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

Current through June 14, 2024
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.