Title of Regulation: 18VAC110-60. Regulations Governing Pharmaceutical Processors (amending 18VAC110-60-280).

Statutory Authority: §§ 54.1-2400 and 54.1-3442.6 of the Code of Virginia.

Public Hearing Information:

June 4, 2021 - 9:10 a.m. - Electronic access only. Instructions will be posted at http://www.dhp.virginia.gov prior to the meeting.

Public Comment Deadline: July 23, 2021.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, 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 Pharmacy the authority to promulgate regulations to administer the regulatory system. Statutory provisions specific to regulation of pharmaceutical processors are found in § 54.1-3442.6 of the Code of Virginia.

Purpose: The purpose is to address the public health concern from a significant number of cases of lung disease associated with vaping or e-cigarettes. Since testing by the Centers for Disease Control and Prevention (CDC) has shown that vitamin E acetate is a chemical of concern, the board has adopted a prohibition against production of cannabis oil containing vitamin E acetate in products intended for vaping or inhalation. The amended regulation is intended to protect the health and safety of consumers who will have access to the oils in the coming months.

Substance: 18VAC110-60-280 on cultivation and production of cannabis oil is amended to prohibit the production of an oil intended to be vaporized or inhaled from containing vitamin E acetate.

Issues: The advantages to the public include greater assurance of the safety and integrity of the vaping products dispensed; there are no disadvantages to the public. There are no advantages or disadvantages to the agency.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy (Board) proposes to prohibit pharmaceutical processors from producing or dispensing any cannabis oil that contains vitamin E acetate if that oil is intended to be vaporized or inhaled.¹ This ban on cannabis oil products containing vitamin E acetate was first implemented via an emergency action in response to a spike in lung injury among users of e-cigarettes and vaping products.² The proposed amendment would make this ban permanent.

Background. The Board seeks to ban the use of vitamin E acetate (also known as tocopheryl acetate) in cannabis oil products that are intended for vaping. Specifically, the proposed amendment would add the following sentence to 18VAC110-60-280 on the cultivation and production of cannabis oil: "No cannabis oil intended to be vaporized or inhaled shall contain vitamin E acetate."³ The Board first sought to address the outbreak of e-cigarette or vaping product use-associated lung injury (EVALI) in November 2019. As of November 13, 2019, the Centers for Disease Control (CDC) reported 2,172 cases of lung disease associated with e-cigarette or vaping product use in 49 states (including Virginia) and 42 deaths in 24 states.⁴ Currently, the CDC's main findings regarding EVALI are as follows:

National and state data from patient reports and product sample testing show tetrahydrocannabinol (THC)-containing e-cigarette, or vaping, products, particularly from informal sources like friends, family, or in-person or online dealers, are linked to most EVALI cases and play a major role in the outbreak.

Vitamin E acetate is strongly linked to the EVALI outbreak. Vitamin E acetate has been found in product samples tested by the Food and Drug Administration and state laboratories and in patient lung fluid samples tested by CDC from geographically diverse states. Vitamin E acetate has not been found in the lung fluid of people who do not have EVALI.

Evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC or non-THC products, in some of the reported EVALI cases.⁵

The Board initially considered a ban on vaping products containing cannabis oil altogether, but decided to more narrowly ban the use of vitamin E acetate in such products once the CDC had identified this chemical to be responsible for EVALI.⁶

Estimated Benefits and Costs. Prohibiting pharmaceutical processors from producing or dispensing THC-containing e-cigarettes or vaping products that contain vitamin E acetate would protect registered patients who are eligible to obtain these products, thereby benefiting them. By selectively banning vitamin-E acetate, the proposed amendment mitigates any costs or losses that pharmaceutical processors may have incurred had the Board sought to implement a general ban on THC-containing e-cigarettes or vaping products.

Businesses and Other Entities Affected. There are currently four pharmaceutical processors who have been issued permits. Assuming they complied with the ban when the emergency action was first promulgated, the proposed amendment to make the ban permanent would not lead to any additional costs to them.⁷ Further, should the Board allow new entrants in the future, they would be unlikely to face additional costs or be discouraged from entry as a result of the proposed amendment.

Small Businesses⁸ Affected. It is unknown if any of the pharmaceutical processors are small businesses, and the Board did not indicate if any processors were small businesses. However, the proposed amendment is unlikely to disproportionately impact any small business processors since it would likely not produce an adverse impact on any of the pharmaceutical processors.

Localities⁹ Affected.¹⁰ The proposed amendment does not introduce new costs for local governments and is unlikely to affect any locality in particular.

Projected Impact on Employment. The proposed amendment is unlikely to affect employment by pharmaceutical processors.

Effects on the Use and Value of Private Property. The proposed amendment is unlikely to affect the use and value of private property. Real estate development costs are not affected.

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¹A pharmaceutical processor is a facility that has obtained a permit from the Board to cultivate cannabis plants for the production of cannabis oil, and dispense the oil to patients registered by the Board for treatment or to alleviate the symptoms of any diagnosed condition or disease determined by the physician to benefit from such use.

²See https://townhall.virginia.gov/L/ViewStage.cfm?stageid=8856, which became effective August 6, 2020.

³The emergency regulation referred to "THC-A oil or cannabidiol oil." However, due to legislation passed in the 2020 General Assembly, these terms have been eliminated and "cannabis oil" is used instead. See https://lis.virginia.gov/cgi-bin/legp604.exe?201+ful+CHAP1278.

⁴See page 2 of the Agency Background Document (ABD): https://townhall.virginia.gov/L/GetFile.cfm?File=30\5452\9166\AgencyStatement_DHP_9166_v1.pdf.

⁵See https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html.

⁶As per the Department of Health Professions (DHP); see note 3 for a link to the ABD.

⁷DHP reported that the Board did not receive any comments or complaints from the pharmaceutical processors following the emergency action.

⁸Pursuant 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."

^9"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.

¹⁰§ 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 proposed amendment prohibits the production of an oil intended to be vaporized or inhaled from containing vitamin E acetate.

18VAC110-60-280. Cultivation and production of cannabis oil.

A. No cannabis oil shall have had pesticide chemicals or petroleum-based solvents used during the cultivation, extraction, production, or manufacturing process, except that the board may authorize the use of pesticide chemicals for purposes of addressing an infestation that could result in a catastrophic loss of Cannabis crops.

B. Cultivation methods for Cannabis plants and extraction methods used to produce the cannabis oil shall be performed in a manner deemed safe and effective based on current standards or scientific literature.

C. Any Cannabis plant, seed, parts of plant, extract, or cannabis oil not in compliance with this section shall be deemed adulterated.

D. A pharmaceutical processor may acquire oil from industrial hemp extract for the purpose of formulating such oil extract with cannabis plant extract into allowable dosages of cannabis oil provided:

1. The pharmaceutical processor acquires the oil from industrial hemp extract processed in Virginia and in compliance with state or federal law from a registered industrial hemp dealer or processor;

2. The oil from industrial hemp acquired by a pharmaceutical processor is subject to the same third-party testing requirements applicable to cannabis plant extract as verified by testing performed by a laboratory located in Virginia and in compliance with state law; and

3. The industrial hemp dealer or processor provides such third-party testing results to the pharmaceutical processor before oil from industrial hemp is acquired.

E. A pharmaceutical processor acquiring oil from industrial hemp extract shall ensure receipt of a record of the transaction that shows the date of distribution, the names and addresses of the registered industrial hemp dealer or processor distributing the product and the pharmaceutical processor receiving the product, and the kind and quantity of product being distributed. The record of the transaction shall be maintained by the pharmaceutical processor with its records of receipt. Such records shall be maintained by each pharmaceutical processor for three years.

F. A pharmaceutical processor shall maintain policies and procedures for the proper storage and handling of oil from industrial hemp extract, to include a process for executing or responding to mandatory and voluntary recalls in a manner that complies with 18VAC110-60-250.

G. No cannabis oil intended to be vaporized or inhaled shall contain vitamin E acetate.