emergency regulations for cannabis manufacturing• no perishable products, except beverages...

Emergency Regulations for Cannabis Manufacturing

Miren Klein California Department of Public Health Center for Environmental Health Manufactured Cannabis Safety Branch

California Department of Public Health

• Who is a manufacturer? • What is a cannabis product?

Role: Protect public health by promoting product safety

California Department of Public Health Manufactured Cannabis Safety Branch

Temporary Licenses Annual Licenses

Licenses

Temporary Licenses

• Valid 120 days • Paper applications submitted via email or mail

• Need copy of local authorization

Annual Licenses

• Valid 1 year • Online application process • Must be “in compliance” with local jurisdiction

Annual License Requirements: • Business, owner and financial interest holder, and premises information • Procedures for inventory and quality control, transportation, security

and cannabis waste disposal


License Categories & Types

Type 7

Type 6

Type N

Type P

Type S

License Categories: M (Medicinal) or A (Adult-use)

License Types:

• Extraction: Volatile Solvents Type 7

• Extraction: Non‐volatile Solvents, Mechanical Methods Type 6

• Infusions Type N

• Packaging & Labeling Only Type P

• Shared Manufacturing Facilities (Coming Soon) Type S


Annual License Fees

Application Fee – Paid when application is submitted

License Fee – Paid when application is approved – Seven scaled tiers – Based on gross annual revenue of the licensed premises

Covers cost of administering the manufactured cannabis safety program


Operational Requirements

• Good manufacturing practices• Cannabis product safety• Chemical extraction requirements:

Ethanol CO2Volatile Solvents

Must meet local fire code and follow all local requirements

Certified closed‐loop system

Solvent must be 99% pure


Product Standards

• No alcohol, nicotine or added caffeine • No perishable products, except beverages

processed in accordance with the regulations • No dairy, except butter purchased from a licensed

entity • No seafood • No low-acid canned products • Product cannot be in the shape of a human being,

animal, insect, or fruit


THC Limits

Edibles Other ProductsEdibles

• 10 milligrams per serving

• 100 milligrams per package

Other Products

• 1000 milligrams per package (adult‐use)

• 2000 milligrams per package (medicinal)


Packaging

Cannot resemble traditional food

packaging

Opaque packaging (Edibles)

Must be packaged before release to

distributor

Must be tamper evident and child

resistant

Must be re‐sealable, if

there are multiple servings

Cannot resemble traditional food

packaging

Opaque packaging (Edibles)

Must be packaged before release to

distributor

Must be tamper evident and child

resistant

Must be re‐sealable, if

there are multiple servings


Labeling

Contain ingredientlist and basic

nutritional facts

May not refer toproduct as candy

Cannot be attractive to children

Must list THC content

Must contain universal symbol and governmentwarning statement

Contain ingredient list and basic

nutritional facts

May not refer to product as candy

Must list THC content

Must contain universal symbol and government warning statement

Cannot be attractive to children


Transition Period

License Designations: • A- and M-License transfer (until July 1, 2018)

Existing manufactured products: • Secondary packaging: Child-resistant • Add: Government warning statement, amount of THC/CBD

per serving and per package

All products manufactured on/after January 1, 2018 must meet THC limits and product restrictions

Thank you

California Department of Public Health Manufactured Cannabis Safety Branch www.cdph.ca.gov/mcsb [email protected]

emergency regulations for cannabis manufacturing• no perishable products, except beverages...

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