5 Colo. Code Regs. § 1005-7-11

Current through Register Vol. 47, No. 24, December 25, 2024

Rule 5 CCR 1005-7-11 - [Effective 1/14/2025] Natural Medicine Testing Facilities: Chain of Custody

11.1General Requirements. A Natural Medicine Testing Facility must establish an adequate Chain of Custody for handling Samples. Instructions that must include, but are not limited to:

11.1.1 Issue instructions for the minimum Sample requirements and storage requirements;

11.1.1.1 Separate Sample into a test and a retain Sample;

11.1.1.1.1 The Sample shall be fully homogenized prior to dividing into test and retain Samples. The test and retain Samples shall each be sufficient to conduct the required analyses on the Sample.

11.1.1.1.2 The test Sample shall be carried through analysis.

11.1.1.1.3 Retain Sample shall be packaged and stored in accordance with rule 6.1.7.

11.1.2 Document identifying information of the submitting Natural Medicine Business, including Harvest Lot or Production Lot identification;

11.1.3 Assign and document a unique Sample identifier;

11.1.4 Document the condition of the external package and integrity seals utilized to prevent contamination of, or tampering with, the Sample;

11.1.5 Document the condition, temperature, Matrix, and amount of Sample provided at the time of receipt;

11.1.6 Document all persons handling the original Samples, aliquots, and extracts;

11.1.7 Document all Transfers of Samples, aliquots, and extracts referred to another certified Natural Medicine Testing Facility for additional testing or whenever requested by a client;

11.1.8 Maintain a current list of authorized personnel and restrict entry to the Natural Medicine Testing Facility to only those authorized;

11.1.9 Secure the Natural Medicine Testing Facility during non-working hours;

11.1.10 Secure short and long-term storage areas when not in use;

11.1.11 Utilize a secured area to log-in and aliquot Samples;

11.1.12 Ensure Samples are stored appropriately as defined in the written SOP; and

11.1.13 Document the disposal of Samples, aliquots, and extracts; and

11.1.14 Document the license number, inventory tracking number, photograph(s), and the reason for rejection of Samples that were rejected and notify the Colorado Department of Revenue within 7 days of Sample submission.

5 CCR 1005-7-11

47 CR 24, December 25, 2024, effective 1/14/2025