State Licensing Update: Virginia HSA-1

Today the Virginia Cannabis Control Authority (CCA) began the long-anticipated process of accepting applications for a permit to operate a pharmaceutical processor in Health Service Area 1 (HSA-1). The winner of this competitive license application will receive the sole license to engage in vertically-integrated medical cannabis operations in the region, which spans much of the northwestern portion of the state, including Charlottesville, Fredericksburg, Spotsylvania, and Stafford.

The application, which is capped at 50 pages of narrative content, is due no later than April 30, 2024. The non-refundable fee to apply is $18,000.


Timeline

If you think you’ve heard this story before, you have. In 2018 the Virginia Board of Pharmacy awarded the first license for HSA-1 to PharmaCann. After failing to complete certain pre-operational milestones within the 1-year timeline, the license was rescinded in June 2020. Later in 2020 the Board of Pharmacy again accepted applications for the license. PharmaCann sued to block the recission of their license and the review of the 2020 applications. Though PharmaCann was ultimately unsuccessful, the lawsuit was not resolved until May 2023, at which point the program was slated to move into the jurisdiction of the newly-formed Cannabis Control Authority.

In the months since the resolution of the PharmaCann lawsuit, industry insiders have waited with bated breath to see whether the previously submitted 2020 applications would be reviewed by the Board of Pharmacy, or whether the CCA would take over the process.

Today the CCA published the application along with the following “Anticipated Timeline for Conditional Approval”

February 28, 2024: Issue Notice of Open Applications

April 30, 2024, at 5:00 pm EDT: Applications Due

June 26, 2024: Board reviews scoring and lottery results to determine which applicant will be awarded conditional approval

July 8, 2024: Deadline for fingerprinting and submission of information for criminal history background checks

August 14, 2024: Finalize the awarding of conditional approval upon review of criminal history background checks or select alternate applicant for conditional approval


Key Takeaways

Applications for a pharmaceutical processor license must be submitted online on or before April 30, 2024 along with the non-refundable $18,000 application fee.

Applicants must submit a variety of business and demographic information along with a robust business plan. The business plan will be judged based on 36 criteria ranging from the suitability of the proposed location to the financial health of the applicant, to the applicant’s expertise in the cultivation, manufacturing, and sale of cannabis and cannabis products. Notably, the applicant’s business plan cannot exceed 50 pages, a far cry from the 1,000+ page applications previously submitted to the Board of Pharmacy in 2018 and 2020.

Once granted conditional approval in August 2024, the winning applicant will have one year to complete all requirements for issuance of a permit, including the build-out of the proposed facility, installation of equipment and security, local zoning approval, and employment of a pharmacist-in-charge and other personnel.

The Fire Business Strategies Team have extensive experience in competitive applications, including previous rounds of HSA-1 applications. Our team is able to provide services ranging from full-service competitive application drafting and consultation to tailored solutions designed to maximize your chances of success. For more on how Fire Business Strategies can help set you up for success in Virginia, please visit our contact page to schedule a free initial consultation!