1 Colo. Code Regs. § 212-3-4-4025
Current through Register Vol. 47, No. 20, October 25, 2024
Section 1 CCR 212-3-4-4025 - Failed Test ProceduresBasis and Purpose - 4025
The statutory authority for this rule includes but is not limited to sections 44-50-202(1)(b), 44-50-203(1)(b), 44-50-203(1)(f), 44-50-203(1)(l), 44-50-203(2)(d), 44-50-203(2)(g), 44-50-203(2)(i), 44-50-203(2)(k), and 44-50-203(2)(r), and 44-50-404(2), C.R.S. The purpose of this rule is to establish the procedures and requirements when a Natural Medicine Business is notified that Regulated Natural Medicine or Regulated Natural Medicine Product fails testing.
These testing rules reflect initial rules that attempt to balance the costs to Natural Medicine Businesses and protect public health and safety. These rules are based on limited available data and prior experience with other similar programs due to the nascent nature of the Regulated Natural Medicine program. The State Licensing Authority will monitor testing data and Participant experiences and may revise testing requirements to require more or less frequent testing, testing for additional or different contaminants, additional testing requirements if additional routes of administration are permitted and other testing updates. Further, if additional Natural Medicines are permitted in the Regulated Natural Medicine program, those may also require additional testing requirements.
A.Failed Contaminant Tests. If a Regulated Natural Medicine Business is notified by a Natural Medicine Testing Facility or the Division of a failed contaminant test, then for each Sample the Natural Medicine Business must destroy and document the destruction of the Harvest Lot or Production Lot in the inventory tracking system, according to the waste Rule 3120.B. If a Licensee's Sample fails contaminant testing, the Licensee shall submit Samples from the next five Harvest Lots or Production Lots for the failed test type(s) by a Natural Medicine Testing Facility regardless of amount of time between each Harvest Lot or Production Lot.1. If the results of any of the next five tests fail a contaminant test, the Natural Medicine Business must complete a required CAPA plan under Rule 5020(E)(3) or 6015(E)(3) and submit the results and any revisions to the Division. The Division will review the revised plan and may conduct an inspection to confirm compliance with the plan.2. If any lot has failed contaminant testing, it cannot be further transferred until the Natural Medicine Business fulfills the CAPA plan and the Division confirms through inspection that the Nonconformances were addressed.47 CR 17, September 10, 2024, effective 10/1/2024