Notice of Public Comment Period

 Board of Pharmacy

Regulations Governing Pharmaceutical Processors

In accordance with subsection N of § 54.1-3442.6 of the Code of Virginia, the Board of Pharmacy is providing an opportunity to comment on a draft of proposed regulations for pharmaceutical processors that will be considered for adoption as an exempt action.

The proposed regulations as drafted make technical corrections to regulations that became effective on September 1, 2021

The 2021 legislation requires posting of a notice 60 days in advance of submittals for public comment. The Board of Pharmacy is scheduled to meet on December 7, 2021 with the intent of adopting amendments to 18VAC110-60 (Regulations Governing Pharmaceutical Processors) by exempt action.

The Board will receive public comment from September 27, 2021 to November 26, 2021, commenters are strongly encouraged to submit comments by November 22, 2021 in order to have them included in the Board’s agenda package and adequately considered for the December meeting.

Comments may be sent to:  elaine.yeatts@dhp.virginia.gov

Elaine J. Yeatts

Agency Regulatory Coordinator

9960 Mayland Drive

Henrico, VA 23233

(804) 367-4688

Proposed amendments to 18VAC110-60: Regulations Governing Pharmaceutical Processors

18VAC110-60-10. Definitions.

"Electronic tracking system" means an electronic radio-frequency identification (RFID) seed-to-sale tracking system that tracks the Cannabis from either the seed or immature plant stage until the cannabis oil product is sold to a registered patient, parent, legal guardian, or registered agent or until the Cannabis, including the seeds, parts of plants, and extracts, are destroyed. The electronic tracking system shall include, at a minimum, a central inventory management system and standard and ad hoc reporting functions as required by the board and shall be capable of otherwise satisfying required recordkeeping.

"Perpetual inventory" means an ongoing system for recording quantities of cannabis oil product received, dispensed, or otherwise distributed by a cannabis dispensing facility.

18VAC110-60-160. Grounds for action against a pharmaceutical processor permit or a cannabis dispensing facility.

In addition to the bases enumerated in § 54.1-3316 of the Code of Virginia, the board may suspend, revoke, or refuse to grant or renew a permit issued; place such permit on probation; place conditions on such permit; or take other actions permitted by statute or regulation on the following grounds:

6. Failure to cooperate or give information to the board on any matter arising out of conduct at a pharmaceutical processor or cannabis dispensing facility; or

18VAC110-60-190. Pharmacy technicians; ratio; supervision and responsibility.

A. The ratio of pharmacy technicians to pharmacists on duty in the areas of a pharmaceutical processor a cannabis dispensing facility designated for production or dispensing or in a cannabis dispensing facility shall not exceed six pharmacy technicians to one pharmacist.

18VAC110-60-230. Inventory requirements.

D. The record of all cannabis products sold, dispensed, or otherwise disposed of shall show the date of sale or disposition; the name of the pharmaceutical processor or cannabis dispensing facility; the name and address of the registered patient, parent, legal guardian, or registered agent to whom the cannabis product was sold; the kind and quantity of cannabis product sold or disposed of; and the method of disposal.

18VAC110-60-300. Laboratory requirements; testing.

B. After processing and before dispensing the cannabis oil product, a pharmaceutical processor shall make a sample available from each homogenized batch of product for a laboratory to (i) test for microbiological contaminants, mycotoxins, heavy metals, residual solvents, and pesticide chemical residue, and, for botanical cannabis, the water activity and moisture content; and (ii) conduct an active ingredient analysis and terpenes profile. Each laboratory shall determine a valid sample size for testing, which may vary due to sample matrix, analytical method, and laboratory-specific procedures. A minimum sample size of 0.5% of individual units for dispensing or distribution from each homogenized batch of cannabis oil is required to achieve a representative sample for analysis.

G. If a sample of cannabis oil product does not pass the microbiological, mycotoxin, heavy metal, pesticide chemical residue, or residual solvent test based on the standards set forth in this subsection, the batch may be remediated with further processing. After further processing, the batch shall be retested for microbiological, mycotoxin, heavy metal, pesticide chemical residue, and residual solvent, and an active ingredient analysis and terpenes profile shall be conducted.

5. For purposes of the active ingredient analysis, a sample of the cannabis oil product shall be tested for:

a. Tetrahydrocannabinol (THC);

b. Tetrahydrocannabinol acid (THC-A);

c. Cannabidiols (CBD); and

d. Cannabidiolic acid (CBDA).

For botanical cannabis products, only the total cannabidiol (CBD) and total tetrahydrocannabinol (THC) are required.

Note: For 300 B: "and, for botanical cannabis, the water activity and moisture content," has been included in 300 C

For 300 G 5 "For botanical cannabis products, only the total cannabidiol (CBD) and total tetrahydrocannabinol (THC) are required and has been included in 300 H 5.