From the beginning of this blog, one of the re-occurring questions has been whether state boards of pharmacy have the resources, the ability, and the "want to" when it comes to regulating compounding pharmacies, especially when some of the board members are owners of compounding pharmacies. We have seen that many states had laws and regulations on the books regarding compounding pharmacies and pharmacist's, but no real enforcement of those laws. Since NECC, we have seen consumers and non-pharmacists added to boards of pharmacy, we have seen some boards of pharmacies enact new rules and regulations with more teeth, and we have seen some ramp up enforcement of compounding pharmacies. We have also seen some make very few changes for whatever reasons. A recent study, Ensuring the Safety of Compounded Drugs, A look at state regulation and oversight, February 23, 2016, By Elizabeth Jungman.
Some compounding organizations and compounding pharmacists still blame the FDA for not preventing NECC--the victims of which are still waiting: waiting for compensation...waiting for justice which takes time in a federal court system because of mandatory rules and constitutional rights of defendants...waiting for their pain and the consequences of a compounding industry run amok to stop.
In an attempt to prevent another NECC, we have seen Congress pass the Drug Quality Security Act (DQSA) and make registering as an Outsourcing Facility "voluntary" rather than mandatory as the compounding industry pushed back and balked and continues to do so. The compounding industry has argued, among other things, they are already heavily regulated by state boards of pharmacy, they don't want the federal government involved in their business, and this is a state matter not a federal matter.
We have seen push back on the language of the MOU between the FDA and state boards of pharmacy. We have seen stances that the 5% or 30% rule won't work, but we have not seen another better solution suggested, leaving all to wonder how state boards or the FDA determine if a compounding pharmacy is manufacturing drugs or if it is another NECC. We have seen a start in Texas with legislation that "can" require a pharmacy to produce financial records; we have not seen yet whether the law will in fact be put to use in Texas.
We have seen many FDA 483s, and we have seen more deaths and illnesses after NECC. We have seen compounders lobby to get a subsequent Congress to declare what a prior Congress' intent in passing the DQSA act was when legislative interpretation is normally left to the judicial branch. We have seen many stories of how much money compounding pharmacists, their family members and the businesses and organizations relating to compounding pharmacies pour into lobbying efforts; notwithstanding that they are the ones always calling out Big Pharma for lobbying and Big Pharma for killing people. We has seen a few use false statements and scare tactics such as announcing that the FDA wants to do away with ALL compounding. We have seen Congress refuse to give the FDA the resources the job that needs to be done in part because compounders have a lot of money--money to lobby and get their way--with questions lingering as to how much of that money was made legally and how much illegally.
We have seen that compounding plays a huge role in the illegal doping of athletes and horses. We have seen more fraud and corruption come to light almost as if the ones involved in the illegal compounding are saying I am going to make as much money as I can and no one will stop me or at I at least I will make as much money as I can until someone does stop me.
We need and must have good compounding pharmacies and pharmacist. There is no question about that. There are patients--humans and animals-- who absolutely must have compounded medications. There are good compounding pharmacists and pharmacies out there who are not part of what is way more than just a few bad apples at this point. The good compounders did not cause what we are seeing come to light, but they will unfortunately be lumped in with the bad,. Please remember, however, they are not all bad. They are not all milking the system. They are not all doing illegal compounding. They have not all run amok. There are compounders who believe in following the law, even if they don't agree with the law. There are good compounders making a difference in individual patients lives on a daily basis. And we must not forgot or lose sight of that and all the good that some of the compounding pharmacies and pharmacist do.
The public, however, needs to educate itself about compounding pharmacies and compounded prescriptions. They need to understand that they are not FDA-approved and that they do not go through the same process and studies that FDA-approved prescription drugs do. They need to question all the claims and advertising of compounding pharmacies just as they do FDA-approved drugs, and in fact more so. The public needs to demand more answers and the best products and services from their compounding pharmacies when a compounded drug is in fact needed for a human or an animal. The public especially doctors, veterinarians, dentist, nurses, and patients etc., needs to do its homework and only work with reputable, above-board compounding pharmacist and pharmacies--ones that follow the law.
When this was posted: Question of the Day October 1, 2013, Is anyone including Congress, the FDA, and State Boards of Pharmacy, paying attention to what is going on in the compounding pain medication world? The discussion on CafePharma board is very telling-- pointing to rampant fraud, Congress and others clearly weren't paying attention. While the FDA and DOJ are paying attention now, it is still not clear that Congress is. The lack of mandatory regulations and oversight of a the compounding industry is partly why we are where we are at today in the United States. Congress needs to step up to the plate and do what needs to be done in this area. Congress needs to fully fund the FDA to do the job it gave them to do in the DQSA. If Congress continues to fail to fully provide the funds and support needed, it will be more to blame than anyone else, and bad compounding pharmacies will continue to rule amok.
Some compounding organizations and compounding pharmacists still blame the FDA for not preventing NECC--the victims of which are still waiting: waiting for compensation...waiting for justice which takes time in a federal court system because of mandatory rules and constitutional rights of defendants...waiting for their pain and the consequences of a compounding industry run amok to stop.
In an attempt to prevent another NECC, we have seen Congress pass the Drug Quality Security Act (DQSA) and make registering as an Outsourcing Facility "voluntary" rather than mandatory as the compounding industry pushed back and balked and continues to do so. The compounding industry has argued, among other things, they are already heavily regulated by state boards of pharmacy, they don't want the federal government involved in their business, and this is a state matter not a federal matter.
We have seen push back on the language of the MOU between the FDA and state boards of pharmacy. We have seen stances that the 5% or 30% rule won't work, but we have not seen another better solution suggested, leaving all to wonder how state boards or the FDA determine if a compounding pharmacy is manufacturing drugs or if it is another NECC. We have seen a start in Texas with legislation that "can" require a pharmacy to produce financial records; we have not seen yet whether the law will in fact be put to use in Texas.
We have seen many FDA 483s, and we have seen more deaths and illnesses after NECC. We have seen compounders lobby to get a subsequent Congress to declare what a prior Congress' intent in passing the DQSA act was when legislative interpretation is normally left to the judicial branch. We have seen many stories of how much money compounding pharmacists, their family members and the businesses and organizations relating to compounding pharmacies pour into lobbying efforts; notwithstanding that they are the ones always calling out Big Pharma for lobbying and Big Pharma for killing people. We has seen a few use false statements and scare tactics such as announcing that the FDA wants to do away with ALL compounding. We have seen Congress refuse to give the FDA the resources the job that needs to be done in part because compounders have a lot of money--money to lobby and get their way--with questions lingering as to how much of that money was made legally and how much illegally.
We have seen that compounding plays a huge role in the illegal doping of athletes and horses. We have seen more fraud and corruption come to light almost as if the ones involved in the illegal compounding are saying I am going to make as much money as I can and no one will stop me or at I at least I will make as much money as I can until someone does stop me.
We need and must have good compounding pharmacies and pharmacist. There is no question about that. There are patients--humans and animals-- who absolutely must have compounded medications. There are good compounding pharmacists and pharmacies out there who are not part of what is way more than just a few bad apples at this point. The good compounders did not cause what we are seeing come to light, but they will unfortunately be lumped in with the bad,. Please remember, however, they are not all bad. They are not all milking the system. They are not all doing illegal compounding. They have not all run amok. There are compounders who believe in following the law, even if they don't agree with the law. There are good compounders making a difference in individual patients lives on a daily basis. And we must not forgot or lose sight of that and all the good that some of the compounding pharmacies and pharmacist do.
The public, however, needs to educate itself about compounding pharmacies and compounded prescriptions. They need to understand that they are not FDA-approved and that they do not go through the same process and studies that FDA-approved prescription drugs do. They need to question all the claims and advertising of compounding pharmacies just as they do FDA-approved drugs, and in fact more so. The public needs to demand more answers and the best products and services from their compounding pharmacies when a compounded drug is in fact needed for a human or an animal. The public especially doctors, veterinarians, dentist, nurses, and patients etc., needs to do its homework and only work with reputable, above-board compounding pharmacist and pharmacies--ones that follow the law.
When this was posted: Question of the Day October 1, 2013, Is anyone including Congress, the FDA, and State Boards of Pharmacy, paying attention to what is going on in the compounding pain medication world? The discussion on CafePharma board is very telling-- pointing to rampant fraud, Congress and others clearly weren't paying attention. While the FDA and DOJ are paying attention now, it is still not clear that Congress is. The lack of mandatory regulations and oversight of a the compounding industry is partly why we are where we are at today in the United States. Congress needs to step up to the plate and do what needs to be done in this area. Congress needs to fully fund the FDA to do the job it gave them to do in the DQSA. If Congress continues to fail to fully provide the funds and support needed, it will be more to blame than anyone else, and bad compounding pharmacies will continue to rule amok.
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