Legal Status of Cannabis Flashcards
What does the Passage of the Controlled Substances Act (CSA) entail for marijuana?
(1) Considers marijuana a Schedule I drug.
(2) In the U.S. it is deemed to have “no currently accepted medical treatment”
(3) Has a high potential for abuse and lack of accepted safety for use under medical supervision
Which state was the first state to legalize marijuana in 1970?
California
Approximately what percentage of Americans live in an area where marijuana is legal to consume?
~50%
Approximately how many Americans are registered as medical marijuana patients?
5 million.
What percent of Americans support marijuana legalization?
~68%
When and what law was signed by President Biden reguarding marijuana?
December 2, 2022
Medical Marijuana and Cannabidiol Research Expansion Act (Also known as the Cannabis Research Bill)
Does this law presented by Biden change marijuana being a schedule I drug?
No lmao
What is the legislation presented by Biden intended to do? (Hint: There are 4 major things)
(1) Advance research on the potential risks and medical benefits of cannabis, their products, and synthetics by streamlining and clarifying the role of the DEA
(2) Expand research sources of marijuana
(3) Promote the commerical development of FDA-approved drugs derived from marijuana and CBD
(4) Ensure that physicians may discuss the potential risks and benefits of marijuana and CBD with their patients.
What is the DEA?
Drug Enforcement Administration
What were the requirements prior to the new legislation?
Researchers investigating the medicial benefits and risk of cannabis had to navigate a multi-step process involving three federal agencies.
Additionally, they had to comply with requirements imposed by the state(s) in which the research was conducted.
What are the three federal agencies involved prior to the new legislation in order to start cannabis related investigations?
(1) Food Drug Administration (FDA)
(2) Drug Enforcement Administration (DEA)
(3) The National Institute on Drug Abuse (NIDA)
What are the steps of FDA authorization?
(1) The sponsor of the study must submit an Investigative New Drug (IND) application outlining protocols for the proposed study and the qualifications of the investigators.
(2) IND sponsors also must provide assurances of informed consent and protection of the rights, safety, and welfare of the human subjects participating in the study.
(3) Studies involving ANY controlled substances sponsors must include protocols to ensure safe and secure storage to prevent theft or diversion
(4) The sponsor must also submit the clinical protocol to an instutional review board
What is an IRB?
Instutional Review Board
What is an IND?
Investigative New Drug (application)
What are some examples of the protocols that need to be submitted to the FDA?
-Certificates of analysis providing cannabinoid profile/purity and testing for contaminants
-Stability Testing
-Manufacturing procedures
Until recently, how many sources did the United States rely on to produce marijuana for domestic research purposes? What is the name of this/these source(s)?
Just one source: National Center for the Development of Natural Products at the University of Mississippi.
Who funded this sole source of marijuana?
NIDA through the NIDA Supply Drug Program
What is the issues with the marijuana supply from the NIDA Supply Drug Program?
-Inadequate
-Low Potency
-Lacking in Diversity
-Not similar to commericially available cannabis from legal dispenceries
-Combersome to aquire
What is the process for the DEA registration?
(1) Researchers must apply for DEA registration under Section 823(f) under the CSA.
(2) The application must provide information about the IND, the investigators’ qualifications, the institution where the research will take place, as well as evidence of IRB approval for human studies, and state licensure to handel controlled substances
(3) Each clinical trial site must be registered
(4) Schedule I researchers must seek seperate approval for the research protocol and certify that they maintain recordkeeping and security protocols sufficient to prevent theft or diversion
(5) Securing and modifying a Schedule I registration has involved significant administrative challenges , and researchers report that obtaining a new registration has taken more than a year
What is the Agriculture Improvement Act of 2018, Public Law 115-334? (This is also known as the 2018 Farm Bill).
Removed hemp, a variety of cannabis naturally low in THC content and naturally high in CBD
What did the Agricultural Improvement Act of 2018 do?
Paved the way for legal cultivation, posession, sale and distribution of the hemp plant.
Additionally removed CBD products from the definition of marijuana in the CSA.
In general what does the new bill change?
Title I of the Cannabis Research Bill makes a number of important changes to streamline the registration process for researchers using annd manufacturing cannabis products for research.
Describe section (a) of the new bill.
Eliminating the duplicate review by DEA.
The bill requires DEA to accept an application for registration if research protocol has been approved by:
(i) The FDA throught the IND process
(ii) By the NIH or another federal agency that funds scientific research
(iii) if the applicant has complied with the DEA’s protocols for researching Schedule I substances.
Describe section (b) of the new bill.
Expediting DEA registration and review.
The bill accelerates DEA’s process for registering marijuana research applicants by imposing strict timelines for DEA’s review of applications. DEA must approve a complete application or request supplement information within 60 days
Describe section (c) of the new bill.
Limiting the scope and pace of review protocol changes.
The bill expedites the process for DEA’s review of changes in study protocols involving marijuana. The bill ensures that researchers are allowed to proceed with certain changes to the protocol w/o notifying the DEA.
Researchers must continue notify the DEA, however, of changes involving quantity, type, source, conditions under which the marijuana is stored, tracked, or administered.
Describe section (d) of the new bill.
In response to concerns that DEA’s security requirements for research involving marijuana have been overly burdensome and inconsistent, the bill specifies that researchers must store marijuana and its components in a “securely locked, substaintially constructed cabinet” and that any other DEA safeguards against diversion of marijuana must be constitent with the same rules imposed for other Schedule I or II substances.
Describe section (e) of the new bill.
The legislation directs the Attorney General, in consultation with the Secretary of Health and Human Services, to determine anually if there is an adequate and uninterrupted supply of marijuana and it’s “derivatives”.
Describe section (f) of the new bill.
Expanding sources of marijuana available for research purposes.
In an effort to increase commerical production and number of entities registered to “manufacturers” (cultivate, harvest and process) marijuana for purposes of research, the bill directs the DEA to file a Federal Register notice to increase the number of manufacturers and then register additional manufacturers no later than 60 days after DEA receives a complete application complying with statutory requirements.
Describe section (g) of the new bill.
Preventing duplication of the HHS review process.
Althought the Department of Health and Human Services ended its policy of requiring Public Health Service review in addition to FDA review of marijuana research applications several years ago, the bill satutorily prohibts the HHS from reinstating any such requirement.
What does the HHS?
Department of Health and Human Services.
What is title II of the new Bill entitled as? This title has to do with the protection of colleges and universities.
Development of FDA-Approved Drugs Using Cannabidiol and Marijuana
What Act has caused concern for loss of federal funding for schools?
Drug-Free Schools and Campuses Act (DFSCA)
What does title II clarify?
A registered IHE, practitioner, or manufacturer may manufacture, distribute , dispense, or posses marijuana for purposes of research.
What does title II require the DEA to do?
The DEA shall register applicants to manufacture or distribute marijuana for purposes of commerical production of marijuana derived drugs approved by the FDA.
What does title III of the bill entitle? This has to do with Doctor-Patient relationships?
Provides an express exemption to the CSA to permit physicians to discuss with their patients the “potential harms and benefits” of marijuana derivatives and CBD as treatments.
Who does title III appear important to? What would this help?
Veterans. This would help treat PTSD, chronic pain, and other disabling conditions.
Has RI legalized the use of cannabis?
Yes.
What is the maximum amount of marijuana a person can have on them in RI?
1 ounce.
Can discpenseries sell recreational use marijuana in RI?
Yes.
How old in RI do you have to be to possess marijuana?
21
How much cannabis can someone in RI possess in their home?
10 ounces
How much cannabis concentrate can someone in RI possess?
5 grams
How much cannabis can one transfer to another adult in RI?
1 ounce
What is the punishment for posession of 1 ounce to 1 kg of cannabis?
One year in jail and $500 fine.
What is the punishment for posession of 1 to 5 kg of cannabis with intent of distrubting?
10-50 years and $500,000 fine.
(Double penalty if within 300 yards of a school)
What is the punishment for posession of more than 5 kg of cannabis with intent of distrubting?
25 years to life and $100,000 fine.
(Double penalty if 300 yards from school)
What is the law on cultivation of cannabis in RI?
3 mature cannabis plants and 3 additional immature cannabis plants.
What is the law on medical marijuana in RI?
Eligible for patient by physican approval (up to 2.5 ounces) or 12 plants and 12 seedlings (indoor cultivation only).
