Licensee Recall Responsibilities

One of the primary goals in the first 24 hours is containment.

• Immediate Notification to OMMA. Any commercial licensee with knowledge of a triggering event must immediately notify OMMA. The notification must include a copy of the applicable COA under 442:10-8-1(h).
  
  • OAC 442:10-8-1(g)(2)(A) Any commercial licensee with knowledge of such event shall immediately notify the Authority.; 
  • OAC 442:10-8-1(h) ...Commercial licensees shall immediately, in the manner and form prescribed by the Authority, provide notification to the Authority of any medical marijuana or medical marijuana products that have failed testing, and such notification shall include copies of the applicable COAs.
• Halt Sales and Transfers. All affected products must be immediately recalled and cannot be sold or otherwise transferred. Necessary measures may include tagging, holds, and/or quarantine of affected batches.
  
  • OAC 442:10-8-1(g)(2)(B) All such medical marijuana and medical marijuana products shall be immediately recalled and cannot be sold or otherwise transferred.; 
  • OAC 442:10-8-1(g)(2)(C)(i) Undertake necessary measures to ensure any affected medical marijuana or medical marijuana products are not transferred.
• Affix Embargo Tag. If the product is subject to embargo, it must be affixed with an electronic tag, physical tag, and/or other appropriate marking. It is unlawful to remove or dispose of embargoed product without permission of OMMA.
  
  • OAC 442:10-8-1(g)(1)(A) All such medical marijuana and medical marijuana products in the possession of a commercial licensee shall be immediately affixed with an electronic tag, physical tag and/or other appropriate marking or hold, including a hold in the State’s inventory tracking system, giving notice of the reason that the medical marijuana or medical marijuana product is subject to embargo. The affixed tag(s) and/or electronic hold shall further warn all persons not to remove or dispose of the medical marijuana or medical marijuana product by sale, donation, or otherwise transfer without permission of the Authority. It shall be unlawful for any person to remove or dispose of the embargoed medical marijuana or medical marijuana products without permission of the Authority.
• Mandatory Recall Assistance. OMMA rules require commercial licensees that currently have, or previously had, possession of the recalled products to assist with the immediate recall. Any commercial licensee in the distribution chain that possessed the recalled products is subject to this responsibility.
  
  • OAC 442:10-8-1(g)(2)(C) Every commercial licensee who is in possession or has ever had possession of such medical marijuana or medical marijuana products shall assist in the immediate recall...
• Notification of Affected Parties. The recall process includes providing formal, urgent notice to affected licensees concerning the recalled product and to affected consumers explaining that they should discontinue use or consumption of the recalled product.
  
  • OAC 442:10-8-1(g)(2)(C) Every commercial licensee...shall assist in the immediate recall, including, but not limited to, the following ...(iv) [p]rovide notice to all affected licensees and consumers once identified...”

Accurate traceability is vital. The following records must be maintained during the recall process.

Compile a comprehensive list of all commercial licensees that received the affected products. At minimum, the list must include the licensee’s name, OMMA license number, business address, and contact information (phone and email).

• OAC 442:10-8-1(g)(2)(C)(ii) Every commercial licensee...shall assist in the immediate recall, including, but not limited to, the following ... (ii) [c]reate a distribution list of all commercial licensees that received the medical marijuana or medical marijuana products subject to the recall, including the licensee’s name, license number, address and contact information...

Draft a detailed list of the recalled products. At minimum, the list must include the product category (e.g., flower, edible, concentrate), product description, net contents (weight or volume), batch number(s), and, if applicable, the name and OMMA license number of the commercial licensee that cultivated or manufactured the product.

• OAC 442:10-8-1(g)(2)(C)(iii) Every commercial licensee...shall assist in the immediate recall, including, but not limited to, the following ... [iii] [c]reate a list identifying all medical marijuana or medical marijuana products subject to the recall, including the category of medical marijuana or medical marijuana products, product description, net contents, batch number, and, if applicable, the name and license number of the commercial licensee that cultivated or manufactured the medical marijuana or medical marijuana product subject to the recall."

Commercial licensees must maintain copies of all COAs for at least seven (7) years, kept on-site and readily accessible. Preserve all COAs, manifests, transporter records, and State inventory tracking system records related to the recalled batches.

• OAC 442:10-8-1(h) Prior to accepting any sale or transfer of any medical marijuana or medical marijuana products, commercial licensees shall obtain copies of any and all COAs for every test conducted on the harvest batch(es), production batch(es), final harvest batch(es), or final production batch(es). Commercial licensees shall maintain copies of any and all COAs for at least seven (7) years and all records shall be kept on-site and readily accessible. Commercial licensees shall immediately, in the manner and form prescribed by the Authority, provide notification to the Authority of any medical marijuana or medical marijuana products that have failed testing, and such notification shall include copies of the applicable COAs. For medical marijuana testing laboratories, submission of a COA by the laboratory into the State’s inventory tracking system is sufficient to meet the testing laboratory’s requirement to report and maintain such records; all other commercial licensees shall obtain and maintain copies of any and all COAs required under this section and all records shall be kept on-site and readily accessible.

Any licensee in possession of a recalled product must immediately halt all sales, transfers, and processing of the affected inventory. Recalled product shall be maintained separately from active operational and retail areas, secured in a designated quarantine or other limited-access area, and clearly labeled as "Not for Distribution" or "Quarantined".

Originators of medical marijuana and/or medical marijuana products bear the administrative and financial compliance responsibilities during a recall:

• Notification: Upon the discovery of any recall-triggering event (e.g., contamination, failed testing, or adverse health events), the originating licensee must notify OMMA immediately.

• Communicate Downstream: The grower or producer must identify all businesses that received the affected product and notify them of the product name, batch/lot numbers, the reason for the recall, and instructions for product return or destruction.

• Effectiveness Checks and Reporting: An effective recall process typically includes measures to verify that affected licensees received the recall notice and responded as instructed. The process may also include regular status reports to OMMA regarding the progress of the recall, including the quantity of product recovered and the quantity that remains in the marketplace.

• Financial Responsibility and Disposal: The commercial licensee whose harvest or production batch triggered the recall is responsible for bearing the costs of disposal for all resulting medical marijuana waste. The product must be permanently destroyed and documented accurately in the state inventory tracking system (e.g., using "Destruction - Recall" adjustment codes in Metrc).

Dispensaries are the frontline of consumer safety and must ensure recalled products do not reach the public, or recover them if they already have:Notification: Upon the discovery of any recall-triggering event (e.g., contamination, failed testing, or adverse health events), the originating licensee must notify OMMA immediately.

• Point-of-Sale Holds: Removal of affected items from the sales floor, updating thePoint of Sale (POS) system to mark the inventory as unsellable, and moving it to a secured location to prevent inadvertent sales is required to occur as soon as possible.

• Customer Outreach: Retailers must use their sales logs to identify any consumers who purchased the recalled product and contact them directly (via email, phone, or in-store signage) to explain health risks may exist and state that they must dispose of or return the item.

• Adverse Event Reporting: Upon patient or customer reports of an injury or illness related to a product, the dispensary must immediately record this in the state inventory tracking system and notify both OMMA and the originating grower/processor without delay.

• Coordination of Returns: Coordination with the distributor or originating licensee to return the quarantined products or execute witnessed destruction of the products on-site if directed by OMMA is vital.

Testing facilities are crucial in detecting product that should be subject to recall. As a commercial licensee, labs are subject to the same responsibilities required of all commercial licensees during a recall:

• Immediate Notification of Hazards: If a laboratory detects contamination (like pesticides, heavy metals, or microbes) above allowable thresholds, or finds unknown/injurious compounds, the lab immediately notifies the licensee that submitted the sample and OMMA of the hazard. If the product has not entered commerce, laboratories simply notify the commercial licensee of the failed test.

• Further steps vary based on the analyte type. According to OMMA rules, a final harvest batch of medical marijuana flower or trim that fails testing can be remediated into a solvent-based concentrate only if it fails for the following specific analytes:

• Microbials

• Foreign materials and filth

• Water activity and moisture content

• It is important to note that for these three categories, only final harvest batches of flower or trim may be remediated. All other types of final harvest batches and final production batches that fail these specific tests cannot be remediated and must be disposed, though they may be eligible for decontamination depending on the analyte. Additionally, any batch that is successfully remediated into a solvent-based concentrate must be fully tested again and pass all required analytes before it can be sold.

• Conversely, OMMA rules explicitly prohibit remediation for batches that fail testing for the following analytes:

• Residual solvents

• Mycotoxins

• Heavy metals

• Pesticide residue

• If a final harvest or production batch fails testing for pesticides, heavy metals, mycotoxins, or residual solvents, the product cannot be remediated and must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq.

• Data Submission: The lab is responsible for uploading the failed COA directly into the state's inventory tracking system.

• Prohibition on Retesting: Once a recall is issued, laboratories are explicitly prohibited from conducting additional compliance testing on the recalled packages.

Testing facilities are crucial in detecting product that should be subject to recall. As a commercial licensee, labs are subject to the same responsibilities required of all commercial licensees during a recall:

• Immediate Notification of Hazards: If a laboratory detects contamination (like pesticides, heavy metals, or microbes) above allowable thresholds, or finds unknown/injurious compounds, the lab immediately notifies the licensee that submitted the sample and OMMA of the hazard. If the product has not entered commerce, laboratories simply notify the commercial licensee of the failed test.
  • Further steps vary based on the analyte type. According to OMMA rules, a final harvest batch of medical marijuana flower or trim that fails testing can be remediated into a solvent-based concentrate only if it fails for the following specific analytes:
    • Microbials
    • Foreign materials and filth
    • Water activity and moisture content
      • It is important to note that for these three categories, only final harvest batches of flower or trim may be remediated. All other types of final harvest batches and final production batches that fail these specific tests cannot be remediated and must be disposed, though they may be eligible for decontamination depending on the analyte. Additionally, any batch that is successfully remediated into a solvent-based concentrate must be fully tested again and pass all required analytes before it can be sold.
    • Conversely, OMMA rules explicitly prohibit remediation for batches that fail testing for the following analytes:
      • Pesticide residue
      • Heavy metals
      • Mycotoxins
      • Residual solvents
    • If a final harvest or production batch fails testing for pesticides, heavy metals, mycotoxins, or residual solvents, the product cannot be remediated and must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq.
• Data Submission: The lab is responsible for uploading the failed COA directly into the state's inventory tracking system.
• Prohibition on Retesting: Once a recall is issued, laboratories are explicitly prohibited from conducting additional compliance testing on the recalled packages.

'Remediation' means the process by which medical marijuana flower or trim, which has failed testing, is processed into solvent-based medical marijuana concentrate and the final product is tested in accordance with Oklahoma law and these Rules. OAC 442:10-1-4.

Medical marijuana waste' means...(B) all product which is deemed to fail laboratory testing and cannot be remediated or decontaminated... OAC 442:10-1-4.

A final harvest batch of medical marijuana flower or of medical marijuana trim that fails microbial testing may be remediated into a solvent-based concentrate. All other types of final harvest batches and final production batches that fail microbial testing shall not be remediated. A final harvest batch, that is remediated into a final production batch, must be fully tested and successfully pass all the analytes required under this Subsection. If that batch fails to pass these testing requirements, it must be disposed of in accordance with the Waste Management Act, 63 O.S. § 427a et seq. and these Rules. OAC 442:10-8-1(i)(1)(F).

A final harvest batch or a final production batch that is decontaminated, in accordance with this Subsection, must be fully tested and successfully pass all the analytes required under this Subchapter. A decontaminated final harvest batch or final production batch that fails to pass these testing requirements must be disposed of in accordance with the Waste Management Act, 63 O.S. § 427a et seq. and these Rules, except that, a final harvest batch of medical marijuana flower or of medical marijuana trim may be remediated in accordance with Subsection (F). OAC 442:10-8-1(i)(1)(G)(iii).

If a final production batch fails mycotoxin testing, that batch shall not be remediated or decontaminated and must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules. OAC 442:10-8-1(i)(2)(H).

If a final production batch fails residual solvent testing, that batch shall not be remediated and must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules. OAC 442:10-8-1(i)(3)(H).

If a final harvest batch or final production batch fails heavy metal testing, that batch shall not be remediated or decontaminated and must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules. The Authority may report to the Oklahoma Department of Environmental Quality all test results showing samples failing heavy metals testing. OAC 442:10-8-1(i)(4)(H).

If a final harvest batch or final production batch fails pesticide testing, that batch shall not be remediated or decontaminated and must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules. The Authority may report to the Oklahoma Department of Agriculture, Food, and Forestry all test results showing samples failing pesticide testing. OAC 442:10-8-1(i)(5)(I).

A final harvest batch of medical marijuana flower or of medical marijuana trim that fails foreign materials and filth testing may be remediated into a solvent-based concentrate. All other types of final harvest batches and final production batches that fail foreign materials and filth testing shall not be remediated. A final harvest batch, that is remediated into a final production batch, must be fully tested and successfully pass all the analytes required under this Subsection. If that batch fails to pass these testing requirements, it must be disposed of in accordance with the Waste Management Act, 63 O.S. § 427a et seq. and these Rules. OAC 442:10-8-1(i)(8)(D).

A final harvest batch of medical marijuana flower or of medical marijuana trim that fails water activity or moisture content testing may be remediated into a solvent-based concentrate. All other types of final harvest batches that fail moisture content testing shall not be remediated. A final harvest batch, that is remediated into a final production batch, must be fully tested and successfully pass all the analytes required under this Subsection. If that batch fails to pass these testing requirements, it must be disposed of in accordance with the Waste Management Act, 63 O.S. § 427a et seq. and these Rules. OAC 442:10-8-1(i)(9)(D).

• If a final harvest batch or final production batch fails any analyte testing, the final harvest batch or final production batch may be retested in accordance with the following...(3) [i]f the first retest fails testing for the same analyte that failed the initial test, the final harvest batch or final production batch must either be remediated or decontaminated in accordance with the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq., and these Rules, or must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq. and these Rules. OAC 442:10-8-1(j)(3).
• If a final harvest batch or final production batch fails any analyte testing, the final harvest batch or final production batch may be retested in accordance with the following (4)[i]f the first retest(s) passes testing, a second retest shall be conducted to confirm the final product does not exceed allowable thresholds and is safe to consume. If the second retest also passes  for the same analyte that failed the initial test, the batch may be processed, sold, or otherwise transferred. If the second retest fails for the same analyte that failed the initial test, the final harvest batch or final production batch must either be remediated or decontaminated in accordance with the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq., and these Rules, or must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq. and these Rules. OAC 442:10-8-1(j)(4).
• (6) Any final harvest batch or final production batch that is retested and does not have two (2) successful tests for each analyte must either be remediated or decontaminated in accordance with the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq., and these Rules, or must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq. and these Rules. OAC 442:10-8-1(j)(6).

Growers and processors must, as applicable: (1) Have detailed procedures for remediation and decontamination processes. (2) Document all re-sampling, re-testing, decontamination, remediation, and/or disposal of marijuana or marijuana-derived products that fail laboratory testing under these Rules. (3) Prior to samples being taken, inform the laboratory that the final harvest batch or final production batch has failed testing and is being re-tested after undergoing remediation or decontamination. (4) Prior to retesting, provide to the testing laboratory a document specifying how the final product was remediated or decontaminated. This document shall be retained by the laboratory together with other testing documentation.OAC 442:10-8-1(k).