reglab/statecodes huggingface dataset:
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 1 - Manufacturing License Types › Section 17118

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The repealed version of this section by
					 Register
					 2022, No. 14, effective
					 3/28/2022 is not
					 yet available.
The repealed version of this section by
					 Register
					 2022, No. 46, effective
					 11/7/2022 is not
					 yet available.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 1 - Manufacturing License Types › Section 17119

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The repealed version of this section by
					 Register
					 2022, No. 14, effective
					 3/28/2022 is not
					 yet available.
The repealed version of this section by
					 Register
					 2022, No. 46, effective
					 11/7/2022 is not
					 yet available.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 1 - Manufacturing License Types › Section 17120

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The repealed version of this section by
					 Register
					 2022, No. 14, effective
					 3/28/2022 is not
					 yet available.
The repealed version of this section by
					 Register
					 2022, No. 46, effective
					 11/7/2022 is not
					 yet available.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 1 - Manufacturing License Types › Section 17121

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The repealed version of this section by
					 Register
					 2022, No. 14, effective
					 3/28/2022 is not
					 yet available.
The repealed version of this section by
					 Register
					 2022, No. 46, effective
					 11/7/2022 is not
					 yet available.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 1 - Manufacturing License Types › Section 17122

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The repealed version of this section by
					 Register
					 2022, No. 14, effective
					 3/28/2022 is not
					 yet available.
The repealed version of this section by
					 Register
					 2022, No. 46, effective
					 11/7/2022 is not
					 yet available.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 1 - Manufacturing License Types › Section 17123

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The repealed version of this section by
					 Register
					 2022, No. 14, effective
					 3/28/2022 is not
					 yet available.
The repealed version of this section by
					 Register
					 2022, No. 46, effective
					 11/7/2022 is not
					 yet available.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 1 - Manufacturing License Types › Section 17123.1 - Manufacturing Licensee Authorization to Release Data to Financial Institutions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  manufacturing licensee may authorize the Department to provide information to a
				  financial institution for purposes of facilitating the provision of financial
				  services. The authorization shall be made in writing, through a form prescribed
				  by the Department, which shall include the following information:
(1) The name of the licensed business for
				  which the licensee is authorizing the release of information;
(2) The business's license
				  number(s);
(3) The financial
				  institution authorized to receive information;
(4) The name, phone number, email address,
				  and signature of the owner submitting the authorization;
(5) The categories of information specified
				  in subsection (b) that are authorized for release; and
(6) An acknowledgement that the authorization
				  to release information includes information that is otherwise protected from
				  disclosure, and waiving privilege and confidentiality is strictly for purposes
				  of disclosure to the financial institution.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 1 - Manufacturing License Types › Section 17123.2 - Financial Institution Request for Manufacturing Licensee Information

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A financial institution as defined in Business and
					 Professions Code section
					 26260(c)(3)
					 may request information related to a manufacturing licensee for purposes of
					 facilitating the provision of financial services for that licensee. The request
					 shall be made in writing, through a form prescribed by the Department, which
					 shall include the following information:
(a) The name of the financial
				  institution;
(b) The name, phone
				  number, email, and signature of the representative of the financial institution
				  requesting information;
(c) The
				  business name and license number of the licensee for which the financial
				  institution is requesting information;
(d) The type of financial services for which
				  the information is requested (including, but not limited to, establishment or
				  maintenance of bank accounts, extending loans, and providing insurance) and
				  whether the request is for consideration of a new service or maintenance of an
				  existing service;
(e) The specific
				  information requested as described in section
				  17123.1(b) if
				  authorized by the licensee; and
(f)
				  An acknowledgment that use of the information is limited to that which is
				  necessary for the provision of financial services.
1. New
					 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.
Note: Authority cited: Section
						26013,
						Business and Professions Code. Reference: Section
						26260,
						Business and Professions Code.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 2 - Shared-Use Facilities › Section 17124 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
For purposes of this article, the following definitions
					 shall apply:
(a) "Common-use area"
				  means any area of the manufacturer's registered shared-use facility, including
				  equipment that is available for use by more than one licensed manufacturer,
				  provided that the use of a common-use area is limited to one licensee at a
				  time.
(b) "Designated area" means
				  the area of the manufacturer's registered shared-use facility that is
				  designated by the primary licensee for the sole and exclusive use of a Type S
				  licensee, including storage of the Type S licensee's cannabis, cannabis
				  concentrates, and cannabis products.
(c) "Primary licensee" means the Type 7, Type
				  6, or Type N licensee that has registered and been approved to operate its
				  licensed premises as a shared-use facility.
(d) "Shared-use facility" means a
				  manufacturing premises operated by a Type 7, Type 6, or Type N licensee in
				  which Type S licensees are authorized to conduct manufacturing
				  operations.
(e) "Use agreement"
				  means a written agreement between a primary licensee and a Type S commercial
				  cannabis business or licensee that specifies the designated area of the Type S
				  licensee, the days and hours in which the Type S licensee is assigned to use
				  the common-use area, any allocation of responsibility for compliance pursuant
				  to section 17128, and an acknowledgement that
				  the Type S licensee has sole and exclusive use of the common-use area during
				  the Type S licensee's assigned time period.
1. New
					 article 2 (sections
					 17124-17128) 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 2 (sections
					 17124-17128) 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 transmitted
					 to OAL 9-26-2022 and filed 11-7-2022 (Register 2022, No. 45).
Note: Authority cited: Sections
						26013
						and
						26130,
						Business and Professions Code. Reference: Sections
						26001,
						26050,
						26051.5
						and
						26130,
						Business and Professions Code.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 2 - Shared-Use Facilities › Section 17125

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The repealed version of this section by
					 Register
					 2022, No. 14, effective
					 3/28/2022 is not
					 yet available.
The repealed version of this section by
					 Register
					 2022, No. 46, effective
					 11/7/2022 is not
					 yet available.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 2 - Shared-Use Facilities › Section 17126 - Registration to Operate a Shared-Use Facility

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) No
				  licensed manufacturer shall operate as a shared-use facility without prior
				  approval by the Department.
(b) To
				  register as a shared-use facility, a Type 7, Type 6, or Type N licensee shall
				  submit the following to the Department through the online licensing system:
(1) A copy of the license, permit, or other
				  authorization issued by the local jurisdiction that enables the licensee to
				  operate as a shared-use facility. The Department shall contact the applicable
				  local jurisdiction to confirm the validity of the authorization upon receipt of
				  the application for registration. If the local jurisdiction does not respond
				  within 10 calendar days, the Department shall consider the authorization
				  valid.
(2) A registration form
				  prescribed by the Department, which includes the following information:
(A) The proposed occupancy schedule that
				  specifies the days and hours the common-use area will be available for use by
				  Type S licensees and when the common-use area will be used by the primary
				  licensee. The occupancy schedule shall allow for maintenance and sanitizing
				  between uses by individual licensees.
(B) A diagram indicating:
(i) Each designated area for Type S
				  licensee(s).
(ii) The common-use
				  area, including identification of any shared
				  equipment.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 2 - Shared-Use Facilities › Section 17127 - Shared-Use Facility Conditions for Operation

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  primary licensee shall operate the shared-use facility in accordance with the
				  conditions of operation specified in this section.
(b) Each Type S licensee shall be assigned a
				  "designated area" that, at minimum:
(1) Is
				  for exclusive use by the Type S licensee; and
(2) Provides an area for storage that is
				  secure, fixed in place, locked with a commercial-grade lock, and accessible
				  only to the Type S licensee for storage of that Type S licensee's cannabis,
				  cannabis concentrates, and cannabis products.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 2 - Shared-Use Facilities › Section 17128 - Shared-Use Facility Compliance Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) As
				  part of the use agreement, the primary licensee and the Type S licensee(s) may
				  allocate responsibility for providing and maintaining commonly used equipment
				  and services, including, but not limited to, security systems, fire monitoring
				  and protection services, and waste disposal services. However, the Department
				  may take enforcement action against either the primary licensee or Type S
				  licensee(s) regardless of the allocation of responsibility in the use
				  agreement.
(b) A primary licensee
				  or a Type S licensee is liable for any violation found at the shared-use
				  facility during that licensee's scheduled occupancy or within that licensee's
				  designated area. However, a violation of any provision of the Act or this
				  division may be deemed a violation for which each Type S licensee and the
				  primary licensee are responsible. In the event of a recall or embargo of a
				  cannabis product produced at a shared-use facility, the Department, in its sole
				  discretion, may include any or all cannabis products produced at the shared-use
				  facility.
(c) The occupancy
				  schedule and designated area for a Type S licensee shall not be altered without
				  prior notification to the Department. Prior to making any changes to the
				  occupancy schedule or the designated area, written notification that includes
				  the intended changes shall be submitted by email or through the Department's
				  online licensing system.
1. New
					 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 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 transmitted
					 to OAL 9-26-2022 and filed 11-7-2022 (Register 2022, No. 45).
Note: Authority cited: Sections
						26013
						and
						26130,
						Business and Professions Code. Reference: Sections
						26011.5,
						26055
						and
						26130,
						Business and Professions Code.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 3 - Solvent Use and Safety › Section 17200

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The repealed version of this section by
					 Register
					 2022, No. 14, effective
					 3/28/2022 is not
					 yet available.
The repealed version of this section by
					 Register
					 2022, No. 46, effective
					 11/7/2022 is not
					 yet available.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 3 - Solvent Use and Safety › Section 17201

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The repealed version of this section by
					 Register
					 2022, No. 14, effective
					 3/28/2022 is not
					 yet available.
The repealed version of this section by
					 Register
					 2022, No. 46, effective
					 11/7/2022 is not
					 yet available.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 3 - Solvent Use and Safety › Section 17202

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The repealed version of this section by
					 Register
					 2022, No. 14, effective
					 3/28/2022 is not
					 yet available.
The repealed version of this section by
					 Register
					 2022, No. 46, effective
					 11/7/2022 is not
					 yet available.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 3 - Solvent Use and Safety › Section 17202.1 - General Requirements for Extraction and Post-Extraction Processing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  licensed manufacturer that uses a volatile solvent, a flammable liquid, or a
				  solvent that creates an asphyxiant gas shall ensure that the solvent is used in
				  accordance with the requirements of:
(1)
				  Chapter 39 of the California Fire Code;
(2) Title 8, California Code of Regulations,
				  sections 5416-5420, which includes ensuring
				  adequate ventilation and controlling sources of ignition;
(3) All Division of Occupational Safety and
				  Health (Cal/OSHA) regulations related to the processing, handling, and storage
				  of the applicable solvent; and
(4)
				  All fire, safety, and building code requirements related to the processing,
				  handling, and storage of the applicable solvent or gas.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 3 - Solvent Use and Safety › Section 17203 - Permissible Extractions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  Except as provided in subsection (b), cannabis extraction shall only be
				  conducted using the following methods:
(1)
				  Mechanical extraction;
(2) Chemical
				  extraction using a nonvolatile solvent, as defined in section
				  15000(uu).
(3) Chemical extraction using
				  CO2 gas in a professional closed-loop extraction
				  system.
(4) Chemical extraction
				  using a volatile solvent, as defined in section
				  15000(yyy), in a
				  professional closed-loop extraction system; or
(5) Any other method authorized by the
				  Department pursuant to subsection (b).
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 3 - Solvent Use and Safety › Section 17204 - Solvent Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Any
				  solvents used for extraction or post-extraction processing shall meet the
				  following minimum purity requirements:
(1)
				  Hydrocarbon-based solvents shall be at least 99 percent purity.
(2) Nonhydrocarbon-based solvents shall be
				  food-grade.
(3)
				  CO2 gas used for extraction shall be
				  food-grade.
(4) Ethanol shall be
				  food-grade in accordance with
				  21 CFR, part 184, subpart B,
				  section 184.1293.
(A) Solutions of ethanol may be used if the
				  ethanol component is food-grade and it is combined with another food-grade
				  solvent or a hydrocarbon-based solvent that meets the requirements of
				  subsection (a)(1).
(B) Solutions of
				  ethanol that include one or more volatile solvents that total 5% or less by
				  volume of the total ethanol solution volume are considered nonvolatile solvents
				  as defined in section
				  15000(uu).
(5) Water and ice shall be potable.
(6) Dry ice shall be
				  food-grade.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 3 - Solvent Use and Safety › Section 17205 - Additional Requirements for Ethanol Operations

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A licensed manufacturer that uses ethanol in manufacturing
					 operations for extractions or post-extraction processing shall receive approval
					 for the facility and equipment from the local fire code official prior to
					 commencing operations, if required by local ordinance.
1. New
					 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 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 transmitted
					 to OAL 9-26-2022 and filed 11-7-2022 (Register 2022, No. 45).
Note: Authority cited: Sections
						26013
						and
						26130,
						Business and Professions Code. Reference: Sections
						26011.5
						and
						26130,
						Business and Professions Code.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 3 - Solvent Use and Safety › Section 17206.1 - Certification of Closed-Loop Systems

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
				  closed-loop system shall be commercially manufactured and bear a permanently
				  affixed and visible serial number.
(b) After installation and before use of a
				  closed-loop system, the licensed manufacturer shall have the closed-loop system
				  certified by a California-licensed engineer that the system was commercially
				  manufactured, safe for use with the intended solvent, and built and installed
				  to codes of recognized and generally accepted good engineering practices. The
				  certification document shall contain:
(1) The
				  name, signature and stamp of the California-licensed professional
				  engineer;
(2) The serial number of
				  the extraction unit being certified;
(3) A list of the solvent(s) deemed safe for
				  use with the equipment; and
(4) The
				  address of the premises where the extraction unit was
				  certified.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 4 - Good Manufacturing Practices › Section 17208 - Quality Control Program

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  licensed manufacturer shall establish and implement a quality control program
				  to ensure that cannabis products are not adulterated or misbranded. The quality
				  control program shall describe how the licensee will comply with the following:
(1) Grounds, building, and manufacturing
				  premises standards, as specified in section
				  17209;
(2) Equipment and utensil requirements, as
				  specified in section
				  17210;
(3) Personnel procedures, as specified in
				  section 17211;
(4) Cannabis product component procedures, as
				  specified in section
				  17212; and
(5) Manufacturing processes and procedures,
				  as specified in section
				  17213.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 4 - Good Manufacturing Practices › Section 17209 - Grounds, Building, and Manufacturing Premises

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  Exterior facility and grounds. A licensed manufacturer shall ensure the
				  facility exterior and grounds under the licensed manufacturer's control meet
				  the following minimum standards:
(1) Grounds
				  shall be equipped with draining areas in order to prevent pooled or standing
				  water;
(2) Weeds, grass, and
				  vegetation shall be cut within the immediate vicinity of the cannabis
				  manufacturing premises, litter and waste shall be removed, and equipment shall
				  be stored in order to minimize the potential for the grounds to constitute an
				  attractant, breeding place, or harborage for pests;
(3) Roads, yards, and parking lots shall be
				  maintained so that these areas do not constitute a source of contamination in
				  areas where cannabis products are handled or transported;
(4) Openings into the building (such as
				  windows, exhaust fans, ventilation ducts, or plumbing vent pipes) shall be
				  screened, sealed, or otherwise protected to minimize potential for pests to
				  enter the building;
(5) Waste
				  treatment and disposal systems shall be provided and maintained so as to
				  prevent contamination in areas where cannabis products may be exposed to such a
				  system's waste or waste by-products.
(6) A licensed manufacturer shall implement
				  precautions within the premises, such as inspection or extermination, if the
				  premises is bordered by grounds outside the licensed manufacturer's control
				  that are not maintained in the manner described in subsections (1) through (5),
				  in order to eliminate any pests, dirt, and filth that pose a source of cannabis
				  product contamination. Any use of insecticide, rodenticide, or other pesticide
				  within the premises shall meet the requirements of Health and Safety Code
				  section
				  114254.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 4 - Good Manufacturing Practices › Section 17210 - Equipment and Utensils

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  Design and construction. Equipment and utensils shall meet the requirements of
				  Health and Safety Code sections
				  114130.1,
				  114130.2,
				  114130.3,
				  and
				  114130.4
				  and shall be used in accordance with their operating instructions to avoid the
				  adulteration of cannabis products with lubricants, fuel, metal fragments,
				  contaminated water, or any other contaminants.
(b) Installation. Equipment shall be
				  installed so as to allow cleaning and maintenance of the equipment and of
				  adjacent spaces. Equipment that is not easily moveable shall meet the
				  requirements of Health and Safety Code section
				  114169.
(c) Cleaning, sanitizing, and maintenance.
				  Equipment and utensils shall be maintained in a clean and sanitary condition
				  and kept in good repair. The quality control program for cleaning, sanitizing,
				  and maintenance of equipment and utensils shall include the following elements,
				  at minimum:
(1) A detailed, written procedure
				  for cleaning, sanitizing, and maintaining (including calibrating) equipment and
				  utensils;
(2) A schedule for
				  cleaning, sanitizing, and maintaining equipment and utensils;
(3) A log for documentation of the date and
				  time of maintenance, cleaning, and sanitizing of equipment and utensils;
				  and
(4) A procedure for storing
				  cleaned and sanitized equipment and utensils in a manner to protect the
				  equipment and utensils from contamination.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 4 - Good Manufacturing Practices › Section 17211.1 - Training Program

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  manufacturing licensee shall establish and implement a training program to
				  ensure that all personnel present at the premises are provided information and
				  training that, at minimum, covers the following topics:
(1) Within 30 days of the start of
				  employment:
(A) Health and safety
				  hazards;
(B) Hazards presented by
				  all solvents or chemicals used at the licensed premises as described in the
				  safety data sheet for each solvent or chemical;
(C) Emergency response procedures;
(D) Security procedures;
(E) Record keeping requirements;
				  and
(F) Training
				  requirements.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 4 - Good Manufacturing Practices › Section 17212 - Cannabis Product Components

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) In
				  order to prevent adulteration of cannabis products, licensed manufacturers
				  shall establish and implement written policies and procedures to ensure and
				  maintain the quality of product components.
(b) Components are subject to the following
				  minimum requirements:
(1) Components that are
				  food must be obtained from a source that complies with federal and state food
				  laws.
(2) Raw materials and other
				  components shall be inspected upon intake to ensure that they are clean and
				  suitable for manufacturing into cannabis products, and shall be stored under
				  conditions that protect against allergen cross-contact and contamination and
				  minimize deterioration.
(3) Raw
				  materials shall be washed or cleaned as necessary to remove soil and other
				  visible contaminants. Water used for washing, rinsing, or conveying cannabis
				  product ingredients shall be potable.
(4) Raw materials and other components shall
				  not contain levels of microorganisms that render the cannabis product injurious
				  to human health, or shall be pasteurized or otherwise treated during
				  manufacturing so that they no longer contain levels of microorganisms that
				  would cause the cannabis product to be adulterated.
(5) Raw materials and other components
				  susceptible to contamination with aflatoxin or other natural toxins, pests, or
				  extraneous material shall not exceed generally acceptable limits set by the
				  U.S. Food and Drug Administration in the
Defect Levels
				  Handbook
(Rev. February 2005), which is hereby incorporated by
				  reference, before these raw materials or other ingredients are incorporated
				  into cannabis products.
(6) Raw
				  materials and other components shall be held in containers designed and
				  constructed to protect against allergen cross-contact or contamination, and
				  shall be held at a temperature and relative humidity and in a manner that
				  prevents the cannabis products from becoming adulterated.
(7) Frozen raw materials and other components
				  shall be kept frozen. If thawing is required prior to use, it shall be done in
				  a manner that prevents the raw materials and other ingredients from becoming
				  adulterated.
(8) Raw materials and
				  other components that are food allergens shall be identified and held in a
				  manner that prevents cross-contact with other raw materials or
				  ingredients.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 4 - Good Manufacturing Practices › Section 17213 - Manufacturing Procedures

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  licensed manufacturer shall implement and maintain the following manufacturing
				  procedures that ensure cannabis product quality:
(1) A product quality plan, as described in
				  section 17214;
(2) Master manufacturing protocols, as
				  described in section
				  17215, for each unique formulation
				  of cannabis product manufactured to ensure only intended components are
				  included and that the cannabis product is packaged and labeled in accordance
				  with product specifications and this division; and
(3) Batch production records, as described in
				  section 17216, to document the production
				  process and, if needed, to verify that the established procedures, including
				  the preventive measures and master manufacturing protocol, were implemented
				  correctly.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 4 - Good Manufacturing Practices › Section 17214 - Product Quality Plan

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  licensed manufacturer shall establish and implement a written product quality
				  plan for each type of product manufactured at the premises. The product quality
				  plan shall address the hazards associated with the premises or the
				  manufacturing process that, if not properly mitigated, may cause the product to
				  be adulterated or misbranded, or may cause the product to fail laboratory
				  testing or quality assurance review.
(b) To create the product quality plan, the
				  licensed manufacturer shall conduct a comprehensive assessment of the overall
				  manufacturing process, as follows:
(1)
				  Identify each step from component intake through transfer of product from the
				  premises;
(2) Evaluate the
				  potential risks associated with each step;
(3) Identify the preventive measures that
				  shall be taken to mitigate the potential risks identified;
(4) Identify the methods to evaluate and
				  monitor the effectiveness of the preventive measures; and
(5) Identify any action to take if a
				  preventive measure was unsuccessful.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 4 - Good Manufacturing Practices › Section 17215 - Master Manufacturing Protocol

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 4 - Good Manufacturing Practices › Section 17216 - Batch Production Record

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  licensed manufacturer shall prepare a written batch production record every
				  time a batch of a cannabis product is manufactured or a batch of cannabis or
				  cannabis product is remediated. The batch production record shall accurately
				  follow the appropriate master manufacturing protocol, and each step of the
				  protocol shall be performed in the production of the batch.
(b) The batch production record shall
				  document all the following information about each batch at the time the batch
				  is produced or remediated:
(1) The licensee
				  number or premises address of the facility at which the production
				  occurred;
(2) The date each step of
				  the master manufacturing protocol was performed and the initials of the
				  employee performing each step;
(3)
				  The identity and weight or measure of each component used in production of the
				  batch;
(4) The specific equipment
				  and processing lines used in producing or remediating the batch;
(5) A statement of the actual yield and the
				  percentage difference from expected yield at appropriate phases of
				  manufacturing as identified in the master manufacturing protocol;
(6) If the product quality plan identifies
				  any monitoring needed to ensure product safety, the results of the monitoring
				  action performed;
(7) An actual or
				  representative label or other identification of the label to be used for the
				  cannabis product;
(8) The actual
				  quantity of the packages and labels used, and the difference from the expected
				  quantity to be used, if the cannabis product will leave the manufacturing
				  premises as a final form cannabis good;
(9) Documentation that quality control
				  personnel:
(A) Reviewed the batch production
				  record;
(B) Reviewed all required
				  monitoring operation(s); and
(C)
				  Either approved and released, or rejected, the finished cannabis product,
				  including any remediated, repackaged or relabeled cannabis
				  product;
(10)
				  Documentation, at the time of performance, of any investigation identified in
				  the product quality plan or master manufacturing protocol, including deviations
				  from the expected yield or package and label count; and
(11) The UID and the batch or lot number of
				  the finished batch of cannabis product and the UIDs of all cannabis or cannabis
				  products used in the batch.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 4 - Good Manufacturing Practices › Section 17217 - Standard Operating Procedures

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  licensed manufacturer shall establish and maintain written standard operating
				  procedures that are easily accessible to onsite personnel. The standard
				  operating procedures shall, at minimum, include the following:
(1) Policies or procedures developed in
				  accordance with the security plan required by section
				  15042.1;
(2) Emergency response procedures, including
				  safety data sheets for any chemicals onsite;
(3) Policies and procedures developed in
				  accordance with section
				  17206;
(4) Policies and procedures developed in
				  accordance with this article;
(5)
				  Procedures for complying with the track and trace requirements established in
				  article 6 of chapter 1; and
(6)
				  Cannabis waste management procedures in compliance with section
				  17223.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 4 - Good Manufacturing Practices › Section 17218 - Inventory Control-Cannabis and Cannabis Products

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  licensed manufacturer shall establish and implement a written inventory control
				  plan capable of tracking the location and disposition of all cannabis and
				  cannabis products at the licensed premises.
(b) A licensed manufacturer shall reconcile
				  the on-hand inventory of cannabis and cannabis products at the licensed
				  premises with the records in the track and trace system at least once every
				  thirty (30) calendar days.
(c) If a
				  licensed manufacturer finds a discrepancy between the on-hand inventory and the
				  track and trace system, the licensee shall conduct an audit.
(d) If the inventory reconciliation conducted
				  pursuant to subsection (b) or the audit conducted pursuant to subsection (c)
				  reveals a discrepancy that is significant pursuant to section
				  15034, the licensed manufacturer
				  shall notify the Department within 24 hours of the discovery. The result of
				  inventory reconciliation and any audit shall be retained in the licensed
				  manufacturer's records and shall be made available to the Department upon
				  request.
(e) The licensed
				  manufacturer shall maintain sales invoices and receipts for all batches of
				  cannabis and cannabis products received at and transferred from its licensed
				  premises. The licensed manufacturer shall prepare a sales invoice or receipt
				  that meets the requirements of Business and Professions Code section
				  26161
				  prior to each sale or transport of cannabis products from the
				  premises.
1. New
					 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 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 subsection (d) and new subsection (e), 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
						26130,
						Business and Professions Code.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 5 - Special Manufacturing › Section 17219 - Juice Manufacturing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Manufacturers of cannabis juice or cannabis-infused juice
					 or beverages shall prepare and implement a written juice hazard analysis and
					 critical control plan in accordance with the requirements of title 21, Code of
					 Federal Regulations, Part 120, subpart A, section
					 120.8 and subpart B, section
					 120.24, (Rev. January 2001), which
					 are hereby incorporated by reference. The hazard analysis and critical control
					 plan shall be made available to the Department upon request.
1. New
					 article 5 (sections
					 17219-17220) 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 5 (sections
					 17219-17220) 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).
Note: Authority cited: Sections
						26013
						and
						26130,
						Business and Professions Code. Reference: Sections
						26011.5
						and
						26039.6,
						Business and Professions Code.
California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 5 - Special Manufacturing › Section 17220 - Dried Meat Manufacturing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Manufacturing of cannabis-infused dried meat products shall
					 be conducted in accordance with the United States Department of Agriculture
FSIS Compliance Guideline for Meat and Poultry Jerky Produced by Small
					 and Very Small Establishments: 2014 Compliance Guideline
(Rev. 2014),
					 which is hereby incorporated by reference. Meat for manufacturing into dried
					 meat products shall be acquired from a commercially-available source.
1. New
					 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 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 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.