Fla. Admin. Code Ann. R. 64-4.212 - MMTC Regulatory Compliance Testing
(1) The capitalized terms used in this rule
shall have the same meaning as provided in Emergency Rule 64ER20-1,
F.A.C.
(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 Rule 64-4.213, F.A.C.; 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 Rule
64-4.207,
F.A.C.
(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 Rule
64-4.207, F.A.C., or remediate
it if permitted by Rule
64-4.213, F.A.C. 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.
Notes
Rulemaking Authority 381.986(8)(e)11.d., 381.986(8)(k) FS. Law Implemented 381.986(8)(e)11. FS.
New 12-20-21.
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