Manufactured Cannabis Safety Branch, CDPH Regulations
Table of Contents
Article 1. Cannabis Product Standards
§40300. Prohibited Products.
Reference: Sections 26011.5 and 26130, Business and Professions Code; Section 37104, Food and Agricultural Code.
§40305. Requirements for Edible Cannabis Products.
(1) Scored or delineated to indicate one serving, if the edible cannabis product is in solid form. For purposes of this section, “delineated” includes directly marking the product to indicate one serving or providing a means by which a consumer can accurately identify one serving; or
(2) If the edible cannabis product is not in solid form, packaged in a manner such that a single serving is readily identifiable or easily measurable.
Reference: Sections 26011.5 and 26130, Business and Professions Code.
§40306. Requirements for Topical Cannabis Products, Concentrates, and Other Cannabis Products.
Reference: Section 26011.5, Business and Professions Code.
§40308. Orally-Consumed Products Containing Alcohol.
Reference: Section 26011.5, Business and Professions Code.
Article 2. Cannabinoid Concentration Limits
§40315. THC Concentration Limits.
§ 40315 (a) An edible cannabis product shall not contain more than:
(1) 10 milligrams THC per serving; and
(2) 100 milligrams THC per package.
§ 40315 (b) Notwithstanding subsection (a), a package containing an edible product that is an orally-dissolving product, such as sublingual lozenges or mouth strips, may contain up to 500 milligrams THC per package, if:
(1) The cannabis product consists of discrete servings of no more than 10 milligrams THC per piece;
(2) The cannabis product is labeled “FOR MEDICAL USE ONLY;” and
(3) The cannabis product is only available for sale to a medicinal-use customer.
§ 40315 (d) Notwithstanding subsection (c), a topical cannabis product or a cannabis concentrate may contain more than 1,000 milligrams THC per package, but not more than 2,000 milligrams THC per package, if the product is labeled “FOR MEDICAL USE ONLY” and is only available for sale to a medicinal-use customer.
Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Section 26011.5, 26120 and 26130, Business and Professions Code.
Article 3. Failed Product Batches
§40330. Failed Product Batches.
§ 40330 (a) A finished cannabis product batch that fails any regulatory compliance laboratory testing requirement established by the Bureau pursuant to section 26100 of the Act shall be destroyed unless:
(1) The cannabis product batch may be remediated by relabeling pursuant to subsection (d); or
(2) A corrective action plan for remediation or reprocessing is approved by the Department pursuant to subsection (e).
§ 40330 (b) Remediation or reprocessing 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 Bureau in Section 5727 of Title 16 of the California Code of Regulations, in addition to the requirements of this article.
§ 40330 (c) Except as provided in subsections (d) and (f), edible cannabis products that fail regulatory compliance laboratory testing shall not be remediated or reprocessed and shall be destroyed. If any edible cannabis product that has failed regulatory compliance laboratory testing is remediated, reprocessed, 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.
§ 40330 (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 laboratory certificate of analysis, provided that the THC limits in Section 40315 are met. In addition, the following conditions apply:
(1) The manufacturer licensee shall notify the Department within 3 business days of notification by a distributor that the product failed cannabinoid content testing and is required to be relabeled.
(2) Notification shall be given to the Department by email and shall include a copy of the certificate of analysis for the batch and the name and license number of the licensee relabeling the product.
§ 40330 (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 or reprocessed unless the Department has approved a corrective action plan submitted by the manufacturer licensee. The corrective action plan shall include, at minimum, a description of how the product or harvest batch will be remediated so that the product or harvest batch, or any product produced therefrom, will meet all regulatory compliance laboratory testing and quality assurance requirements. Edible cannabis products may only be remediated by relabeling or repackaging as provided in subsection (f). Corrective action plans will be reviewed by the Department on a case-by-case basis.
§ 40330 (f) Edible cannabis products that fail regulatory compliance laboratory 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 that packaged the product;
(3) The product itself is not altered in any way; and
(4) The product is labeled to accurately state the contents.
§ 40330 (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 tested and undergo quality assurance review in accordance with the requirements established by the Bureau in Chapter 2 of Division 42 of Title 16 of the California Code of Regulations prior to retail sale.
Reference: Section 26131, Business and Professions Code.