Enforcement? Medical Cannabis in Maryland

1. Enforcement?
Medical Cannabis in Maryland
A presentation to
Cannabis Science and Policy Summit
New York University
April 18, 2016
By
Eric E. Sterling, J.D.
Chair, Policy Committee
Maryland Medical Cannabis Commission
mmcc.maryland.gov

2. 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.

3. Background
• Link to compiled statute on Commission
website: mmcc.maryland.gov
• http://mmcc.maryland.gov/pages/law/docum
ents/Subtitle%2033_Sept2015_Corrected.pdf

4. Appreciation
• Delegates Dan Morhaim, M.D. and
Cheryl Glenn
• Senator Jamie Raskin
• The key advocates in General Assembly
throughout development of program

5. 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

6. 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

7. 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

8. Funding
• Program costs not funded by Maryland
taxpayers
• Program costs entirely paid for by fees from
licensees

9. 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

10. 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

11. 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

12. 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

13. Current Status of Program
• Deadline for applications was November 6,
2015
• Commission received 1081 applications:
• 146 grower applications
• 124 processor applications
• 811 dispensary applications

14. Current Status of Program
• Independent third party now reviewing
applications to score and rank

15. Current Status of Program
• Commission now registering physicians
• 117 physicians registered as of last week
• Registry for patients being subjected to load
testing before going online

16. Security - Safety
• Shaping the Program:
– Commission includes Chief of Police
(representative of law enforcement)
– A State’s Attorney
– A representative of the Comptroller

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. Security - Safety
• Cannabis products packaging:
– 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

27. Security - Safety
• Cannabis products packaging:
– Finished product lot number, expiration date
– Conspicuously itemized contents
– Personalized label

28. 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

29. 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

30. 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

31. Quality
• Strict horticultural control required
• Incoming materials must be segregated and
inspected to prevent contamination

32. 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

33. Quality
• Every batch and lot must be analyzed and labeled
with cannabinoid ingredients:
– THC
– THCA
– CBD
– CBDA
– Certain terpenes
– CBG
– CBN

34. 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

35. 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

36. 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

37. 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

38. 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

39. Physician Registration
• 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

40. Physician Registration
• 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

41. Physician Registration
• 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)

42. Physician Registration
• 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.”

43. 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

44. 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

45. 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

46. 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

47. Written Certification
• 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

48. Written Certification
• 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

49. Written Certification
• 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

50. 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)

51. 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

52. 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

53. 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

54. 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

55. 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)

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

57. 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)

58. 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

59. MMCC Responsiveness
Regular updates and answers to FAQs at
mmcc.maryland.gov
Questions can be sent to
dhmh.medicalcannabiscommission@maryland.gov
Presenter today: Eric E. Sterling, J.D.
Chair, Policy Committee, MMCC
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