NYS Medical Cannabis Laws & Regulations for Practitioners & Healthcare Professionals. Brief Overview.

1. z MEDICAL
CANNABIS:
Laws & Regulations for Practitioners
Dr. Minchul An
min@basalhealth.co

2. z
PRESENTATION OBJECTIVES:
 Explain the discovery of the ECS and how this led to new therapeutic uses in select patient
populations.
 Understand the differences between hemp and marijuana from the C.Sativa family.
 Explain how the CSA in 1970 had an impact on cannabis for centuries.
 Understand how the recent passing of the 2018 Farm Bill impacted hemp and its uses today.
 Contrast state and federal laws and how these conflicting policies affect prescribers, patients, and
consumers.
 Understand provider roles and the qualifications and specifications to prescribe medical cannabis.
 Understand the requirements from NYS DOH to register as a prescriber for medical cannabis.

3. z
The Endocannabinoid System:
 The endocannabinoid system, or ECS, was discovered by
scientists in the early 1990s.
 CB1 and CB2 receptors located throughout the body.
 CB1 receptors are found mostly in the brain and central nervous
system, connective tissues, glands, and organs.
 CB2 receptors are found mostly in the immune system and
peripheral nervous system.

4. z
C. SATIVA
Infographic by dreamstime.com

5. z
HEMP
 CBD, or cannabidiol, is the most popular and well-studied
cannabinoid.
 CBD is 1 out of 100+ compounds found in the C.Sativa plant.
 Hemp is federally legal per 2018 Farm Bill, under strict conditions.
 Some studies suggest cannabinoids to have therapeutic benefits.
 Touted as ”organic Xanax.”
 Non-intoxicating.
 No more than 0.3% THC dry weight.

6. z
MARIJUANA
 Recreational vs. Medical uses (legalization varies per state).
 Medical marijuana is legal in NY per state specific program.
 >0.3% THC dry weight.
 Federally illegal per CSA 1970.3
 Psychoactive / intoxicating (due to higher THC content)

7. z
Controlled Substance Act 1970
 Commonly known as the “CSA.”
 Established federal U.S. drug policy under which the manufacture, importation,
possession, use and distribution of certain substances is regulated.
 Classified cannabis as a Schedule 1 drug.
 Cannabis is federally illegal in the U.S.
 Comprehensive Drug Abuse Prevention and Control Act of 1970 signed into law by
President Nixon.7
 Single Convention on Narcotic Drugs.

8. z
AGRICULTURAL IMPROVEMENT ACT
2018
 Commonly known as the “Farm Bill.”
 Removed hemp and its derivatives from the Controlled
Substances Act.
 Defines hemp as “cannabis (Cannabis sativa L.), and derivatives
of cannabis with extremely low (less than 0.3 percent on a dry
weight basis) concentrations of the psychoactive compound
delta-9-tetrahydrocannabinol (THC).”

9. z
FEDERAL LAW
 Per Controlled Substance Act of 1970, cannabis remains a
Schedule 1 drug: 2
 Has the potential for abuse,
 Has no currently accepted medical use in treatment in the U.S.,
and
 Has a lack of accepted safety for use of the drug under medical
supervision.

10. z
STATE LAW
 New York allows for the limited use of medical marijuana within
the state.
 No more than twenty dispensaries can operate statewide.
 Those facilities can prescribe non-smokable preparations (i.e.
tinctures, edibles) of marijuana to people with cancer, glaucoma,
or other diseases on state list.

11. z
Legality of
cannabis in the
US:
 Although federally cannabis
is illegal per the CSA, state
policies regarding medical
and recreational use of
cannabis vary greatly per
state, and in many states
conflict significantly with
federal law.1
 The medical use of cannabis
is legalized in 33 states.
 The recreational use of
cannabis is legalized in 11
states.
 Another 16 states and the
US Virgin Islands have
decriminalized.
[Infographic source: Wikipedia] https://en.wikipedia.org/wiki/Legality_of_cannabis

12. z
FDA regulatory framework:
 “It’s unlawful under the FD&C Act to introduce food containing added
CBD or THC into interstate commerce, or to market CBD or THC
products as, or in, dietary supplements, regardless of whether the
substances are hemp-derived. This is because both CBD and THC are
active ingredients in FDA-approved drugs and were the subject of
substantial clinical investigations before they were marketed as foods
or dietary supplements. Under the FD&C Act, it’s illegal to introduce
drug ingredients like these into the food supply, or to market them as
dietary supplements. This is a requirement that we apply across the
board to food products that contain substances that are active
ingredients in any drug.”
FDA commissioner’s, Scott Gotlieb, full statement here.

13. z
NYS regulatory framework:
 “Governor Andrew M. Cuomo signed legislation (S.6184/A.7680) establishing a
regulatory framework for the production and sale of hemp and hemp extract in New
York State. The measure also requires the hemp industry to test and label their
products, protecting consumers from potential harm. The legislation was signed
pursuant to a chapter agreement, which provided for a more streamlined regulatory
pathway for hemp products, granted the Department of Agriculture and Markets
supervision over hemp growers and the Department of Health supervision over
hemp extract; created a registration requirement for sellers of hemp extract
products; made conforming regulatory changes to the 2018 Farm Bill; and defers
decision making on hemp extracts, including CBD, as additives for food and
beverages.”

14. z
STATE VS. FEDERAL CONFLICT:
 Conflict 1:
 FDA: cannot market as dietary supplement.
 NY: must be marketed and sold as dietary supplement.
 See slides: FDA regulatory framework vs. NYS regulatory framework
 Conflict 2:
 FDA: marijuana is illegal.
 NY: state program allows for medical marijuana to be used for select
patients for treatment.
 The Department of Justice (DOJ) is responsible for enforcing the Controlled Substances Act of 1970 which banned
and criminalized marijuana. In 2014, Congress passed the Continuing Resolution Omnibus Spending Bill that
prevents the DOJ, including the FBI from interfering with state medical marijuana laws. 6

15. z
PROVIDER ROLES:
 Despite Federal law, through the regulatory requirements of the Medical Marijuana
Program in NYS, practitioners can demonstrate how medical marijuana may fit into
medical practice for pain management, explain safety, potential risks and benefits
of medical marijuana use, provide information on the effect marijuana may have on
the following severe debilitating or life-threatening conditions.5
 Cancer, Chronic Pain, HIV positive status or AIDS, Amyotrophic Lateral Sclerosis (ALS), Parkinson’s Disease,
Multiple Sclerosis, Spinal cord damage with objective indication of intractable spasticity, Epilepsy, Inflammatory
Bowel Disease, Neuropathies, Huntington’s Disease, and/or the condition is clinically associated with cachexia,
severe or chronic pain, severe nausea, seizures or severe or persistent muscle spasms.1
 Frequently asked questions here.

16. z
PROVIDER ROLES CONT’D:
To register with the NYSDOH Medical Marijuana Program, click here.
Content provided by NYSDOH

17. z
NYS Practitioner Registration:
 Practitioners must be qualified to treat patients with one or more of the serious
conditions in the Compassionate Care Act.
 Click here for information about serious conditions.
 To be qualified to treat patients with substance use disorder or opioid
use disorder, the practitioner must hold a federal Drug Addiction
Treatment Act of 2000 (DATA 2000) waiver.
 Have completed the department-approved course on the medical use of
marijuana.

18. z
NYS Practitioner Registration cont’d:
 Licensed in good standing as a physician and practicing medicine as defined in article 131 of the
Education Law, in New York state; or
 Certified in good standing as a nurse practitioner and practicing, as defined in article 139 of the
Education Law, in New York state; or
 Licensed in good standing as a physician assistant and practicing medicine as defined in article 131-B of
the Education Law, under the supervision of a physician registered with the program.
 Any questions regarding the practitioner registration process should be emailed to mmp@health.ny.gov
 For more information, visit NYS DOH website here.

19. z
References / Additional Resources:
 1 Federation of State Medical Boards. Model Guidelines for the Recommendation of Marijuana in Patient Care. April 2016.
Retrieved from: https://www.fsmb.org/siteassets/advocacy/policies/model-guidelines-for-the-recommendation-of-marijuana-in-
patient-care.pdf
 2 Hodroff MB. The Controlled Substances Act: Time to Reevaluate Marijuana. Whittier Law Review. 2014;(Issue1):117.
http://search.ebscohost.com/login.aspx?direct=true&db=edshol&AN=edshol.hein.journals.whitlr36.7&site=eds-live. Accessed
September 12, 2020.
 3 Hudak J. Early Regulation and a New (Drug) Deal. In: Marijuana A Short History. Second Edition. Washington, D.C.: Brookings
Institution Press; 2020:29-37.
 4 Hudak J. The farm bill, hemp legalization and the status of CBD: An explainer. Brookings Institution. 14 December 2018.
 5 Martin J. Medical marijuana: Legal considerations for physicians. Medical Economics. 2015;92(23):43-44.
http://search.ebscohost.com/login.aspx?direct=true&db=cmedm&AN=26875333&site=eds-live. Accessed September 20, 2020.
 6 National Academies of Sciences, Engineering, and Medicine. 2017. The health effects of cannabis and cannabinoids: The
current state of evidence and recommendations for research. Washington, DC: The National Academies Press. doi:
10.17226/24625.
 7 Slaughter JB. Marijuana Prohibition in the United States: History and Analysis of a Failed Policy. Columbia Journal of Law and
Social Problems; 1988;21(4):417-74