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§ 17305. Failed Product Batches.

4 CA ADC § 17305Barclays Official California Code of RegulationsEffective: November 7, 2022

Barclays California Code of Regulations
Title 4. Business Regulations
Division 19. Department of Cannabis Control
Chapter 10. Cannabis and Cannabis Products
Article 3. Failed Product Batches
Effective: November 7, 2022
4 CCR § 17305
§ 17305. Failed Product Batches.
Currentness
(a) A finished cannabis product batch that fails any regulatory compliance laboratory testing requirement established in this division shall be destroyed unless:
(1) The cannabis product batch or harvest batch may be remediated by relabeling pursuant to subsection (d); or
(2) A corrective action plan for remediation is approved by the Department pursuant to subsection (e). The licensed manufacturer or microbusiness authorized to engage in manufacturing who submits a corrective action plan for remediation shall be the manufacturer that remediates the subject batch. The licensed manufacturer shall not receive the batch from the licensed distributor until the Department has approved the corrective action plan.
(b) Remediation of a failed product batch or the use of a harvest batch that has failed any regulatory compliance laboratory test shall comply with the requirements and procedures established by the Department in section 15306, in addition to the requirements of this article.
(c) Except as provided in subsections (d) and (f), edible cannabis products that fail regulatory compliance laboratory testing shall not be remediated and shall be destroyed. If any edible cannabis product that has failed regulatory compliance laboratory testing is remediated or otherwise mixed with another batch of cannabis product in violation of this section, such action shall render the final cannabis product adulterated, regardless of the defect level of the final cannabis product.
(d) A cannabis product batch that fails regulatory compliance laboratory testing for cannabinoid or terpenoid content may be remediated by relabeling the product with the correct information from the certificate of analysis for regulatory compliance, provided that the THC limits in section 17304 are met.
(e) Except as provided in subsection (d), a cannabis product batch or a harvest batch that fails regulatory compliance laboratory testing or quality assurance review shall not be remediated unless the Department has approved a corrective action plan submitted by the licensed manufacturer or microbusiness authorized to engage in manufacturing who will be performing the remediation. Edible cannabis products may only be remediated by relabeling pursuant to subsection (d) or repackaging as provided in subsection (f). Corrective action plans will be reviewed by the Department on a case-by-case basis. A corrective action plan shall be submitted to the Department at [email protected] and contain the following:
(1) The licensed manufacturer's license number and legal business name;
(2) The licensed manufacturer's DBA, if any;
(3) The brand name of the product being remediated, the UID for the batch, and the size of the batch;
(4) The licensed manufacturer's premises address;
(5) The name, email address, and phone number of the licensed manufacturer's contact person for this remediation;
(6) A description of how the cannabis product or harvest batch will be remediated so that the cannabis product or harvest batch, or any product produced therefrom, will meet all regulatory compliance testing standards and quality assurance requirements; and
(7) Any additional information requested by the Department.
(f) Edible cannabis products that fail regulatory compliance testing because the per-package limit of THC has been exceeded may be remediated by repackaging under the following conditions:
(1) The Department has approved a corrective action plan for repackaging the product;
(2) The product batch is returned to the manufacturer who packaged the product;
(3) The product itself is not altered in any way; and
(4) The product is labeled to accurately state the contents.
(g) All remediation of harvest or product batches shall be documented in the batch production records. Remediated products, harvest batches, or products produced therefrom shall be transported to a licensed distributor and undergo regulatory compliance testing in accordance with chapters 2 and 6 and quality assurance review pursuant to sections 15307 and 15307.1 prior to being transported to a licensed retailer.

Credits

Note: Authority cited: Sections 26013 and 26130, Business and Professions Code. Reference: Section 26039.6, Business and Professions Code.
History
1. New article 3 (section 17305) and section filed 9-27-2021 as an emergency; operative 9-27-2021 (Register 2021, No. 40). This filing is a deemed emergency pursuant to Business and Professions Code sections 26013(b)(3) and 26153.1(k). A Certificate of Compliance must be transmitted to OAL by 3-28-2022 or emergency language will be repealed by operation of law on the following day.
2. New article 3 (section 17305) and section refiled 3-28-2022 as an emergency; operative 3-28-2022 (Register 2022, No. 13). This filing is a deemed emergency pursuant to Business and Professions Code sections 26013(b)(3) and 26153.1(k). A Certificate of Compliance must be transmitted to OAL by 9-26-2022 or emergency language will be repealed by operation of law on the following day.
3. Certificate of Compliance as to 3-28-2022 order, including amendment of section and Note, transmitted to OAL 9-26-2022 and filed 11-7-2022; amendments effective 11-7-2022 pursuant to Government Code section 11343.4(b)(3) (Register 2022, No. 45).
This database is current through 5/10/24 Register 2024, No. 19.
Cal. Admin. Code tit. 4, § 17305, 4 CA ADC § 17305
End of Document