R 1503 – Potency Testing

Basis and Purpose

The statutory authority for this rule includes but is not limited to sections 44-12-202(2)(b), 44-12- 202(3)(a)(IV), 44-12-202(3)(a)(VII), 44-12-202(3)(a)(X), 44-12-202(3)(a)(XII), 44-12-202(3)(c)(III), 44-12- 202(3)(c)(VIII), 44-12-202(3)(d)(IV), 44-12-202(3)(d)(V), 44-12-202(3)(d)(VI), 44-12-402(4), 44-12-403(4), and 44-12-404(6), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VII). The purpose of this rule is to protect the public health and safety by establishing the potency testing and related process validation portion of the Division’s Retail Marijuana sampling and testing program.

Potency Testing

A. Potency Testing – General

  1. Test Batches. A Test Batch submitted for potency testing may only be comprised of Samples that are of the same strain of Retail Marijuana or from the same Production Batch of Retail Marijuana Concentrate or Retail Marijuana Product.
  2. Cannabinoid Profile. A potency test conducted pursuant to this rule must at least determine the level of concentration of THC, THCA, CBD, CBDA and CBN.

B. Potency Testing for Retail Marijuana.

  1. Initial Potency Testing. A Retail Marijuana Cultivation Facility must have potency tests conducted by a Retail Marijuana Testing Facility on four Harvest Batches, created a minimum of one week apart, for each strain of Retail Marijuana that it cultivates.
    1. The first potency test must be conducted on each strain prior to the Retail Marijuana Cultivation Facility Transferring or processing into a Retail Marijuana Concentrate any Retail Marijuana of that strain.
    2. All four potency tests must be conducted on each strain no later than December 1, 2014 or six months after the Retail Marijuana Cultivation Facility begins cultivating that strain, whichever is later.
  2. Ongoing Potency Testing. After the initial four potency tests, a Retail Marijuana
    Cultivation Facility shall have each strain of Retail Marijuana that it cultivates tested for potency at least once per quarter.

C. Potency Testing for Retail Marijuana Concentrate. 

A Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility must have a potency test conducted by a Retail Marijuana Testing Facility on every Production Batch of Retail Marijuana Concentrate that it produces prior to Transferring or processing into a Retail Marijuana Product any of the Retail Marijuana Concentrate from that Production Batch.

C.1. Potency Testing for Retail Marijuana – Kief.

A Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility must have a potency test conducted by a Retail Marijuana Testing Facility on every Harvest Batch of Kief that it produces prior to Transferring the Kief.

D. Potency Testing for Retail Marijuana Product

  1. Potency Testing Required for Retail Marijuana Product. A Retail Marijuana Products Manufacturing Facility shall have potency tests conducted by a Retail Marijuana Testing Facility on every Production Batch of each type of Retail Marijuana Product that it produces prior to Transferring any of the Retail Marijuana Product from that Production Batch, unless the Retail Marijuana Products Manufacturing Facility has successfully completed process validation for potency and homogeneity for the particular type of
    Retail Marijuana Product.
    1.5 Repealed.
  2. Required Tests. Potency and homogeneity tests conducted on Retail Marijuana Product must determine the level of concentration of the required Cannabinoids and whether or not THC is homogeneously distributed throughout the product.
  3. Partially Infused Retail Marijuana Products. If only a portion of a Retail Marijuana Product is infused with Retail Marijuana, then the Retail Marijuana Products Manufacturing Facility must inform the Retail Marijuana Testing Facility of exactly which portions of the Retail Marijuana Product are infused and which portions are not infused.

E. Process Validation – Potency and Homogeneity

  1. A Retail Marijuana Products Manufacturing Facility may process validate potency and homogeneity for each type of Retail Marijuana Product it manufactures.
  2. A Retail Marijuana Products Manufacturing Facility’s production process for a particular type of Retail Marijuana Product shall be deemed valid regarding potency and homogeneity if every Production Batch that it produces for that particular type of Edible Retail Marijuana Product during at least a four-week period but no longer than an eight week period passes all potency and homogeneity tests required by Rule R 1503(D)(2). This must include at least four Test Batches.
  3. Expiration of Process Validation. Once a Retail Marijuana Products Manufacturing Facility shall be required to re-validate its process every 12 months from the date process validation is achieved, after which point the process validation expires. If the process validation expires, the Retail Marijuana Products Manufacturing Facility shall comply with the requirements of Paragraph (D)(1) of this Rule.
  4. Retail Marijuana Product Ongoing Potency and Homogeneity Testing. After successfully obtaining process validation, once per quarter a Retail Marijuana Products Manufacturing Facility shall subject at least one Production Batch of each type of Retail Marijuana Product that it produces to potency and homogeneity testing required by Paragraph (D) of this Rule. If during any quarter a Retail Marijuana Products Manufacturing Facility does not possess a Production Batch that is ready for testing, the Retail Marijuana Products Manufacturing Facility must subject its first Production Batch that is ready for testing to the required potency and homogeneity testing prior to Transfer or processing of the Retail Marijuana. If a Test Batch submitted for ongoing potency and homogeneity testing fails potency and homogeneity testing, the Retail Marijuana Products Manufacturing Facility shall follow the procedure in Paragraph (F)(2) of this Rule. Ongoing potency and homogeneity testing pursuant to this Rule R 1503 shall be subject to the requirements in Rule R 1504. See Rule R 1504(A) – Collection of Samples.
    1. The Division may reduce the frequency of ongoing potency and homogeneity testing required by Retail Marijuana Products Manufacturing Facilities if the Division has reasonable grounds to believe Retail Marijuana Testing Facilities have reached maximum capacity to perform testing required by this Rule. The Division will provide notification of any reduction to the frequency of ongoing potency and homogeneity testing to the Licensee’s last electronic mailing
      address provided to the Division.

F. Required Re-Validation – Potency and Homogeneity – Retail Marijuana Product.

  1. Material Change Re-Validation. If a Retail Marijuana Products Manufacturing Facility elects to process validate any Retail Marijuana Product for potency and homogeneity and it makes a Material Change to its production process for that particular type of Retail Marijuana Product, then the Retail Marijuana Products Manufacturing Facility must revalidate the production process.
    1. New Equipment. It shall be considered a Material Change if the Retail Marijuana Products Manufacturing Facility begins using new or different equipment for any material part of the production process.
    2. Notification. A Retail Marijuana Product Manufacturing Facility must notify the Retail Marijuana Testing Facility of a Material Change.
    3. Testing Required Prior to Transfer. When a Production Batch is required to be submitted for testing pursuant to this rule, the Marijuana Product Manufacturing Facility that produced it may not Transfer Retail Marijuana Product from that Production Batch unless or until it obtains a passing test.
  2. Failed Potency Testing Re-Validation. If a Sample the Division requires to be tested fails potency testing, the Retail Marijuana Products Manufacturing Facility shall follow the procedures in Rule R 1507(C) for any Inventory Tracking System package or Production Batch associated with the failed Sample. The Retail Marijuana Products Manufacturing Facility shall also submit three additional Test Batches of the Retail Marijuana Product for potency testing by a Retail Marijuana Testing Facility within no more than 30 days. If any one of the three submitted Test Batches fails potency testing, the Retail Marijuana
    Products Manufacturing Facility shall re-validate its process for potency.
  3. Repealed.

G. Violation Affecting Public Safety.

Failure to comply with this rule may constitute a license violation affecting public safety.

Updated on July 21, 2019

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