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

California Department of Public Health Manufactured Cannabis Safety Branch

Bureau of Cannabis Control (Bureau)

Retailers Distributors Testing Labs Microbusinesses

CA Department of Food & Agriculture

CalCannabis Cultivation Licensing

Cultivators Track-and-Trace

CA Department of Public Health

Manufactured Cannabis Safety Branch (MCSB)

Manufacturers

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 & Consumer Safety Public Health & Consumer Safety Neither Food Nor Drug Neither Food Nor Drug Dual Licensing Structure Dual Licensing Structure Vertical Integration* Vertical Integration*

* Except for Testing Labs

California Department of Public Health Manufactured Cannabis Safety Branch

Dual Licensing Structure

Local Authorization Local Authorization

Must comply with local

• rdinances

Local cannabis

• rdinances and

permitting

State Licensing State Licensing

All cannabis businesses must be licensed State cannabis licensing authorities

California Department of Public Health Manufactured Cannabis Safety Branch

MANUF MANUFACTURED CANNABIS CTURED CANNABIS PR PRODUCTS ODUCTS

REGULATIONS

Regulations

Emergency Regulations

• Focused on medicinal and

adult‐use manufacturing

• f cannabis products
• Became effective on

December 7, 2017

• Effective for 180 days,

possible two 90‐day re‐ adoption Permanent Regulations

• Regular Rulemaking Process
• Plan to release in first

quarter of 2018

• 45‐day public comment

period

• Potential for additional two

15‐day comment periods

California Department of Public Health Manufactured Cannabis Safety Branch

Operational Requirements

• Clean, sanitary work environment
• Control of hazards

Good Manufacturing Practices Good Manufacturing Practices

• Free of contaminants
• Uniform distribution of THC

Cannabis Product Safety Cannabis Product Safety

• Must adhere to local fire code and restrictions
• Closed loop system certification

Extraction System Safety Extraction System Safety

California Department of Public Health Manufactured Cannabis Safety Branch

Product Standards

California Department of Public Health Manufactured Cannabis Safety Branch

• 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

THC Limits

Edibles Edibles

• 10 milligrams per

serving

• 100 milligrams per

package

Other Products Other Products

• 1,000 milligrams per

package (adult‐use)

• 2,000 milligrams per

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

• Includes product

identity, THC content, universal symbol

Primary Panel

• Includes product

identity, THC content, universal symbol

Other Labeling:

• Includes list of

ingredients, warning statement, UID

Other Labeling:

• Includes list of

ingredients, warning statement, UID

May not refer to product as candy May not refer to product as candy Cannot be attractive to children Cannot be attractive to children

California Department of Public Health Manufactured Cannabis Safety Branch

Transition Period (Jan 1 – July 1, 2018)

California Department of Public Health Manufactured Cannabis Safety Branch

• A‐ and M‐License overlap (until July 1,

2018)

License Designations License Designations

• Secondary packaging: Child‐resistant
• Add: Government warning statement,

amount of THC/CBD per serving and per package

Existing manufactured products Existing manufactured products

• All products manufactured on/after

January 1, 2018 must meet THC limits, and product restrictions

On/after January 1, 2018 On/after January 1, 2018

MANUF MANUFACTURED CANNABIS CTURED CANNABIS PR PRODUCTS ODUCTS

LICENSES

License Categories and Types

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

• Extraction: Volatile Solvents

Type 7 Type 7

• Extraction: Non‐volatile Solvents,

Mechanical Methods Type 6 Type 6

• Infusions

Type N Type N

• Packaging & Labeling Only

Type P Type P

California Department of Public Health Manufactured Cannabis Safety Branch

Licenses

Temporary Licenses Temporary Licenses

• Valid 120 days
• Paper applications

submitted via email or mail

• Need copy of local

authorization

Annual Licenses Annual Licenses

• Valid 1 year
• Online application

process

• Must be “in compliance”

with local jurisdiction

California Department of Public Health Manufactured Cannabis Safety Branch

Annual License Requirements:

• Business, owner and financial interest holder, and premises

information

• Procedures for inventory and quality control, transportation,

security and cannabis waste disposal

Local Authorization

What is a local authorization? Temporary License Requirement:

• Local authorization to operate a cannabis

manufacturing business

• Examples: Cannabis business permit, letter
• f authorization, etc.

California Department of Public Health Manufactured Cannabis Safety Branch

OUTREA OUTREACH AND EDUCA CH AND EDUCATION TION

MCSB READINESS & OUTLOOK

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

Resources, Procedures and Processes Resources, Procedures and Processes Emergency Regulations November/ December 2017 Emergency Regulations November/ December 2017 Industry Outreach November/ December 2017 Industry Outreach November/ December 2017 Issue Licenses Effective 1/1/2018 Issue Licenses Effective 1/1/2018 Permanent Regulations Early 2018 Permanent Regulations Early 2018

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