FDA regulation of compounding pharmacies



so things are changing it da who's in charge do they know yet well after dr. Hamburg leaves they planned dr. Steven austra will be acting commissioner okay great and how long does it usually take to choose a new commissioner will be you or no i mean i think this depends on the time in the electoral cycle and a lot of other factors because the Commissioner has to be confirmed the presidential appointee and requires confirmation so there's a long cycle that has to be gone through so we're going to talk about a couple topics today very timely one is compounding pharmacies that was in the news two years ago and now it's back in the news again through 60 minutes and then I'd like to talk about also second after that biosimilars which is a big dramatic move you guys made after many years of deliberation so let's talk about the compounding pharmacies for the viewer out there explain what it is in other words you can go to CVS or rite aid and get a pill but then there's special medications that have to be made on the spot that so what is a compounding pharmacy sure compounding pharmacy is one it could be a regular pharmacy that does compounding or could be a pharmacy that only does compounding and compounding means making up a special preparation based on a prescription you get from a doctor say when I was practicing I used to ask for special prescriptions for eye drops for antihistamines because we didn't have the good eye drops at the time now you can get them you know in the pharmacy and you don't need to have them compounded and so there its anything from augments to injections and that's what went so wrong up in the New England compounding pharmacy where there was fungus infections and so these are unusual in that the FDA as a federal agency can't quite regulate them because they're controlled by the state what's the role there what's the role of the state in terms of inspecting these plants vs. you the federal agency well in general compounding is regulated as part of pharmacy practice and pharmacy practice is regulated by the boards of pharmacy or similar organizations each state and they regulate the licensing of pharmacists and also the pharmacy practices in that state so compounding is part of that but also some compounding pharmacies may send drugs across state lines that they have compounded and then obviously sometimes that can become a larger volume and definitely FDA is interested in that but we can also inspect any pharmacy that's compounding and look at how their practices are their practices correct or are they having some problems with quality now the drug quality and security act of 2013 was that a result of the New England compounding pharmacy and the news on that or whether it caused or not what is the drug Quality Act of 2013 and how does it help the agency nouns deal with compounding pharmacies well that acted several things that it removed a provision of an older act that had to do with compounding that have been part of the advertising provisions that have been struck down by the courts creating some uncertainty all right so it changed that and sort of reinstated that in layman's terms ok and then it established a new class of compounding called outsourcers outsourcers who makes sterile products often for hospitals or clinics because what has happened is what used to happen in the basement of the hospital say they'd make up things sterile products for patients many of those have downsides that are eliminated that and outsource it to another organization and this new law allows groups to sign up to be one of these groups and then they're required to make these sterile products under good manufacturing practices and FDA will regulate that so so those new category of compounders are now more under the envelope of the FDA because it's the good practicing laws yes it so they won't be FDA approved products generally they'll be taking FDA approved products and making them into a different form you know that could be used by a clinic that might be in an office building or or hospital but or they may be actually compounding them but whatever they're doing they'll need to do it under the FDA regulations about quality manufacturing however this is a law that was passed is attempting to put in new regulations for the outsourcers who make this in bulk make larger volumes of sterile products for hospitals generally and for outpatient clinics and also FDA has stepped up its regulation and so would those injections for the spine for pain that was the problem in the New England pharmacy would that now fall under this new category pharmacies can register or other facilities can register as outsourcer outsourcing facilities and there's a small user fee associated with that and then FDA will do inspections and make sure that those facilities that are making these sterile products are making them under the proper condition why would anyone want no one no company wants to be more regulated so what's the advantage why would they want to become do they get better payments if they're suddenly regulated why would they do this well FDA is also working to put some boundaries on what traditional pharmacy compounding should look like all right and so we've put out different guidances and so forth and we working with all the state boards of pharmacy we just had a 50-state meeting about pharmacy compounding and how the states will regulate it and how FDA regulated and we're making agreements and a standard memorandum of understanding that will have that has to do in part with how much of zero products the state regulated pharmacies would make

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