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

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).

18VAC110-60. Regulations Governing Pharmaceutical Processors (amending 18VAC110-60-20).

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

Public Hearing Information: No public hearings are currently scheduled.

Public Comment Deadline: March 3, 2021.

Effective Date: March 18, 2021.

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.

Basis: Regulations are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which provides the Board of Counseling the authority to promulgate regulations to administer the regulatory system. The specific mandate for collection of a handling fee is found in the Virginia Debt Collection Act, § 2.2-4805 et seq. of the Code of Virginia.

Purpose: The amendments conform the regulation to the Virginia Debt Collection Act (§ 2.2-4800 et seq.) of the Code of Virginia in which the General Assembly has determined that the cost for handling returned checks or dishonored credit or debit cards is $50. The department and its regulatory boards license and discipline health care practitioners with the mission of protecting the health and safety of the public, which must be supported by its licensing and miscellaneous fees.

Rationale for Using the Fast-Track Rulemaking Process: The Office of the Comptroller has advised the department that the costs for handling a returned check or dishonored credit card or debit card payment is $50, as set forth in § 2.2-4805 of the Code of Virginia. Therefore, all board regulations are being amended to delete the returned check fee of $35 and replace it with a handling fee of $50. The Office of the Attorney General concurs with amending regulations accordingly but advised that it is not an exempt action. The rulemaking is concurring with financial policy of the Commonwealth and is not expected to be controversial.

Substance: All board regulations are being amended to delete the returned check fee of $35 and replace it with a handling fee of $50 for a returned check or dishonored credit card or dishonored debit card.

Issues: There are no primary advantages or disadvantages to the public. The primary advantage to the department is compliance with auditors from the Office of the Comptroller.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy (Board) proposes to amend five of its regulations to state that the handling fee for a returned check or dishonored credit card or debit card is $50.

Background. Code of Virginia § 2.2-614.1 specifies that:

If any check or other means of payment tendered to a public body in the course of its duties is not paid by the financial institution on which it is drawn, because of insufficient funds in the account of the drawer, no account is in the name of the drawer, or the account of the drawer is closed, and the check or other means of payment is returned to the public body unpaid, the amount thereof shall be charged to the person on whose account it was received, and his liability and that of his sureties, shall be as if he had never offered any such payment. A penalty of $35 or the amount of any costs, whichever is greater, shall be added to such amount.

With the exception of 18 VAC 110-60 Regulations Governing Pharmaceutical Processors, the Board’s current regulations that include fees include a $35 returned check charge.

On the other hand, Code of Virginia § 2.2-4805 specifies that "Returned checks or dishonored credit card or debit card payments shall incur a handling fee of $50 unless a higher amount is authorized by statute to be added to the principal account balance." According to the Department of Health Professions (DHP), the Office of the Attorney General has advised that the handling fee of $50 in Virginia Code 2.2-4805 governs.

Estimated Benefits and Costs. Based on the view of the Office of the Attorney General that Virginia Code 2.2-4805 prevails, the fee by law for a returned check or dishonored credit card or debit card is $50. The Board’s proposal therefore conforms the regulations to current law. DHP has indicated that in practice they will not raise the fee to $50 until this proposed regulatory action becomes effective. The services provided by DHP are funded by the fees paid by the regulated individuals and entities. To the extent that the $50 fee more accurately represents the cost incurred by DHP, the proposed change may be beneficial in that the cost would need not be subsidized by other regulants who did not cause the cost to be incurred.

Businesses and Other Entities Affected. The proposal pertains to fee-paying individuals and entities regulated by the Board. As of March 31, 2020, there were 1,373 businesses with controlled substance registrations,¹ 9 continuing education programs, 220 medical equipment suppliers, 186 non-resident manufacturers, 325 non-resident medical equipment suppliers, 28 non-resident outsourcing facilities, 796 non-resident pharmacies, 611 non-resident wholesale distributors, 31 non-resident manufacturers, 129 non-resident third-party logistics providers, 33 non-resident warehousers, 15,360 pharmacists, 1 pharmaceutical processor, 1,787 pharmacies, 1,577 pharmacy interns, 12,819 pharmacy technicians, 135 pharmacy technician training programs, 607 physicians licensed to dispense drugs to their own patients, 166 facilities where physicians are licensed to dispense drugs to their own patients, 22 pilot/innovative programs,² 340 registered physicians for CBD/THC-A oil, 2 repackaging training programs, 44 restricted manufacturers, 6 third-party logistic providers, 109 warehousers, and 64 wholesale distributors regulated by and required to pay fees to the Board.³ If any of these individuals or entities (other than pharmaceutical processors and registered physicians for CBD/THC-A oil) have a check returned or a credit card or debit card dishonored, the proposal would increase their cost by $15. It is not known whether pharmaceutical processors and registered physicians for CBD/THC-A oil would be charged a $35 returned check fee if they had a check returned prior to the proposed regulatory action becoming effective.⁴ If they would not receive the charge, the proposal would increase their costs by $50 in the event that they have a check returned or a credit card or debit card dishonored. Since adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits of the proposal exceed the costs for all entities combined, adverse impact is indicated for this action.

Small Businesses Affected. Types and Estimated Number of Small Businesses Affected. The proposal would potentially affect the 1,373 businesses with controlled substance registrations, 9 continuing education programs, 220 medical equipment suppliers, 186 non-resident manufacturers, 325 non-resident medical equipment suppliers, 28 non-resident outsourcing facilities, 796 non-resident pharmacies, 611 nonresident wholesale distributors, 31 non-resident manufacturers, 129 non-resident thirdparty logistics providers, 33 non-resident warehousers, 1 pharmaceutical processor, 1,787 pharmacies, 135 pharmacy technician training programs, 166 facilities where physicians are licensed to dispense drugs to their own patients, 22 pilot/innovative programs, 2 repackaging training programs, 44 restricted manufacturers, 6 third-party logistic providers, 109 warehousers, and 64 wholesale distributors. Data is not available to determine how many of these entities would qualify as a small business, though many likely would.⁵

Costs and Other Effects. If any of the small entities, other than a small pharmaceutical processor, has a check returned or a credit card or debit card dishonored, the proposal would increase their cost by $15. Since the current Regulations Governing Pharmaceutical Processors does not include a $35 returned check charge, it is not clear whether a small pharmaceutical processor would be charged a $35 returned check fee if they had a check returned prior to the proposed regulatory action becoming effective. If they would not receive the charge, the proposal would increase their costs by $50 in the event that they have a check returned or a credit card or debit card dishonored.

Alternative Method that Minimizes Adverse Impact. There are no clear alternative methods that both reduce adverse impact and meet the intended policy goals

Localities⁶ Affected.⁷ The proposal does not disproportionately affect any particular localities or introduce costs for local governments.

Projected Impact on Employment. The proposal does not affect employment.

Effects on the Use and Value of Private Property. The proposal does not substantially affect the use and value of private property or real estate development costs.

______________________________________

¹18 VAC 110-20-690: "Persons or entities that may be [controlled substance] registered by the board shall include hospitals without in-house pharmacies, nursing homes without in-house pharmacies that use automated drug dispensing systems, ambulatory surgery centers, outpatient clinics, alternate delivery sites, crisis stabilization units, persons authorized by the Department of Behavioral Health and Developmental Services to train individuals on the administration of naloxone and to dispense naloxone for opioid overdose reversal, and emergency medical services agencies provided such persons or entities are otherwise authorized by law and hold required licenses or appropriate credentials to administer the drugs for which the registration is being sought."

²Code of Virginia § 54.1-3307.2: "Any person who proposes to use a process or procedure related to the dispensing of drugs or devices or to the practice of pharmacy not specifically authorized by Chapter 33 (§ 54.1-3300 et seq.) of this title or by a regulation of the Board of Pharmacy may apply to the Board for approval to use such process or procedure. The application under this section may only include new processes or procedures, within the current scope of the practice of pharmacy, that relate to the form or format of prescriptions, the manner of transmitting prescriptions or prescription information, the manner of required recordkeeping, the use of unlicensed ancillary personnel in the dispensing process, and the use of new technologies in the dispensing process."

³Sources: https://www.dhp.virginia.gov/about/stats/2020Q3/04CurrentLicenseCountQ3FY2020.pdf, the current Board regulations, and DHP

⁴The fees for pharmaceutical processors and registered physicians for CBD/THC-A oil are in 18 VAC 110-60 Regulations Governing Pharmaceutical Processors, which currently does not specify a returned check charge.

⁵Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

⁶"Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

⁷§ 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis of the Department of Planning and Budget.

Summary:

The amendments delete the returned check fee of $35 and replace it with a handling fee of $50 to conform the regulations to the Virginia Debt Collection Act (§ 2.2-4800 et seq.) of the Code of Virginia.

18VAC110-20-20. Fees.

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

B. Initial application fees.

1. Pharmacy permit	$500
2. Permitted physician licensed to dispense drugs	$500
3. Medical equipment supplier permit	$235
4. Outsourcing facility permit	$350
5. Nonresident pharmacy registration	$350
6. Nonresident outsourcing facility registration	$350
7. Controlled substances registrations	$120
8. Innovative program approval.	$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	$65

C. Annual renewal fees.

1. Pharmacy permit – due no later than April 30	$350
2. Physician permit to practice pharmacy – due no later than February 28	$350
3. Medical equipment supplier permit – due no later than February 28	$235
4. Outsourcing facility permit – due no later than April 30	$350
5. Nonresident pharmacy registration – due no later than the date of initial registration	$350
6. Nonresident outsourcing facility registration – due no later than the date of initial registration	$350
7. Controlled substances registrations – due no later than February 28	$120
8. Innovative program continued approval based on board order not to exceed $260 per approval period.
9. Repackaging training program	$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	$120
2. Physician permit to practice pharmacy	$120
3. Medical equipment supplier permit	$80
4. Outsourcing facility permit	$120
5. Nonresident pharmacy registration	$120
6. Nonresident outsourcing facility registration	$120
7. Controlled substances registrations	$40
8. Repackaging training program	$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	$315
	b. Physician permit to practice pharmacy	$315
	c. Medical equipment supplier permit	$275
	d. Outsourcing facility permit	$315
	e. Nonresident pharmacy registration	$150
	f. Nonresident outsourcing facility registration	$315
	g. Controlled substances registration	$235
	h. Repackaging training program	$65

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

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

G. Miscellaneous fees.

1. Returned check Handling fee for returned check or a dishonored credit card or debit card	$35 $50
2. Duplicate permit or registration	$15
3. Verification of permit or registration	$35

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	$235
2. Pharmacy intern registration	$20
3. Pharmacy technician registration	$35
4. Approval of a pharmacy technician training program	$200
5. Approval of a continuing education program	$130

D. Annual renewal fees.

1. Pharmacist active license – due no later than December 31	$120
2. Pharmacist inactive license – due no later than December 31	$60
3. Pharmacy technician registration – due no later than December 31	$35
4. Pharmacy technician training program	$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	$40
2. Pharmacist inactive license	$20
3. Pharmacy technician registration	$15
4. Pharmacy technician training program	$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	$275
2. Pharmacist license after revocation or suspension	$650
3. Pharmacy technician registration	$45
4. Pharmacy technician registration after revocation or suspension	$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	$50
2. Returned check Handling fee for returned check or a dishonored credit card or debit card	$35 $50
3. Duplicate license or registration	$15
4. Verification of licensure or registration	$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: $235.

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

C. Annual renewal fees.

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

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

2. Permit for facility in which practitioners of the healing arts sell controlled substances: $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: $195.

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

3. Application fee for reinstatement of a license or permit that has been revoked or suspended indefinitely: $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 300.

H. The fee for a returned check handling fee for returned check or a dishonored credit card or debit card shall be $35 $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	$350
2. Restricted manufacturer permit	$235
3. Wholesale distributor license	$350
4. Warehouser permit	$350
5. Nonresident wholesale distributor registration	$350
6. Controlled substances registration	$120
7. Third-party logistics provider permit	$350
8. Nonresident manufacturer registration	$350
9. Nonresident warehouser registration	$350
10. Nonresident third-party logistics provider registration	$350

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

1. Nonrestricted manufacturer permit	$350
2. Restricted manufacturer permit	$235
3. Wholesale distributor license	$350
4. Warehouser permit	$350
5. Nonresident wholesale distributor registration	$350
6. Controlled substances registration	$120
7. Third-party logistics provider permit	$350
8. Nonresident manufacturer registration	$350
9. Nonresident warehouser registration	$350
10. Nonresident third-party logistics provider registration	$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	$120
2. Restricted manufacturer permit	$80
3. Wholesale distributor license	$120
4. Warehouser permit	$120
5. Nonresident wholesale distributor registration	$120
6. Controlled substances registration	$40
7. Third-party logistics provider permit	$120
8. Nonresident manufacturer registration	$120
9. Nonresident warehouser registration	$120
10. Nonresident third-party logistics provider registration	$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	$315
b. Restricted manufacturer permit	$275
c. Wholesale distributor license	$315
d. Warehouser permit	$315
e. Nonresident wholesale distributor registration	$315
f. Controlled substances registration	$235
g. Third-party logistics provider permit	$315
h. Nonresident manufacturer registration	$315
i. Nonresident warehouser registration	$315
j. Nonresident third-party logistics provider registration	$315

F. Application for change or inspection fees.

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

G. The handling fee for a returned check or a dishonored credit card or debit card shall be $35 $50.

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

18VAC110-60-20. Fees.

A. Fees are required by the board as specified in this section. Unless otherwise provided, fees listed in this section shall not be refundable.

B. Registration of practitioner.

1. Initial registration.	$50
2. Annual renewal of registration.	$50
3. Replacement of registration for a qualifying practitioner whose information has changed or whose original registration certificate has been lost, stolen, or destroyed.	$50

C. Registration by a qualifying patient, parent, or legal guardian.

1. Initial registration of a patient.	$50
2. Annual renewal of registration of a patient. 3. Initial registration of a parent or legal guardian. 4. Annual renewal of registration of a parent or guardian.	$50 $25 $25
5. Replacement of registration for a qualifying patient, parent, or legal guardian whose original registration certificate has been lost, stolen, or destroyed.	$25

D. Pharmaceutical processor permit.

1. Application.	$10,000
2. Initial permit.	$60,000
3. Annual renewal of permit.	$10,000
4. Change of name of processor.	$100
5. Change of PIC or any other information provided on the permit application.	$100
6. Change of ownership not requiring a criminal background check.	$100
7. Change of ownership requiring a criminal background check.	$250
8. Any acquisition, expansion, remodel, or change of location requiring an inspection.	$1,000
9. Reinspection fee. 10. Registration of each cannabis oil product.	$1,000 $25

E. The handling fee for returned check or dishonored credit card or debit card shall be $50.