1 Colo. Code Regs. § 212-3-9-9050

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

Section 1 CCR 212-3-9-9050 - Penalties

Basis and Purpose - 9050

The statutory authority for this rule includes but is not limited to sections 44-50-202(1)(a), 44-50-202(1)(b), 44-50-203(1)(a), 44-50-203(1)(b), 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 establish guidelines for enforcement and penalties that will be imposed by the State Licensing Authority for non-compliance with the Natural Medicine Code or these Rules.

A. This penalty structure is a framework providing guidance as to the range of violations, suspension description, fines, and mitigating and aggravating factors. The circumstances surrounding any penalty imposed will be determined by the State Licensing Authority on a case-by-case basis.

B.Penalty Schedule. The State Licensing Authority will make determinations regarding the type of penalty to impose based on the severity of the violation(s) in the following categories:

1.Level I Violation(s). This category of violation is the most severe and generally has an immediate or potential negative effect on public health, safety, or welfare.

a. The range of available penalties for Level I violations include one or more of the following: license suspension, a fine of up to $25,000.00 per individual violation, and/or license revocation. Sanctions may also include restrictions on the license.

b.Level I Violation(s). This category of violations includes the most severe and may include willful or deliberate violations or violations that result in harm or the potential to harm public safety, health or welfare. Level I violations include, but are not limited to:

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

ii. Diversion of Regulated Natural Medicine or Regulated Natural Medicine Product to a person other than a Natural Medicine Business or a Facilitator;

iii. Any transfer of Regulated Natural Medicine or Regulated Natural Medicine Product to an individual under the age of 21 years;

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

v. Conduct by a Natural Medicine Testing Facility that demonstrates a deliberate or willful violation of a testing rule, a 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);

vi. The manufacture or transfer of Regulated Natural Medicine or Regulated Natural Medicine Product in violation of the Natural Medicine Code or these Rules, including but not limited to the manufacture or transfer of synthetic Natural Medicine;

vii. Violations related to the sharing of Licensed Premises between Natural Medicine Businesses;

viii. Advertising violations including misleading, deceptive, or false advertising or advertising targeting individuals under the age of 21;

ix. Packaging or labeling violations that have an immediate or potential negative impact on public health and safety; or

x. Releasing personally identifying information or medical data maintained or stored at a Natural Medicine Business's Licensed Premises other than as permitted by the Code, these Rules, or any other local, state or federal law.

2.All other Violation(s). This category of violation generally does not have an immediate or potential negative impact on the public health, safety, and welfare.

a. The range of available penalties for all other violations include one or more of the following: license suspension, a fine of up to $10,000.00 per individual violation, and/or license revocation. Sanctions may also include restrictions on the license.

C.Mitigating and aggravating factors. The State Licensing Authority may consider mitigating and aggravating factors when considering the imposition of a penalty. Mitigating and aggravating factors may impact the severity of the penalty imposed for the violation(s).

1. Mitigating factors include:

a. No prior written warning(s), assurance(s) of voluntary compliance, or disciplinary action against Licensee in the preceding 24 months;

b. Corrective action(s) taken by the Licensee related to the violation(s);

c. The Licensee initiated a voluntary recall of the Natural Medicine or Regulated Natural Medicine Product;

d. Good faith efforts taken by the Licensee to comply with the rules;

e. Good faith measures by the Licensee to prevent the violation(s) prior to the Division's investigation, including standard operating procedures which comply with the rules and directly address the conduct leading to the violation, proper supervision, and regularly provided and documented employee training;

f. Licensee self-reported the violation(s); and

g. Any other relevant circumstances which mitigate the violation(s).

2. Aggravating factors include:

a. Licensee transferred unsafe or potentially unsafe Regulated Natural Medicine or Regulated Natural Medicine Product;

b. Conduct or violation(s) resulted in a recall pursuant to Rule 3215, an embargo pursuant to Rule 3220, or a health and safety advisory;

c. Willful or deliberate nature of actions by Licensee;

d. Duration of conduct and violations(s) by Licensee;

e. The quantity of Regulated Natural Medicine or Regulated Natural Medicine Product involved in the conduct or violation(s) by Licensee;

f. Licensee received verbal or written warning(s) or signed assurance(s) of voluntary compliance pursuant to Rule 9035 for the same conduct or violation(s) in the previous 24 months;

g. Prior disciplinary action against Licensee in the previous 24 months for the same conduct or violation(s);

h. Licensee subject to a summary suspension for any conduct or violation(s) in the previous 24 months;

i. Owner or manager involvement in the conduct or violation(s);

j. Involvement by a person unlicensed to work for a Natural Medicine Business;

k. Substantial risk for diversion of Regulated Natural Medicine or Regulated Natural Medicine Product as a result of the Licensee's conduct or violation(s); and

l. Any other relevant circumstances which aggravate the violation(s).

1 CCR 212-3-9-9050

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