This one little word could trip you up

When the California BOP made major revisions to its compounding regulations a few months ago, it changed how “essentially a copy” is defined — and a single word could have significant repercussions for compounders. 

Here’s how section 503A of the federal Food, Drug, and Cosmetics Act (and FDA guidance) defines it:

[T]he term ‘essentially a copy of a commercially available drug product’ does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug.

The new California regulations, however, say that the change must produce a “clinically significant difference” — and the pharmacist is the one who must verify and document that difference. 

What does that mean? Well, it could mean nothing. Or, it could mean that even if the prescriber, patient, and pharmacist all agree that a compounded formulation is needed, and the pharmacist documents the medical rationale of the Pharmacy. The BoP could decide the reason isn’t good enough to qualify as a “clinically significant” difference for a patient. Since there’s no precedent yet, we don’t know how this one-word change is going to play out in the grand scheme of compounding enforcement in California. But we will be keeping an eye on this issue, and we’ll keep you updated as the way the Board plans to enforce this specific provision becomes clearer.