Manuf Manufactured Cannabis Saf ctured Cannabis Safety ty - PowerPoint PPT Presentation

Manuf Manufactured Cannabis Saf ctured Cannabis Safety ty Regulations and Licensing gulations and Licensing Asif Maan, Ph.D. Manufactured Cannabis Safety Branch California Department of Public Health December 20, 2017

Today’s Informational Session • Progression of State Cannabis Law • Emergency Regulations • Licensing • Outreach and Education • Readiness Roadmap California Department of Public Health Manufactured Cannabis Safety Branch

State Cannabis Law 1996 Compassionate Use Act Proposition 215 2015 Medical Cannabis Regulation & Safety Act (MCRSA) AB 266, AB 243, SB 643 2016 Adult Use of Marijuana Act (AUMA) Proposition 64 20 2017 Medicinal and A Medicinal and Adult-Use Cannabis R ult-Use Cannabis Regulation & gulation & Saf Safety A ty Act t (MA (MAUCRSA) CRSA) SB 94 and AB 133 California Department of Public Health Manufactured Cannabis Safety Branch

State Cannabis Licensing Authorities CA Department of Bureau of CA Department of Public Health Food & Agriculture Cannabis Control (Bureau) Manufactured CalCannabis Cannabis Safety Cultivation Licensing Retailers Branch (MCSB) Distributors Cultivators Testing Labs Manufacturers Microbusinesses Track-and-Trace California Department of Public Health Manufactured Cannabis Safety Branch

California Department of Public Health Role: Protect public health by promoting product and workplace safety Manufactured Cannabis Safety Branch • Regulations • Licensing • Compliance

Cannabis Manufacturing Extraction – separating cannabinoids from cannabis plant material Infusion – using cannabis concentrates or plant material to create a cannabis product Packaging and Labeling - putting finished cannabis products into a container and marking them for sale

Principles of MAUCRSA Public Health & Public Health & Neither Food Neither Food Consumer Consumer Nor Drug Nor Drug Safety Safety Dual Licensing Dual Licensing Vertical Vertical Structure Structure Integration* Integration* * Except for Testing Labs California Department of Public Health Manufactured Cannabis Safety Branch

Dual Licensing Structure State State Local Local Authorization Authorization Licensing Licensing All cannabis Must comply businesses with local must be ordinances licensed Local cannabis State cannabis ordinances and licensing authorities permitting California Department of Public Health Manufactured Cannabis Safety Branch

REGULATIONS MANUF MANUFACTURED CANNABIS CTURED CANNABIS PR PRODUCTS ODUCTS

Regulations Emergency Regulations Permanent Regulations • Focused on medicinal and • Regular Rulemaking Process adult‐use manufacturing • Plan to release in first of cannabis products quarter of 2018 • Became effective on • 45‐day public comment December 7, 2017 period • Effective for 180 days, • Potential for additional two possible two 90‐day re‐ 15‐day comment periods adoption California Department of Public Health Manufactured Cannabis Safety Branch

Operational Requirements Good Good • Clean, sanitary work environment Manufacturing Manufacturing • Control of hazards Practices Practices Cannabis Product Cannabis Product • Free of contaminants Safety Safety • Uniform distribution of THC Extraction System Extraction System • Must adhere to local fire code and restrictions Safety Safety • Closed loop system certification California Department of Public Health Manufactured Cannabis Safety Branch

Product Standards • Product Restrictions – No alcohol, nicotine or added caffeine – No perishable products – 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 • Requirements for Edibles: Servings California Department of Public Health Manufactured Cannabis Safety Branch

THC Limits Edibles Edibles Other Products Other Products • 10 milligrams per • 1,000 milligrams per serving package (adult‐use) • 100 milligrams per • 2,000 milligrams per package package (medicinal) California Department of Public Health Manufactured Cannabis Safety Branch

Packaging Cannot resemble traditional food packaging Cannot resemble traditional food packaging Opaque packaging (Edibles) Opaque packaging (Edibles) Must be packaged before release to distributor Must be packaged before release to distributor Must be tamper evident and child resistant Must be tamper evident and child resistant Must be re‐sealable, if there are multiple servings Must be re‐sealable, if there are multiple servings California Department of Public Health Manufactured Cannabis Safety Branch

Labeling Primary Panel Primary Panel Other Labeling: Other Labeling: • Includes product • Includes product • Includes list of • Includes list of identity, THC content, identity, THC content, ingredients, warning ingredients, warning universal symbol universal symbol statement, UID statement, UID Cannot be Cannot be May not refer to May not refer to attractive to attractive to product as candy product as candy children children California Department of Public Health Manufactured Cannabis Safety Branch

Transition Period (Jan 1 – July 1, 2018) License License • A‐ and M‐License overlap (until July 1, Designations Designations 2018) • Secondary packaging: Child‐resistant Existing Existing • Add: Government warning statement, manufactured manufactured amount of THC/CBD per serving and products products per package • All products manufactured on/after On/after January 1, On/after January 1, January 1, 2018 must meet THC limits, 2018 2018 and product restrictions California Department of Public Health Manufactured Cannabis Safety Branch

LICENSES MANUF MANUFACTURED CANNABIS CTURED CANNABIS PR PRODUCTS ODUCTS

License Categories and Types License Categories: M (Medicinal) or A (Adult-use) License Types: Type 7 Type 7 • Extraction: Volatile Solvents • Extraction: Non‐volatile Solvents, Type 6 Type 6 Mechanical Methods Type N Type N • Infusions Type P Type P • Packaging & Labeling Only California Department of Public Health Manufactured Cannabis Safety Branch

Licenses Temporary Licenses Temporary Licenses Annual Licenses Annual Licenses • Valid 120 days • Valid 1 year • Paper applications • Online application process submitted via email or mail • Need copy of local • Must be “in compliance” authorization 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 California Department of Public Health Manufactured Cannabis Safety Branch

Local Authorization What is a local authorization? Temporary License Requirement: • Local authorization to operate a cannabis manufacturing business • Examples: Cannabis business permit, letter of authorization, etc. California Department of Public Health Manufactured Cannabis Safety Branch

MCSB READINESS & OUTLOOK OUTREA OUTREACH AND EDUCA CH AND EDUCATION TION

Outreach and Education • Pre-licensing – Ten workshops from Nov 28 to Dec 27, 2017 – Focus on licensing requirements and how to apply for a license • Post-licensing – Subject-focused workshops, web tools, guidance documents – Compliance inspections California Department of Public Health Manufactured Cannabis Safety Branch

“Readiness ‐ Road Map Emergency Emergency Industry Industry Issue Issue Resources, Resources, Permanent Permanent Regulations Regulations Outreach Outreach Licenses Licenses Procedures Procedures Regulations Regulations November/ November/ November/ November/ and and Effective Effective December December December December Early 2018 Early 2018 Processes Processes 1/1/2018 1/1/2018 2017 2017 2017 2017 California Department of Public Health Manufactured Cannabis Safety Branch

Thank you Manufactured Cannabis Safety Branch www.cdph.ca.gov/mcsb mcsb@cdph.ca.gov Cannabis Portal www.cannabis.ca.gov