Rhode Island Code of Regulations
Title 216 - Department of health
Chapter 60 - Laboratories and Medical Examiner
Subchapter 05 - State Laboratory
Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis
Section 216-RICR-60-05-6.17 - Sample Collection - General Requirements

A. Sample collection procedures must be applicable to any cannabis product that registered compassion centers or licensed cultivators may dispense, including, but not limited to, finished plant material; liquid concentrates, resins, edibles, waxes, creams, or other semi-solid or solid CIP products. The analytical laboratory sample collection must be conducted in a manner that provides representative samples so that laboratory testing of all cannabis products is accurate and product labelling requirements can be met. The analytical laboratory sample collector must document every sampling event and provide this documentation to RIDOH upon request.

B. Analytical laboratories may be directed to perform emergency sampling and testing of cannabis products by RIDOH or DBR. Additional costs must be charged to establishment where the cannabis was collected.

C. Cannabis cultivation and production facilities must provide floor plans to the analytical laboratory prior to sample collection that identifies the location and storage of all finished products in the production facility prior to distribution or dispensing.

D. The analytical laboratory sample collector must record the state cannabis tracking identification from the label on each batch of cannabis product collected. The information that accompanies samples must be sufficiently detailed and clearly printed to allow the sample collector to accurately and document the sample identification and tracking number on the chain of custody.

E. The analytical laboratory sample collector must collect representative samples of finished plant material products, liquid concentrates, and resins from each cannabis production batch for analysis. Each sample collected must be representative of the cannabis in its production batch. A minimum range of 0.3 - 0.5% of a batch of plant material is required.

F. Samples from each production batch must be collected in a ready-to-use condition, either for dispensing to patients, or for use as an intermediate or ingredient in making other products. Nothing in this paragraph should be interpreted to supersede any other provision or order requiring and/or authorizing testing at an earlier production stage. Samples of concentrates or oils must be collected following each production batch if they are to be sold, and before any further processing into CIPs.

G. After samples are collected, the establishment where the cannabis was collected must store the entire production batch in a quarantined, secure, cool, and dry location until analytical results are returned by the laboratory. The products must not be released for packaging or sale until the Cannabis Tracking System provides notice of clearance to do so.

H. Sampling frequency is dictated by the production schedules, which may vary among registered compassion centers and licensed cultivators due to scale, product types dispensed, and patient demand. The registered compassion centers and licensed cultivators are responsible for implementing a production batch tracking approach that meets the requirements of these regulations.

I. Analytical laboratory sample collectors must be able to determine that finished products they collect from compassion centers and licensed cultivators are representative of the production process and the finished product's tracking information matches its label.

J. The amount of sample to be collected for cannabinoid or contaminant testing may vary by analytical method and laboratory-specific procedures, therefore the licensed analytical laboratory will specify the minimum sample size required for evaluation. In all cases, the amount of sample collected by the laboratory must be within the range of 0.3 - 0.5% of the batch, large enough and sufficiently homogenized to provide a representative sample of the production batch but not in excess to raise issues with possible diversion or waste disposal.

K. The analytical laboratory must follow its approved sampling plan for collecting finished cannabis products. The sampling plan's procedures required for collecting samples of finished cannabis production batches must result in an accurate sample of the production batch. Production batches will vary in physical form (e.g., plant material, liquid extracts, concentrates and resins), density, and viscosity. Procedures for representative sampling of finished cannabis production batches must be based on those used for food products and herbal medicines in the manner described "General Guidelines on Sampling" CAC/GL 50-2004 incorporated above at § 6.3(A) of this Part, and "Guidance on Obtaining Defensible Samples" incorporated at § 6.3(B) of this Part, and account for differences in the physical forms of the production batches as they relate to homogeneity and quantity.