Is it illegal to compound commercially available products?

[CynicalIntern]

Oh a study with 12 people over 5 days...case closed then I guess. So go ahead and keep compounding your salty mess of a suspension that only stays somewhat uniformly suspended for about a minute and i will use the kit. I will use it because it tastes better, because I'm lazy, because third party reimbursement/discount cards knock down compound payment to about $20, because im in retail and not a compound setting, and because despite doing this job for 20 years and taking a wet board I'm not smart/snarky enough to dare question the value/legitimacy of this particular compound. To all you new grads just remember this isn't a hard science, it's a practice. You will do things and dispense things that are backed up by studies(with more than 12 people) and it will turn out later that not only was everyone wrong but that med or compound or viewpoint made things worse. Question everything(and try not to be a know it all jerk when you do).

You've now gone off track from the original point. I, too, prefer to use the kits, because they're easier and I'm lazy.

This was not an option for the child in the original post. Medicaid WILL NOT PAY for the kits because it's on the exclusion list, as it does not have FDA approval as a product. So the mother of a child was given the option of pay $80 a month or have a compound made. And the argument was made that the compound was illegal, and this is 100% false.

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[Bubba98]

You've now gone off track from the original point. I, too, prefer to use the kits, because they're easier and I'm lazy.

This was not an option for the child in the original post. Medicaid WILL NOT PAY for the kits because it's on the exclusion list, as it does not have FDA approval as a product. So the mother of a child was given the option of pay $80 a month or have a compound made. And the argument was made that the compound was illegal, and this is 100% false.

Agreed this thread has gone a bunch of different directions but I was responding as I saw fit. And I also think it is a legitimate question the original post made because although yes it's not illegal and kits are different, it's enough of a gray area to warrant it's posting. I am of the mind that the FDA would like nothing more than to end all compounding to those not registered (paid the fee and inspected and regulated).

 

[Bubba98]

Agreed this thread has gone a bunch of different directions but I was responding as I saw fit. And I also think it is a legitimate question the original post made because although yes it's not illegal and kits are different, it's enough of a gray area to warrant it's posting. I am of the mind that the FDA would like nothing more than to end all compounding to those not registered (paid the fee and inspected and regulated).

And I would also add I would never get anything compounded at a retail pharmacy even if old timer is the one making it. Take that to an accredited compounding pharmacy and pay the extra cash...i don't care how much bleach solution was used the techs may have eaten pizza on that counter

 

[Old Timer]

Would you trust any random pharmacist in the whole US to compound things for you or your loved ones? I wouldn't. The kit makes it safer and more standardized, and the manufacturer's facilities are inspected by the FDA. I trust their kits more than a compound some random pharmacist made. It requires less steps and no measuring or calculating at the pharmacy. Even if all the pharmacists in the US were excellent, there would still be a bigger difference in quality between the compounds made by thousands of different pharmacists, than ones made using the kit.

We compound sterile and non-sterile medications all the time at the hospital. I still think the premix IVPBs and compounding kits make things safer. There's more oversight and quality control for the manufacturer than for a regular pharmacy.

If you would prefer a pharmacist who only passed the NAPLEX on the third try and makes mistakes doing calculations 50% of the time to make compounds for you, go for it. I'm not going to trust randoms. Give me the kit any day over a compound. In fact, I'd rather not even have them mix the kit. LOL. I'd rather do it myself.

This is my favorite argument. The Non-Sequitur. When you lose the argument, you chnage the rules. When you cannot convince people it's illegal to compound Ompeprazole Suspension, you switch the argument to pharmacists are not competent to compound ompeprazole susp. That's fascinating, Do you have data to back that up? How many pharmacists have you observed compounding? Of those you observed how many were deficient?

I'll tell you this. I'll put my compounding skills up against anybody. I've done a ton of it in my career. What else have pharmacists been trained for that they can't do? Count pills? Evaluate drug interactions? Counsel patients?

Your entire argument is just plain foolish.

Do I use the kits? Yes I do. The main reason is it is a much moire elegant product. It tastes better and anything that makes it easier for parents to give medication to sick kids is ok with me. But if their insurance will not pay for the kit, I am confident that when I compound Omeprazole it is properly prepared, it has exact amount of medication the doctor ordered and has sufficient potency to last until the expiration date I place on the label.

 

[Old Timer]

I found stability data at 14 days. And it doesn't dissolve fine, it's stubborn as heck. And you go ahead and give mom that salty chalky tasting mess and I'll give them something that tastes like chocolate.

Again, this is as a silly argument. I personally prefer the kits for the reason you stated and for the ease of preparation. But if their insurance does not pay I am certain the compound I make is safe, effective and prepared according a recipe that has tested stability and a physicians order.

 

[deleted820760]

This is my favorite argument. The Non-Sequitur. When you lose the argument, you chnage the rules. When you cannot convince people it's illegal to compound Ompeprazole Suspension, you switch the argument to pharmacists are not competent to compound ompeprazole susp. That's fascinating, Do you have data to back that up? How many pharmacists have you observed compounding? Of those you observed how many were deficient?

I'll tell you this. I'll put my compounding skills up against anybody. I've done a ton of it in my career. What else have pharmacists been trained for that they can't do? Count pills? Evaluate drug interactions? Counsel patients?

Your entire argument is just plain foolish.

Do I use the kits? Yes I do. The main reason is it is a much moire elegant product. It tastes better and anything that makes it easier for parents to give medication to sick kids is ok with me. But if their insurance will not pay for the kit, I am confident that when I compound Omeprazole it is properly prepared, it has exact amount of medication the doctor ordered and has sufficient potency to last until the expiration date I place on the label.

I was incorrect in thinking it's illegal to compound it. I was under the impression that the kits count as a commercially available product since they are commercially available and they're a product in the traditional sense of the word. I don't practice in the retail setting. When you guys said I'm wrong, I researched it myself. I have no problem admitting when I am wrong. I still think it's stupid that the kits don't count as commercially available products, and I hope the FDA changes the law the include them.

I still stand by everything else I said. You can read my posts above.

 

[Old Timer]

I was incorrect in thinking it's illegal to compound it. I was under the impression that the kits count as a commercially available product since they are commercially available and they're a product in the traditional sense of the word. I don't practice in the retail setting. When you guys said I'm wrong, I researched it myself. I have no problem admitting when I am wrong. I still think it's stupid that the kits don't count as commercially available products, and I hope the FDA changes the law the include them.

I still stand by everything else I said. You can read my posts above.

I read your posts and I understand you feel that many of your colleagues are incompetent. What other skills do they lack? Do you think big companies are perfect. I suggest you dig into the Tylenol recall that had medication sitting on pesticide infused pallets so the poison could infuse into the medication. Big companies, big greed..........

 

[deleted820760]

I read your posts and I understand you feel that many of your colleagues are incompetent. What other skills do they lack? Do you think big companies are perfect. I suggest you dig into the Tylenol recall that had medication sitting on pesticide infused pallets so the poison could infuse into the medication. Big companies, big greed..........

You say you've been a pharmacist for a long time. Out of curiousity, do you not notice a difference in the quality of pharmacists these days compared to 10-20 years ago?

I know companies are not perfect, but they do have better quality control and they have more oversight. They do testing on their products, and when they find something wrong, they do a recall.

I'm the last person who would think big companies are perfect so your comment about that was amusing. I'm one of the biggest critics of big corrupt companies. The manufacturer of these kits does not fall into that category in my opinion. Big Pharma, Banks, and insurance companies fall into the "Big companies, big greed" category.

 

[zelman]

Question everything(and try not to be a know it all jerk when you do).

Don't you try and tell me what kind of jerk I should or shouldn't be!

 

[trailerpark]

Just to clarify from my original post making the omeprazole compound was something that was worked out between the Mayo Clinic (where this special-needs child is treated at) and State Medicaid as the only thing they would pay for. It wasn't as though the pharmacist was making the choice to compound VS using FIRST. The recipe came from the mayo clinic and it's administered via G-tube.

 

[wickedone]

This guy is 100% right.

No NDA or ANDA filed thus not making it a commercially marketed product. When we say illegal? Do you mean criminal or simple civil infringement on someone's patent or marketing right?

perfumes cannot be patented. So you can make those.

Does a commercially available product simply need a patent on a formulation and if a pharmacy compounds this product, are they simply infringing on a patent which might expose them to an infringement lawsuit or are we speaking of illegal as in revoked licenses. Also, has a case like this ever been brought against a pharmacy?

The other pharmacist suffers from a chronic disease rampant among my colleagues. THEY DON'T KNOW ****. They don't understand the law. As one of the most regulated professions I can't for the life of me understand why we make up regulations to follow that don't exist. As was pointed the First-Omeprazole is a compounding kit. It is not a commercially available product as the law envisions it. It does not have an NDA, it was not tested for safety and efficacy by the FDA as all other drugs are, it's just a compounding kit anyone who says it is not needs to put the spatula down, step away from the counter and go the F**K back to school.

 

[owlegrad]

This guy is 100% right.

No NDA or ANDA filed thus not making it a commercially marketed product. When we say illegal? Do you mean criminal or simple civil infringement on someone's patent or marketing right?

perfumes cannot be patented. So you can make those.

Does a commercially available product simply need a patent on a formulation and if a pharmacy compounds this product, are they simply infringing on a patent which might expose them to an infringement lawsuit or are we speaking of illegal as in revoked licenses. Also, has a case like this ever been brought against a pharmacy?

The FDA has sent clear signals in the past they they are not in the business of protecting drug company patents from compounding pharmacies. Individual states BOPs might be more interested in inforcing the "no commercial products" law but personally I am unfamiliar with any cases brought against any pharmacies. Of course I would think a drug company could sue through the court system but I am not aware of any such cases. FWIW, I have seen and heard about all kinds of compounding pharmacies that will make anything regardless of patent status. Doesn't seem like all compounding pharmacists are as morally upright as OP.

 

[BidingMyTime]

And I would also add I would never get anything compounded at a retail pharmacy even if old timer is the one making it. Take that to an accredited compounding pharmacy and pay the extra cash...i don't care how much bleach solution was used the techs may have eaten pizza on that counter

Seriously???? Um, you know the First compound kits are going to be mixed up on the same counter that "the techs may have eaten pizza on." And you don't trust bleach solution to kill pizza germs? What's your take on the regular anti-microbial handsoap stocked in bathrooms.....do you trust that to kill all the germs on the pharmacists hands who just used the bathroom? Certain compounds requires absolute sterility....po omeprazole suspension is not one of those compounds.

And compounding omeprazole suspension from scratch isn't that hard, as OT explained. Just time consuming.

OldTimer, I am impressed with your compounding experience!

 

[Old Timer]

You say you've been a pharmacist for a long time. Out of curiousity, do you not notice a difference in the quality of pharmacists these days compared to 10-20 years ago?

I know companies are not perfect, but they do have better quality control and they have more oversight. They do testing on their products, and when they find something wrong, they do a recall.

I'm the last person who would think big companies are perfect so your comment about that was amusing. I'm one of the biggest critics of big corrupt companies. The manufacturer of these kits does not fall into that category in my opinion. Big Pharma, Banks, and insurance companies fall into the "Big companies, big greed" category.

The answer to your first question is yes and no, I see a huge difference. Today's grads are more clinically oriented. Way better and more in depth training than I received. On the other hand not much changes. There are students who cram for exams and get great grades but when you ask them a question they don't no anything and then there are B students who really know the material and will turn out to be good pharmacists. I'm also spoiled by the fact that my students come from Temple, which has one of the highest NABPLEX pass rates on the east coast. No crap schools where I am.

As for compounding, no today's students are not as good as when I was a student simply due to experience. I graduated in 1982 and compounding was a regular occurrence.

I also think your assertions are silly. Nobody is making Omeprazole under a laminar flow hood. Oral medications require cleanliness not sterility. I do not do sterile compounding, I don't have the equipment. The bottle you put the Ompeprazole in is not sterile whether you use a kit or hand make it.

 

[deleted820760]

The answer to your first question is yes and no, I see a huge difference. Today's grads are more clinically oriented. Way better and more in depth training than I received. On the other hand not much changes. There are students who cram for exams and get great grades but when you ask them a question they don't no anything and then there are B students who really know the material and will turn out to be good pharmacists. I'm also spoiled by the fact that my students come from Temple, which has one of the highest NABPLEX pass rates on the east coast. No crap schools where I am.

As for compounding, no today's students are not as good as when I was a student simply due to experience. I graduated in 1982 and compounding was a regular occurrence.

I also think your assertions are silly. Nobody is making Omeprazole under a laminar flow hood. Oral medications require cleanliness not sterility. I do not do sterile compounding, I don't have the equipment. The bottle you put the Ompeprazole in is not sterile whether you use a kit or hand make it.

Lol. I never said it needed to be sterile. When did I ever say it needed to be sterile, or prepared in a laminar flow good? Food doesn't need to be sterile either, but the preparation and handling is important so people don't get sick.

I understand that you disagree with my opinion. You think any and every pharmacist can calculate and compound correctly every time, and they can do whatever they want with regards to cleanliness because it's not a sterile product. I just do not agree, but I respect your opinion.

 

[BidingMyTime]

Lol. I never said it needed to be sterile. When did I ever say it needed to be sterile, or prepared in a laminar flow good? Food doesn't need to be sterile either, but the preparation and handling is important so people don't get sick.

You most certainly did, or at least imply, it had to be sterile. You specifically said that "bleach" wasn't a good enough cleaner, but reality is, using bleach as a disinfectant is as clean as you can get.....so yeah, the next step is a sterile hood.

I understand that you disagree with my opinion. You think any and every pharmacist can calculate and compound correctly every time, and they can do whatever they want with regards to cleanliness because it's not a sterile product. I just do not agree, but I respect your opinion.

Nobody thinks pharmacists can do "whatever they want" with regards to cleanliness. It was you who said the accepted standard of using bleach as a disinfectant wasn't good enough for you. Because even though bleach kills pretty much all germs, including HIV, according to you, it doesn't kill pizza germs (whatever those are.)

Do humans, including pharmacists make mistakes? Of course they do. Do you not think the humans working in factories also make mistakes? Have you seen how many drug recalls happen each week? Drug recalls for pretty serious stuff like "particulates" or "glass" in IV medicine vials, medication vials or bottles completely labeled for a different medication, because of the strength of the medicine being off. Do you think a First-Omeprazole kit is going to be magically immune form being recalled?

 

[deleted820760]

You most certainly did, or at least imply, it had to be sterile. You specifically said that "bleach" wasn't a good enough cleaner, but reality is, using bleach as a disinfectant is as clean as you can get.....so yeah, the next step is a sterile hood.



Nobody thinks pharmacists can do "whatever they want" with regards to cleanliness. It was you who said the accepted standard of using bleach as a disinfectant wasn't good enough for you. Because even though bleach kills pretty much all germs, including HIV, according to you, it doesn't kill pizza germs (whatever those are.)

Do humans, including pharmacists make mistakes? Of course they do. Do you not think the humans working in factories also make mistakes? Have you seen how many drug recalls happen each week? Drug recalls for pretty serious stuff like "particulates" or "glass" in IV medicine vials, medication vials or bottles completely labeled for a different medication, because of the strength of the medicine being off. Do you think a First-Omeprazole kit is going to be magically immune form being recalled?

Uh, no. I never said anything about bleach. You've got me mistaken with another poster.

 

[CetiAlphaFive]

And I would also add I would never get anything compounded at a retail pharmacy even if old timer is the one making it. Take that to an accredited compounding pharmacy and pay the extra cash...i don't care how much bleach solution was used the techs may have eaten pizza on that counter

Accredited?

What? Who is doing what accreditizumations?

 

[deleted820760]

Accredited?

What? Who is doing what accreditizumations?

I knew somebody would pick up on this. Of course it would be you. LOL. You know what he means.