Tag Archives: news

DEA has 5 Importers and 3 Manufacturers of Cannabis in the US

According to information just released under FOIA there are only 5 importers and 3 “manufacturers” of Cannabis in the US.  Under the Freedom Of Information Act we just obtained a listing of the current importers and manufacturers of Cannabis that are licensed with the DEA.

The importers are Minnesota Depart of Ag, North Carolina Depart of Ag, PA Department of Ag, Washing State Department of Ag and Palomo Farms of North Carolina.  These people are most likely importing seed for use in the test plantings of Cannabis for Hemp Stalk production.

The three Manufacturers are Natl Ctr Natural Products Research, Catalent Pharma Solutions and Synthcon LLC.

Catalent puts it’s self as a “provider of drug delivery technology and development solutions for drugs, biologics and consumer health products.”  From their website information it appears they are actively looking at delivery methods for cannabinoids.

Synthcon appears to be a company that “develops and manufactures innovative medical devices“.  There isn’t much more information available about the company.

Natl Ctr Natural Products Research, is the University of Mississippi Farm.

 

DEA Information Removed From Site

Back in January ASA filed a suit against the DEA about information that was on the Public Website for the DEA that was faulty.  The DEA removed information from the site.

We were interested in what did the DEA remove from it’s website.  We filed a FOIA request with them and received a response.  In the response it appears the DEA has only removed two documents from it’s website.  The total content of materials removed constitute about 17 pages mostly dealing with Medical Cannabis.

The Documents they released are here at this link 17-00351-F documents

While this is a small victory it could lead to additional victories against other agencies which use essentially the same information on their sites.

If you would like to see the other information we have collected from the DEA and other agencies check this link – DEA FOIA

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)

 

DEA says Inhaled is Better

Today the DEA announced that they have a new FDA approved form of THC called Syndros.  Syndros is the result of work of Insys Therapeutics to create a new oral THC that has 5mg per ML of solution. – FEDERAL REGISTER LINK

In the DEA’s findings they are planning to schedule this as a Schedule II drug because.

Dronabinol is a generic name for the (-) delta-9-trans isomer of tetrahydrocannabinol (THC). THC is the primary psychoactive substance in marijuana. Dronabinol is the active pharmaceutical ingredient in Syndros. As stated by HHS, Marinol (synthetic dronabinol in sesame oil and encapsulated in a soft gelatin capsule) was approved by the FDA for medical use on May 31, 1985 and placed in schedule II based on its accepted medical use and high abuse potential. On July 2, 1999, Marinol was rescheduled from schedule II to schedule III because of the findings of the DEA that the difficulty of separating dronabinol from the sesame oil formulation and the delayed onset of behavioral effects due to oral route administration supported a lower abuse potential of Marinol as compared to substances in Schedule II. 64 FR 35928.

Going on to state:

HHS indicated that the formulation of Syndros (oral solution) is easier to abuse than Marinol because this liquid formulation can be manipulated to produce concentrated extracts of dronabinol for abuse by inhalation (smoking or vaping) or through other routes of administration. Because of the large amount of dronabinol in Syndros oral solution it has a greater potential for extraction than Marinol and thus has a greater abuse potential.

Based on the use of Cannabis by the general public DEA feels that this form of THC needs to be a Schedule II drug.

What you find when reading further down is that it appears DEA would rather people smoke it because of the onset of effects are easier to control.

Oral consumption of dronabinol, compared to inhaled THC, may result in psychoactive effects that are delayed and stronger with an increased risk of experiencing serious adverse events.

But then they quickly add:

When dronabinol (THC) is smoked, the drug rapidly reaches the brain and psychoactive effects are felt within minutes of inhalation, which allows the subject to control the dose more readily.

The DEA is full of contradictory things but this just about takes the cake.  Using a substance via oral methods pose issues that smoking or inhalation don’t and is better at controlling the dose.  However they are afraid that people will do just that.  Take this new drug and turn it into something they can control the dose better.

There is a time that this potential rule can be commented on, see the link at the top of the page to the federal register.

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, CBD, THC, Cannabis Extracts, Oh MY

There are lots of stories out there about how the DEA has classified CBD as a Schedule I substance. Nothing could be further from the truth.

This all stems from the DEA announcement of a new code for Cannabis Extracts.  Cannabis extracts are just that extracts from the Cannabis plant.  In the initial filing in 2011 the DEA stated:

The United Nations Conventions on international drug control treat extracts from the cannabis plant differently than marihuana or tetrahydrocannabinols. The creation of a new drug code in DEA regulations for marihuana extracts will allow for more appropriate accounting of such materials consistent with treaty provisions.

In the announcement DEA clarified a question brought up in a comment:

One comment requested clarification of whether the new drug code will be applicable to cannabidiol (CBD), if it is not combined with cannabinols.

DEA response: For practical purposes, all extracts that contain CBD will also contain at least small amounts of other cannabinoids.[1] However, if it were possible to produce from the cannabis plant an extract that contained only CBD and no other cannabinoids, such an extract would fall within the new drug code 7350. In view of this comment, the regulatory text accompanying new drug code 7350 has been modified slightly to make clear that it includes cannabis extracts that contain only one cannabinoid.

The operative words are produced from the cannabis plant.  This means just that produced from the plant itself and, that any synthetic cannabinoid is exempt from the code classification.

They again reiterate this in their final action:

“Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.”

The same would be true for THC extracted from the plant.  As an Extract it is a schedule I substance.  However THC produced in a Lab remains in it’s current schedule.  The difference is one is extracted from the plant the other is produced by a combination of chemicals and processing.

The DEA has done nothing with CBD, there has been no scheduling change, there is NO DRUG CODE for CBD.  If it is extracted from the plant then it is an Extract and Schedule I if it is made synthetically it’s a different story. You can see what is on what schedule at this link – DEA List of Controlled Substances and Drug Code

CBD is not in the controlled substance schedules or controlled by the DEA.  Provided it is not extracted from the Cannabis Plant.

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

 

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

 

Effects of Vaporized Marijuana

clinicalWhat are the affects of Effects of Vaporized Marijuana?  Are there any adverse events?  How about Serious adverse events? According to a small study done at the University of California, Davis with the collaboration of the Center for Medicinal Cannabis Research, VA Northern California Health Care System, nope.

In a study on Effects of Vaporized Marijuana on Neuropathic Pain they not only found that a significant number of participants benefited with lower pain levels, they also reported No Events of any significance.  The study included what they call low (1.29% THC) and medium (3.53%) and a placebo.

Surprisingly this study has been sitting on ClinicalTrials.gov since it’s completion in 2013

Here is a link to the study – ClinicalTrials.gov NCT01037088

 

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.