Tag Archives: legal cannabis

DEA Releases Legal Cannabis Import Data

The DEA today replied to our FOIA request for information on Legal Cannabis Seed imports into the US in the last 20 years.  While they weren’t able to supply some information as it was contained on a “retired” PC, they did supply information since 2010 and the numbers are amazing.

The clear trend has been a dramatic increase throughout the last 7 years.  It is assumed that this is Cannabis Seed that is being imported for hemp production but it will take further investigation to determine who is importing what.  Unfortunately the DEA doesn’t keep track of the difference between Cannabis Seed Imports and other forms of Cannabis.

The numbers are clear, yet muddied and we are seeking clarification but it appears that they are counting Grams in the report. (*EDIT 03-30-2017 – DEA confirms the weight unit is Grams** )

In 2010 it appears must be the year in which the switch was made from the old retired PC to the new system, so taking the low of 18,000 grams  (roughly 33 lbs) in 2011 and the high of almost 60 million grams (131,825 lbs) in 2016 the growth in imports is on a steady increase year over year.

The full FOIA can be found on our DEA FOIA page or this link 17-00256-F (DET)

 

Congressional Research Service Report on Cannabis

On March 10th the Congressional Research Service released it’s report on “The Marijuana Policy Gap and the Path Forward”

“Given the current marijuana policy gap between the federal government and many of the states, there are a number of issues that Congress may address. These include, but are not limited to, issues surrounding availability of financial services for marijuana businesses, federal tax treatment, oversight of federal law enforcement, allowance of states to implement medical marijuana laws and involvement of federal health care workers, and consideration of marijuana as a Schedule I drug under the CSA. The marijuana policy gap has widened each year for some time. It has only been a few years since states began to legalize recreational marijuana, but over 20 years since they began to legalize medical marijuana. In addressing state – level legalization efforts and considering marijuana’s current placement on Schedule I, Congress could take one of several routes. It could elect to take no action, thereby upholding the federal government’s current marijuana policy. It may also decide that the CSA must be enforced in states and not allow them to implement conflicting laws on marijuana. Alternatively, Congress could choose to reevaluate marijuana’s placement as a Schedule I controlled substance.”

Here is the document – R44782

And a link to the CRS report

DEA and Marijuana Extract Means.. NOTHING

On Dec 14th the DEA announced a new drug code for “Marijuana Extract” and there has been a lot of furor over the decision.  For those that have read the CSA and understand the meaning of the definition of “Marijuana” it already meant:

The term “marihuana” means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

Prior to this announcement everything other than THC, which already has it’s own drug code, all other Cannabinoids were classified under the Marijuana Code.  What this does is separate out for purposes of clerical and data collection a difference between raw Cannabis plant material and Extractions made from the plant.

NOTHING has changed, no substance scheduling has changed, no laws have been changed.

So what does it really mean?  What it really means is that now the extracts that researchers have been getting from the Mississippi Farm now have a separate code.  This allows the DEA, FDA, HHS, NIDA to track what kind of research is being done.  Is it whole plant or an extract that is being used.

Frankly it wouldn’t be a bad idea to put each cannabinoid it’s own drug code.  This could do two things.  First it would track what research is being done with what cannabinoids.  It could also lead to many more cannabinoids being put into different schedules like THC is in a different schedule.  One by one move the cannabinoids to other schedules and you less reason to keep the whole plant scheduled in schedule I

 

Pharmacists want more information

pmcIn a First of it’s kind study posted to PubMED shows that pharmacists want more information about medical cannabis.   The study conducted in Minnesota prior to Minnesota’s medical Cannabis program implementation shows that Pharmacists want more information on medical cannabis.  The Study was done by Joy Hwang, PharmD, MPH, Tom Arneson, MD, MPH, and Wendy St. Peter, PharmD

First the report determines that Minnesota Pharmacists, in general, have limited Knowledge of cannabis polices, regulations and felt they were not adequately trained.

Pharmacists reported limited knowledge of Minnesota state-level cannabis policies and regulations and felt that they were inadequately trained in cannabis pharmacotherapy. Most pharmacists were unprepared to counsel patients on medical cannabis and had many concerns regarding its availability and usage. Only a small proportion felt that the medical cannabis program would impact their practice. Pharmacists’ leading topics of interest for more education included Minnesota’s regulations on the medical cannabis program, cannabis pharmacotherapy, and the types and forms of cannabis products available for commercialization.

Unlike most states which have legal medical Cannabis Minnesota and a couple others have Licensed Pharmacists as the dispensers.  However in Minnesota these pharmacists are trained by their respective companies and have a great deal of knowledge about Cannabis use for medical purposes.

In these three states, pharmacists provide registered patients with consultations at one of the state-approved cannabis distribution centers. Moreover, they are the only health care professionals who are permitted to dispense cannabis products. This distinguishes these states from most other legalization states, where cannabis products—both medical and recreational—can be purchased from retail dispensaries that operate under the guidance of certified personnel known as “budtenders.”

The study was done to assess gaps in knowledge and concerns of Minnesota pharmacists.  The study conducted voluntarily via a web-based survey and had a 10% response rate by the states Pharmacists. The questionnaire had 14 questions they asked the pharmacists and also room for them to put in their own comments.

The majority of the respondents completed the survey and reported little concern about medical cannabis.

Most pharmacists rated themselves on the lower end of the Likert scale for self-perceived knowledge about medical cannabis and readiness to counsel patients on medical cannabis use (1 = poor; 7 = excellent) and concerns about medical cannabis use under the Minnesota program (1 = no concern; 7 = most concern)

Almost 90% of the respondents responded that they were less than moderately prepared to provide counseling services to patients using cannabis for medical purposes.

Pharmacists in general want more education.  This survey is of all pharmacists registered in Minnesota. Of those only a small number of them actually work with cannabis patients in the clinics that are available.  However it’s clear from this study that they want more education on Cannabis.

Respondents were very interested in learning more about medical cannabis in the following areas: state-specific rules and regulation (87%), pharmacotherapy (88%), and available types and forms of products on the market (82%). Fifty-three percent were interested in learning more about federal laws related to marijuana. Only 7% indicated no interest in learning more about any of these topics.

The study was conducted 2 months prior to Minnesota implementation of it’s cannabis program and there was a great deal of confusion about it.  Since the time of the survey information from a variety of sources including educational presentations to many hospitals, clinics, and hospital-clinic organizations in Minnesota with pharmacists as part of the audience, The University of Minnesota College of Pharmacy, Medical School and School of Nursing, full-day educational symposium on medical cannabis in April 2016, the Minnesota Pharmacists Association (MPhA) and the Minnesota College of Clinical Pharmacists.

The Study Concludes:

This study suggests that Minnesota pharmacists were not sufficiently prepared to work with patients in the medical cannabis program. Of those who provided survey responses, an overwhelming majority felt incompetent in medical cannabis clinical knowledge; however, almost half were unconcerned about the potential impact the program’s implementation would have on their practice. Nonetheless, pharmacists were interested in learning about medical cannabis and its state-specific regulation. Targeted education regarding cannabis pharmacotherapy, product availability and variability, and state-specific regulations should be available for health care professionals practicing in states with medical cannabis programs prior to program implementation and patient access.

 

Link to the study here – LINK

Copy of the study here – minnesota-pharmacists-and-medical-cannabis_-a-survey-of-knowledge-concerns-and-interest-prior-to-program-launch

 

WHO Pre-review Report Cannabis and Cannabis resin

With the upcoming meeting of the World Health Organization (WHO) Expert Committee on Drug Dependence Thirty-eight Meeting in Geneva, on 14 – 18 November 2016 many are calling for Cannabis to be an agenda item.

coverIn a pre-view Report “Cannabis and Cannabis Resin Pre-Review Report A document prepared for the World Health Organization” was prepared by H. Valerie Curran, Philip Wiffen, David J. Nutt, Willem Scholten.  In their report they give all the reasons why Cannabis should be more than an Update Item on the agenda.

In their report to the WHO they state in the preface:

In the eighty years since cannabis and cannabis resin were last reviewed by the Health Committee of the League of Nations in 1935, both the social context of cannabis use and the science of drug dependence have dramatically changed. Yet, cannabis and cannabis resin continue to remain under the strictest control regime possible under the Single Convention, without a valid scientific re-assessment of this decision. Cannabis and cannabis resin are listed in Schedule I and Schedule IV respectively, which means that both remain strictly prohibited worldwide.

then adding that the WHO is acting in a manner that appears to make continued prohibition illegitimate

The current scheduling of cannabis is in marked divergence with the Convention’s principle that scheduling of substances should be based on a scientific assessment by WHO. In the absence of a recent assessment, the continued prohibition of cannabis appears completely illegitimate even though it may be legal.

38ccdThey then proceed to ask the WHO to conduct a Scientific Review of cannabis and cannabis resin

A scientific review by the WHO, the only authoritative global body to make such an assessment, would greatly legitimize international policies and their national implementation. A scientific assessment of cannabis and cannabis resin appears most timely given the many debates that have emerged on this issue across the world in recent years.

In the fifty years since it’s inception the WHO has never conducted a scientific review of cannabis.  Despite it’s mandate to review the substance.

The scheduling under the Single Convention on Narcotic Drugs assumes a scientific justification. However, cannabis and cannabis resin have never been evaluated by WHO since it was mandated the review of psychoactive substances in 1948.

The purpose of the pre-review report is to clarify the position of the current state of use both medically and none medically.

The purpose of a Pre-review is to determine whether current information justifies a Critical Review. For evaluating substances in a Pre-review, the categories of information are identical to those used in Critical Reviews. At the stage of the Pre-review, the Expert Committee must decide whether the information justifies a Critical Review. If it finds that the data available may justify changing the scheduling of cannabis and/or cannabis resin, the Committee should recommend a Critical Review in its next Meeting.

The 53 page report, or 75 with cites, covers everything from adverse reactions, LD50 level, and pretty much everything you ever wanted to know about cannabis and how it works.  The report is remarkable in it’s completeness.

Conclusions Despite that the scheduling system of substances under the Single Convention on Narcotic Drugs is supposed to be based on scientific assessments, the WHO has never reviewed cannabis and cannabis resin. This means also that the Expert Committee continues to recommend that cannabis is not to be used medically despite growing evidence of considerable medical use world-wide, including the availability of a pharmaceutical preparation with a marketing authorization in multiple countries. Many countries are struggling with the impact of the prohibition of cannabis with its wide negative impact on societies (including through human rights violations) and on drug markets and drug use, including on the market of synthetic cannabinoids.

Committee recommendations are needed on the following topics:

1. Whether a Critical Review should be conducted for reviewing the current scheduling in Schedules I and IV. Each of the following reasons would justify a recommendation for a Critical Review: a. because WHO has never conducted a Critical Review, meaning that there is no scientific justification for the current scheduling; b. because the wide-spread medical use, including the use of preparations with a marketing authorization is in contradiction to listing in Schedule IV; c. because it is not clear whether the dependence-producing properties of cannabis and cannabis resin are between codeine and morphine (justification for Schedule I) or between dextropropoxyphene and codeine (justification for Schedule II) or below those of dextropropoxyphene (justification for not scheduling).

2. On the medical use of cannabis and its preparations (which can include revoking old recommendations by the Committee)

3. On the need of quality control on cannabis and cannabis products for medical and non-medical use.

Here is a link to the piece – LINK

Here is the report itself just in case it disappears from the net – whocannabisreport

Therapeutic Cannabinoid Research

The State of The States, Cannabis

wss_skunk_cured_budEvery year the president, governors, city leaders give a state of the state address so we thought why not make a state of the states for Cannabis.  We’ve been able to kinda find all the laws as they are now, subject to change in Nov, so people can see the number of states that have legalized cannabis for one use or another.

It’s actually a pretty impressive list, a few years ago this list would have been much shorter

Alaska Stat. §§ 17.37.010 et seq. (medical), §§ 17.38.010 et seq. (recreational);
Arizona Rev. Stat. §§ 36-2801 et seq. (medical);
California Health & Safety Code §§ 11362.5 et seq. (medical);
Colorado Rev. Stat. §§ 12-43.3-101 et seq. (medical), §§ 12-43.4-101 et seq. (recreational);
Connecticut Gen. Stat. §§ 21a-408 et seq. (medical);
Delaware Code Ann. tit. 16, §§ 4901A et seq. (medical);
D.C. Code §§ 7.1671.01 et seq.(medical);
Hawaii Rev. Stat. §§ 329-121 et seq. (medical);
Ill. Comp. Stat. Ann. 130/1 et seq.(medical);
Maine Rev. Stat. tit. 22, §§ 2421 et seq. (medical);
Maryland Code Ann. Health-Gen §§ 13-3301 et seq. (medical);
Massachusetts Ann. Laws ch. 94C, §§ Appx. 1 et seq. (medical);
Michigan Comp. Laws Serv. §§ 333.26421 et seq. (medical);
Minnesota Stat. Ann. §§ 152.27 et seq. (medical);
Nevada Rev. Stat. §§ 453A.___ [2015 ch. 401, § 29] et seq. (medical);
New Hampshire Rev. Stat. Ann. §§ 126-X:2 et seq. (medical);
New Jersey Stat. Ann. §§ 24:6I-1 et seq. (medical);
New Mexico Stat. Ann. §§ 26-2B-1 et seq. (medical);
New York CLS Pub. Health Law §§ 1004.1 et seq. (medical);
Oregon Rev. Stat. §§ 475.300 et seq. (medical), Or. Rev. Stat. §§ ___.___ [2015 c.1, § 3] et seq. (recreational);
Rhode Island Gen. Laws §§ 21-28.6-1 et seq. (medical);
Vermont Stat. Ann. tit. 18 §§ 4472 et seq. (medical);
Washington. Rev. Code §§ 69.51A et seq. (medical), Rev. Code §§ 69.50.360, 69.50.363, 69.50.66, 69.50.401 (recreational).

 

Price of Big Pharm Cannabis

It’s pretty clear with the recent developments that Big Pharm is seriously looking at Cannabinoids.logo  hgDPF-j4_400x400While the vast majority like GW Pharm are using synthetic versions there are plant derived cannabinoids and the plant itself being used in clinical studies.

The cost of Synthetic Cannabinoids is easy to determine.  Sigma-Aldrich offers Cannabinol for $25 a milligram.  A single milligram of THC costs almost $50.  Cannabidiol is also nearly $50 a milligram.  Synthetic Cannabinoid medications are going to be expensive.  Given that a dose of 10mg THC – <1mg CBD needed for pain the cost per dose is going to be over $500.

marijuana-001Plant based medications are in comparison cheap.  Even at the expensive distributors in a very restrictive state like MN you can get 100mg of THC and 4mg of CBD for only $47.00 .  This comes down to $4.70 per effective dose. Clearly plant based extracts of Cannabinoids are cheaper than synthetically produced ones.

Big Pharmacy seems to be interested in making Cannabinoids but will the public be able to afford what they synthetically produce?  Not at $500+ a dose

 

USP Door For Cannabis?

uspThere are a number of ways that Cannabis could be recognized as a medical substance or at least treated differently than it is now.  One is the DEA, well we already know how helpful they are.  Another would be the FDA, they already supply the misinformation used by the DEA so are they an option?  Maybe.  The other is to get something back into the Formulary through the USP.

The USP has legal authority given to it by the FDA back in 1966:

The U.S. Federal Food, Drug, and Cosmetics Act designates the USP–NF as official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding.

Could the USP be a door for Medical Cannabis?  The USP (United States Pharmacopeia) is one of several formularies used by Health Care Practitioners and the FDA to determine medical value of substances and plants.

What most people don’t know is that while the USP creates monographs for chemicals they do the same for Food Ingredients and Dietary Supplements.  Again with legal authority given to them by the FDA

Currently, over 200 FDA regulations cited in the U.S. Code of Federal Regulations incorporate the food ingredient standards that USP publishes in the Food Chemicals Codex (FCC) compendium. The first edition of the FCC, which was published in 1966 by the Institutes of Medicine, was given quasi-legal recognition in July 1966 by means of a letter of endorsement from FDA Commissioner James L. Goddard, which was reprinted in the book. The letter stated that “the FDA will regard the specifications in the Food Chemicals Codex as defining an ‘appropriate food grade’ within the meaning of Sec. 121.101(b)(3) and Sec. 121.1000(a)(2) of the food additive regulations, subject to the following qualification: this endorsement is not construed to exempt any food chemical appearing in the Food Chemicals Codex from compliance with requirements of Acts of Congress or with regulations and rulings issued by the Food and Drug Administration under authority of such Acts.”

and

USP’s standards for dietary supplements may be found in USP–NF and Food Chemicals Codex (FCC) compendia. Legal recognition varies depending from which compendia the standards are published.

To do this the USP works with manufacturers to develop monographs for items:

USP develops public standards to provide quality oversight for dietary supplements and their ingredients. Public input and interaction are vital to the development of these standards, which originate from the draft monographs and data provided by dietary supplement manufacturers, users, and suppliers. USP’s scientific staff and the volunteer Dietary Supplements Expert Committee review data, conduct necessary laboratory tests, and ensure that the information is subject to a process of public review and comment.

They do this through several public forums which they operate:

Proposals for new or revised dietary standards from USP–NF and FCC that appear in the DSC are first published for public review and comment in either the Pharmacopeial Forum or the FCC Forum. Through these free online forums, interested parties have the ability to provide feedback on the proposed standards and revisions and participate in the USP standards-setting process.

They encourage people to submit their substances for inclusion:

USP encourages you to submit draft monographs for the dietary supplements you manufacture or supply. Your draft monograph will become the starting point for the public standard. USP staff will involve you in the public process of review and comment to refine and finalize the monograph for publication in the next USP-NF edition or supplement.

The USP sounds like it is an avenue that is open to Medical Cannabis in the form of a Food Ingredient or as a Dietary Supplement and they tell you how to do it.

US Pharmacopeia looking at Medical Cannabis

uspFollowing up on why would the USP want to be registered with the DEA we found, The US Pharmacopeia is looking at medical Cannabis and how to set a Monograph.  This is extremely important for anyone seeking to get FDA approval and DEA to re-schedule.

Based on what we have found in the USP website it’s clear that they are aware that Cannabis has a long history of medical use. “In 1850, USP admitted cannabis as a recognized drug in the United States Pharmacopeia (USP) and published an Extractum Cannabis (or Extract of Hemp) monograph”

usp-mjIt’s also pretty clear that they can develop standards for Cannabis products.  “USP has a long history of developing quality standards for herbal medicines, either as pharmaceuticals or as dietary supplements. USP has state-of-the-art laboratories throughout the world, and global scientific expertise in the form of USP staff and expert volunteers. This cumulative experience and expertise at USP could be used as a foundation for standard development for cannabis products.”  adding  “USP is considering organizing an open forum for discussion of these proposals to gather input for a suitable path forward toward the potential development of quality standards for medical cannabis.”

However they fear the results without working closely with the FDA and DEA.  “Another important consideration would be where to publish the standards that USP may develop for medical cannabis. USP’s flagship compendia, the USP–NF, are recognized as “official compendia” under United States law and contain standards for identity, strength, quality, and purity of medicines that are enforceable by the FDA. Generally, USP–NF only contains monographs for drugs that were included in USP before the 1938 amendment to the Food, Drug and Cosmetic Act, or drugs that are legally marketed in the U.S., which presents an important challenge given that marijuana is currently illegal under federal law. Given medical cannabis’ current legal status, the regulatory implications of publishing cannabis standards in USP–NF would need to be carefully reviewed and analyzed with input from regulators and other stakeholders. In particular, input from the FDA and U.S. Drug Enforcement Administration will be critical.”

USP is clearly looking at Medical Cannabis and how they might control or help it’s regulation and use.  “As the use of medical cannabis is growing, the need for a USP public scientific standard to help ensure identity, purity, quality, and strength has been identified. Public quality standards for medical cannabis are important for many reasons, including the avoidance of adulteration, accurate identification, control of contaminants, and considerations regarding constituent composition and strength.”

Concluding “USP is committed to working with stakeholders to determine the advisability and feasibility of developing public quality standards for medical cannabis. USP welcomes comments on the issues and ideas presented in this Stimuli article and on all aspects of developing such standards, including scientific and public health considerations, legal and regulatory issues, and mechanisms for obtaining appropriate scientific expertise and ongoing stakeholder input.”

USP recognizing medical cannabis would help change DEA scheduling of Cannabis.  For more information and link to the Article they published follow here – LINK

The USP recently filed an application with the DEA to deal with Cannabis a schedule I substance.