Or. Admin. Code § 333-333-7120

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-333-7120 - Failed Test Samples

(1) If a sample or a field duplicate sample (collectively referred to as "sample" for purposes of this rule) fails any initial test, the laboratory that did the testing may reanalyze the sample. The laboratory that did the initial test may not subcontract the reanalysis. If a primary sample or a field duplicate sample fails, both must be reanalyzed. If the sample passes, another laboratory must resample the batch and confirm that result for the batch to pass testing.

(a) If a manufacturer wishes to have a sample reanalyzed, the manufacturer must request a reanalysis within seven calendar days from the date the laboratory sent notice of the failed test to the manufacturer. The reanalysis must be completed by the laboratory within 30 days from the date the reanalysis was requested.

(b) If a manufacturer has requested a reanalysis in accordance with subsection (1)(a) of this rule and the sample passes, the manufacturer has seven calendar days from the date the laboratory sent notice of the passed test to request that another laboratory resample the batch and confirm the passed test result. The retesting must be completed by the second laboratory within 30 days from the date the retesting was requested.

(c) A manufacturer must inform the Oregon Health Authority (Authority) immediately, of the following, in a manner prescribed by the Authority:

(A) A request for reanalysis of a sample;

(B) The testing results of the reanalysis;

(C) A request for retesting; and

(D) The results of retesting.

(2) If a sample fails a test or a reanalysis under section (1) of this rule the batch:

(a) May be remediated in accordance with these rules; or

(b) If it is not or cannot be remediated under this rule, must be destroyed in a manner specified by the Authority.

(3) If a manufacturer is permitted to remediate under this rule, the manufacturer must provide notice to the Authority of the registrant's intent to remediate.

(4) A psilocybin extract that is permitted to undergo remediation cannot be further processed into a psilocybin product during the remediation process.

(5) Failed microbiological contaminant testing. If a sample from a batch psilocybin product fails microbial contaminant testing the batch may not be remediated and must be destroyed as ordered by the Authority.

(6) Failed solvent testing.

(a) If a sample from a batch fails solvent testing the batch may be remediated using procedures that would reduce the concentration of solvents to less than the action level.

(b) A batch that is remediated in accordance with subsection (a) of this section must be re-sampled and re-tested in accordance with these rules and must be tested if not otherwise required for that product under these rules for solvents.

(c) A batch that fails solvent testing that is not remediated or that if remediated fails testing must be destroyed in a manner specified by the Authority.

(7) Failed pesticide testing. If a sample from a batch of psilocybin product fails pesticide testing the batch may not be remediated and must be destroyed as ordered by the Authority

(8) Failed heavy metal testing. If a sample from a batch of psilocybin product fails heavy metal testing the batch may not be remediated and must be destroyed as ordered by the Authority

(9) Failed potency testing. A psilocybin product that fails potency testing under OAR 333-333-7040 may be re-mixed in an effort to meet the standards in OAR 333-333-7040. A psylocibin product that is re-mixed must be re-sampled and re-tested in accordance with these rules.

(10) If a sample fails a test after undergoing remediation as permitted under this rule the batch must be destroyed in a manner approved by the Authority.

(11) A manufacturer must inform a laboratory prior to samples being taken that the batch has failed a test and is being retested after undergoing remediation.

(12) A manufacturer must document all sampling, testing, remediation and destruction that are a result of failing a test under these rules.

(13) If a batch fails a test under these rules a manufacturer:

(a) Must store and segregate the batch in a secure area and label the batch clearly to indicate it has failed a test and the label must include a test batch number.

(b) May not remove the batch from the registered premises without permission from the Authority.

Or. Admin. Code § 333-333-7120

PH 74-2022, adopt filed 05/19/2022, effective 5/20/2022; PH 58-2023, amend filed 12/21/2023, effective 1/1/2024

Statutory/Other Authority: ORS 475A.235 & ORS 475A.590

Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590