When it comes to pharmaceutical products, medications, or nutritional supplements, as members of the contamination control industry – and as consumers – we like to believe that they are health-promoting, safe, and pure. From a professional standpoint, we understand the critical importance of preparing, packaging, and storing materials and compounds that will be absorbed into our bodies in sanitary, sterile, and hygienic conditions. And we expect others to understand and respect this too.
So the publication last month of a draft document ‘Insanitary Conditions at Compounding Pharmacies: Guidance for Industry’ by the Food and Drug Administration (FDA) has us scratching our heads once again.(1) On one hand, we welcome governmental oversight of an at times problematic industry. But equally, we can’t help but reflect with some measure of consternation on the continuing need for this document. Could it really be that the compounding pharmacy industry needs to be taught how to operate in a sanitary way? Given the number of articles we’ve published on Cleanroom-News.com on pharmacies whose practices have ranged from flouting conventions to an outright breaking of the law it might indeed appear so.
From the FDA’s standpoint, the rules – while complex and numerous – are clear. To mitigate the risk to public health, all pharmaceuticals must be produced under certain conditions and within stringently controlled environments. The conditions for manufacturing are laid down within the Federal Food, Drug, & Cosmetic Act (FD&C Act) which came into effect in 1938. Authored by then U.S. Senator from New York, Royal S. Copeland, this new set of laws replaced the ‘Pure Food and Drug Act’ of 1906 which had failed to prevent the deaths, in 1937, or some one hundred victims of ‘Elixir Sulfanilamide,’ a preparation that combined sulfanilamide – an antibiotic and antibacterial – with the highly poisonous solvent diethylene glycol. Following a public outcry over the deaths and the suicide of the lead pharmacist while awaiting trial, the FD&C Act with its ten separate chapters and myriad subsections aimed to toughen up the law and prevent history from repeating itself. But as recent cases have shown, there’s still a long road ahead.
Although Section 503A of the Act specifically covers pharmacy compounding it might appear that modern compounders are not necessarily up to speed with the regulations outlined. Which may, of course, be the reason for the FDA’s August release of the non-binding recommendations on questions of insanitary conditions. So before we delve into that document, let’s take a moment to review the definitions of terms involved… Read More on Cleanroom-News.com