Title of Regulation: 18VAC110-30. Regulations for Practitioners of the Healing Arts to Sell Controlled Substances (amending 18VAC110-30-10, 18VAC110-30-20, 18VAC110-30-21, 18VAC110-30-40, 18VAC110-30-270).

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

Public Hearing Information:

September 24, 2021 - noon - Department of Health Professions, Conference Center, 2nd Floor, 9960 Mayland Drive, Henrico, VA 23233

Public Comment Deadline: October 15, 2021.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 527-4456, 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 Pharmacy the authority to promulgate regulations to administer the regulatory system. The specific statutory provisions for regulations governing issuance of a limited-use license for a practitioner at a nonprofit facility are found in §§ 54.1-3304.1 and 54.1-3467 of the Code of Virginia.

Purpose: The purpose of the regulation is to expand access to certain Schedule VI drugs and hypodermic needles and syringes for the administration of these drugs to underserved persons who seek services from nonprofit clinics. Limited licenses will only be issued for dispensing of Schedule VI drugs, so no drugs scheduled by the Drug Enforcement Administration can be dispensed. There is accountability to the Board of Pharmacy for the facility permit and to the Boards of Medicine and Nursing for the limited license issued to the practitioner. Therefore, there are sufficient protections for the health and safety of the drugs and the citizens of the Commonwealth.

Substance: Amendments to 18VAC110-30 will (i) amend the term practitioner to include nurse practitioners or physician assistants for the purpose of issuance of a limited-use license; and (ii) include the allowance for issuance of a limited-use permit for nonprofit facilities for the sale of Schedule VI drugs, excluding the combination of misoprostol and methotrexate, and hypodermic needles and syringes used in administration of such drugs. The allowance set out in § 54.1-3304.1 excludes the sale of a combination of misoprostol and methotrexate, so that is also excluded in regulation.

Issues: The advantage to the public will be the expansion of access to and availability of certain prescription drugs and hypodermic needles and syringes for administration of these drugs at nonprofit clinics. Some of those clinics are run by nurse practitioners or physician assistants who are otherwise not eligible for a practitioner of the healing arts to sell controlled substances license. There are no disadvantages to the public. There are no advantages or disadvantages to this agency or the Commonwealth.

Department of Planning and Budget Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapters 609 and 610 of the 2020 Acts of Assembly (legislation), an emergency regulation became effective on January 4, 2021, that: 1) amended the term "practitioner" to include nurse practitioners or physician assistants for the purpose of issuing a limited-use license, and 2) added a limited-use license for practitioners to sell Schedule VI controlled substances (excluding the combination of misoprostol and methotrexate), and hypodermic syringes and needles for the administration of prescribed controlled substances from a nonprofit facility, and 3) specify that a limited-use facility permit may be issued to a nonprofit facility for the purpose of dispensing the same.

The emergency regulation will expire on July 3, 2022. Also pursuant to the legislation, the Board proposes to replace the emergency regulation with an identical permanent regulation.

Background. Practitioner of the Healing Arts: "Practitioner" or "practitioner of the healing arts" is currently defined as "a doctor of medicine, osteopathic medicine or podiatry who possesses a current active license issued by the Board of Medicine." The Board proposes to add the following sentence to the definition: "For the purpose of a limited-use permit for a nonprofit facility, a "practitioner" or "practitioner of the healing arts" may also mean a physician assistant with a current active license issued by the Board of Medicine or a nurse practitioner with a current active license issued by the Joint Boards of Nursing and Medicine."

Licenses: Both the current (pre-emergency) regulation and the proposed regulation require that prior to engaging in the sale of controlled substances, practitioners must be issued a license for this purpose by the board. The board proposes to add the following statement:

Prior to engaging in the sale of Schedule VI controlled substances, excluding the combination of misoprostol and methotrexate, and hypodermic syringes and needles for the administration of prescribed controlled substances from a nonprofit facility, a doctor of medicine, osteopathic medicine or podiatry, a nurse practitioner, or a physician assistant shall make application on a form provided by the board and be issued a limited-use license.

The statement is essentially straight from the legislation

Permits: The current (pre-emergency) regulation and the proposed regulation both require that any location at which practitioners of the healing arts are to sell controlled substances must first obtain a permit issued by the Board. Both the current and proposed regulations also state the following concerning limited-use permits:

B. For good cause shown, the board may issue a limited-use facility permit when the scope, degree, or type of services provided to the patient is of a limited nature. The permit to be issued shall be based on conditions of use requested by the applicant or imposed by the board in cases where certain requirements of this chapter may be waived.

1. The limited-use facility permit application shall list the regulatory requirements for which a waiver is requested, if any, and a brief explanation as to why each requirement should not apply to that practice.

2. A policy and procedure manual detailing the type and volume of controlled substances to be sold and safeguards against diversion shall accompany the application.

3. The issuance and continuation of a limited-use facility permit shall be subject to continuing compliance with the conditions set forth by the board.

The Board proposes to add:

4. A limited-use facility permit may be issued to a nonprofit facility for the purpose of dispensing Schedule VI controlled substances, excluding the combination of misoprostol and methotrexate, and hypodermic syringes and needles for the administration of prescribed controlled substances.

Thus, under the current (pre-emergency) regulation, facilities may already obtain a limited-use permit when the practitioner is a doctor of medicine, osteopathic medicine or podiatry. Combining the proposed new sentence for the definition of "practitioner" or "practitioner of the healing arts" with the proposed added text on permits, subdivision B 4, limited-use permits could also be issued for the specific purpose described in subdivision B 4 when the practitioner is a physician assistant or a nurse practitioner.

Schedule VI Controlled Substances: The U.S. Drug Enforcement Administration (DEA) classifies drugs, substances, and certain chemicals used to make drugs into five categories based on their abuse potential.¹ States generally follow the DEA classifications with some exceptions.² Virginia adds a sixth category known as "Schedule VI" for controlled substances with the lowest abuse potential. Schedule VI includes:³

Any compound, mixture, or preparation containing any stimulant or depressant drug that is exempt from the first five categories.

Any potentially toxic drug not included in the first five categories that has not yet been determined safe except under supervision of a licensed practitioner.

Any drug not included in the first five categories that is otherwise restricted by federal law

Examples of Schedule VI controlled substances include blood pressure and cholesterol lowering agents, antibiotics, birth control, diabetes medications, etc.⁴

Estimated Benefits and Costs. The primary impacts of the legislation and the proposal are that: 1) physician assistants and nurse practitioners may be issued a limited-use license to sell Schedule VI controlled substances, excluding the combination of misoprostol and methotrexate, and hypodermic syringes and needles for the administration of prescribed controlled substances from a nonprofit facility, and 2) nonprofit facilities may be issued a limited-use facility permit where physician assistants and nurse practitioners may make such sales. Under the current (pre-emergency) regulation, physician assistants and nurse practitioners cannot sell controlled substances.

Some nonprofit clinics are run by nurse practitioners or physician assistants. The proposal would newly allow Schedule VI controlled substances, excluding the combination of misoprostol and methotrexate, and hypodermic syringes and needles for the administration of prescribed controlled substances to be sold at such clinics. Free clinics are among nonprofit clinics that could be affected; thus the proposal could potentially increase access to needed medication for their clients.

Through the first five months of the emergency regulation being in effect, the Department of Health Professions has not received any applications for either the limited-use license from nurse practitioners or physician assistants or the limited-use facility permit issued to a nonprofit facility for the purpose of dispensing Schedule VI controlled substances. Based on this evidence, it does not appear that the legislation and the proposal will have a large impact.

Businesses and Other Entities Affected. The proposal would potentially affect nurse practitioners and physician assistants who provide care in nonprofit health clinics who wish to dispense Schedule VI controlled substances and hypodermic syringes and needles for the administration of prescribed controlled substances. The proposal would also potentially affect such nonprofit clinics. To the extent that nurse practitioners and physician assistants obtain the limited-use license and do dispense in nonprofit health clinics, some poor citizens of the Commonwealth may get increased access to needed medications. Since through the first five months of the emergency regulation being in effect no nurse practitioners or physician assistants have applied for the limited-use license, and no nonprofit facilities have applied for the associated limited-use permit, it does not appear that many entities will be affected in practice.

The proposal does not produce any costs.

Small Businesses⁵ Affected. The proposed amendments do not appear to adversely affect small businesses.

Localities⁶ Affected.⁷ The proposed amendments apply throughout the Commonwealth, but may particularly affect poorer localities since free clinics are expected to be among the entities most affected. The proposed amendments do not introduce costs for local governments.
Projected Impact on Employment. The proposed amendments do not appear to affect total employment.

Effects on the Use and Value of Private Property. The proposal is unlikely to substantively affect the use and value of private property. The proposed amendments do not affect real estate development costs.

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¹See https://www.dea.gov/drug-information/drug-scheduling

²For example, Gabapentin was classified as Schedule VI in Virginia until July 1, 2019, when the Virginia General Assembly reassigned it to Schedule V
although it is not currently on the DEA Schedule. See
https://www.deadiversion.usdoj.gov/drug_chem_info/gabapentin.pdf
https://www.dhp.virginia.gov/pharmacy/docs/Gabapentin06172019.pdf
https://www.carlislemedical.com/2019/06/gabapentin-to-become-acontrolled-substance-in-virginia/
https://lis.virginia.gov/cgi-bin/legp604.exe?191+ful+CHAP0214+hil

³See https://law.lis.virginia.gov/vacode/title54.1/chapter34/section54.1-3455/

⁴Source: Department of Health Professions

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:

Pursuant to Chapters 609 and 610 of the 2020 Acts of Assembly, the proposed amendments (i) define the term "practitioner" to include nurse practitioners or physician assistants for the purpose of issuance of a limited-use license and (ii) include the allowance for issuance of a limited-use permit for nonprofit facilities for the sale of Schedule VI drugs and devices used in administration of such drugs.

18VAC110-30-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise.

"Board" means the Virginia Board of Pharmacy.

"Controlled substance" means a drug, substance or immediate precursor in Schedules I through VI of the Drug Control Act.

"Licensee" means a practitioner who is licensed by the Board of Pharmacy to sell controlled substances.

"Personal supervision" means the licensee must be physically present and render direct, personal control over the entire service being rendered or acts being performed. Neither prior nor future instructions shall be sufficient nor shall supervision be rendered by telephone, written instructions, or by any mechanical or electronic methods.

"Practitioner" or "practitioner of the healing arts" means a doctor of medicine, osteopathic medicine or podiatry who possesses a current active license issued by the Board of Medicine. For the purpose of a limited-use permit for a nonprofit facility, a "practitioner" or "practitioner of the healing arts" may also mean a physician assistant with a current active license issued by the Board of Medicine or a nurse practitioner with a current active license issued by the Joint Boards of Nursing and Medicine.

"Sale" means barter, exchange, or gift, or offer thereof, and each such transaction made by any person, whether as an individual, proprietor, agent, servant or employee. It does not include the gift of manufacturer's samples to a patient.

"Special packaging" means packaging that is designed or constructed to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the controlled substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time.

"U.S.P.-N.F." means the United States Pharmacopeia-National Formulary.

18VAC110-30-20. Application for licensure.

A. Prior to engaging in the sale of controlled substances, a practitioner shall make application on a form provided by the board and be issued a license. After June 7, 2016, the practitioner shall engage in such sale from a location that has been issued a facility permit.

B. In order to be eligible for a license to sell controlled substances, a practitioner shall possess a current, active license to practice medicine, osteopathic medicine, or podiatry issued by the Virginia Board of Medicine. Any disciplinary action taken by the Board of Medicine against the practitioner's license to practice shall constitute grounds for the board to deny, restrict, or place terms on the license to sell. Prior to engaging in the sale of Schedule VI controlled substances, excluding the combination of misoprostol and methotrexate, and hypodermic syringes and needles for the administration of prescribed controlled substances from a nonprofit facility, a doctor of medicine, osteopathic medicine, or podiatry, a nurse practitioner, or a physician assistant shall make application on a form provided by the board and be issued a limited-use license.

C. Any disciplinary action taken by the Board of Medicine, or in the case of a nurse practitioner, by the Joint Boards of Nursing and Medicine, against the practitioner's license to practice shall constitute grounds for the board to deny, restrict, or place terms on the license to sell.

18VAC110-30-21. Application for facility permit.

A. After June 7, 2016, any location at which practitioners of the healing arts sell controlled substances shall have a permit issued by the board in accordance with § 54.1-3304.1 of the Code of Virginia. A licensed practitioner of the healing arts shall apply for the facility permit on a form provided by the board.

B. For good cause shown, the board may issue a limited-use facility permit when the scope, degree, or type of services provided to the patient is of a limited nature. The permit to be issued shall be based on conditions of use requested by the applicant or imposed by the board in cases where certain requirements of this chapter may be waived.

1. The limited-use facility permit application shall list the regulatory requirements for which a waiver is requested, if any, and a brief explanation as to why each requirement should not apply to that practice.

2. A policy and procedure manual detailing the type and volume of controlled substances to be sold and safeguards against diversion shall accompany the application.

3. The issuance and continuation of a limited-use facility permit shall be subject to continuing compliance with the conditions set forth by the board.

4. A limited-use facility permit may be issued to a nonprofit facility for the purpose of dispensing Schedule VI controlled substances, excluding the combination of misoprostol and methotrexate, and hypodermic syringes and needles for the administration of prescribed controlled substances.

C. The executive director may grant a waiver of the security system when storing and selling multiple strengths and formulations of no more than five different topical Schedule VI drugs intended for cosmetic use.

18VAC110-30-40. Acts to be performed by the licensee.

A. The selection of the controlled substance from the stock, any preparation or packaging of a controlled substance or the preparation of a label for a controlled substance to be transferred to a patient shall be the personal responsibility of the licensee.

1. Any compounding of a controlled substance shall be personally performed by the licensee or a registered pharmacy technician under the supervision of the licensee.

2. A licensee may supervise one person who may be present in the storage and selling area to assist in performance of pharmacy technician tasks, as set forth in § 54.1-3321 of the Code of Virginia, provided such person is not licensed to sell controlled substances and is either:

a. A pharmacy technician registered with the board; or

b. A licensed nurse or physician assistant who has received training in technician tasks consistent with training required for pharmacy technicians.

3. Unless using one of the board-approved training courses for pharmacy technicians, a licensee who uses a nurse or physician assistant to perform pharmacy technician tasks shall develop and maintain a training manual and shall document that such licensee has successfully completed general training in the following areas:

a. The entry of prescription information and drug history into a data system or other recordkeeping system;

b. The preparation of prescription labels or patient information;

c. The removal of the drug to be dispensed from inventory;

d. The counting or measuring of the drug to be dispensed to include pharmacy calculations;

e. The packaging and labeling of the drug to be dispensed and the repackaging thereof;

f. The stocking or loading of automated dispensing devices or other devices used in the dispensing process, if applicable; and

g. Applicable laws and regulations related to dispensing.

4. A licensee who employs or uses pharmacy technicians, licensed nurses or physician assistants to assist in the storage and selling area shall develop and maintain a site-specific training program and manual for training to work in that practice. The program shall include training consistent with that specific practice to include, but not be limited to, training in proper use of site-specific computer programs and equipment, proper use of other equipment used in the practice in performing technician duties, and pharmacy calculations consistent with the duties in that practice.

5. A licensee shall maintain documentation of successful completion of the site-specific training program for each pharmacy technician, nurse or physician assistant for the duration of the employment and for a period of two years from date of termination of employment. Documentation for currently employed persons shall be maintained on site or at another location where the records are readily retrievable upon request for inspection. After employment is terminated, such documentation may be maintained at an off-site location where it is retrievable upon request.

B. Prior to the dispensing, the licensee shall:

1. Conduct a prospective drug review and offer to counsel a patient in accordance with provisions of § 54.1-3319 of the Code of Virginia; and

2. Inspect the prescription product to verify its accuracy in all respects, and place his initials on the record of sale as certification of the accuracy of, and the responsibility for, the entire transaction.

C. If the record of sale is maintained in an automated data processing system as provided in 18VAC110-30-200, the licensee shall personally place his initials with each entry of a sale as a certification of the accuracy of, and the responsibility for, the entire transaction.

18VAC110-30-270. Grounds for disciplinary action.

In addition to those grounds listed in § 54.1-3316 of the Code of Virginia, the board may revoke, suspend, refuse to issue or renew a license to sell controlled substances or may deny any application if it finds that the licensee or applicant has had his license to practice medicine, osteopathic medicine, or podiatry or license as a physician assistant or nurse practitioner suspended or revoked in Virginia or in any other state or no longer holds a current active license to practice in the Commonwealth of Virginia.