clarkbar

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I had a rotation in a non-sterile outpatient compound pharmacy, and though it dealt with prescription drugs, e.g. hormones, it also had OTC drugs compounded in different dosage forms, such as omeprazole and aspirin lozenges, solutions, etc. In my city there is a large natural herb community, and I was thinking of selling supplements online in different dosage forms, e.g capsules, lozenges, and suckers, etc.

This is a new prospect for me, so if anyone can steer me in the right direction, that would be great. Does anyone know how to buy the equipment cheaply, basically a mold for lozenges, the capsule holder and the empty capsules. Additionally, how can one buy active ingredients in bulk? What kind of regulatory issues would this provide, non-prescribed, OTC medications and/or commercially available herbs and supplements? Thanks, guys; look forward to your feedback!
 

zelman

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I don’t know that you can provide those things without a prescription. When CVS first contracted with FlavoRx we couldn’t flavor OTCs unless we got a prescription for it (thus changing what we were doing from adulteration to dispensing). You can’t blindly assume changes in dose or dosage form will retain the same indications and warnings of the source product.
 

Dred Pirate

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If you want to sell OTC's without a rx that you reformulate- you are going to have to go through the FDA, they are still FDA approved, and by you manipulating them, you have created a new drug. Unless you have big $$, it is a non-started. Herbals are a different story, so I cannot comment on them.
 
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clarkbar

10+ Year Member
Nov 3, 2007
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If you want to sell OTC's without a rx that you reformulate- you are going to have to go through the FDA, they are still FDA approved, and by you manipulating them, you have created a new drug. Unless you have big $$, it is a non-started. Herbals are a different story, so I cannot comment on them.


What about herbal medicines, St. John's Wort, Valoren, etc.? These have much less regulation. Additionally, where can one find the devices for compounding cheaply?
 

Dred Pirate

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What about herbal medicines, St. John's Wort, Valoren, etc.? These have much less regulation. Additionally, where can one find the devices for compounding cheaply?
I would suggest you check with the actual regulatory authorities vs asking a forum where the likelyhood of someone actually doing what you want to do is low. I know we paid 100k for our packaging device thou
 

clarkbar

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I was thinking if something much less big, like a placehokder to hand package capsules or a mold for hand making lozenges. Buying ora plus solution etc. any resources for this
 

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