Virginia’s medical cannabis program is moving forward, with a notice of proposed regulations and a new physician registration form. However, the Board of Pharmacy, whose ad hoc committee is currently evaluating pharmaceutical processor applications, has signaled that it will not be announcing the conditional permit recipients at its August 14th meeting, as was previously expected. The 53 applicants to the Board may be looking at a delay of weeks or months.
In the meantime, physicians can begin to prepare for increased demand from Virginians for medical cannabis certifications by registering with the Board of Pharmacy using its new application form. Also, industry stakeholders have until August 22nd to comment on the proposed regulations to replace the emergency regulations adopted by the Board earlier this summer.
Patients require a valid certification from a Board-registered physician in order to legally possess medical cannabis in Virginia. Physicians who wish to issue such certifications, or have issued such certificates within the last 12 months must fill out the new application to register with the Board of Pharmacy. The previous Board of Medicine form has been removed from the Board of Medicine website. Once an application has been submitted, the Board anticipates it will take 7-10 days for the applying physician to receive approval. If approved, the Board will send the registered physician a link to the new written certification form to issue to patients.
Issuing certificates to patients without first registering with the Board constitutes a violation of the emergency regulations (and, presumably, the final regulations that are adopted in September) and will likely compromise a patient’s affirmative defense if a certification is called into question. In addition, physicians should be aware of the requirements for issuing certifications, including the assessment and evaluation, and notification of risks and benefits.
On July 23rd, the Virginia Board of Pharmacy (the “Board”) published a notice stating it plans to adopt final regulations for pharmaceutical processors to replace the current emergency regulations at its upcoming meeting on September 25th. The original emergency regulations became effective August 7, 2017. These regulations were amended to align with the passage of HB1251, which expanded the original law to allow doctors to recommend cannabis oils for “any diagnosed condition or disease.” The Board formally adopted the amended emergency regulations at its June 2018 meeting. Key changes proposed in the Board notice are summarized below.
The amended regulations allow physicians to provide certifications to their patients, based on their clinical judgment, for any diagnosed condition or disease. Physicians were formerly restricted to certifications only for patients with “intractable epilepsy”.
The amended regulations add a $25 fee for “Registration of each cannabidiol oil or THC-A oil product” as part of the pharmaceutical processor permit fee schedule.
The amended regulations no longer require that practitioners register with the Virginia Prescription Monitoring Program. However, physicians will need to use the Program to determine which, if any, covered substances have been dispensed to a particular patient receiving a certification. “Covered substance” means all controlled substances included in Schedules II, III, and IV; controlled substances included in Schedule V for which a prescription is required; naloxone; and all drugs of concern that are required to be reported to the Prescription Monitoring Program, pursuant to this chapter. “Covered substance” also includes cannabidiol oil or THC-A oil dispensed by a pharmaceutical processor in Virginia.
The amended regulations increase the maximum supply of CBD and/or THC-A oils that a patient may obtain from a one-month supply within a one month period to a 90-day supply within a 90-day period.
The amended regulations clarify that the Board requires sufficient information to conduct background checks on all pharmaceutical processor “applicants”. The previous language was inconsistent and seemed to indicate that only “owners” would require background checks. The term “applicant” is ill-defined in the regulations, and requires some clarification, so it remains unclear which individuals are subject to this requirement.
The amended regulations significantly increase the number of plants allowed at a pharmaceutical processor. First, a pharmaceutical processor may initially cultivate enough plants for the number of patients anticipated in the first nine (9) months of operation. The emergency regulations limited that amount to the number of patients anticipated in the first three (3) months. Second, the amended regulations increase the per-patient plant count from four (4) plants per patient to twelve (12) plants per patient. Third, a pharmaceutical processor may base its patient count estimation on the previous 90 days’ dispensing data. That is an increase of 60 days as compared to the emergency regulations.
The amended regulations make clearer the Board’s desire to see a complete plan for the branded products of each Pharmaceutical Processor, including (beyond THC, THC-A, and CBD), CBD-A and all additional active ingredients constituting at least 1% of the batch used in the product.
The amended regulations include a revised list of labeling requirements, included below:
A. A pharmaceutical processor shall label each cannabidiol oil or THC-A oil product prior to dispensing by a pharmacist and shall securely affix to the package a label that states in legible English:
1. The brand name of the cannabidiol oil or THC-A oil that was registered with the board pursuant to 18VAC110-20-285;
2. A serial number as assigned by the pharmaceutical processor;
3. The date of dispensing the cannabidiol oil or THC-A oil;
4. An appropriate expiration date, not to exceed six months;
5. The quantity of cannabidiol oil or THC-A oil contained therein;
6. A terpenes profile and a list of all active ingredients, including:
a. Tetrahydrocannabinol (THC);
b. Tetrahydrocannabinol acid (THC-A); and
c. Cannabidiol (CBD);
7. A pass or fail rating based on the laboratory’s microbiological, mycotoxins, heavy metals, and chemical residue analysis;
8. The name and registration number of the qualifying patient;
9. The name of the certifying practitioner;
10. Such directions for use as may be included in the practitioner’s written certification or otherwise provided by the practitioner;
11. Name and address of the pharmaceutical processor; and
12. Any cautionary statement as may be required by statute or regulation.
B. No person except a pharmacist or pharmacist technician under the direct supervision of a pharmacist at the pharmaceutical processor shall alter, deface, or remove any label so affixed.
Rebecca E. Gwilt, Esq. is a Virginia-licensed attorney, Partner at Nixon Law Group, and leader of Nixon Law Group’s Cannabis Business practice. She provides legal, regulatory, and business guidance to healthcare clients, including those clients in and ancillary to the medical cannabis industry. She is focused primarily on healthcare entrepreneurship and compliance, cannabis licensing and compliance, and privacy/security of patient data. She also provides corporate and transactional services to clients, including business formation and dissolution, employment contracts and disputes, licensing, board and general compliance, mergers and acquisitions, and reimbursement.
“Rebecca is also an Advisory Board Member of Cannabis Commonwealth, a 501(c)(3) that unites the patients, parents, professionals and policy makers dedicated expanding Virginia’s regulated medical cannabis program.” She can be contacted at [email protected]
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