Basis and Purpose - 7025
The statutory authority for this Rule includes but is not limited to sections 25-2.5-120, 44-50-202(1)(b), 44-50-203(1)(b), 44-50-203(1)(f), 44-50-203(1)(j), 44-50-203(2)(g), 44-50-203(2)(k), and 44-50-404(2), C.R.S. The purpose of this Rule is to establish chain of custody requirements for a Natural Medicine Testing Facility to track and document the Samples received from Licensees.
A.General Requirements. A Natural Medicine Testing Facility must establish an adequate chain of custody for handling Samples. Instructions must include, but are not limited to: 1. Issue instructions for the minimum Sample requirements and storage requirements;2. Document the condition of the external package and integrity seals utilized to prevent contamination of, or tampering with, the Sample;3. Document the condition and amount of Sample provided at the time of receipt;4. Document all persons handling the original Sample, aliquots, and extracts;5. Document all transfers of Samples, aliquots, and extracts referred to another certified Natural Medicine Testing Facility Licensee for additional testing or whenever requested by a client;6. Maintain a current list of authorized personnel and restrict entry to the laboratory to only those authorized;7. Secure the Licensed Premises during non-working hours;8. Secure short and long-term storage areas when not in use;9. Utilize a secured area to log-in and aliquot Samples;10. Ensure Samples are stored appropriately;11. Document the disposal of Samples, aliquots, and extracts; and12. Document the License number, inventory tracking number, photograph(s), and the reason for rejection of Samples that were rejected and notify the Division within 7 days of Sample submission.47 CR 17, September 10, 2024, effective 10/1/2024