for a license, permit or registration:

	1. Pharmacist active license	$50
	2. Pharmacist inactive license	$25
	3. Pharmacy technician registration	$15
	4. Pharmacy permit	$210
	5. Physician permit to practice pharmacy	$210
	6. Medical equipment supplier permit	$140
	7. Humane society permit	$20
	8. Nonresident pharmacy	$210
	9. Controlled substances registrations	$50

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
	2. Restricted manufacturer permit	$180
	3. Wholesale distributor license	$270
	4. Warehouser permit	$270
	5. Nonresident wholesale distributor	$270
	6. Controlled substances registration	$90

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

	1. Nonrestricted manufacturer permit	$270
	2. Restricted manufacturer permit	$180
	3. Wholesale distributor license	$270
	4. Warehouser permit	$270
	5. Nonresident wholesale distributor	$270
	6. Controlled substances registration	$90

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
	2. Restricted manufacturer permit	$60
	3. Wholesale distributor license	$90
	4. Warehouser permit	$90
	5. Nonresident wholesale distributor	$90
	6. Controlled substances registration	$30

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
	b. Restricted manufacturer permit	$210
	c. Wholesale distributor license	$240
	d. Warehouser permit	$240
	e. Nonresident wholesale distributor	$240
	f. Controlled substances registration	$180

F. Application for change or inspection fees.

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

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

H. For the annual renewal due on or before December 31, 2006, the following fees shall be imposed for a license or permit:

	1. Nonrestricted manufacturer permit	$210
	2. Restricted manufacturer permit	$140
	3. Wholesale distributor license	$210
	4. Warehouser permit	$210
	5. Nonresident wholesale distributor	$210

VA.R. Doc. No. R09-1311; Filed September 23, 2008, 1:34 p.m.