OFFICE OF MEDICAL CANNABIS
DRAFT MANUFACTURER RULES
August 8, 2014
Manny Munson-Regala
Assistant Commissioner
Patricia Winget
MDH Rules Coordinator and Legal Counsel
Office of Medical Cannabis
The Rulemaking Process
The Legislature grants authority to state agencies to create
and adopt rules.
Office of Medical Cannabis
The Rulemaking Process
“Rule” is a general statement adopted by an agency to
make the law it enforces or administers more specific or to
govern the agency's organization or procedure.
Office of Medical Cannabis
Formal Rulemaking Process
Request
For
Comments
Agency
develops
rules and
SONAR
Govnr’s
Office
Review
Notice of
Intent to
Adopt
Rules
Dual Notice
Requests <25 ≠ Hearing
OAH
Review
Adopt
Without
A Hearing
Dual Notice
Govnr’s
Office
Prelim.
Review
Adopt
With
A Hearing
Requests >25 = Hearing
Govnr’s
Office
Final
Review
Agency files
Order Adopting
Rules with OAH;
Govnr’s
Veto Period
OAH Files with
Secretary
of State
Publish
Notice of
Adoption
Office of Medical Cannabis
Expedited Rules Process
Govnr’s
Office
Prelim.
Review
Agency
develops
rules
Agency
publishes
rules
Agency
finishes
rules
Govnr’s
Office
Final
Review
OAH
Review
Agency files
Order Adopting
Rules with OAH;
Govnr’s
Veto Period
OAH Files with
Secretary
of State
Publish
Notice of
Adoption
Office of Medical Cannabis
MDH’s Rulemaking Authority
MDH is specifically authorized to use the expedited
process to adopt manufacturers’ registration rules under
Minnesota Statutes, section 152.26.
Office of Medical Cannabis
MDH’s Goals For These Expedited Rules
Develop the details that implement the statute by:
• Making the manufacturer’s requirements clear to every
affected
• Specifying manufacturers’ requirements so that they know
what they can do, must do and, also, what they are
prohibited from doing.
• Specifying the MDH’s, responsibilities, and authorities so
that everyone know how it will regulate the manufacturers.
that the Department can operate predictably and fairly
Office of Medical Cannabis
MDH’s Draft Rules
• “Draft” means roughly formulated ideas that we have
pulled together.
• Contents will change dramatically both in content and
structure between now and mid-September.
• We are seeking the public’s feedback.
Office of Medical Cannabis
Draft – Where This Came From
• Drawn from MDH’s regulatory expertise
• Document contains many of the topics MDH needs to
address, but perhaps not all
• Other states’ rules
• Advice from other Minnesota agencies
Office of Medical Cannabis
Structure of Manufacturer Expedited Rules
• The Rules contain numerous sections but can be
summarized into the following groups:
• Definitions
• Commissioner Duties
• Manufacturer Operations & Requirements
• Security
• Transportation
• Disposal
• Record Keeping
• Distribution
• Laboratory Approval
Office of Medical Cannabis
Noteworthy Rule Contents
The definitions clarify by making specific details that the
statute does not have, for example:
“Distribute” or “distribution”. “Distribute” or “distribution” means the
delivery of medical cannabis to a patient, parent or legal guardian, or
registered caregiver that is packaged in a suitable container appropriately
labeled for subsequent administration to or use by a patient who is
participating in the registry program and who is authorized to receive
medical cannabis.
• By including “parents, legal guardians, and registered
caregivers” everyone knows that it will be legal to deliver
medical cannabis to these parties, as the Legislature
clearly intended.
Office of Medical Cannabis
Noteworthy Rule Contents
A few areas list topics that still need to be fully explained, for
example:
Disposal (1200) – 4770.1200.A - Cannabis waste must be stored, secured,
locked, and managed in accordance with […] and the operating documents of
the medical cannabis manufacturer.
Deregistration (1500) – 4770.1500 - [PLACEHOLDER: Procedures for facility
shutdown]
Office of Medical Cannabis
Noteworthy Rule Contents
Some suggested rules need additional discussion with
regulated parties to make the rules workable, for example:
Transportation (1100) - Transportation of Medical Cannabis – our
language requires transmitting shipping manifests to the
Commissioner of Health before transport.
• We need to develop the details for balancing what the
Commissioner needs to know and when, while not making
the requirements too onerous for the parties.
Office of Medical Cannabis
Noteworthy Rule Contents
MDH is particularly interested in public input on certain topics,
such as security:
• What should the rule specify for video equipment?
• What should the alarm requirements be?
• How do manufacturers distribute and trace their products?
Office of Medical Cannabis
Changes – What Happens Next
• Collect advice from prospective manufacturers and the
public
• Further develop the ideas we have proposed, especially
those now only outlined
• Make sure the pieces fit together and are consistent with
other law
Office of Medical Cannabis
Feedback – How To Communicate With Us
• Communicate through your representative for constituent
groups
• Writing directly to us at
[email protected]
or
Office of Medical Cannabis
Minnesota Department of Health
PO Box 64882
St. Paul, MN 55164-0882