1 Colo. Code Regs. § 212-3-3-3015

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

Section 1 CCR 212-3-3-3015 - Natural Medicine Business Reporting Requirements

Basis and Purpose - 3015

The statutory authority for this rule includes but is not limited to sections 44-50-202(1)(b), 44-50-202(6), 44-50-202(7), 44-50-203(1)(g), 44-50-203(1)(j), and 44-50-203(2)(g), C.R.S. The purpose of this Rule is to identify notice and reporting requirements for Adverse Health Events by Natural Medicine Businesses and Healing Centers, specifically.

A.Adverse Health Event Reporting. If a Natural Medicine Business is notified of any possible Adverse Health Event, as defined in Rule 1025, associated with Regulated Natural Medicine, Regulated Natural Medicine Product, or Natural Medicine Services it must report the Adverse Health Event to the Division no later than within two business days from being notified.

1. To the extent known after reasonable diligence to discover relevant information, the report must contain the name and contact information of the complainant, the date the complaint was received, the nature of the complaint, identifying information found on the label of the Regulated Natural Medicine or Regulated Natural Medicine Product, and any other information that may be requested by the Division for purposes of investigation.

2. Natural Medicine Businesses must maintain records of Adverse Health Event reports in accordance with Rule 3010.

B.Healing Center Requirements. In addition to the requirements in paragraph A of this Rule, a Healing Center must report Adverse Health Events to the Division no later than within two business days from being notified including:

1. Any Participant reaction requiring medical attention; and

2. Any incident requiring emergency response.

C.Crimes on the Licensed Premises or Otherwise Related to the Natural Medicine Business. Natural Medicine Businesses and all Licensees employed by a Natural Medicine Business shall report to the Division any discovered plan or other action of any individual to commit theft, burglary, sales of Regulated Natural Medicine and Regulated Natural Medicine Product, diversion of Regulated Natural Medicine and Regulated Natural Medicine Product, or other crime related to the operation of the Natural Medicine Business. A report shall be made as soon as possible after the discovery of the action or conduct, but not later than 14 days. Nothing in this paragraph C alters or eliminates the obligation a Natural Medicine Business or Licensee may have to report criminal activity to a local law enforcement agency.

1 CCR 212-3-3-3015

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