5 Colo. Code Regs. § 1005-7-4

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

Rule 5 CCR 1005-7-4 - [Effective 1/14/2025] Natural Medicine Testing Facilities: Certification Requirements

4.1Certification Category. For required tests, the Natural Medicine Testing Facility must be certified by the Department in the category in order to perform that type of testing.

4.1.1 Microbials;

4.1.2 Tryptamine content; and

4.1.3 Homogeneity.

4.2Certification Procedures and Principles. The Natural Medicine Testing Facility certification program is contingent upon successful on-site inspection, successful participation in proficiency testing, and ongoing compliance with the requirements in this Rule.

4.2.1Certification Inspection. A Natural Medicine Testing Facility must be inspected prior to initial certification and annually thereafter by the Department.

4.2.2Standards for Certification. A Natural Medicine Testing Facility must meet standards of performance, as established by these rules, in order to obtain and maintain certification. Standards of performance include but are not limited to: Personnel Qualifications, Standard Operating Procedures, analytical processes, Proficiency Testing, Quality Control, quality assurance, security, Chain of Custody, Sample retention, Sample disposal, space, records, and results reporting.

4.2.2.1 A Natural Medicine Testing Facility must be accredited under the International Organization for Standardization/International Electrotechnical Commission 17025:2017 Standard (ISO/IEC 17025), or any subsequent superseding ISO/IEC 17025 standard, by an Accreditation body that conforms to ISO/IEC 17011:2017 and is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). In order to obtain and maintain certification in a testing category from the Department, the Natural Medicine Testing Facility's Scope of Accreditation must specify that particular testing category, including the applicable methods and Analytes.

4.2.2.2 Certification will be granted when facilities have met all certification requirements, including ISO/IEC 17025 Accreditation.

4.2.2.3 The Department may grant provisional certification for a testing category if the Natural Medicine Testing Facility has not yet obtained ISO/IEC 17025 Accreditation, but meets all other certification requirements. Such provisional certification shall be for a period not to exceed twelve months.

4.2.3Disclosure of Certification. Prior to performing non-required testing on Regulated Natural Medicine or Regulated Natural Medicine Product, the Natural Medicine Testing Facility must notify the Natural Medicine Business that the Natural Medicine Testing Facility is not certified to perform non-required tests and that such test results have not been certified or subject to state regulator oversight and disclose this on the certificate of analysis

4.2.4Personnel Qualifications.

4.2.4.1Natural Medicine Testing Facility Director. A Natural Medicine Testing Facility must employ, at a minimum, a Natural Medicine Testing Facility director with sufficient education and experience in a regulated laboratory environment in order to obtain and maintain certification. See Rule 5 - Natural Medicine Testing Facilities: Personnel.

4.2.4.2Employee Competency. A Natural Medicine Testing Facility must evaluate and document that employees are competent to perform all aspects of laboratory work for which the employee is responsible.

4.2.4.2.1 Prior to independently analyzing Samples, testing employees must demonstrate acceptable performance on precision, accuracy, and specificity.

4.2.4.2.2 Continued employee competency assessment must be conducted annually and may be conducted using either internally or externally prepared competency tests.

4.2.4.2.3 Qualitative and quantitative information regarding the Analytes being assessed shall remain unknown to the employee(s) performing the assessment until the competency assessment has been completed.

4.2.5Standard Operating Procedures. A Natural Medicine Testing Facility must have written Standard Operating Procedures meeting the minimum standards set forth in these rules detailing the performance of all methods employed by the facility used to test the Analytes it reports that are available for testing analysts to follow at all times.

4.2.5.1 The current Natural Medicine Testing Facility director must approve, sign and date each procedure. If any modifications are made to those procedures, the Natural Medicine Testing Facility director must approve, sign, and date the revised version prior to use.

4.2.5.2 A Natural Medicine Testing Facility must maintain a copy of all Standard Operating Procedures to include any revised copies for a minimum of three years. See Rule 12 - Natural Medicine Testing Facilities: Records Retention and Rule 13 - Natural Medicine Testing Facilities: Business Records Required.

4.2.5.3 A Natural Medicine Testing Facility must inform the Department of any major method changes to Standard Operating Procedures pertaining to certified analytical methods, prior to implementing the changes. Major method changes include, but are not limited to: modifications to Sample preparation, changes in column type, enrichment media, solvent(s) used, instrumentation or instrumentation parameters.

4.2.6Analytical Processes. A Natural Medicine Testing Facility must maintain a listing of all analytical methods used and all Analytes tested and reported. The Natural Medicine Testing Facility must provide this listing to the Department upon request.

4.2.7Proficiency Testing. A Natural Medicine Testing Facility must successfully participate in a Department approved Proficiency Testing program in order to obtain and maintain certification.

4.2.8Quality Assurance and Quality Control. A Natural Medicine Testing Facility must establish and follow a quality assurance and Quality Control program to ensure sufficient monitoring of Natural Medicine Testing Facility processes and quality of results reported.

4.2.9Security. A Natural Medicine Testing Facility must be located in a secure setting to prevent unauthorized persons from gaining access to the testing and storage areas of the Natural Medicine Testing Facility.

4.2.10Chain of Custody. A Natural Medicine Testing Facility must establish a system to document the complete Chain of Custody for Samples from receipt through disposal.

4.2.11Space. A Natural Medicine Testing Facility must be located in a fixed structure that provides adequate infrastructure to perform analysis in a safe and compliant manner consistent with federal, state, and local requirements.

4.2.12Records. A Natural Medicine Testing Facility must establish a system to retain and maintain records for a period not less than three years. See Rules 12 - Natural Medicine Testing Facility: Records Retention and Rule 13 - Natural Medicine Testing Facilities: Business Records Required.

4.2.13Results Reporting. A Natural Medicine Testing Facility must establish processes to ensure results are reported in a timely and accurate manner. A Natural Medicine Testing Facility's process may require that the Natural Medicine Cultivator or Natural Medicine Product Manufacturer remit payment for any test conducted by the Natural Medicine Testing Facility prior to reporting results. A Natural Medicine Testing Facility's process established under this subparagraph (12) must be maintained on the premises of the Natural Medicine Testing Facility.

4.2.14Conduct While Seeking Certification. A Natural Medicine Testing Facility, and its agents and employees, shall provide all documents and information required or requested by the Department and its employees in a full, faithful, truthful, and fair manner.

5 CCR 1005-7-4

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