cannabis science & policy summit - day 2 - sterling

Enforcement?Medical Cannabis in Maryland

A presentation to

Cannabis Science and Policy SummitNew York University

April 18, 2016By

Eric E. Sterling, J.D.Chair, Policy Committee

Maryland Medical Cannabis Commissionmmcc.maryland.gov

Background

• In 2013, Maryland General Assembly created Natalie M. LaPrade Medical Cannabis Commission to carry out a program to dispense cannabis to Maryland patients

• Statute has been amended in 2014, 2015 and 2016.

Background

• Link to compiled statute on Commission website: mmcc.maryland.gov

• http://mmcc.maryland.gov/pages/law/documents/Subtitle%2033_Sept2015_Corrected.pdf

http://mmcc.maryland.gov/pages/law/documents/Subtitle%2033_Sept2015_Corrected.pdf

Appreciation

• Delegates Dan Morhaim, M.D. and Cheryl Glenn

• Senator Jamie Raskin

• The key advocates in General Assembly throughout development of program

Commission

• 16 Commissioners now

• Secretary of Health and Mental Hygiene

• Representative of Comptroller

• 14 appointees of Governor

– Variety of backgrounds

– Staggered terms

– Chair appointed by Governor

Code of Maryland Regulations

• COMAR Title 10: Department of Health and Mental Hygiene

• Subtitle 62: Natalie LaPrade Medical Cannabis Commission Regulations

• Chapters 1 to 35

• Link to regulations on Commission website: mmcc.maryland.gov

• Took effect September 14, 2015

Program Principles

• Principles of Maryland’s Medical Cannabis Program:

– Ensure proper security and protection of public safety

– Assure the highest quality medicine is produced and distributed

– Expedite patient access

Funding

• Program costs not funded by Maryland taxpayers

• Program costs entirely paid for by fees from licensees

Funding

• Application fees:

• Grower: Stage 1 - $2,000; Stage 2 - $4,000

• Processor: Stage 1 - $2,000; Stage 2 - $4,000

• Dispensary: Stage 1 - $1,000; Stage 2 - $4,000

• Annual fees:

• Grower: $125,000

• Processor: $40,000

• Dispensary: $40,000

Funding

• No fees to be paid by physicians

• No fees to be paid by patients to register or to obtain a written certification

• If patient wishes to obtain an identification card from the Commission, fee $50

• Independent testing laboratory registration fee $100, valid for 2 years

• Independent testing laboratory agent fee $200

Application for license

• For Growers, Dispensaries and Processors, there are two stages in applying:

First stage – Pre-approval:

• Detailed application

• Application reviewed, scored and ranked by independent third party reviewer

• Commission considers scored & ranked applications to issue a pre-approval of license to successful applicants

Application for license

Second stage – Qualify for License:

• Pre-approved applicant completes financing, construction, hiring, training, etc.

• Commission investigates financial background

• Applicant tells Commission that it is ready for inspection of premises and operation

• Commission inspects premises, reviews S.O.P.s, training

• If inspection passed , Commission awards license to start operating

Current Status of Program

• Deadline for applications was November 6, 2015

• Commission received 1081 applications:

• 146 grower applications

• 124 processor applications

• 811 dispensary applications


• Independent third party now reviewing applications to score and rank


• Commission now registering physicians

• 117 physicians registered as of last week

• Registry for patients being subjected to load testing before going online

Security - Safety

• Shaping the Program:

– Commission includes Chief of Police (representative of law enforcement)

– A State’s Attorney

– A representative of the Comptroller

Security - Safety

• Limited number of growers and licensees

– No more than 15 licensed growers

– Growers may operate one dispensary

– Additionally, other licensees may operate a single dispensary. No more than two such dispensaries in each of the 47 senatorial districts

– Maximum number of dispensaries statewide –109

Security - Safety

• Personnel in industry – Fingerprint-based criminal history check of all

investors, managers, employees– Background investigations of all applicants,

including investors, managers– Detailed financial investigation of investors– No one with a felony drug conviction can be part

of the program– Pre-employment urine testing for all personnel– All personnel must be trained in safety and

security– Licensees need drug-free workplace policy

Security - Safety

• No one can obtain cannabis from a licensed dispensary without a written certification from a Maryland physician who is registered with the Commission

Security - Safety

• Premises used for production, dispensing & processing:

• Constructed to prevent unauthorized entry

• 24 – 7 recording surveillance cameras throughout

• Security lighting

• Security alarm systems

• Must meet local zoning and planning codes

• Procedure to control public access

Security - Safety

• Control of cannabis

– Demanding inventory controls from “seed to sale”

– Any diversion reported to Maryland State Police

– All transactions recorded

– Strict transportation security

– Strict control in dispensaries

– Vaults for cannabis

– Exclusion of persons other than patients

– Commission review of security plans

Security - Safety

• Commission will regularly inspect all licensees

• Licenses can be revoked for violations

• Commission can fine violators up to $10,000

• Any possession, distribution or use of cannabis diverted from the program can be prosecuted with penalty up to five years in prison and a $10,000 fine in addition to other CDS penalties

Security - Safety

• Commission very aware that it can seek assistance of U.S. Department of Justice to investigate and prosecute activities outside those permitted by regulation

Security - Safety

• Patients, and patient use of cannabis, not excluded from offenses of:

– Operating vehicles under the influence

– Smoking cannabis in a motor vehicle

– Smoking cannabis in a public place

Patients must acknowledge these restrictions every time the obtain medicine

Security - Safety

• Cannabis products packaging:

– Plain, opaque and, if requested, child-resistant (Many patients may be handicapped and need easy-to-open package)

– No feature that might mislead anyone about the contents

– No cartoon, color scheme, image, or feature that might make the package attractive to children

Security - Safety


– No resemblance to trademarked or product-specialized packaging of candy, snack, baked good or beverage

Note: Regulations do not authorize production or distribution of Cannabis products in “edible” form

Security - Safety


– Finished product lot number, expiration date

– Conspicuously itemized contents

– Personalized label

Security - Safety

• Packages must bear warnings:

– Keep away from children

– Illegal for any person other than the patient to possess or consume the contents

– Illegal to transfer (other than caregiver to transfer to patient)

– Poison Control Center telephone number

– Telephone number to report adverse patient event

Quality

• Regulatory goal: produce medicine that is consistent, batch to batch, lot to lot

• Growers and processors encouraged to produce cannabis in a range of means and routes of administration

• Growers and processors to produce plant varieties and products containing high CBD levels, in addition to other plants & products

Quality

• Detailed written Standard Operating Procedures for all cultivation, processing and dispensing

• Licensees required to follow S.O.P. as a condition of the license

• Every batch of cannabis and every lot of cannabis-infused product must be uniquely identified and tracked at all production stages

• Records of production must be retained to enable a review of all stages of production of every batch and lot

Quality

• Strict horticultural control required

• Incoming materials must be segregated and inspected to prevent contamination

Quality

• Every batch and lot must be analyzed by a registered, accredited Independent Testing Laboratory

• Every batch and lot must have a certificate of analysis from Independent Testing Laboratory

Quality

• Every batch and lot must be analyzed and labeled with cannabinoid ingredients:

– THC

– THCA

– CBD

– CBDA

– Certain terpenes

– CBG

– CBN

Quality

• Prevention of contamination essential

• Analysis must look for presence of:

– Heavy metals, mercury, lead, arsenic, cadmium

– Foreign matter (insects, hair, other adulterants)

– Microbiological impurity

Quality

• Prevention of contamination essential

• Analysis must detect and report any microbiological impurity:– Total aerobic microbial count (TAMC)

– Total yeast mold count (TYMC)

– Pseudomonas aeruginosa bacterium

– Aspergillus spp. molds

– Staphylococcus aureau bacterium

– Aflatoxin B1, B2, G1 & G2 mycotoxins

– Ochratoxin A toxin (produced by molds)

– Pesticide residue

Quality

• No batch or lot may be released unless it meets the pre-established specification

• Producers must do stability testing

• Producers must retain samples sufficient for follow-up testing

Quality

• Complaints, adverse events and recalls

– All licensees and registered physicians must be prepared to receive, organize, record and respond to complaints and reports of adverse events

– All substantive complaints and reports of serious adverse events must be investigated

– If re-analysis reveals that the retention sample does not meet specification, producers must order a recall

Physician Registration

• Before issuing “written certifications” to qualifying patients, a physician must register at Commission website

• No Registration fee

– Registration valid for two years

– No specialized or minimum additional training required

• Maryland medical license must be Active, Unrestricted, and In Good Standing

• Must be registered to prescribe Controlled Dangerous Substances in Maryland


• Registering physician affirms to follow detailed practice standards including

• Will complete standard patient evaluation

• Will assess patient outcome

• Will provide follow-up care

• Will collect and analyze data


• Check off medical conditions for which physician might issue certifications for medical cannabis

• Identify other patient inclusion criteria

• Specify any reasons physician may deny issuing a certification to a patient


• Physicians encouraged to register to treat:

• Chronic or debilitating disease or medical condition, or treatment, that causes:– Cachexia

– Anorexia

– Wasting Syndrome

– Severe or chronic pain

– Severe nausea

– Seizures

– Severe or persistent muscle spasm

– Glaucoma

– Post Traumatic Stress Disorder (PTSD)


• Sec. 13-3304(e) “The Commission may approve applications that

• Include any other condition that is severe and

• For which other medical treatments have been ineffective

• If the symptoms reasonably can be expected to be relieved by the medical use of cannabis.”

Qualifying Patients

• Patient must register with Commission before physician can issue written certification

• Patient must – Live in Maryland; or– Be physically present in Maryland for the purpose

of receiving medical care from a medical facility in Maryland

• If younger than 18 years old, parent or guardian must be caregiver

• No fee for patient unless patient desires ID card

Qualifying Patients

• Physician and patient must have a “bona fide” relationship:

• Treatment or counseling relationship

• Physician has

– Reviewed patient’s relevant medical records

– Completed an in-person assessment of the patient’s medical history and current medical condition

– Created and maintained records of patient condition in accord with medically accepted standards

Qualifying Patients

Bona fide relationship (Continued)

• Reasonable expectation physician will– Monitor patient progress while using medical

cannabis

– Take medically indicated action

• To provide follow-up care

• Regarding efficacy of medical cannabis as treatment

• Report any adverse event associated with use of medical cannabis

Written Certification

• Written Certification is issued by logging onto commission website and entering

– Physician’s name, license number, telephone number

– Patient’s name, DoB, address, county

– Condition(s) requiring medical cannabis

– Date patient is qualified

(Optional) Print out certification for patient use


• Basic quantity limit of 30-day supply

• 30-day supply defined as:

– 120 grams of usable cannabis or

– 36 grams of Delta9-THC in a medical cannabis infused product

• Physician may authorize greater quantity on determination that those amounts inadequate to meet patient’s medical needs


• Physician shall terminate certification if

– Patient meets exclusion criteria

– Treatment no longer medically necessary

– Adverse effects outweigh medical benefits

– Evidence patient is diverting cannabis

• May terminate for abuse of any substance

• Notify Commission of termination in one (1) business day


• Patient may seek renewal not less than 30 calendar days after issuance

• Physician may renew if

– All criteria are met

– Medical benefits likely outweigh health risks

• Cannot renew without full in-person patient assessment within 365 days before renewal

Dispensaries

• Dispensaries to be located throughout the state:

–Up to two per each of 47 state senatorial districts

–Up to 15 associated with licensed growers (not counted in senatorial district allocation)

Dispensaries

• Extensive training of dispensary agents in:

– Pharmacology of cannabis

– Potential therapeutic and adverse effects of cannabis

– Dosage forms and pharmacodynamics

– Potential drug interactions

– Recognition of symptoms of substance use disorders and acute intoxication

• Patient consults trained dispensary agent on appropriate medication

At Dispensary

• Patient or caregiver goes to the dispensary, or contacts dispensary for delivery by dispensary

• Patient or caregiver presents proof of identity

• Dispensary logs onto Commission database

– Confirm validity of written certification

– Determine amount of Cannabis that can be dispensed

– Record amount of Cannabis that is dispensed

At Dispensary

• Every time cannabis is dispensed• Patient must acknowledge that the patient is not

immune from liability or prosecution for:– Operating a vehicle under the influence of medical

cannabis– Smoking in a public place– Smoking in a motor vehicle– Acting under the influence in a manner that would

constitute negligence or professional malpractice.– Smoking cannabis on private property where not

allowed

At Dispensary

• Every time cannabis is dispensed

• Patient must also acknowledge:

– It is illegal to transfer the cannabis to any person

– Obtaining medical cannabis does not exempt patient from prosecution under federal law

– Scientific research has not established the safety of medical cannabis by pregnant women

– Use of medical cannabis to treat a medical condition is not approved by the U.S. FDA

Federal role

• Since 2009, U.S. Department of Justice has issued three memoranda that it will not prosecute physicians, patients, dispensaries and growers who comply with their state’s medical cannabis law

– 2009 Ogden Memorandum (Oct. 19, 2009)

– 2011 Cole Memorandum (June 29, 2011)

– 2013 Cole Memorandum (Aug. 29, 2013)

Federal role

• Feb. 2014 – U.S. Treasury issued memorandum that said “financial institutions can provide services to marijuana-related businesses” operating under state law

Federal role

• In 2014, Congress enacted a law barring the U.S. Department of Justice from interfering in the implementation of state medical cannabis laws (Section 538 of Continuing Appropriations Act of 2016, P.L. 114-53, sec. 103, 129 Stat. 502 (2015))

• Re-enacted on Dec. 18, 2015 for 2016 (Sec. 542 of P.L. 114-113)

Federal role

• In October 2015, interpreting the Appropriations Act rider, a Federal Court blocked U.S. Department of Justice from trying to stop a California dispensary from operating (U.S. v. Marin Alliance for Medical Marijuana, U.S.D.C., No. Dist. Cal., Case No. C-98-00086-CRB, Oct. 19, 2015)

• Affirmed by 9th Circuit, April 2016

MMCC Responsiveness

Regular updates and answers to FAQs at

mmcc.maryland.gov

Questions can be sent to

[email protected]

Presenter today: Eric E. Sterling, J.D.

Chair, Policy Committee, MMCC

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mailto:[email protected]