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Reliability of Compounding Pharmacies

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The chief of Endocrinology at my state university medical school has stated he will not send Rxs to any compounding pharmacies because of their alleged substandard dosages for meds. If a patients needs an Rx, he requires that all be “FDA approved products” (i.e. not compounded) and dispensed at “regular retail pharmacies” (no compounding pharmacies). While Urologists, Dermatologists, OB/GYN and HIV physicians will utilize these compounding pharmacies for various injectables, creams and PO capsules, the Chief of Endocrinology is not persuaded with those outlets that register with the FDA as 503B outsourcing pharmacies, citing that those that are, often have a history of being issued Form FDA-483.

questions:

How reliable are compounded products as to guaranteeing their dosages/formulations vs “FDA approved” products? e.g. test cyp, tadaladil qd capsule, bimix, clindamycin gel for acne, tretinoin gel, etc?

What incentive exists for a compounding pharmacy to register as a 503B pharmacy? Why bother?

do the occasional issuance of Form FDA-483 reveal grave concerns or are they much ado about nothing?

Now I am doubting whether we should use compounding pharmacies since I assumed they were safe, reliable and their products were as trustworthy as “FDA approved“ products. OTOH, the cost savings to patients with compounding pharmacies can be significant with cash payments vs “covered insurance” with sizeable copayments

thanks
 

DinosaurRx

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Compounded medications are intended to fill a need that FDA-approved formulations cannot. This includes when a product is unavailable because of a prolonged back order, because of a patient allergy (think progesterone for a patient with a severe peanut allergy), or because the required strength/dosage form/combination does not exist. We use compounded medications all the time for veterinary patients. It's a risk vs. benefit situation where the patient's need for a medication outweighs the potential safety/efficacy risks. And even then, these compounds should have safety, efficacy, and stability data whenever possible.

HOWEVER, it is not appropriate to compound a medication that is available as an FDA-approved manufactured product simply to save the patient money. This is essentially circumventing the generic drug approval process and the FDA does not like that. I would never choose a compounded product over a manufactured product if it can adequately meet your patient's needs. There is simply no way a compound can meet the same standards of consistency that are required from an FDA-approved product.

The 503A/503B situation is a completely different deal. 503A are traditional compounding pharmacies that may compound to a prescription for a specific patient. 503B pharmacies are more like mini-manufacturers. There are stricter rules on the facilities, different inspections, and they may compound medications at a higher volume and for office use. The Drug Quality and Security Act of 2013 breaks this down pretty nicely, which was passed in response to the deaths caused by the New England Compounding Center.

Hope that helps!
 
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Seriously Serious

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Your chief of endocrinology is dumb. No compounding pharmacy (in the US) is allowed to reproduce products that are already manufactured (unless there is an allergy issue). So, having to write his prescription that way really shows how out-of-touch he is.

Moreover, there is a quality control aspect to compounding 503A/B pharmacies (especially when we are talking about 503B). There are certificates of analysis on potency and endotoxin testing done. You can objectively show an MD how potent your product is.
 
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Sparda29

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Compounded medications are intended to fill a need that FDA-approved formulations cannot. This includes when a product is unavailable because of a prolonged back order, because of a patient allergy (think progesterone for a patient with a severe peanut allergy), or because the required strength/dosage form/combination does not exist. We use compounded medications all the time for veterinary patients. It's a risk vs. benefit situation where the patient's need for a medication outweighs the potential safety/efficacy risks. And even then, these compounds should have safety, efficacy, and stability data whenever possible.

HOWEVER, it is not appropriate to compound a medication that is available as an FDA-approved manufactured product simply to save the patient money. This is essentially circumventing the generic drug approval process and the FDA does not like that. I would never choose a compounded product over a manufactured product if it can adequately meet your patient's needs. There is simply no way a compound can meet the same standards of consistency that are required from an FDA-approved product.

The 503A/503B situation is a completely different deal. 503A are traditional compounding pharmacies that may compound to a prescription for a specific patient. 503B pharmacies are more like mini-manufacturers. There are stricter rules on the facilities, different inspections, and they may compound medications at a higher volume and for office use. The Drug Quality and Security Act of 2013 breaks this down pretty nicely, which was passed in response to the deaths caused by the New England Compounding Center.

Hope that helps!

We should lobby to be allowed to do this.
 

BidingMyTime

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The chief of Endocrinology at my state university medical school has stated he will not send Rxs to any compounding pharmacies because of their alleged substandard dosages for meds. If a patients needs an Rx, he requires that all be “FDA approved products” (i.e. not compounded) and dispensed at “regular retail pharmacies” (no compounding pharmacies).

That is pretty funny.

1) legally he can not dictate what pharmacy a patient goes to. He can write in on the RX-but it is meaningless, but if the patient goes to a compounding pharmacy, they will fill the RX, there is no reason why they wouldn't. Maybe the patient would think they couldn't go to a "compounding" pharmacy and voluntarily not go there, but most patients have no idea what "compounding" is, or if the pharmacy they go to "compounds."

2) writing "FDA approved products" is redundant, by law all RX's must be filled with FDA approved products (OK there are some quasi-exceptions like DESI drugs, but even they have to follow FDA regulations and are, well I don't know what they are actually called, they don't have full-FDA approval, but they are sold only because of the FDA's blessing.) So, if a pharmacy were going to break the law, well they wouldn't be stopped by a doctor writing "please don't break the law" on the RX, which is essentially what he is doing.

3) At the retail levels, "compounding" pharmacies also operate a "regular retail" as well. It sounds like he thinks they are 2 different things, but they aren't. If you go to a compounding pharmacy with a "regular" prescription, it will be filled like a regular prescription. If you go with a prescription that can only be filled by compounding, then it will be filled as a compounded prescription. There is no cross-over between the prescription, even if they are filled at the same physical location.

So, bottom line, the doctor is just doing busywork, and it has zero effect on the prescriptions.
 
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BidingMyTime

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We should lobby to be allowed to do this.

Egads, NO. Can you imagine the liability if there were allowed? Anyone doing this would go out of business from the lawsuits.

As Dinosaur mentioned, there is no way a compounded prescription can meet the standardization that a manufactured prescription meets. We compound because it is the best choice available for some patients, not because it is the best choice overall.
 
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deleted1103055

Compounded medications are intended to fill a need that FDA-approved formulations cannot. This includes when a product is unavailable because of a prolonged back order, because of a patient allergy (think progesterone for a patient with a severe peanut allergy), or because the required strength/dosage form/combination does not exist. We use compounded medications all the time for veterinary patients. It's a risk vs. benefit situation where the patient's need for a medication outweighs the potential safety/efficacy risks. And even then, these compounds should have safety, efficacy, and stability data whenever possible.

HOWEVER, it is not appropriate to compound a medication that is available as an FDA-approved manufactured product simply to save the patient money. This is essentially circumventing the generic drug approval process and the FDA does not like that. I would never choose a compounded product over a manufactured product if it can adequately meet your patient's needs. There is simply no way a compound can meet the same standards of consistency that are required from an FDA-approved product.

The 503A/503B situation is a completely different deal. 503A are traditional compounding pharmacies that may compound to a prescription for a specific patient. 503B pharmacies are more like mini-manufacturers. There are stricter rules on the facilities, different inspections, and they may compound medications at a higher volume and for office use. The Drug Quality and Security Act of 2013 breaks this down pretty nicely, which was passed in response to the deaths caused by the New England Compounding Center.

Hope that helps!

it did help so thanks. Your explanation helps me understand why the FDA issues Form FDA-483 to compounding pharmacies stating

Your firm compound drugs that are essentially a copy of one or more approved drugs within the meaning of sections 503B(a)(5) and 503B(d)(2).

However, reality is a different scenario. Many plans will not cover tadalfil qd, offering instead 6 tabs max per month. Some Urologists who Rx tadalafil qd will send that Rx to a compounding pharmacy that will make a capsule of say 23 mg instead of 20 mg, and dispense 90 capsules cash at a fraction of the retail cost without plan coverage. Likewise for Dermatologists who Rx tretinoin cream, HIV physicians who will Rx test cypionate, deca-durabolin, growth hormone for HIV associated wasting syndrome, all with similar reimbursement scenarios. So I see the dilemma.

Egads, NO. Can you imagine the liability if there were allowed? Anyone doing this would go out of business from the lawsuits.

As Dinosaur mentioned, there is no way a compounded prescription can meet the standardization that a manufactured prescription meets. We compound because it is the best choice available for some patients, not because it is the best choice overall.
it seems that all parties should abide by what are best business practices. However if a plan wont cover an “FDA approved prescription” that a physician believes the patient needs, and the patient can get it at a compounding pharmacy cash, then issuing an FDA Form 483 seems like bullying. But we know medicine is broken so there is that

thanks for the education.
 

radio frequency

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it did help so thanks. Your explanation helps me understand why the FDA issues Form FDA-483 to compounding pharmacies stating

Your firm compound drugs that are essentially a copy of one or more approved drugs within the meaning of sections 503B(a)(5) and 503B(d)(2).

However, reality is a different scenario. Many plans will not cover tadalfil qd, offering instead 6 tabs max per month. Some Urologists who Rx tadalafil qd will send that Rx to a compounding pharmacy that will make a capsule of say 23 mg instead of 20 mg, and dispense 90 capsules cash at a fraction of the retail cost without plan coverage. Likewise for Dermatologists who Rx tretinoin cream, HIV physicians who will Rx test cypionate, deca-durabolin, growth hormone for HIV associated wasting syndrome, all with similar reimbursement scenarios. So I see the dilemma.


it seems that all parties should abide by what are best business practices. However if a plan wont cover an “FDA approved prescription” that a physician believes the patient needs, and the patient can get it at a compounding pharmacy cash, then issuing an FDA Form 483 seems like bullying. But we know medicine is broken so there is that

thanks for the education.
The tadalafil example is not a very good one. That probably just needs a PA if it's for BPH purposes. Even if the PA is denied (which it still may be), the patient should be paying for the Rx. It's generic and not that expensive anymore, and as a pharmacist, offering 23 mg vs 20 mg is just skirting the rules. That is bad pharmacy.

I have never seen a need for a compounded tretinoin cream. My pharmacy has a very large and active compounding department, and we work with many many dermatologists and I do not know why you would compound tretinoin cream. We certainly don't. The FDA approved products are reasonable.

Not sure what the issue with the testosterone is; there are so many formulations already; what is the specific need here that cannot be met using FDA approved medications?
 
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Sparda29

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The tadalafil example is not a very good one. That probably just needs a PA if it's for BPH purposes. Even if the PA is denied (which it still may be), the patient should be paying for the Rx. It's generic and not that expensive anymore, and as a pharmacist, offering 23 mg vs 20 mg is just skirting the rules. That is bad pharmacy.

I have never seen a need for a compounded tretinoin cream. My pharmacy has a very large and active compounding department, and we work with many many dermatologists and I do not know why you would compound tretinoin cream. We certainly don't. The FDA approved products are reasonable.

Not sure what the issue with the testosterone is; there are so many formulations already; what is the specific need here that cannot be met using FDA approved medications?

Cost.

The bulk powders and creams are cheaper.
 

BidingMyTime

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it did help so thanks. Your explanation helps me understand why the FDA issues Form FDA-483 to compounding pharmacies stating

Your firm compound drugs that are essentially a copy of one or more approved drugs within the meaning of sections 503B(a)(5) and 503B(d)(2).

However, reality is a different scenario. Many plans will not cover tadalfil qd, offering instead 6 tabs max per month. Some Urologists who Rx tadalafil qd will send that Rx to a compounding pharmacy that will make a capsule of say 23 mg instead of 20 mg, and dispense 90 capsules cash at a fraction of the retail cost without plan coverage. Likewise for Dermatologists who Rx tretinoin cream, HIV physicians who will Rx test cypionate, deca-durabolin, growth hormone for HIV associated wasting syndrome, all with similar reimbursement scenarios. So I see the dilemma.


it seems that all parties should abide by what are best business practices. However if a plan wont cover an “FDA approved prescription” that a physician believes the patient needs, and the patient can get it at a compounding pharmacy cash, then issuing an FDA Form 483 seems like bullying. But we know medicine is broken so there is that

thanks for the education.
That surprises me. I haven't seen doctors purposely trying to skirt the law by writing for something just a little bit off, like tadalafil.. Pretty shady, and I would think the pharmacy runs the risk of the FDA considering them a manufacturer, if they are frequently doing the same slightly off dosage. The doctor would risk getting into trouble as well, because investigators would start to look at the doctor to see if he was getting bribes to right the compounded prescriptions.
Or maybe not....since it seems like they have been doing this for some time.

I'm also surprised that these compounds would be cheaper, since their are FDA generic versions for tadalafil (and testosterone like Sparda mentioned.) Especially with a GoodRX card, doesn't everybody use GoodRX these days?
 
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deleted1103055

have never seen a need for a compounded tretinoin cream. My pharmacy has a very large and active compounding department, and we work with many many dermatologists and I do not know why you would compound tretinoin cream. We certainly don't. The FDA approved products are reasonable.

I just did a quick search on the internet for ”tretinoin compounding pharmacies” and found 5 outlets:

Woodland Hills Pharmacy
Care First Specialty Pharmacy
PCCA Rx
Pavilion Pharmacy with this gem: Our experts can help doctors and patients choose the right formulation based on their needs
Empower Pharmacy



Not sure what the issue with the testosterone is; there are so many formulations already; what is the specific need here that cannot be met using FDA approved medications?

not sure about today but wasting and lipodystrophy were fairly common in HIV patients back in the 1990s and early 2000s. HIV physicians responded with test, deca and GH which, IIRC, difficult to find at that time since they were all off-patent, and their use in HIV off label.

as for reasonable cost, I think that is a fairly personal matter that I would not suppose to answer for patients.
 

radio frequency

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Cost.

The bulk powders and creams are cheaper.
Based on today's FDA rules, that's not allowed. And I can't say I disagree; you head straight into manufacturing territory here, but without FDA approval.
I just did a quick search on the internet for ”tretinoin compounding pharmacies” and found 5 outlets:

Woodland Hills Pharmacy
Care First Specialty Pharmacy
PCCA Rx
Pavilion Pharmacy with this gem: Our experts can help doctors and patients choose the right formulation based on their needs
Empower Pharmacy





not sure about today but wasting and lipodystrophy were fairly common in HIV patients back in the 1990s and early 2000s. HIV physicians responded with test, deca and GH which, IIRC, difficult to find at that time since they were all off-patent, and their use in HIV off label.

as for reasonable cost, I think that is a fairly personal matter that I would not suppose to answer for patients.
Just because things are done by a small group of pharmacies does not mean they should be done or that they aren't skirting rules.

And yes, wasting and lipodystrophy were common in the 90s and 2000s with HIV patients, but when was the last time you saw that? The only time I've seen lipodystrophy since pharmacy graduation was in an insulin user (who ended up needing a special compounded insulin with a steroid -- weird, but an actual real use of compounding that makes sense). This just isn't common today. That testosterone formulation would probably be very hard to justify now since there are so many testosterone formulations available today.
 

Sparda29

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Based on today's FDA rules, that's not allowed. And I can't say I disagree; you head straight into manufacturing territory here, but without FDA approval.

Just because things are done by a small group of pharmacies does not mean they should be done or that they aren't skirting rules.

And yes, wasting and lipodystrophy were common in the 90s and 2000s with HIV patients, but when was the last time you saw that? The only time I've seen lipodystrophy since pharmacy graduation was in an insulin user (who ended up needing a special compounded insulin with a steroid -- weird, but an actual real use of compounding that makes sense). This just isn't common today. That testosterone formulation would probably be very hard to justify now since there are so many testosterone formulations available today.

The way they get around that is by adding other active ingredients to form a compound that is not available commercially. Example: Desonide/Hydroxyquinone/Tretinoin.
 
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