How so? PCCA sells ndc CBD I believe?
Edit: Fagron, Medisca and Letco too looks like
I dont have a clue who your talking about.
The DEA would have a field day with that one.
Thatās practiceing out of their defined scope of practice.
The DEA has a fit with a pharmacy selling CBD tinctures. Theyād blow their tops finding one compounding CBD.
My first white label gig was for a Pharmacist in Hawaii who got raided by the DEA (for another reason). They gave him the option of selling CBD or selling pharma meds but not both. 
4 Likes
PCCA is probably the biggest API provider in the country for (whatās left) of the compounding pharmaceutical market.
I see CBD being compounded all over the place and available in most pharmacies in my area. Not to mention the big box pharmacies all stock it.
Not saying Iām right here, but how exactly would the DEA have a say in compounding with CBD? Would fall to FDA, no? You are either licensed with DEA or not, they donāt stop by too often. Can you point me to something from the DEA or Hawaii BOP? Genuinely curious, Iāve never heard anyone say this.
I come from a compounding background FWIW, before NECC blew up the market. Iām no PharmD though.
Edit: Just spoke with the last PharmD I worked with and they are telling me itās definitely a grey area. Not sure anyone is going to be losing their license over it though.
3 Likes
Itās not gray at all, its pretty clear. Iām taking a smoke break from planting the veggie garden, when Iām through Iāll link you the info.
5 Likes
Truly appreciate all of the knowledge and support. All precautions are being taken. I own 4 pharmacies so I am in constant contact with the DEA. I have created a totally separate LLC and all cannabinoid compounding is taking place in a lab that is not licensed as a pharmacy. I have everything totally dialed in except for 1 issue, I cannot seem to rid my final product of the bitter distillate flavor!! I have tried extra citric acid, sucrose, stevia, flavorings, salts, and even bitter blockers. Now what?
3 Likes
So tell us a few things.
What you are using in your recipe?
How big are you gummies, volume?
I wonder what units of measurement a pharmacist would use.
Lol
2 Likes
I have both 1.5ml and 2ml molds. I have spent a long time reading through this forum, I understand some people can get very frustrated with individuals that are novices. I am here out of desperation, I have many young children with cancer and seizure disorders because I am located very close to a large childrenās hospital. I initially created a topical product which has worked very well for many but obviously that will only go so far. I now need an oral product that tastes good for children to ensure they receive their therapy. I have spent the past 2 months on my free time working on this with no luck on flavors
2 Likes
Thrrr is a cbd compounding pharmacy in Asheville
I mean, itās cbd but still, it comes from cannabis
For reference here is a stock compounding formula for proprietary syrup base sildenafil lean. I empathize with how vague a lot of compounding formulas are.
How much distillate are you putting into these molds? If itās too bitter I would suggest spreading the dose over more gummy.
Have you tried lollipops or hard candy? The sweetness you can get with lollipops using all sorts of stuff like sorbitol70, corn syrup, sugar, xylitol, etc can help mask the taste too and is a bit easier than gummies in my opinion.
Where are you sourcing your flavors and which flavors have you tried?
1 Like
I use Medisca for compounding recipes, I pay an annual membership fee which gives me access to the fully detailed SOPs. I am trying to make 25mg gummies in a 1.5ml cavity. Because of the ages of the children I cannot make lollipops or hard candy. I have tried Lorann flavorings and Mediscaās flavorings
1 Like
I would say thatās too small a mold for your dose, can you go to 3ml with 25mg?
You may be able to change some ratios around or make a more complex sweetness with sorbitol, xylitol, maltitol, corn syrup depending what you have on hand. Have you tried sugar or sour sanding?
If you post your formula or sop, anything really would help.
At what percent of formula? This can make stuff bitter too if you go overboard thinking itāll mask the distillate.
1 Like
@raghanded is better suited to help you with your flavors.
However I will give you some good nuggets of info.
As stated before, decrease the dose in each candy OR increase the volume. I prefer increasing the volume. Also a sugar coating will erase that bitterness.
Added volume plus sugar coating, FTW.
Editā¦ lol @raghanded
2 Likes
I have tried all of the recipes that I have found on this website and others. I have tried a citric acid/sugar coating. I have tried tartaric acid/sugar coating. I have tried substituting stevia for sugar on coatings. I have tried sugar only coatings.
I was hoping not to go larger than 1.5ml, for children this young the hope is for them to quickly chew and swallow.
I have not tried anything with sorbitol, xylitol, maltitol however. Any suggestions regarding these would be much appreciated!!
News flash, kids love candy. So making them larger or more of them shouldnāt be an issue.
1 Like
I would suggest starting with sorbitol. What else is in the current formula you are using as far as sweeteners? I understand you are jumping around trying stuff but do you at least have one thatās the best so far? Itās hard to recommend a starting point when I have no idea where you are on the map. I like to at least reach a āsave pointā for lack of a better term when Iām doing formulation.
Theyāll probably prefer a tasty 3gm gummy over a bitter 1.5gm one. Is total sugar intake for the patients an issue?
1 Like
In the pt population they are referring to. I would say no, or not very often.
Ever been on a pediatric floor?
Lots of icecream and things of the sort.
1 Like
I totally understand how you are thinking about this. Unfortunately I see many young children with oral cancer, throat cancer, cleft palate, noma, and other birth defects. Larger could be an issue for them. I can certainly try decreasing the dose in each gummy thoughā¦thanks
1 Like
Thank you! I will play around with sorbitol and update asap.
1 Like
Iād suggest a simple tincture, for those pts.
You know most of thoes types of pts have a peg tube.
1 Like
Just start with a third of your sugars portion being sorbitol I would say.
You should probably tilt the total formula % of sugar up as well if still sticking with 1.5ml or 2.0ml.
1 Like