Code of Colorado Regulations
200 - Department of Revenue
213 - Natural Medicine Division
1 CCR 213-1 - COLORADO REGULATED NATURAL MEDICINE RULES
Part 3 - General Privileges and Limitations
Section 1 CCR 212-3-3-3205 - Recall of Regulated Natural Medicine or Regulated Natural Medicine Product

Universal Citation: 200 CO Code Regs 1 CCR 212-3-3-3205

Current through Register Vol. 47, No. 17, September 10, 2024

Basis and Purpose - 3205

The statutory authority for this rule includes but is not limited to sections 44-50-202(1)(b), 44-50-203(1)(j), 44-50-203(1)(b), 44-50-203(2)(g), 44-50-203(2)(i), 44-50-203(2)(k), and 44-50-203(2)(p), C.R.S. The purpose of this rule is to establish minimum requirements for a recall plan and the process by which the Division or a Natural Medicine Business initiates, performs, and terminates a recall.

A. Applicability. This Rule 3205 applies to all Natural Medicine Business Licensees. Owner Licensees are responsible for the recall plan and the necessary steps for a recall in accordance with this Rule. The recall plan may designate additional Natural Medicine Handler Licensees as points of contact in the event of a recall.

B. Initiating a Recall. A Natural Medicine Business may initiate a recall at any time, or a recall may be initiated at the Division's request. Natural Medicine Businesses must comply with the requirements of this Rule 3205.

1. Division Request for Recall.
a. If the Division requests a Natural Medicine Business initiate a recall pursuant to this Rule, the Division's correspondence, which may be electronic, must include the reasons for the recall request and any other information necessary for the Natural Medicine Business to initiate the recall.

b. A Division request for recall does not require the Natural Medicine Business to initiate a recall. However, if the Division has reasonable grounds to believe a Licensee's Regulated Natural Medicine or Regulated Natural Medicine Product is contaminated or otherwise presents a risk to public safety, the Division may require a Natural Medicine Business to quarantine or embargo the affected inventory.

2. Voluntary Recall.
a. A Natural Medicine Business may voluntarily initiate a recall.

b. If a Natural Medicine Business elects to initiate a recall, the Licensee must notify the Division at least 24 hours prior to notifying other Licensees, Facilitators, Participants, or other interested or affected persons in order to facilitate coordination between the Licensee and the Division.

C. Recall Plan Required. Natural Medicine Cultivation Facilities and Natural Medicine Products Manufacturers must have a written recall plan. A recall plan shall include, but is not limited to, the following:

1. Evaluation of a Complaint or Condition. Natural Medicine Businesses must maintain a record of all complaints it receives regarding the quality of Regulated Natural Medicine and Regulated Natural Medicine Product that has any potential negative impact to health or an adverse reaction in accordance with Rule 3015. If an initial assessment indicates a recall may be necessary, the Natural Medicine Business shall:
a. Determine the hazard and evaluate the safety concerns with the product;

b. Undertake necessary product quarantine measures for any affected Regulated Natural Medicine and Regulated Natural Medicine Product; and

c. Determine the appropriate product removal strategy considering the potential adverse reactions and amount of product transferred to other Licensees and Participants.

2. Identification of Affected Regulated Natural Medicine and Regulated Natural Medicine Product. A recall plan must establish a process for identifying affected Regulated Natural Medicine and/or Regulated Natural Medicine Product, which shall include the following:
a. Distribution List. When identifying Regulated Natural Medicine and/or Regulated Natural Medicine Product subject to a recall, the Licensee shall create a distribution list that includes the following information:
i. The name, license number, and address of the Natural Medicine Business(es) that received the Regulated Natural Medicine and/or Regulated Natural Medicine Product subject to the recall;

ii. Ship or transfer date(s) for the Regulated Natural Medicine and/or Regulated Natural Medicine Product subject to the recall; and

iii. Business contact information for each Natural Medicine Business that received Regulated Natural Medicine and Regulated Natural Medicine Product subject to the recall, including names and telephone numbers.

b. Product Information. When identifying Regulated Natural Medicine and/or Regulated Natural Medicine Product subject to a recall, the Licensee shall document the following product information:
i. Product description;

ii. Net contents;

iii. Harvest Lot and/or Production Lot number;

iv. The license number(s) for the Natural Medicine Business(es) that cultivated or manufactured the Regulated Natural Medicine and/or Regulated Natural Medicine Product subject to the recall; and

v. To the extent known after reasonable diligence to collect information, the recall plan must also include the following additional product information: the amount of affected Regulated Natural Medicine and Regulated Natural Medicine Product returned to the Natural Medicine Cultivation or Natural Medicine Product Manufacturer in response to the recall.

3. Notifications.
a. A Licensee initiating a recall pursuant to this Rule shall issue a recall notice to all Natural Medicine Businesses identified on the Licensee's distribution list.

b. No later than 48 hours after issuing a recall notice to all Natural Medicine Businesses on the Licensee's distribution list, the Licensee shall also:
i. Notify the Division and the Department of Public Health & Environment that the recall has been initiated; and

ii. Post an alert on the Licensee's website, social media, or other method of notifying Participants and Facilitators.

c. Recall Notice. A recall notice issued by a Natural Medicine Business pursuant to this Rule shall include at least the following information:
i. The reason for recall and related hazards, if any. If the Regulated Natural Medicine and/or Regulated Natural Medicine Product is being removed for quality rather than health reasons, the notice may state that the Regulated Natural Medicine and Regulated Natural Medicine Product does not meet internal company specifications and is being removed from distribution;

ii. Natural Medicine Businesses that received the Regulated Natural Medicine and/or Regulated Natural Medicine Product;

iii. The License number(s) and name(s), including trade names or "doing business as" names, of the Natural Medicine Business(es) that cultivated or manufactured the Regulated Natural Medicine and/or Regulated Natural Medicine Product subject to the recall;

iv. Product description(s) for Regulated Natural Medicine and/or Regulated Natural Medicine Product subject to the recall;

v. Expiration date(s) for the Regulated Natural Medicine and/or Regulated Natural Medicine Product subject to the recall, if applicable;

vi. Ship or transfer date(s) for the Regulated Natural Medicine and/or Regulated Natural Medicine Product subject to the recall; and

vii. Instructions regarding the disposition of Regulated Natural Medicine and/or Regulated Natural Medicine Product subject to the recall.

4. Removal of Affected Regulated Natural Medicine and Regulated Natural Medicine Product.
a. Removal. A Natural Medicine Business shall make all reasonable efforts to remove the affected Regulated Natural Medicine and/or Regulated Natural Medicine Product from licensed Facilities. Affected Regulated Natural Medicine and Regulated Natural Medicine Product that is either still in control of the originating Licensee or located at another Licensed Premises shall be secured, segregated, clearly labeled "Not for Distribution," and separated from any other Regulated Natural Medicine and Regulated Natural Medicine Product.

b. Disposal. Regulated Natural Medicine and Regulated Natural Medicine Product subject to a recall under this Rule shall be disposed of in accordance with Rule 3120.

c. Recall Effectiveness. A Natural Medicine Business initiating a recall pursuant to this Rule is responsible for determining whether the recall is effective. The Licensee shall complete recall effectiveness checks to verify that all receiving Licensees have been notified and have taken the appropriate action.
i. Effectiveness checks shall determine:
A. If the receiving Licensee(s) received the recall notification;

B. If the recalled Regulated Natural Medicine and Regulated Natural Medicine Product was handled as instructed in the recall notification; and

C. If the Regulated Natural Medicine and Regulated Natural Medicine Product was further dispensed by the receiving Licensee before receipt of the recall notification, and if so, were additional Licensees, Participants, and Facilitators notified.

ii. If the Licensee accounts for 100 percent of the affected Regulated Natural Medicine and Regulated Natural Medicine Product, then no effectiveness checks are required.

5. Annual Audit of Recall Plan. The Natural Medicine Business must annually audit their recall plan to determine if any changes in the operation of their business would require an update to the plan.

D. Termination of Recall.

1. A Natural Medicine Business initiating a recall pursuant to this Rule may terminate a recall when the Licensee determines that reasonable efforts have been made to remove or correct the affected Regulated Natural Medicine and/or Regulated Natural Medicine Product in accordance with the recall plan, and when it is reasonable to assume that the Regulated Natural Medicine and/or Regulated Natural Medicine Product subject to the recall has been removed and properly disposed of, or correction has been made commensurate with the degree of the hazard of the recalled Regulated Natural Medicine and/or Regulated Natural Medicine Product.

2. Upon termination of the recall, the Natural Medicine Business shall provide notice to the Division with a recall status report and a description of the disposition of the recalled Regulated Natural Medicine and/or Regulated Natural Medicine Product. The recall status report shall contain the following information:
a. Number of receiving Licensees notified of the recall, the date, and method of notification;

b. Number of receiving Licensees who responded to the recall notice and both the quantity of affected Regulated Natural Medicine and/or Regulated Natural Medicine Product in the possession of the Licensee at the time of the response, and quantity of affected product returned or corrected;

c. Number and results of the effectiveness checks that were made; and d. Approximate time that was required to complete the recall.

Disclaimer: These regulations may not be the most recent version. Colorado may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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