Source: http://register.dls.virginia.gov/details.aspx?id=6508
Timestamp: 2017-10-23 05:58:31
Document Index: 102714656

Matched Legal Cases: ['§ 54', '§ 54', '§ 54', '§ 54', '§ 54', 'art 205']

Vol. 33 Iss. 25 (Emergency Regulation) 18VAC110-60, Regulations Governing Pharmaceutical Processors August 07, 2017
Title of Regulation: 18VAC110-60. Regulations Governing Pharmaceutical Processors (adding 18VAC110-60-10 through 18VAC110-60-330).
Statutory Authority: §§ 54.1-2400 and 54.1-3442.6 of the Code of Virginia.
Effective Dates: August 7, 2017, through February 6, 2019.
Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4578, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.
Pursuant to Chapter 577 of the 2016 Acts of Assembly and Chapter 613 of the 2017 Acts of Assembly, the Board of Pharmacy is promulgating emergency regulations governing (i) the registration process for a patient who has been issued a written certification for the use of cannabidiol oil or THC-A oil and (ii) the issuance of a permit for a pharmaceutical processor to manufacture and provide cannabidiol oil and THC-A oil to be used for the treatment of intractable epilepsy. The regulation includes (i) the fees for application, registration, and permitting; (ii) requirements for issuance or denial of registration for certifying physicians, patients, parents, or legal guardians; (iii) the application and approval process for issuing a permit to a pharmaceutical processor, including the information that must be submitted, the requirements for issuing conditional and then final approval, the rules for notification to the board of any changes or of closure of the processor, and the causes for action against a processor; (iv) the provisions for personnel at the pharmaceutical processor, including a requirement that a pharmacist with a current, unrestricted Virginia license provide personal supervision on the premises at all times during hours of operation or whenever the processor is accessed, employee training, supervision of pharmacy technicians, and the responsibilities of the pharmacist-in-charge; and (v) provisions for the operation of a pharmaceutical processor, including requirements for inventory, security, storage and handling, recordkeeping, and reportable events; (vi) requirements for the cultivation, production, and dispensing of cannabidiol oil, including labeling, laboratory and testing standards, dispensing errors and quality assurance, and proper disposal.
The goals of the new regulation are accessibility of cannabidiol oil or THC-A oil for patients with intractable epilepsy in compliance with the conditions and restraints imposed by the statute and in consideration of the need for security of the facility and its contents and the integrity of the dispensed product. The statute sets limits on the number of permits that the board may issue and requires that the board adopt regulations establishing health, safety, and security requirements for pharmaceutical processors. It also provides that only a licensed practitioner of medicine or osteopathy who is a neurologist or who specializes in the treatment of epilepsy may issue a written certification to a patient for the use of cannabidiol oil or THC-A oil. It requires that a practitioner who issues a written certification for cannabidiol oil or THC-A oil, the patient issued such certification, and, if the patient is a minor or incapacitated, the patient's parent or legal guardian register with the board. The statute further provides that a pharmaceutical processor shall not provide cannabidiol oil or THC-A oil to a patient or a patient's parent or legal guardian without first verifying that the patient, the patient's parent or legal guardian if the patient is a minor or incapacitated, and the practitioner who issued the written certification have registered with the board. The safeguards put in place in statute and regulations are essential to protect the health and safety of the general public and, in particular, the health of the patients to whom cannabidiol oil or THC-A oil is dispensed.
"Certification" means a written statement, consistent with requirements of § 54.1-3408.3 of the Code of Virginia, issued by a practitioner for the use of cannabidiol oil or THC-A oil for treatment or to alleviate the symptoms of a patient's intractable epilepsy.
"Intractable epilepsy" means drug-resistant epilepsy (DRE), which is defined as failure of adequate trials of two tolerated, appropriately chosen and used antiepileptic drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
"One-month supply" means the amount of cannabidiol oil or THC-A oil reasonably necessary to ensure an uninterrupted availability of supply for a 30-day period for registered patients, which cannot exceed 20 fluid ounces.
"Qualifying patient" means a Virginia resident who has received a written certification for the use of cannabidiol oil or THC-A oil for treatment of intractable epilepsy from a practitioner, as defined in § 54.1-3408.3 of the Code.
A. Prior to issuing a certification for cannabidiol oil or THC-A oil for the treatment or to alleviate symptoms of intractable epilepsy, the practitioner shall meet the requirements of § 54.1-3408.3 of the Code, shall submit an application and fee as prescribed in 18VAC110-60-20, and shall be registered with the board.
2. Diagnose the patient as having intractable epilepsy;
5. Be available or ensure that another practitioner, as defined in § 54.1-3408.3 of the Code, is available to provide follow-up care and treatment to the qualifying patient, including physical examinations, to determine the efficacy of cannabidiol oil or THC­­-A oil for treating the intractable epilepsy;
9. Be registered with and able to access the Virginia Prescription Monitoring Program.
3. Examine a qualifying patient for purposes of diagnosing intractable epilepsy at a location where cannabidiol oil or THC-A oil is dispensed or produced; or
4. The patient, parent, or legal guardian obtained more than a one-month supply of cannabidiol oil or THC-A oil in a one-month period;
f. Information necessary for the board to conduct a criminal background check on owners and any other person who is employed by or acts as an agent of the proposed pharmaceutical processor;
3. The board shall conduct criminal background checks on the owner or owners and may verify information contained in each application and accompanying documentation in order to assess the applicant's ability to operate a pharmaceutical processor.
D. A pharmaceutical processor shall not market or advertise cannabidiol oil or THC-A oil products, except it may post the following information on websites:
H. No cannabidiol oil or THC-A oil shall be sold, dispensed, or distributed via a delivery service or any other manner outside of a pharmaceutical processor, except that a registered parent or legal guardian may deliver cannabidiol oil or THC-A oil to the registered patient.
I. Notwithstanding the requirements of subsection E of this section, an agent of the board, local law enforcement or other federal, state, or local government officials may enter any area of a pharmaceutical processor if necessary to perform their governmental duties.
A. A pharmaceutical processor shall initially cultivate only the number of Cannabis plants necessary to produce cannabidiol oil or THC-A oil for the number of patients anticipated within the first three months of operation. Thereafter, the processor shall:
1. Not maintain more than four Cannabis plants per patient at any given time based on dispensing data from the previous 30 days;
A. Cannabidiol oil or THC-A oil produced for dispensing shall not be adulterated and shall be:
2. Labeled with the results of an active ingredient analysis, a microbiological contaminants analysis, a mycotoxin analysis, a heavy metal analysis, and a pesticide chemical residue analysis that have been completed on a batch basis by a laboratory.
F. A pharmaceutical processor shall not label cannabidiol oil or THC-A oil products as "organic" unless the Cannabis plants have been organically grown and the cannabidiol oil or THC-A oil products have been produced, processed, manufactured, and certified to be consistent with organic standards in compliance with 7 CFR Part 205.
A. A pharmacist, in good faith, may dispense cannabidiol oil or THC-A oil to any registered patient, parent, or legal guardian as indicated on the written certification. A pharmacist or pharmacy technician shall require the presentation of a current registration for the patient and parent or legal guardian, if applicable, current written certification and current valid photographic identification issued to a registered patient, parent, or legal guardian, prior to selling oil to such registered patient, parent, or legal guardian. The pharmacist or pharmacy technician shall verify in the prescription monitoring program or other program recognized by the board that the registrations are current, the written certification has not expired, and the date and quantity of the last dispensing of cannabidiol oil or THC-A oil to the registered patient.
B. A pharmacist may dispense a portion of a registered patient's one-month supply of cannabidiol oil or THC-A oil. The pharmacist may dispense the remaining portion of the one-month supply of cannabidiol oil or THC-A oil at any time except that no registered patient, parent, or legal guardian shall receive more than a one-month supply of cannabidiol oil or THC-A oil in a one-month period from any pharmaceutical processor.
5. The quantity of cannabidiol oil or THC-A oil dispensed, which cannot exceed 20 fluid ounces;
G. A pharmacist shall document a registered patient's self-assessment of the effects of cannabidiol oil or THC-A oil in treating the registered patient's intractable epilepsy or the symptoms thereof. A pharmaceutical processor shall maintain such documentation in writing or electronically for two years from the date of dispensing and such documentation shall be made available in accordance with regulation.
VA.R. Doc. No. R17-4878; Filed July 7, 2017, 7:32 a.m.