PharmaCann Virginia, LLC v. Virginia Board of Pharmacy

CourtCourt of Appeals of Virginia
DecidedApril 4, 2023
Docket0616222
StatusPublished

This text of PharmaCann Virginia, LLC v. Virginia Board of Pharmacy (PharmaCann Virginia, LLC v. Virginia Board of Pharmacy) is published on Counsel Stack Legal Research, covering Court of Appeals of Virginia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
PharmaCann Virginia, LLC v. Virginia Board of Pharmacy, (Va. Ct. App. 2023).

Opinion

COURT OF APPEALS OF VIRGINIA PUBLISHED

Present: Judges Athey, Chaney and Lorish Argued at Richmond, Virginia

PHARMACANN VIRGINIA, LLC OPINION BY v. Record No. 0616-22-2 JUDGE LISA M. LORISH APRIL 4, 2023 VIRGINIA BOARD OF PHARMACY

FROM THE CIRCUIT COURT OF HENRICO COUNTY Richard S. Wallerstein, Jr., Judge

John C. Ivins, Jr. (Mihir V. Elchuri; Hirschler Fleischer, P.C., on briefs), for appellant.

James E. Rutkowski, Assistant Attorney General (Jason S. Miyares, Attorney General; Coke Morgan Stewart, Deputy Attorney General; Allyson K. Tysinger, Senior Assistant Attorney General, on brief), for appellee.

The Virginia Board of Pharmacy granted PharmaCann Virginia, LLC conditional approval

to operate a pharmaceutical processor to grow cannabis plants, manufacture and package cannabis-

based products, and dispense the products to patients. Board regulations and the conditional

approval order required PharmaCann to complete many requirements necessary for the operation of

a pharmaceutical processor within one year. At the end of that year, PharmaCann had not yet

started construction. Ultimately the Board rejected PharmaCann’s proposal for additional time and

denied the permit application. We consider whether the Board abused its discretion by rescinding

PharmaCann’s conditional approval or by treating PharmaCann differently from other applicants

who received conditional approval and additional time to complete the permit requirements.

Finding no error in the trial court’s review of the same questions, we affirm. BACKGROUND

PharmaCann’s Permit Application

The Board may issue one pharmaceutical processing facility permit for each of the five

Health Service Areas (HSAs) in Virginia. Code § 54.1-3442.6. Out of a field of nine applicants,

the Board conditionally approved PharmaCann’s application to operate a new pharmaceutical

processor in HSA I in December 2018. The Board’s conditional approval order stated that

PharmaCann “will have one year from the date of this Order” to complete all regulatory

requirements for the acquisition of a permit. The Board’s regulations likewise required all

applicants to complete the requirements within a year. 18 VAC 110-60-120(E) (“If granted

conditional approval, an applicant shall have one year from date of notification to complete all

requirements for issuance of a permit . . . .”).

PharmaCann then bought about seven acres of land to build the new facility.

PharmaCann knew that a gas line was running through the middle of the property when it

purchased the land, but did not realize the gas line would prevent construction. The gas line was

finally relocated in October 2019, but PharmaCann still did not start construction. Instead,

internal documents show PharmaCann decided in September 2019 to not take any further steps

on the project without “additional direction” from the Board.

In November 2019, the Board notified PharmaCann that December 21, 2019, was the

deadline for PharmaCann to submit an “initial permit” application and that the Board had to also

conduct an inspection of the site by that date. This email said that “if deficiencies are identified

during the inspection, a written response must be submitted within 14 days of the inspection date

that either summarizes the corrective actions taken or provides a date, to be approved by the

Board, by which the deficiencies will be corrected.” The email also stated that “[t]he Board will

-2- review the submission for approval” and that the Board may conduct a reinspection before

issuing a permit.

PharmaCann submitted the permit application with a $60,000 fee, and the Board

conducted the inspection. But as there was “nothing to inspect” because PharmaCann had not

yet started construction, the Board’s inspection found that PharmaCann was not compliant with

any of the requirements for a processing facility permit.

In a December 2019 letter, the Board sent a copy of the inspection summary to

PharmaCann attached to a letter that stated, “For any cited deficiencies, complete the Corrective

Steps Taken section and return to the Board of Pharmacy no later than January 9, 2020.” The

letter also said that the “written response must either summarize the corrective actions taken or

provide a date, to be approved by the Board, by which the deficiencies will be corrected” and

that “[t]he Board will review the submission for approval.”

PharmaCann submitted a timely corrective action plan, requesting re-inspection in

November 2020. The plan contained an updated construction schedule, estimating that the

company would complete construction in October 2020 and would complete all required audits

and state inspections by December 2020. PharmaCann followed up with the Board in February

2020, asking whether the Board had any feedback on the proposed action plan. The Board

responded the next day, stating that it was waiting on advice from the Attorney General’s office

before responding to any applicant about their pending inspections. Shortly after that, the Board

notified PharmaCann that it intended to review their plan at the next full Board meeting, in

March 2020. The Board stated that it would allow for a “public comment period during which

you may provide information to the Board for consideration in making a determination to accept

the plan or deny the pharmaceutical processor application.”

-3- The Board could not hold its March meeting, however, because of public health concerns

related to COVID-19. After the General Assembly authorized public bodies to meet virtually,

see Va. Acts ch. 1283, § 4-0.01 (April 2020), the Board advised PharmaCann in May that it

would review its corrective action plan during a virtual meeting in June 2020. Again, the Board

stated that it would allow for a “public comment period during which you may provide

information to the Board for consideration in making a determination to accept the plan or deny

the pharmaceutical processor application.” Leading up to the meeting, PharmaCann sent a letter

to the Board requesting a new re-inspection date of June 30, 2021.

Following the June meeting, the Board denied PharmaCann’s request for an extension of

time to comply with the necessary permit requirements, rescinded conditional approval, and

denied the pending permit application. In its written order explaining its decision, the Board

made factual findings including that (1) conditional approval was granted on December 21,

2018, by a Board order that “required PharmaCann to complete all of the requirements for the

issuance of a permit, including the requirements of 18 VAC 110-60-130(A) through (E), within

one year from the date of the Order”; (2) PharmaCann applied for issuance of a pharmaceutical

processor permit on December 2, 2019; (3) on December 13, 2019, “an inspector for the Virginia

Department of Health Professions found that PharmaCann had failed to complete any of the

requirements for the issuance of a permit,” specifically citing the fact PharmaCann “had not

started construction on a pharmaceutical processor facility”; (4) PharmaCann requested an

extension of time on January 9, 2020; (5) “As of June 16, 2020, PharmaCann had not started

construction on a pharmaceutical processor facility”; and (6) “PharmaCann asked the Board for

an extension until, and a reinspection date of, June 30, 2021.” The order then concluded that

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PharmaCann Virginia, LLC v. Virginia Board of Pharmacy, Counsel Stack Legal Research, https://law.counselstack.com/opinion/pharmacann-virginia-llc-v-virginia-board-of-pharmacy-vactapp-2023.