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Frequently Asked Questions

 

 

 

Patients, Parents, or Legal Guardians

Q:  Who is eligible for obtaining cannabidiol (CBD) oil and THC-A oil?

A:  Currently, the law restricts the use of either oil to a Board of Pharmacy-registered patient or, if such patient is a minor or an incapacitated adult as defined in 18.2-369, such patient's parent or guardian for treatment or to alleviate the symptoms of any diagnosed condition or disease determined by the practitioner to benefit from such use.

Q:  Does the law provide for an affirmative defense for possession of CBD oil or THC-A oil?

A:  Yes. 18.2-250.1(C) states, “In any prosecution under this section involving marijuana in the form of cannabidiol oil or THC-A oil as those terms are defined in § 54.1-3408.3, it shall be an affirmative defense that the individual possessed such oil pursuant to a valid written certification issued by a practitioner in the course of his professional practice pursuant to § 54.1-3408.3 for treatment or to alleviate the symptoms of (i) the individual's diagnosed condition or disease or (ii) if such individual is the parent or legal guardian of a minor or of an incapacitated adult as defined in § 18.2-369, such minor's or incapacitated adult's diagnosed condition or disease. If the individual files the valid written certification with the court at least 10 days prior to trial and causes a copy of such written certification to be delivered to the attorney for the Commonwealth, such written certification shall be prima facie evidence that such oil was possessed pursuant to a valid written certification."

Q:  What other conditions must be met to assert the affirmative defense?

A:  In addition to being issued a valid written certification from a Board of Pharmacy-registered practitioner, the patient and, if such patient is a minor or an incapacitated adult as defined in 18.2-369, such patient's parent or guardian, must obtain registration from the Board of Pharmacy.  The written certification alone does not satisfy the conditions for asserting an affirmative defense for possessing CBD or THC-A oil.

Q:  When may a patient, parent, and legal guardian apply for board registration? 

Patients, parents, and legal guardians may now apply to obtain registration from the Board of Pharmacy.  A patient, parent, or legal guardian must have a written certification issued to them by a practitioner prior to applying for registration with the Board of Pharmacy and possessing the oils.

Q:  What is the registration fee for a patient, parent, or guardian?

A:  The initial registration fee is $50 and the annual renewal fee is $50.

Q:  If the patient is a minor or an incapacitated adult as defined in 18.2-369, who must obtain board registration?

A:  The parent or legal guardian must apply for board registration for both the patient and for himself or herself as the parent or legal guardian. 

Q:  Must each parent or legal guardian be issued a written certification by the practitioner?

A:  Each parent or legal guardian who intends to possess the oils must be issued a written certification in his or her name.  Additionally, each parent or legal guardian issued a written certification must obtain board registration in order to possess the oils.

Q:  Is CBD or THC-A oil currently available to obtain from a pharmaceutical processor located in Virginia?

A:  No.  The Board awarded conditional approval to up to 5 pharmaceutical processors in December 2018.  It is anticipated they will become operational by December 2019.  It will take approximately 4-6 months to cultivate, produce, and test the products prior to dispensing. 

 

Practitioners

Q:  Who is eligible for obtaining cannabidiol (CBD) oil and THC-A oil?

A:  Currently, the law restricts the use of either oil to a Board of Pharmacy-registered patient or, if such patient is a minor or an incapacitated adult as defined in 18.2-369, such patient's parent or guardian for treatment or to alleviate the symptoms of any diagnosed condition or disease determined by the practitioner to benefit from such use.

Q: What practitioners are eligible to obtain board registration for issuing a written certification for recommending the use of cannabidiol oil or THC-A oil?

A: A practitioner of medicine or osteopathy licensed by the Board of Medicine, and as of July 1, 2019,  a physician assistant licensed by the Board of Medicine, or a nurse practitioner jointly licensed by the Board of Medicine and the Board of Nursing.

Q:  Does the law provide for an affirmative defense for possession of CBD oil or THC-A oil?

A:  Yes. 18.2-250.1(C) states, “In any prosecution under this section involving marijuana in the form of cannabidiol oil or THC-A oil as those terms are defined in § 54.1-3408.3, it shall be an affirmative defense that the individual possessed such oil pursuant to a valid written certification issued by a practitioner in the course of his professional practice pursuant to § 54.1-3408.3 for treatment or to alleviate the symptoms of (i) the individual's diagnosed condition or disease or (ii) if such individual is the parent or legal guardian of a minor or of an incapacitated adult as defined in § 18.2-369, such minor's or incapacitated adult's diagnosed condition or disease. If the individual files the valid written certification with the court at least 10 days prior to trial and causes a copy of such written certification to be delivered to the attorney for the Commonwealth, such written certification shall be prima facie evidence that such oil was possessed pursuant to a valid written certification."

Q:  What other conditions must be met to assert the affirmative defense?

A:  In addition to being issued a valid written certification from a Board of Pharmacy-registered practitioner, the patient and, if such patient is a minor or an incapacitated adult as defined in 18.2-369, such patient's parent or guardian, must obtain registration from the Board of Pharmacy.  The written certification alone does not satisfy the conditions for asserting an affirmative defense for possessing CBD or THC-A oil.

Q:  Must a practitioner obtain Board of Pharmacy registration prior to or continuing to issue a written certification for a patient to posess  cannabidiol (CBD) oil or THC-A oil? 

A: Yes, before a practitioner can issue or continue issuing written certifications, he or she must register with the Board of Pharmacy. Learn More about practitioner registration.

Q:  What is the registration fee for a practitioner?

A:  The initial registration fee is $50 and the annual renewal fee is $50.

Q:  May a practitioner issue a prescription for the oil? 

A:  No.  A written certificate must be issued.

Q:  Where may a practitioner locate the written certification form?

A:The Board of Pharmacy will email the practitioner a link to the written certification form once the board issues the practitioner registration. Please allow 7-10 days for processing the registration application and receiving the email with the link to the written certification.

 

 

Pharmaceutical Processor Permit

Q:  What is the process for applying for a pharmaceutical processor permit?

A:  The application process for pharmaceutical processor permits will occur in three stages: submission of initial application, awarding of conditional approval, and granting of a pharmaceutical processor permit. As of April 16, 2018, a Request for Application (RFA) process has opened for obtaining conditional approval for a pharmaceutical processor permit. For consideration, a complete application, required documentation, and the nonrefundable application fee of $10,000 must be received no later than 2pm on June 8, 2018. The RFA may be downloaded here.

Q:  How do I become a registered user of Regulatory Town Hall?

A:  Click here to become a registered user of Regulatory Town Hall and receive email notifications regarding the notice for the Request for Application for pharmaceutical processors, regulatory actions, and meetings of the Board of Pharmacy within the Health and Human Resource Secretariat.

Q: How many pharmaceutical processor permits will be issued?

A: §54.1-3442.6 of the Code of Virginia restricts the number of permits that the Board may issue or renew in any year to a maximum of 5 permits, one for each health service area established by the Board of Health.

Q:  Where may I find a listing of the five health service areas as established by the Board of Health?

A: Click here for a list of the five health service areas.

Q:  What are the three stages in the application process for a pharmaceutical processor permit?

A:  Submission of initial application, awarding of conditional approval, and granting of a pharmaceutical processor permit.  Refer to Regulations 18VAC110-60-110 through 18VAC110-60-130.

Q:  What are the licensure fees associated with obtaining a pharmaceutical processor permit?

A:  The initial application fee is $10,000.  The permit fee is $60,000 and the annual renewal fee is $10,000.