Florida Regulations 64-4.212: MMTC Regulatory Compliance Testing
Current as of: 2024 | Check for updates
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(1) The capitalized terms used in this rule shall have the same meaning as provided in Emergency Fl. Admin. Code R. 64ER20-1
(2) An MMTC must contact a Certified Marijuana Testing Laboratory (CMTL) and arrange for the CMTL to select and collect a random and representative sample of Final Product from every Retail Batch for regulatory compliance testing from an MMTC’s department-approved processing facility or department-approved fulfillment and storage facility.
(3) All Final Products must pass regulatory compliance testing as provided in the CMTL Sample Testing rule prior to being transported by an MMTC to a dispensing facility and prior to being dispensed to a qualified patient or caregiver.
(4) Within 14 calendar days of receipt of a failed Certificate of Analysis from a CMTL due to Contaminants Unsafe for Human Consumption, an MMTC must:
(a) Provide the department with a completed Notification of Resampling and Retesting form as provided in paragraph (5)(a);
(b) Provide the department with a completed Notification of Remediation form as provided in Fl. Admin. Code R. 64-4.213; or
(c) Provide notice to the department via email to OMMUlabs@flhealth.gov indicating that the MMTC will dispose of the Retail Batch in accordance with Fl. Admin. Code R. 64-4.207
(5) An MMTC may arrange for a previously failed Retail Batch to be resampled and retested by a CMTL.
(a) Prior to the resampling and retesting of a previously failed Retail Batch, the MMTC must provide the failed Certificate of Analysis together with completed Form DH8024-OMMU-03/2021, Notification of Resampling and Retesting, which is incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-13904 to the department via email to OMMUlabs@flhealth.gov. An MMTC must arrange for resampling and retesting of the previously failed Retail Batch within 30 calendar days of submission of the Notification of Resampling and Retesting form to the department.
(b) Prior to the resampling and retesting of a previously failed Retail Batch, the MMTC must ensure the CMTL conducting resampling and retesting has a copy of the failed Certificate of Analysis.
(c) The previously failed Retail Batch must be quarantined, clearly marked “”not for retail sale,”” and shall not be transported by the MMTC to any dispensing facility or dispensed to a qualified patient or caregiver except as provided in subparagraph (5)(d)2.
(d) A previously failed Retail Batch must pass two complete regulatory compliance tests using two new samples in order for the Retail Batch to be eligible for dispensation by an MMTC. The previously failed Retail Batch may only be resampled and retested twice.
1. If the previously failed Retail Batch passes the first retest, an MMTC may arrange for the Retail Batch to be retested again by a CMTL.
2. If the previously failed Retail Batch passes the second retest, the Retail Batch is eligible for dispensation by the MMTC. An MMTC must provide two passing Certificates of Analysis for the previously failed Retail Batch to the department via email to OMMUlabs@flhealth.gov prior to removing the Retail Batch from quarantine and transferring it to a dispensing facility or dispensing it to a qualified patient or caregiver.
3. If the previously failed Retail Batch fails either retest, the MMTC shall dispose of the Retail Batch in accordance with Fl. Admin. Code R. 64-4.207, or remediate it if permitted by Fl. Admin. Code R. 64-4.213 The MMTC shall provide the department with the appropriate notice required by paragraph (4)(b) or (4)(c).
(e) If a CMTL is unable to complete regulatory compliance testing after sampling as provided in the CMTL Submission of Product for Testing rule, the MMTC from which the sample was collected may have the impacted Retail Batch(es) resampled and tested as an initial Retail Batch sample.
(6) If a Retail Batch fails regulatory compliance testing due to the labeled potency of total active THC, total active CBD, or any individual cannabinoid printed on the Final Product packaging, the MMTC shall correct the labeled potency to display the accurate concentration measured by the CMTL prior to dispensing the Final Product to qualified patients or caregivers.
(7) An MMTC may request testing of marijuana at any point during cultivation or processing. However, such testing does not exempt an MMTC from regulatory compliance testing in accordance with CMTL rules prior to dispensing the Final Product to qualified patients or caregivers.
(8) An MMTC shall bear the costs associated with resampling and retesting of a previously failed Retail Batch.
(9) This rule shall be reviewed, and if necessary, repealed, modified, or renewed through the rulemaking process five years from the effective date.
Rulemaking Authority 381.986(8)(e)11.d., 381.986(8)(k) FS. Law Implemented 381.986(8)(e)11. FS. History—New 12-20-21.
(3) All Final Products must pass regulatory compliance testing as provided in the CMTL Sample Testing rule prior to being transported by an MMTC to a dispensing facility and prior to being dispensed to a qualified patient or caregiver.
(4) Within 14 calendar days of receipt of a failed Certificate of Analysis from a CMTL due to Contaminants Unsafe for Human Consumption, an MMTC must:
(a) Provide the department with a completed Notification of Resampling and Retesting form as provided in paragraph (5)(a);
(b) Provide the department with a completed Notification of Remediation form as provided in Fl. Admin. Code R. 64-4.213; or
(c) Provide notice to the department via email to OMMUlabs@flhealth.gov indicating that the MMTC will dispose of the Retail Batch in accordance with Fl. Admin. Code R. 64-4.207
(5) An MMTC may arrange for a previously failed Retail Batch to be resampled and retested by a CMTL.
(a) Prior to the resampling and retesting of a previously failed Retail Batch, the MMTC must provide the failed Certificate of Analysis together with completed Form DH8024-OMMU-03/2021, Notification of Resampling and Retesting, which is incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-13904 to the department via email to OMMUlabs@flhealth.gov. An MMTC must arrange for resampling and retesting of the previously failed Retail Batch within 30 calendar days of submission of the Notification of Resampling and Retesting form to the department.
(b) Prior to the resampling and retesting of a previously failed Retail Batch, the MMTC must ensure the CMTL conducting resampling and retesting has a copy of the failed Certificate of Analysis.
(c) The previously failed Retail Batch must be quarantined, clearly marked “”not for retail sale,”” and shall not be transported by the MMTC to any dispensing facility or dispensed to a qualified patient or caregiver except as provided in subparagraph (5)(d)2.
(d) A previously failed Retail Batch must pass two complete regulatory compliance tests using two new samples in order for the Retail Batch to be eligible for dispensation by an MMTC. The previously failed Retail Batch may only be resampled and retested twice.
1. If the previously failed Retail Batch passes the first retest, an MMTC may arrange for the Retail Batch to be retested again by a CMTL.
2. If the previously failed Retail Batch passes the second retest, the Retail Batch is eligible for dispensation by the MMTC. An MMTC must provide two passing Certificates of Analysis for the previously failed Retail Batch to the department via email to OMMUlabs@flhealth.gov prior to removing the Retail Batch from quarantine and transferring it to a dispensing facility or dispensing it to a qualified patient or caregiver.
3. If the previously failed Retail Batch fails either retest, the MMTC shall dispose of the Retail Batch in accordance with Fl. Admin. Code R. 64-4.207, or remediate it if permitted by Fl. Admin. Code R. 64-4.213 The MMTC shall provide the department with the appropriate notice required by paragraph (4)(b) or (4)(c).
(e) If a CMTL is unable to complete regulatory compliance testing after sampling as provided in the CMTL Submission of Product for Testing rule, the MMTC from which the sample was collected may have the impacted Retail Batch(es) resampled and tested as an initial Retail Batch sample.
(6) If a Retail Batch fails regulatory compliance testing due to the labeled potency of total active THC, total active CBD, or any individual cannabinoid printed on the Final Product packaging, the MMTC shall correct the labeled potency to display the accurate concentration measured by the CMTL prior to dispensing the Final Product to qualified patients or caregivers.
(7) An MMTC may request testing of marijuana at any point during cultivation or processing. However, such testing does not exempt an MMTC from regulatory compliance testing in accordance with CMTL rules prior to dispensing the Final Product to qualified patients or caregivers.
(8) An MMTC shall bear the costs associated with resampling and retesting of a previously failed Retail Batch.
(9) This rule shall be reviewed, and if necessary, repealed, modified, or renewed through the rulemaking process five years from the effective date.
Rulemaking Authority 381.986(8)(e)11.d., 381.986(8)(k) FS. Law Implemented 381.986(8)(e)11. FS. History—New 12-20-21.