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

REGULATIONS

Vol. 25 Iss. 20 - June 08, 2009

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Chapter 50

Proposed 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.

Public Hearing Information:

June 10, 2009 - 9 a.m. - Perimeter Center, 9960 Mayland Drive, 2nd Floor, Richmond, VA

Public Comments: Public comments may be submitted until August 7, 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].

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Pharmacy the authority to promulgate regulations to administer the regulatory system.

The legal authority to promulgate regulations to set the renewal date for permitted and registered facilities is found in Chapter 330 of the 2008 Acts of Assembly.

Purpose: 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. 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. 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.

A single expiration date means that the Board of Pharmacy staff annually renews all of its 20,000+ licenses at the same time. This creates a very unequal workload during this time of the year. Because of recent significant increases in numbers of licensees, the addition of registered pharmacy technicians, and increases in nonresident facility licenses, the board's ability to renew licenses in a timely manner is being challenged. Even though a number of persons use online licensure renewal, many facilities choose not to do so, and nonresident facilities are not able to do this because of the requirement to show proof of resident licensure and a pharmacist-in-charge who holds a Virginia license.

The action is necessary to protect the health and safety of the citizens because a staggered renewal system will assist staff in assuring that all requirements of renewal have been met.

Substance: Renewal dates for pharmacies and other types of licenses and permits, other than pharmacists and technicians, have been changed to February 28 or April 30.

Issues: There are no particular advantages or disadvantages to the public.

There is an advantage to the agency in greater distribution of the workload associated with renewals.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy (Board) proposes to amend its Regulations Governing the Practice of Pharmacy and its Regulations Governing Wholesale Distributers, Manufacturers and Warehousers so the licenses, permits and registrations issued under these regulations do not all expire on the same day each year. These amended regulations will replace emergency provisions that are set to expire September 22, 2009.

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

Estimated Economic Impact. Prior to the promulgation of emergency regulations (effective September 23, 2008), all Board licenses, permits and registrations expired on December 31 each year. The Department of Health Professions (DHP) reports that this not only led to an uneven workload for Board staff but was also burdensome for pharmacies that chose to pay for the renewal of the pharmacy’s permit and also for the renewal of licenses and registrations held by pharmacy staff.

These proposed regulations, and the emergency regulations that they replace, institute a staggered schedule for renewal. Under these regulations, pharmacist active license, pharmacist inactive license and pharmacist technician registration renewals are still due December 31 each year. Physician permit to practice pharmacy, medical equipment supplier permit, Humane Society permit and controlled substances registration renewals are due February 28 each year. Pharmacy permit and nonresident pharmacy permit renewals are due April 30 each year. All licenses, permits and registrations issued under 18 VAC 110-50 will need to be renewed February 28^th each year. Current facility permits and registrations that would have expired on the 31^st of December will be valid until the new expiration dates set out in these proposed regulations.

It is unlikely that any regulated entity will incur any costs on account of these proposed regulations. Both Board employees and regulated entities will likely benefit under these regulatory changes. Board employees will likely benefit from having their renewal workload more widely distributed. Pharmacies that choose to pay for renewal of employee licenses and registrations as well as paying for the renewal of their pharmacy permit will likely benefit from having these fees due over a span of several months rather than all at once. Permit and registration holders who would have had to renew on December 31, but will now have until the end of February or the end of April to do so, will receive a one time benefit as their permits/registrations will be good for 14 or 16 months rather than 12 months.

Businesses and Entities Affected. These proposed regulations will affect all pharmacies, non-resident pharmacies, drug manufacturers, drug wholesale distributors, drug warehousers, physicians who are permitted to practice pharmacy, medical equipment suppliers and holders of controlled substance registrations in the Commonwealth. DHP reports that the Board currently permits 1,663 pharmacies, 541 nonresident pharmacies, 96 manufacturers, 42 warehousers, 14 physicians who are permitted to practice pharmacy and 421 medical equipment suppliers. DHP also reports that there are 746 wholesale distributors currently licensed by the Board and that there are 673 controlled substance registrations held in the Commonwealth. DHP does not know the exact number of affected license, permit or registration holders that would qualify as small businesses but suspects it is a small number since most pharmacies are now owned by large national chains.

Localities Particularly Affected. No locality will be particularly affected by this proposed regulatory action.

Projected Impact on Employment. This regulatory action will likely have no impact on employment in the Commonwealth.

Effects on the Use and Value of Private Property. This regulatory action will likely have no effect on the use or value of private property in the Commonwealth.

Small Businesses: Costs and Other Effects. Small businesses in the Commonwealth are unlikely to incur any costs on account of this regulatory action.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Small businesses in the Commonwealth are unlikely to incur any costs on account of this regulatory action.

Real Estate Development Costs. This regulatory action will likely have no effect on real estate development costs in the Commonwealth.

Legal Mandate. 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 Administrative Process Act and Executive Order Number 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the 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. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB’s best estimate of these economic impacts.

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The Board of Pharmacy concurs with the analysis of the Department of Planning and Budget on proposed amended regulations for 18VAC110-20, Regulations Governing the Practice of Pharmacy, and 18VAC110-50, Regulations Governing Wholesale Distributors, Manufacturers and Warehousers relating to a change in renewal dates.

Summary:

The proposed amendments establish annual renewal dates for various licenses, permits, and registrations under the Board of Pharmacy. The amendments are currently in effect under emergency regulations that will expire September 22, 2009.

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

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 (18VAC110-20)

Application for Registration as a Pharmacy Intern (rev. 8/07).

Affidavit of Practical Experience, Pharmacy Intern (rev. 8/07).

Application for Licensure as a Pharmacist by Examination (rev. 8/07).

Instructions for Reinstating or Reactivating a Pharmacist License (rev. 11/07).

Application to Reinstate or Reactivate a Pharmacist License (rev. 11/07).

Application for Approval of a Continuing Education Program (rev. 8/07).

Application for Approval of ACPE Pharmacy School Course(s) for Continuing Education Credit (rev. 8/07) 4/09).

Application for License to Dispense Drugs (permitted physician) (rev. 8/07).

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

Application for a Nonresident Pharmacy Registration (rev. 7/08).

Application for a Permit as a Medical Equipment Supplier (rev. 8/07) 3/09).

Application for a Controlled Substances Registration Certificate (rev. 8/07).

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

Application for Registration as a Pharmacy Intern for Graduates of a Foreign College of Pharmacy (rev. 8/07).

Closing of a Pharmacy (rev. 8/07).

Application for Approval of a Robotic Pharmacy System (rev. 8/07).

Inspection Required for Approval of a Robotic Pharmacy System (rev. 8/07).

Application for Approval of an Innovative (Pilot) Program (rev. 8/07).

Pharmacy Technician Registration Instructions and Application (rev. 7/08) 3/09).

Instructions for Reinstating a Pharmacy Technician Registration (rev. 11/07).

Application to Reinstate a Pharmacy Technician Registration (rev. 11/07).

Application for Approval of a Pharmacy Technician Training Program (rev. 8/07).

Application for Registration for Volunteer Practice (rev. 8/07).

Sponsor Certification for Volunteer Registration (rev. 8/07).

Preceptor Verification Form (rev. 8/07).

Application for Reinstatement of Registration as a Pharmacy Intern (eff. 9/07).

Affidavit for Limited-Use Pharmacy Technician (rev. 8/07).

Limited-Use Pharmacy Technician Registration Instructions and Application (rev. 7/08).

Application for Registration as a Limited-Use Pharmacy Technician (eff. 7/08).

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

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 May 20, 2009, 11:13 a.m.