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4-125 – Potency Testing

Basis and Purpose

The statutory authority for this rule includes but is not limited to sections 44-10-202(1)(c), 44-10-203(1)(a), 44-10-203(1)(c), 44-10-203(1)(g), 44-10-203(1)(j), 44-10-203(2)(d), 44-10-203(2)(f), 44-10-203(3)(d), 44- 10-203(3)(e), 44-10-501(6), 44-10-502(3), 44-10-503(8), 44-10-504(1)(b), 44-10-504(2), 44-10-601(4), 44-10-602(4), 44-10-603(6), 44-10-604(1)(b), and 44-10-604(2), 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 Regulated Marijuana sampling and testing program. This Rule 4-125 was previously Rules M and R 1503, 1 CCR 212-1 and 1 CCR 212-2.

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 Medical Marijuana or Retail Marijuana or from the same Production Batch of Medical Marijuana Concentrate or Medical Marijuana Product, 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 Regulated Marijuana.

  1. Initial Potency Testing. A Medical Marijuana Cultivation Facility or a Retail Marijuana Cultivation Facility must have potency tests conducted by a Medical Marijuana Testing Facility or a Retail Marijuana Testing Facility on four Harvest Batches, created a minimum of one week apart, for each strain of Regulated Marijuana that it cultivates. See Rule 4-105(B).
    • The first potency test must be conducted on each strain prior to the Medical Marijuana Cultivation Facility or the Retail Marijuana Cultivation Facility Transferring or processing into a Medical Marijuana Concentrate any Medical Marijuana of that strain, or into a Retail Marijuana Concentrate any Retail Marijuana of that strain.
    • All four potency tests must be conducted on each strain no later than December 1, 2014 or six months after the Medical Marijuana Cultivation Facility or the Retail Marijuana Cultivation Facility begins cultivating that strain, whichever is later.
  2. Ongoing Potency Testing. After the initial four potency tests, a Medical Marijuana Cultivation Facility or a Retail Marijuana Cultivation Facility shall have each strain of Regulated Marijuana that it cultivates tested for potency at least once per quarter.
    • If the Licensee fails to comply with paragraph (B)(2) of this Rule, the Medical Marijuana Cultivation Facility or Retail Marijuana Cultivation Facility is no longer process validated.

C. Potency Testing for Regulated Marijuana Concentrate.

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

D. Potency Testing for Regulated Marijuana – Kief.

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

E. Potency Testing for Regulated Marijuana Product.

  1. Potency Testing Required for Regulated Marijuana Product. A Medical Marijuana Products Manufacturer or a Retail Marijuana Products Manufacturer shall have potency tests conducted by a Medical Marijuana Testing Facility or a Retail Marijuana Testing Facility on every Production Batch of each type of Regulated Marijuana Product that it produces prior to Transferring any of the Regulated Marijuana Product from that Production Batch, unless the Medical Marijuana Products Manufacturer or the Retail Marijuana Products Manufacturer has successfully completed process validation for potency and homogeneity for the particular type of Regulated Marijuana Product.
  2. Required Tests. Potency and homogeneity tests conducted on Regulated 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 Regulated Marijuana Products. If only a portion of a Regulated Marijuana Product is infused with Regulated Marijuana, then the Medical Marijuana Products Manufacturer or Retail Marijuana Products Manufacturer must inform the Medical Marijuana Testing Facility or Retail Marijuana Testing Facility of exactly which portions of the Regulated Marijuana Product are infused and which portions are not infused.

F. Process Validation – Potency and Homogeneity

  1. A Retail Marijuana Products Manufacturer may process validate potency and homogeneity for each type of Retail Marijuana Product it manufactures.
  2. A Medical Marijuana Products Manufacturer may process validate potency and homogeneity for each type of non-Edible Medical Marijuana Product and each type of Edible Medical Marijuana Product that it manufactures so long as the Edible Medical Marijuana Product contains 100 milligrams or less of THC.
  3. A Medical Marijuana Products Manufacturer’s production process for a particular type of Medical Marijuana Product, and a Retail Marijuana Products Manufacturer’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 Regulated 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 4- 125(D)(2). This must include at least four Test Batches.
  4. Expiration of Process Validation. A Medical Marijuana Products Manufacturer or a Retail Marijuana Products Manufacturer 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 Medical Marijuana Products Manufacturer or Retail Marijuana Products Manufacturer shall comply with the requirements of Paragraph (D)(1) of this Rule.
  5. Regulated Marijuana Product Ongoing Potency and Homogeneity Testing. After successfully obtaining process validation, once per quarter a Medical Marijuana Products Manufacturer and a Retail Marijuana Products Manufacturer shall subject at least one Production Batch of each type of Medical Marijuana Product or Retail Marijuana Product that it produces to potency and homogeneity testing required by Paragraph (D) of this Rule. If during any quarter a Medical Marijuana Products Manufacturer or a Retail Marijuana Products Manufacturer does not possess a Production Batch that is ready for testing, the Medical Marijuana Products Manufacturer or Retail Marijuana Products Manufacturer 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 Regulated Marijuana. If a Test Batch submitted for ongoing potency and homogeneity testing fails potency and homogeneity testing, the Medical Marijuana Products Manufacturer or the Retail Marijuana Products Manufacturer shall follow the procedure in Paragraph (F)(2) of this Rule. Ongoing potency and homogeneity testing pursuant to this Rule 4-125 shall be subject to the requirements in Rule 4-110. See Rule 4-110(A) – Collection of Samples.
    • The Division may reduce the frequency of ongoing potency and homogeneity testing required by Medical Marijuana Products Manufacturers and Retail Marijuana Products Manufacturers if the Division has reasonable grounds to believe Medical Marijuana Testing Facilities and 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.
    • If the Licensee fails to comply with paragraph (F)(5) of this Rule, the Medical Marijuana Cultivation Facility or Retail Marijuana Cultivation Facility is no longer process validated.

G. Exemption

Any Regulated Marijuana that will be allocated for extraction in the Inventory Tracking System shall be considered exempt from potency testing pursuant to this Rule and the 4-100 Series Rules.

H. Required Re-Validation – Potency and Homogeneity – Regulated Marijuana Product.

  1. Material Change Re-Validation. If a Medical Marijuana Products Manufacturer or a Retail Marijuana Products Manufacturer elects to process validate any Medical Marijuana Products or Retail Marijuana Product for potency and homogeneity and it makes a Material Change to its production process for that particular type of Medical Marijuana Product or Retail Marijuana Product, then the Medical Marijuana Products Manufacturer or Retail Marijuana Products Manufacturer must re-validate the production process.
    • New Equipment. It is a Material Change if the Medical Marijuana Products Manufacturer or Retail Marijuana Products Manufacturer begins using new or different equipment for any material part of the production process.
    • Notification. A Medical Marijuana Products Manufacturer or a Retail Marijuana Product Manufacturer must notify the Medical Marijuana Testing Facility or Retail Marijuana Testing Facility of a Material Change.
    • Testing Required Prior to Transfer. When a Production Batch is required to be submitted for testing pursuant to this Rule, the Medical Marijuana Products Manufacturer or Retail Marijuana Products Manufacturer that produced it may not Transfer Regulated Marijuana Product from that Production Batch unless or until it obtains a passing test.
  2. Failed Potency Testing Re-Validation. Failed potency testing may constitute a violation of these rules.
    • If a Sample is required to be tested by these Rules or required to be tested by the Division pursuant to Rule 4-120(A) and fails potency testing, the Medical Marijuana Products Manufacturer or Retail Marijuana Products Manufacturer shall follow the procedures in Rule 4-135(C) for any Inventory Tracking System package or Production Batch associated with the failed Sample.
    • The Medical Marijuana Products Manufacturer or Retail Marijuana Products Manufacturer shall also submit Test Batches from three new Production Batches of the Medical Marijuana Product or Retail Marijuana Product for potency testing by a Medical Marijuana Testing Facility or Retail Marijuana Testing Facility within no more than 30 days. If any one of the three submitted Test Batches fails potency testing, the Medical Marijuana Products Manufacturer or Retail Marijuana Products Manufacturer shall re-validate its process for potency.

I. Violation Affecting Public Safety.

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

Updated on May 6, 2020

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