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Do you think compounding pharmacists should have to send out samples for testing before dispensing?

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TheOnlinePharmacist

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We learned some interesting things in class today that occur prior to a new drug being released on the drug market, and I found it crazy how there's a whole 10-20 year process involving pre-examining, testing on animals, more examining and trials, all leading to the last step which is to test them on humans, and all that goes on BEFORE someone can have their new-found drug publicized and hope to make a **** ton of money. That's a really, really long time, but almost always pays off well!

As for compounding pharmacists, turns out they're not required to send samples to the FDA/DEA before dispensing their compounded drugs, and I feel like that's putting a little too much trust in the pharmacist. Of course it's not really...fatal...per se, considering the USP/NF has all the recipes one would need to make the best version of a compound possible, but I feel like some small sampling process needs to go on before they're able to dispense their compounds.

What do you think?
 

owlegrad

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Well this has to be pretty high up the list for impractical solutions to problems. You realize compounding involves products that have already gone through those "10-20 years" of testing, right? It's not like you compound untested investigational drugs in your standard compounding pharmacy.

There does need to be a lot more oversight in the compounding space, but having to send samples of everything you make for some kind of FDA approval is ridiculous, even more so when you realize how much compounding is done based on the same recipes used everywhere.
 
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Doktor_dud3

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We learned some interesting things in class today that occur prior to a new drug being released on the drug market, and I found it crazy how there's a whole 10-20 year process involving pre-examining, testing on animals, more examining and trials, all leading to the last step which is to test them on humans, and all that goes on BEFORE someone can have their new-found drug publicized and hope to make a **** ton of money. That's a really, really long time, but almost always pays off well!

As for compounding pharmacists, turns out they're not required to send samples to the FDA/DEA before dispensing their compounded drugs, and I feel like that's putting a little too much trust in the pharmacist. Of course it's not really...fatal...per se, considering the USP/NF has all the recipes one would need to make the best version of a compound possible, but I feel like some small sampling process needs to go on before they're able to dispense their compounds.

What do you think?
Most of this compounding stuff is just placebo to begin with, in my opinion. There's no way you're going to get good absorption from some of these compounded ointments and creams.
 
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CountByFives

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Most of this compounding stuff is just placebo to begin with, in my opinion. There's no way you're going to get good absorption from some of these compounded ointments and creams.

Sounds like something a patient would say after self-diagnosing their pneumonia that they caught from the flu shot... then they would buy insulin syringes to give their dogs parvovirus shots.
 
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TheOnlinePharmacist

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So when I compound a stat levophed drip, you want a sample sent off for testing before administration to the patient?

Not practical.
Good point. I've actually completely changed my mind on this topic after reading this lol. Great example haha!
 

Doktor_dud3

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Topicals make up a rather small fraction of compounded drug products.
True, most of the experience I have doing extemporaneous compounding is from creams and ointments.
 
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BenJammin

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Sounds like a great way to kill compounding pharmacy
 
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lord999

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Bulk compounding materials do get tested for issues in USP/NP. The entire "hope" of USP 797 is even with minor screwups, the product is still decent enough that you're not going to get someone sick with it. Honestly, you have to be a real incompetent or intentionally stupid to screw up a nonsterile product to be unsafe for human use. Steriles, not so much, I've seen some bacteremia and other sepsis caused by incompetent sterile compounding.

It's kind of like McDonald's. The corporate prepared food is such that it's very unlikely that a person would manage to replicate Jack in the Box food poisoning, but a lot of the magic for certain drugs isn't quite there for cosmeceuticals. Only Chipotle as of recently has managed to screw that up, and which is why the new corporate food taste too much like McDonalds. (Although for someone who really enjoys Mexican food, Chipotle is bland and tasteless even compared with the regional chains like Filiberto's or Taco Tote).

Also, it's kind of an open secret that companies falsify their testing records. We're finding that out the hard way with valsartan.
 
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mentos

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