Pharm grade Cannabis?

I have a request to make pharm grade cannabis topicals. My client gave told me a pharm company is working with the FDA on some products.  They are under the assumption because the FDA is working with a Pharm. company this is something very easy to do.  

I am asking how feasible is making "pharm" grade topicals infused with cannabis and not be a pharm company? What clearances would you need? Could you do this without FDA blessing? What particulars would I need to know?  

Comments

  • I am guessing this will be regulated state by state. What country/State will you be producing for? When you mention cannabis, are you refering to cannabidiol (CBD)?



  • I am talking about CBD oil right now.  I am sure this will expand.  I am California.  Any information to give me an idea would help.  Are there claims of people making pharmaceutical grade topicals for prescription ????
  • The FDA is not working with anyone to come up with Pharm grade cannabis.

    If a product is making drug claims then it is not a cosmetic. If a product is a drug then it has to be approved by the FDA for application to the specific thing it's been approved for.

    The FDA does not work with companies to produce products.
  • So far the FDA advisory panel has only recommended a drug, and to my knowledge, had not approved it as CBD and cannabis is still schedule 1. Until they reschedule, I doubt any drugs will be approved by the FDA.
  • The FDA is NOT working with any companies. In fact, the FDA seems to be doing their best to avoid weighing in at this point. This was covered at length at a Seminar I attended on this topic.
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications.
  • @Microformulation @Perry @Dirtnap1
    thanks for the info....

    I didn't think the FDA was in any rush to work with CBD companies or CBD pharm companies  but my client kept telling me the FDA is working with a pharm company named GP pharmaceuticals on an epilepsy style drug...
    ****************************
    I rather believe my client is using the pharm grade as a buzz word more than anything.  So if something is used as a topical it would be considered a cosmetic therefore not a pharmaceutical product.  For pharmaceutical product (cream, lotion, pills, etc) you have to submit an application with the FDA to be approved...… correct????
  • edited December 4
    Pharmaceutical grade is really not even a term that has a wide usage. I would imagine that ultimately they could seek a USP or NF designation, but this is a way down the road as these are Federal responsibilities.

    Developing a new drug is a huge endeavor. It is not likely in the reach of many in the Cosmetic field. It would approach 7 figures and is slow to get approved. I did the samples for such a study years ago and the company is waiting for approval.

    One could make an argument that CBD in CA is treated as a drug in many aspects. The 135 plus page Law they published last December sets these responsibilities. Honestly, in my opinion, if you want to promote it like a drug, you better produce, test and substantiate it like a drug.

    The FDA did prove a specific cannabinoid derivative for seizures this year.

    "The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome."

    THAT is the GW Pharmaceutical Product. I doubt after the money they spent on research, they would be happy with a client piggybacking on their patented product.


    I would caution not to take any advice in here as the final word. In my opinion, you have multiple reasons to consult with a Regulatory Expert.
     

    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications.
  • @Microformulation ;
    Thanks for the info...  My client didn't want to duplicate the GW product but was using this as an example that the FDA is suddenly open to acceptable CBD.  I didn't think so since it wasn't in the news and such.  They want to use the buzz words that pharm grade with out the check and balances and research.

    Just for my reference.... the GW product has a CBD "derivative" what is the difference in this derivative and CBD?  
  • I would have to read the initial press release, but I believe that they have altered the molecule slightly, thus making it more effective and a new compound. I will look later.
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications.
  • There's no real pharmaceutical cannabis in California as previously stated. The FDA still considers cannabis an illegal drug.

    For recreational use (inhaled), some testing is required, usually done with expensive chromatography equipment.


    https://cannacallabs.com/regulations

    https://www.analyticalcannabis.com/articles/cannabis-potency-testing-whats-in-your-weed-289026

    So you need to ask your weed supplier for these test reports.

    I believe that being for a cosmetic use, you can buy weed wholesale from any farm,
    send it to a lab for testing, and get a money back guarantee if it doesn't meet regulations.
  • Not to beat a dead horse.....

    Is there a big difference between cannabinoids coming from HEMP and those coming from WEED  when it comes to the FDA and their involvement with new infused drugs?  I know the obvious that one is classified as schedule 1 drug and illegal (technically)

    I assume the wording "derived" may be a little confusing to me. When it is stated that cannabinoids derived from hemp I have to question if this is a big enough difference for the FDA.  
  • Their is no difference between the cannabinoids coming from hemp or from "weed", its all cannabis.  The difference comes in the cannabinoid content, hemp is grown with very minimal THC and higher CBD, its legal hemp if the THC is below .3%.  The new farm bill will make it easier to grow and transport hemp, but it also gives jurisdiction of CBD products to the FDA as opposed to the DEA.  I'm pretty sure the FDA is not going to care where your CBD comes from.  
  • I think Hemp has a very specific definition in the farm bill as containing less than 0.3% THC content. (Industrial Hemp is the term) see here
    https://www.colorado.gov/pacific/agplants/industrial-hemp

    Also attached more legalese if people are interested.

    it's still pretty unclear  to me at least the direction of hemp-based products in general, but people are making products anyway. 
  • The DEA only addresses the 0.3% THC threshold for Interstate Commerce. This is much lower than what you will get from most hemp-based CBD's.

    There are some great studies out there performed in Canada, UK, and Israel showing that to be effective there must be a 20:1 or 10:1 ratio of CBD to THC, called the entourage effect. This can also be shown anecdotally, but of course, that carries less credibility.

    One of the issues is the processing of Cannabis-Based versus Hemp-Based CBD's. Hemp contains rough 3.5% of the CBD that is contained in an equal mass of cannabis-based CBD. I have personally seen and performed (once) the CO2 Extraction of Cannabis-based CBD and the yield is spectacular. I have seen the process done on Hemp-Based CBD and they have to use more organic solvents to extract the yield.

    Lastly, much of the promise behind CBD now is the role of the terpenes, compounds found in the Cannabis-Based CBD. These terpenes show great promise. Under the organic solvent extraction, the bulk of the terpenes are removed. In fact, they only test the terpenes in Cannabis-based CBD. Here is a screen clip of it reflected NT from a hemp-based product.

    I could post the entire testing sheet but it has some IP on the full form.



    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications.
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