1 Colo. Code Regs. § 212-3-9-9010

Current through Register Vol. 47, No. 20, October 25, 2024

Section 1 CCR 212-3-9-9010 - Written Warnings and Assurances of Voluntary Compliance

Basis and Purpose - 9010

The statutory authority for this rule includes but is not limited to sections 44-50-202(1)(a), 44-50-202(1)(b), 44-50-202(1)(c), 44-50-203(1)(a), 44-50-203(2)(l), 44-50-203(2)(m), 44-50-203(2)(r), and 44-50-701, C.R.S. The purpose of this rule is to provide a procedure for written warnings and assurances of voluntary compliance for non-compliance with the Natural Medicine Code or these Rules.

A.Written Warnings. If a Division investigator identifies a violation(s) of the Natural Medicine Code or these Rules that is eligible for a written warning pursuant to subpart (D) of this Rule, the Division investigator may issue a written warning in lieu of recommending administrative action.

1. The written warning shall identify the alleged violation(s).

2. The written warning shall not constitute an admission of a violation(s) for any purpose or finding of a violation(s) by the State Licensing Authority, and shall not be evidence that the Licensee violated the Natural Medicine Code, or these Rules.

3. A written warning shall constitute evidence in any subsequent administrative proceeding, if relevant, that the Licensee was previously warned of the violation(s).

4. The Division may in its discretion initiate a subsequent administrative action and prove the violation(s) that was the subject of the written warning.

B.Assurances of Voluntary Compliance. The Director of the Division may accept an assurance of voluntary compliance regarding any act or practice alleged to violate the Natural Medicine Code or these Rules that is eligible for an assurance of voluntary compliance pursuant to subpart (D) of this Rule.

1. The assurance must be in writing and may include a stipulation for the voluntary payment of the cost commensurate with the acts or practices and an amount necessary to restore money or property which may have been acquired by the alleged violator because of the acts or practices.

2. An assurance of voluntary compliance may not be considered an admission of a violation(s) for any purpose or a finding of a violation(s) by the State Licensing Authority; however, the assurance of voluntary compliance shall constitute evidence in any subsequent administrative proceeding that Licensee entered into an agreement to comply with the Natural Medicine Code, and/or these Rules.

3. The State Licensing Authority may review an assurance of voluntary compliance.

C.Not an Administrative Action. Neither a written warning nor an assurance of voluntary compliance constitutes an administrative action.

D.Not Eligible for Written Warning or Assurance of Voluntary Compliance. If a Division investigator identifies a violation(s) of the Natural Medicine Code or these Rules, the following conduct is not eligible for a Written Warning or Assurance of Voluntary Compliance:

1. Knowingly adulterating or altering a Sample, Production Lot, or Harvest Lot;

2. A violation by a Natural Medicine Testing Facility including a deliberate or willful violation of a testing rule, a violation or deviation from a rule or a standard operating procedure that results in the potential to harm public health of safety, or any acts by a Natural Medicine Testing Facility that produce a test result favorable to a Licensee (over reporting tryptamine content, under reporting contaminants, other inaccurate test results).

3. Any sale or transfer of Regulated Natural Medicine or Regulated Natural Medicine Product in violation of the Natural Medicine Code or these Rules;

4. Transferring Regulated Natural Medicine or Regulated Natural Medicine Product to an individual under the age of 21 years;

5. Any unlawful act by a Person licensed pursuant to article 50 in violation of section 44-50-501, C.R.S.; and

6. Inversion of unregulated Natural Medicine or Natural Medicine Product to a Natural Medicine Business from a source other than another Natural Medicine Business.

1 CCR 212-3-9-9010

47 CR 17, September 10, 2024, effective 10/1/2024