In the first quarter of 2014, 3 Indian companies were issued warning letter (see my posting on the blog) whereas 7 pharmacies were hit. Statistically significant? Perhaps.
After the debacle of the New England Compounding Center about a year ago, the FDA has been on a rampage in the Pharmacy world. I am no lawyer but the way I read it is the pharmacies are using a loophole in the law centered around the issues of FDA jurisdiction. FDA basically regulates interstate distribution of drugs, so make a drug in state X and “export” it to state Y – yep FDA has jurisdiction. So the manufacturers of drugs are under FDA rule.
Now, pharmacies are allowed to take these drugs and dispense prescriptions. So when you go to your corner pharmacist, you can see them dispensing. Counting out pills and putting them into bottles. Hardly much risk here so long as they don’t muddle them up, get them cross contaminated etc. But they can also do further dispensing. For instance, they can take a sterile vial or bottle of a drug and dispense it to another sterile container. Now this is another matter. What we are describing is aseptic processing. As we all know that’s a risky business. How many manufacturers fall foul of the regulations in industry? The number of warning letters are numerous.
But it seems that FDA can not step in unless there is a demonstrated safety calamity. But we don’t want to wait for that each and every time. So what can the FDA do? Their tack is to inspect these operations when they suspect that the Pharmacy has overstepped their authority. It seems that in a majority of the 7 letter this quarter they have seen that the pharmacies have been dispensing these aseptically prepared drugs without prescriptions and compounding several drugs together. Some of these drugs have different regimes of taking the drug. Ergo, they are no longer dispensing, but manufacturing.
Now when they go in and inspect they cite for lack of GMP adherences and the story goes on. Call me naive, but if I go to a pharmacy, I want an assurance that the drugs I am receiving are not adulterated. I don’t care who regulates them but I want it done properly. Clearly the Boards of Pharmacy have not been doing a good job (they are the ones who regulate at a state level rather than FDA). What we have here is a standard clash between Federal and state control – we see it every day in other matters but in this case they are using our health as a pawn in the game.
Keep up the good work FDA.
He is the link to the 7 warning letters