In yesterday’s Federal Register (FR) prepublication page, the FDA described three drugs that were nominated for inclusion on the bulk list but all three were declined for the same basic reason.
Inclusion on the bulk list would have provided 503B-registered compounding facilities with the ability to utilize the substances in bulk in order to prepare finished-drug compounded product directly from the active pharmaceutical ingredient. The FR notice discusses how the FDA reached its decisions, as well as defining fully how the FDA views the term “clinical need” when evaluating a bulk substance for inclusion on the list. The Agency also noted that cost is not considered a factor in establishing a clinical need.
The three drugs that were nominated for inclusion on the list were Bumetanide, Nicardipine Hydrochloride, and Vasopressin. The FDA concluded that, since all three drugs were components of FDA‑approved parenteral drug products, the use of bulk drug substance to compound sterile parenteral products (albeit in different lesser concentrations) was deemed less safe than diluting an already approved parenteral product to achieve the same result.
The FR notice provides a glimpse into how the Agency will deal with other requests and the need to steer clear of certain concepts.
