Revisiting the Unsanitary/Insanitary Conundrum of Custom Biopharmaceuticals

If we were called upon to characterize last year in just two words, we would undoubtedly select unprecedented and pandemic as the most obvious watchwords of 2020. And at this point in time their definition is abundantly clear. But, as we start 2021, a couple of terms have resurfaced that apparently remain somewhat opaque, among them insanitary, unsanitary, and the difference – in in respect of compounding pharmacy hygiene – between them. So, given the recent release by the U.S. Food and Drug Administration (FDA) of the updated ‘Insanitary Conditions at  Compounding Pharmacies. Guidance for Industry,’ we thought it might be time to take a look at what is meant by these terms, at what a ‘compounding pharmacy’ actually is, and at the new regulatory guidance itself. After all, transparency in terminology is especially critical when public health is at stake.