Cal. Code Regs. Tit. 4, § 17215 - Master Manufacturing Protocol
(a)
A licensed manufacturer shall establish and follow a written master
manufacturing protocol for each unique formulation of cannabis product
manufactured, and for each batch size, in order to mitigate the potential for
adulteration through incorporation of incorrect amounts of cannabinoids,
unintended ingredients, or hazards identified in the product quality plan; the
potential for misbranding through incorporation of ingredients not identified
on the label or mislabeling of the product; and to ensure uniformity in
finished batches and across all batches produced.
(b) The master manufacturing protocol shall
include:
(1) The name and intended cannabinoid
concentration(s) of the cannabis product to be manufactured;
(2) A complete list of components to be
used;
(3) The weight or measure of
each component to be used. The master manufacturing protocol for any given
product may include the ability to adjust the weight or measure of
cannabinoid-containing ingredients in order to account for the variability of
cannabinoid content in harvest batches;
(4) The identity and weight or measure of
each ingredient that will be declared on the ingredients list of the cannabis
product;
(5) The expected yield of
the finished cannabis product, based upon the quantity of components or
packaging to be used in the absence of any loss or error in actual production,
and the maximum and minimum percentages of expected yield beyond which a
deviation investigation of a batch will be necessary, material review will be
conducted, and a decision on the disposition of the product will be
made;
(6) A description of
packaging and a representative label, or a cross-reference to the physical
location of the actual or representative label;
(7) The expected number of packages and
labels to be used, if the cannabis product will leave the manufacturing
premises in final form and packaged and labeled as it will be sold at
retail;
(8) Written instructions
for each point, step, or stage in the manufacturing process; and
(9) Written instructions for any action to
mitigate risk(s) identified in the product quality plan.
(c) Master manufacturing protocols shall be
in writing and made available to the Department upon request.
(d) Nothing in this chapter requires
disclosure of the master manufacturing protocol to any person other than the
individuals conducting activities that utilize the protocol or to the
Department and its inspectors and agents. The licensee may consider the master
manufacturing protocol subject to trade secret protection.
Notes
2. New 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 subsections (b)(5) and (b)(7) and amendment of 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).
Note: Authority cited: Sections 26013 and 26130, Business and Professions Code. Reference: Sections 26011.5 and 26039.6, Business and Professions Code.
2. New section refiled 3-28-2022 as an emergency; operative
3. Certificate of Compliance as to 3-28-2022 order, including amendment subsections (b)(5) and (b)(7) and amendment of Note, transmitted to OAL 9-26-2022 and filed 11-7-2022; amendments effective
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