Getting a manufacturing license in California starts with identifying which state agency regulates your product, because there is no single license that covers all manufacturing. Drugs and medical devices go through the California Department of Public Health, cannabis products through the Department of Cannabis Control, alcoholic beverages through the Department of Alcoholic Beverage Control, and many processed foods through CDPH as well. Once you know your agency, the path is roughly the same: form a business, secure local zoning and environmental clearances, assemble the application, pay the fees, and pass a site inspection.
Find the Right Agency for Your Product
The agency determines the application, the fees, the timeline, and the rules you’ll live under. Send paperwork to the wrong one and it simply won’t be processed.
- Drugs and medical devices: CDPH Food and Drug Branch, under the Sherman Food, Drug, and Cosmetic Law. No one may manufacture a drug or device in California without a valid CDPH license.1California Legislative Information. California Health and Safety Code HSC 111615
- Cannabis products: Department of Cannabis Control. The license type depends on your extraction method and whether you operate in a shared facility. A Type 6 license, for example, covers non-volatile solvent extraction and mechanical extraction.2Department of Cannabis Control. Manufacturing License Types
- Alcoholic beverages: Department of Alcoholic Beverage Control, which licenses distilleries, breweries, and wineries.3Alcoholic Beverage Control. Licensing
- Processed foods: CDPH licenses many food processors. When your product spans categories, such as a cannabis-infused edible, the more heavily regulated component governs.
If your product doesn’t clearly fit any of these, review the relevant sections of the California Health and Safety Code or contact the agency you think applies before you build an application around a guess.
Federal Registrations You Also Need
A state license doesn’t replace federal requirements, and the federal paperwork runs in parallel.
- Alcohol and tobacco: the federal Alcohol and Tobacco Tax and Trade Bureau requires approval before you can manufacture. There’s no federal fee, but you must register through TTB’s Permits Online system before operating.4Alcohol and Tobacco Tax and Trade Bureau. Applying for a Permit and/or Registration
- Medical devices: the FDA requires owners or operators of device establishments to register annually and list every device manufactured at the facility, electronically.5U.S. Food and Drug Administration. Device Registration and Listing
- Food products: facilities that manufacture, process, pack, or hold food for U.S. consumption must register with the FDA and renew every two years.6U.S. Food and Drug Administration. Registration of Food Facilities and Other Submissions
Start these early. The TTB application alone can take weeks, and you cannot legally operate until both your state license and any required federal approvals are in hand.
Form the Business and Get Local Approvals First
State agencies won’t process your manufacturing application until the business exists on paper and the location is cleared for use.
Business Entity and EIN
Register the entity with the California Secretary of State. Corporations file Articles of Incorporation; LLCs file Articles of Organization. You’ll also designate an agent for service of process and file a Statement of Information on the agency’s schedule.7California Secretary of State. Business Entities Once the entity is on record, apply for a federal Employer Identification Number through the IRS. The online application is free and issues the EIN immediately. Do the state entity first; an EIN issued before the entity is registered can create mismatches that take time to unwind.8Internal Revenue Service. Get an Employer Identification Number
Seller’s Permit
If you’ll sell or lease the goods you manufacture, whether wholesale or retail, you need a seller’s permit from the California Department of Tax and Fee Administration. The application is free and available online through CDTFA’s registration system.9California Department of Tax and Fee Administration. Obtaining a Seller’s Permit
Zoning and Local Business License
Your facility must sit in a zone that allows industrial or manufacturing use. Confirm zoning with the city or county planning department before signing a lease or buying property, because a state agency will not license a facility that lacks proper zoning.
You’ll also pull a local business license. Under Senate Bill 205, if your operation falls under a regulated industrial classification, you must show enrollment in the National Pollutant Discharge Elimination System stormwater permit program when applying. That means providing a Waste Discharger Identification number, a No Exposure Certification number, or proof that coverage is pending.10State Water Resources Control Board. Senate Bill 205/891 – Business License Requirements
Environmental, Safety, and Insurance Clearances
This is where first-time manufacturers underestimate the timeline. Air, water, safety, and insurance requirements layer on top of one another, and several of them must be in place before you can produce anything.
If your process generates emissions of any kind, including dust, fumes, or volatile organic compounds, you likely need a permit from the local air quality management district. If it discharges wastewater, you’ll need a permit from the State Water Resources Control Board or the relevant regional board. Air district approvals alone can take several months.
Workers’ compensation coverage is mandatory. California Labor Code Section 3700 requires every employer to carry it, with no exceptions for small operations, and coverage must be active before the first employee starts work. Operating without it is a criminal offense and can shut down the facility.11California Department of Industrial Relations. DWC FAQs for Employers
Cal/OSHA enforces workplace safety through Title 8 of the California Code of Regulations, including machine guarding, hazard communication, and injury prevention program rules. Operations involving hazardous materials, flammable liquids, or certain high-risk processes may need a Cal/OSHA permit before starting those specific activities.12Occupational Safety and Health Administration. Machine Guarding Standards
If your process involves flammable liquids, combustible dust, hazardous production materials, or additive manufacturing equipment, expect to need an operational permit from the local fire authority. Contact the fire marshal before buildout so the space is designed to what they’ll require.
What Goes in the Application
The specifics vary by agency, but the core components are consistent.
Ownership and Background Checks
Every agency wants to see who controls the business. Expect to name corporate officers, directors, and anyone with a significant financial interest. Cannabis licenses reach anyone holding an ownership stake. Key personnel typically submit to Live Scan fingerprinting, which the California Department of Justice processes at the state and FBI levels.13California Department of Justice. Fingerprint Background Checks
Premises Diagram
Provide a to-scale diagram of the facility showing boundaries, entrances, exits, and all areas where manufacturing or commercial activity will happen. Mark restricted-access areas, security camera locations, and waste disposal areas. Cannabis manufacturers using a closed-loop extraction system must show its location and serial number on the diagram.14Department of Cannabis Control. Manufacturing Premises Diagram You’ll also need to prove the legal right to occupy the premises with a recorded deed or signed lease.
Standard Operating Procedures
Written SOPs must cover product safety and quality control. Reviewers look for procedures tailored to your specific processes, contamination risks, and corrective actions, not boilerplate. Cannabis manufacturers must also describe inventory tracking procedures tied to the state’s track-and-trace system.15Legal Information Institute. California Code of Regulations Title 4 Section 17218 – Inventory Control – Cannabis and Cannabis Products
Fees by Category
Drug Manufacturers
The base drug manufacturing license fee is $200 per year. Manufacturers of human prescription drugs pay an additional $100 per year, plus the Department of Justice fingerprint processing fee.16Legal Information Institute. California Code of Regulations Title 17 Section 10376 – Drug and Device Manufacturing Fees
Medical Device Manufacturers
Fees are set within a range by the CDPH Food and Drug Branch. As of the most recent published fee schedule, the range spans roughly $230 to over $4,000 depending on facility type.17California Department of Public Health. Drug Manufacturing, Medical Device Manufacturing, and Home Medical Device Retailer Licensing Costs and Fee Analysis Annual Report The license is valid for two calendar years.1California Legislative Information. California Health and Safety Code HSC 111615
Cannabis Manufacturers
Cannabis fees scale with gross annual revenue on top of a flat application fee:
- Type 6, 7, N, and P licenses: $1,000 application fee. Annual license fees run from $2,000 (revenue up to $100,000) to $75,000 (revenue of $10 million or more).
- Type S licenses for shared-use facilities: $500 application fee. Annual license fees run from $2,000 to $7,500.
Registering a shared-use facility for a Type 6, 7, or N license carries no additional fee.18Department of Cannabis Control. Manufacturing License Fees
Most application fees are non-refundable, regardless of outcome.
Submission, Review, and Site Inspection
Submit through the agency’s online licensing portal with fees attached. Review happens in two phases. First, an administrative check confirms every required document is present and properly formatted. If anything is missing, the agency sends a deficiency notice detailing what to correct. This is where sloppy packets lose weeks, so completeness up front matters more than speed.
Second, reviewers evaluate ownership, background results, SOPs, and facility plans against the regulatory requirements for your license type. For cannabis applications, the DCC also checks proposed track-and-trace procedures and extraction safety measures.
Once the paperwork clears, the agency schedules a pre-licensure site inspection. An inspector visits to verify that the physical space, security systems, and equipment match what you described. Inspectors have broad authority under the Health and Safety Code to examine equipment, raw materials, finished products, containers, labeling, and records relevant to compliance.19Justia. California Code HSC 110140-110165 – Inspection and Sampling Pass, and the inspector recommends licensure.
Keeping the License Active
Renewal periods vary. Drug manufacturing licenses renew annually; drug and device licenses under Health and Safety Code Section 111615 run two calendar years.1California Legislative Information. California Health and Safety Code HSC 111615 Cannabis licenses renew annually with updated documentation and payment. Miss a renewal and you may face penalties or a lapse that forces you to stop production until it’s restored.
You have a continuing duty to notify the agency of significant changes: ownership shifts, facility relocations, major changes to processes or equipment. Cannabis licensees must report even premises layout changes that differ from the approved diagram. Failing to disclose can lead to suspension or revocation.
Expect periodic inspections after licensure, and don’t count on advance notice. Agencies can conduct unannounced visits to confirm the facility still meets the standards in your approved SOPs and premises documentation. Any violation triggers a corrective action requirement that the agency verifies on reinspection.19Justia. California Code HSC 110140-110165 – Inspection and Sampling