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

REGULATIONS

Vol. 26 Iss. 6 - November 23, 2009

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Chapter 50

Final 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: December 23, 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].

Summary:

The amendments change the annual renewal dates for pharmacies and other types of licenses and permits other than pharmacists and technicians to February 28 or April 30.

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. 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

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.
	11. Approval of a pharmacy technician training program	$75 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

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

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 the stated dates, the following fees shall be imposed for a license, permit or registration:

	1. Pharmacist active license – December 31, 2009	$50
	2. Pharmacist inactive license – December 31, 2009	$25
	3. Pharmacy technician registration – December 31, 2009	$15
	4. Pharmacy permit – April 30, 2010	$210
	5. Physician permit to practice pharmacy – February 28, 2010	$210
	6. Medical equipment supplier permit – February 28, 2010	$140
	7. Humane society permit – February 28, 2010	$20
	8. Nonresident pharmacy – April 30, 2010	$210
	9. Controlled substances registrations – February 28, 2010	$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 February 28, 2010, 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

NOTICE: The forms used in administering the above regulation are not being published; however, the name of each form is listed below. The forms are available for public inspection by contacting the agency contact for this regulation, or at the office of the Registrar of Regulations, General Assembly Building, 2nd Floor, Richmond, Virginia.

FORMS (18VAC110-50)

Application for a Permit as a Restricted Manufacturer (rev. 8/07) 3/09).

Application for a Permit as a Nonrestricted Manufacturer (rev. 8/07) 3/09).

Application for a Permit as a Warehouser (rev. 8/07) 3/09).

Application for a License as a Wholesale Distributor (rev. 8/07) 3/09).

Application for a Nonresident Wholesale Distributor Registration (rev. 8/07) 9/08).

Application for a License as a Wholesale Distributor -- Limited Use for Distribution of Medical Gases Only (rev. 8/07) 3/09).

VA.R. Doc. No. R09-1311; Filed November 4, 2009, 2:40 p.m.