A Texas proposal you couldn’t comply with if you wanted to

We submitted a comment letter to the chair and vice-chair of the Texas House of Representatives’ Committee on Public Health this week opposing HB 3785, a bill that would impose prescription labeling requirements that make claims that pharmacies are prohibited from making under federal law.

Forgetting the logistical and financial issues, the bill would require compounded-drug labels to include a list of side effects, which is, frankly, legally impossible — there’s obviously no data on side effects for compounded drugs. More problematically, the bill would also require language saying, “substitute for [drug name]”. That’s something we pointed out was “not only misleading — it suggests interchangeability with a brand name drug that is unsupported by federal definitions.”

We concluded: “For these reasons, we respectfully recommend withdrawing H.B. 3785 and deferring to [the Texas State Board of Pharmacy’s] regulatory process, which is better suited to balance patient safety, clarity, and pharmacy practice realities.”