230 R.I. Code R. 230-RICR-80-05-1.11

Current through November 7, 2024

Section 230-RICR-80-05-1.11 - Quarantined Marijuana Products, Retests, Remediation and Recalls

A. All marijuana products must undergo and comply with all required testing as stated in the DOH Testing Regulations in order to be designated as medical and be offered for sale by a licensed compassion center. Until the product is designated as medical or upon a recall of a medical product, all marijuana and marijuana products shall be quarantined in accordance with § 1.11 of this Part.

B. Product that has yet to sampled for testing:

1. Prior to required testing samples being taken from a batch of marijuana plant material and/or a batch of processed concentrate or extract, a licensee must store the batch in one or more sealed containers enclosed on all sides, so as to:

a. Prevent the product from being tampered with, transferred, or sold prior to sampling and compliant test results being reported; and

b. Be able to be easily located.

2. Each container in which plant material and/or a batch of processed concentrate or extract is stored must be affixed with a label that includes the following information:

a. The licensee's license number and tradename or business name;

b. The unique identifier generated by the Medical Marijuana Program Tracking System;

c. Strain name or product name (waste excluded);

d. The quantity of the product; and e. In bold, capital letters, no smaller than 12-point font, "PRODUCT NOT SAMPLED FOR TESTING".

C. Product that is awaiting/pending test results:

1. After required testing samples have been taken from a batch of marijuana plant material and/or a batch of processed concentrate or extract, a licensee must store the batch in one or more sealed containers enclosed on all sides, so as to:

a. Prevent the product from being tampered with, or transferred, or sold prior to compliant test results being reported; and

b. Be able to be easily located.

2. Each container in which the marijuana product is stored must be affixed with a label that includes the following information:

a. The licensee's license number and tradename or business name;

b. The batch number generated by the Medical Marijuana Program Tracking System;

c. Name and registry identification card number of the person who took the samples;

d. Name and license number of the testing facility that will perform the tests;

e. The test sample(s) unique identification number;

f. The quantity of the product;

g. The date the samples were taken; and h. In bold, capital letters, no smaller than 12-point font, "PRODUCT NOT TESTED".

D. Failed Test Batches

1. If a sample's result exceeds an action level in 216-RICR- 60-05-6 or as otherwise adopted by DOH, the testing facility must report to DBR and to the licensee that the sample failed the test for which the result exceeds the action level.

2. The licensee may then request in writing for permission from DBR to have the lab retest the sample.

3. If the sample is approved by DBR for a retest, the laboratory must follow the retesting guidelines outlined in § 1.11(E) of this Part.

4. If a retest is not granted, if the sample failed the retest, or if the batch is not approved for remediation, the batch that the sample was taken from must be immediately destroyed by the licensee.

5. The destruction of the failed test batch must be logged in the Medical Marijuana Program Tracking System.

E. Retesting

1. In the event of a retest, the following protocol shall be followed:

a. If there is enough remaining material from the initial sample to retest, the testing facility will use that sample material.

b. If there is not enough material from the initial sample, the laboratory sample collector will collect another sample from the same batch using the same collection process.

c. If the sample passes the retest, the sample will be deemed to have passed that test and the passing results will apply.

2. Within two (2) business days from issuance of final test results, the lab must upload results into the Medical Marijuana Program Tracking System if this system is currently in operation or submit the certificate of analysis to DBR as directed by DBR.

F. Remediation

1. In the event a testing facility determines that a sample has failed testing, the compassion center or licensed cultivator may request from DBR in writing an opportunity to remediate the batch before requesting the batch be re-tested. DBR shall review and determine in its sole discretion whether the request to remediate will be approved.

2. The compassion center or licensed cultivator requesting an opportunity for remediation must demonstrate to DBR that the issues identified by the testing facility are of the kind that can be remediated.

3. In determining if remediation is appropriate, DBR shall consider the public health and safety consequences of remediation, as well as the frequency and history of failed tests from the requesting licensee.

4. Any testing of a remediated batch must be conducted by the same testing facility that originally determined that the sample failed testing.

5. No remediated harvest, lots or batches may be sold or transported until the completion and successful passage of quality assurance testing as required in 216-RICR- 60-05-6 or as otherwise adopted by DOH.

G. Recalls

1. DBR or DOH may require a licensee to recall any marijuana or marijuana product that the licensee has sold or transferred upon a finding that circumstances exist that pose a risk to public health, safety and welfare.

a. The recall must be initiated by the licensee immediately as determined by their approved recall plan; and

b. The licensee must comply with any additional instructions made by DBR.

2. A recall may be based on, without limitation, evidence that the marijuana, marijuana product, or medical marijuana product:

a. Contains unauthorized pesticide(s);

b. Failed a mandatory test and was not mitigated pursuant to testing protocols;

c. Is contaminated or otherwise unfit for human use, consumption or application;

d. Is not properly packaged or labeled;

e. Was not cultivated, processed or manufactured by a licensee or otherwise is not in accordance with the Act, DBR regulations or DOH regulations; or f. Otherwise poses a threat to public health or safety as determined by DBR or DOH.

3. DBR may at any time require the destruction of medical marijuana product or marijuana product upon a finding that circumstances exist that pose a risk to public safety and health.

4. If DBR finds that a recall is required, DBR:

a. Must notify the public and licensees of the recall;

b. Must affect an administrative hold on all affected medical marijuana and/or medical marijuana products in the tracking system;

c. May require a licensee to place all marijuana, marijuana product, medical marijuana and medical marijuana product in quarantine itself or with a third-party custodian at the licensee's expense.

d. May require a licensee to notify all individuals to whom such medical marijuana or a medical marijuana product was sold; and e. May require that the licensee destroy the recalled product.

230 R.I. Code R. 230-RICR-80-05-1.11

Adopted effective 3/25/2020