States Need To Move Quickly

Florida Department of Health entered an emergency order shutting down or as the order states "suspensi[ing] [ ] Rejuvi's permit to operate as a community and sterile products and special — parenteral enteral compounding pharmacy in the State of Florida."  See order here.  This is a terrific pro-active approach that should have been done long ago by the states.  More states need to be taking this approach and shutting down dangerous, non-complaint compounding pharmacies.  This needs to be done not only for public health reasons but also,  if the states have any interest at all in retaining at least some of the authority to regulate compounding pharmacies.  While it is true that the United States Congress has plans to introduce legislation granting the FDA more authority to regulate these entities, that legislation has not been introduced, it is unclear at this point how broad the legislation will be, and there is always a question of which version, if any, of a draft piece of legislation will pass.  This leaves states a chance to take action as Florida has done.

States should be inspecting compounding pharmacies, noting  whether those compounding pharmacies have been previously written up for violations, and taking the strongest action allowed under the state law.  For example, if allowed under the state laws, state boards should issue orders shutting pharmacies down that are a public health risk; if closure is not allowed then state boards should impose the maximum fine allowed.  In any event state boards should require the pharmacies to become compliant within so many days before they can begin operating again.  Also state boards should make compounding pharmacies that have such violations recall all drugs linked to any possible contamination or public health risk.    

If states do not already have strict compounding laws and regulations,  they should promptly adopted and enact the needed laws and regulation to deal with the problems.  The laws need to give the state boards (i.e., inspectors)  authority to immediately shut down compounding pharmacies that pose a public heath risk.  They also need to give the state boards authority to impose significant fines.  The fines need to be significant enough that the bad compounders would rather comply with the rules than pay the fines.  When the fine is a dollar amount that is merely a slap on the wrist and cheaper than actually complying  with most rules and regulations, then the bad pharmacies opt to pay the fine and continue to operate in an unsafe manner.  This also penalizes and is unfair to the good compounding pharmacies, and yes, there are some, who spend the money required to comply the rules and regulations.

One other key to fixing the compounding world that I have repeatedly stressed on this blog, is TRANSPARENCY.  The inspection reports, the orders and the fines need to be made readily available to the public.  While putting them on the Internet cost money--it is well worth the lives it could save.  Doctors, Veterinarians, Hospitals, Clinics, Consumers, . . .everyone can then look up the compounding pharmacy to see if their inspection report contained any violations, what corrections to the violations were made, etc.  For example, it was great that I could immediately go to the Florida Department of Health and download and read the emergency order as could any member of the public.  Reporters are reporting on it. Bloggers are blogging about it.  The public is becoming aware of it.   Florida has done a good job of making their disciplinary records for compound pharmacies transparent. Other states should follow Florida's lead.