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Frequently Asked Questions

 

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 on http://townhall.virginia.gov/L/Register.cfm 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.

Q:  Who is eligible for obtaining CBD 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 legal guardian for treatment or to alleviate the symptoms of any diagnosed condition or disease determined by the physician to benefit from such use.

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

The Board is currently developing a registration process for patients, parents, and guardians to obtain registration when a written certification has been issued. It is anticipated this registration process will be implemented by early to mid-summer 2018.

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:  Must a physician obtain Board of Pharmacy registration prior to issuing a written certification for a patient to obtain CBD or THC-A oil from a pharmaceutical processor operating in Virginia? 

A:  Yes. The Board is currently developing a registration process for physicians to obtain registration for issuing a written certification. Once the registration process has been implemented, physicians must obtain registration prior to continuing to issue written certifications. It is anticipated this registration process will be implemented by late spring or early summer 2018.

Q:  What is the registration fee for a physician?

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

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

A:  No.  A written certificate must be issued.

Q:  Where may a physician locate the written certificate form?

A:  Click here to access the written certificate form

Q:  Does the written certification provide an affirmative defense for possession of the cannabidiol 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 physician 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."