A problematic proposal in Texas

As the Texas State Board of Pharmacy continues to work to modernize its rules regarding sterility testing, we still have concerns about what’s been published in the latest version of the draft rule. In a letter to the board, we outlined those concerns — specifically, what seem like contradictions that could lead to confusion … and a lapse in patient safety.

On the one hand, the latest draft of the rule says that if you're compounding fewer than 24 units, you can skip sterility testing — as long as you have published data showing the product stays stable.

But on the other hand, it requires that Category 3 compounded products be tested for sterility every time they’re made.

It puts a cap on batch size — 250, unless you’re using automation, then it’s 1,000 … but the cap only applies to batches that are tested for sterility.

Confusing? Yeah, we thought so too. Are pharmacies supposed to test every time? And is the board really allowing small batches to have a 60-day shelf life at room temperature without testing? That doesn’t jibe with USP <797>, and honestly it’s asking for trouble.

What we’ve asked the board to do instead is require sterility and endotoxin testing for all Category 3 products, no matter how small the batch. (Or at least limit the BUD for untested products to something much shorter.) In other words, if you're going to let pharmacies skip safety testing on sterile meds, at least don’t let them sit on a shelf for two months.