It took David Miller and the International Association of Compounding Pharmacies awhile to jump on board with the new proposed federal legislation that would allow the FDA to oversee and enforce laws and regulations relating to compounders who are considered manufacturers, but this is a step in the right direction and a big step at that. This is not to say that they or anyone agrees with the FDA taking over completely or part of the regulation of compounders. What this does say to me is they saw the writing on the wall that some federal legislation is going to be passed into law. So it is better for them to be on board and have a say in that legislation than to oppose it completely and have no say in the new federal laws and regulations. With IACP backing the federal legislation that allows FDA limited oversight over compounders this helps prevent there being federal legislation that allows for the FDA to take over all compounding regulation and enforcement. Now, in my opinion, what needs to happen it that Congress, the FDA, and the groups representing compounders need to come up with a fairly clear list of determining factors as to whether a compounding pharmacies qualifies as a "manufacturer" and is under whatever federal legislation is ultimately passed. What are some of the factors that should determine if a compounding pharmacy is a manufacturer?
Although I agree with you that David Miller and the IACP wants to have input on the Federal Regulations, there is something more here. What really rubs a lot of the compounding pharmacies the wrong way is that due to this disaster with NECC, almost every state board of pharmacy is reflexively clamping down writing onerous laws and rules that will make it very, very expensive for compounding pharmacies to operate.
ReplyDeletePharmacies are no longer just a corner store that services patients in the surrounding 5 miles. Well, let me rephrase that. Most pharmacies are exactly that, but "big compounding pharmacies" that make up the power structure of the IACP are not. No, they aren't the corner drugstore. These compounding pharmacies do more than just mailing a token prescription to a patient who is a snowbird living in both New York and Florida. They have marketing arms that travel to national conferences, attracting prescriptions from prescribers from states other than their own. Many compounding pharmacies have more out-of-state business than in-state business.
The bigger driver for the IACP to choose FDA oversight is that one federal authority will be easier to manipulate into writing rules and regulations favorable to them, than trying to manipulate 50 separate state boards of pharmacy.
And the thing they fear the most is regulations so strict that they won't be able to send prescriptions over state lines at all. What if California, or Florida, wrote laws/rules that said something such as, "Due to the added cost of sending inspectors to visit out-of-state non-resident pharmacies, the licensing fee per 2-year cycle will be $10,000.00" (as opposed to the token $100 the Oklahoma Board of Pharmacy charges).. So the Boards of Pharmacy now have the ability to swoop in from another state, and suspend/revoke your ability to send scripts into California, Florida and other big states. Almost instantaneously, 20% of your business is gone.
I am a physician who prescribes compounded drugs. Many of my patients do receive compounded drugs locally, but at least a third have chosen pharmacies to mail them their drugs due to cost concerns (Everything costs more in Boca Raton than it does practically anywhere else). I don't mind pharmacies shipping meds across state lines, but I frankly think the IACP made its own bed by protecting the big manufacturing compounding pharmacies for so long.
Kenneth Woliner, MD
www.holisticfamilymed.com