Can FDA get its MOU right this time?

Remember the MOU? The memorandum of understanding between the FDA and states that covered reporting of interstate distributions of compounded drugs?

Way back in 1997 — when the Internet was dial-up and Elton John’s “Candle in the Wind” was the hot single — the FDA was supposed to devise an agreement that the states would sign and that would help track (and limit) bulk distribution of non-patient-specific compounded drugs.

Distribution is the key word here; the MOU never got traction, and states refused to sign it, because the FDA’s proposed version would also limit the legitimate dispensing of patient-specific compounded drugs. That’s not what Congress authorized back in 1997. So the MOU process has been stumbling along for almost 30 years.

Now, apparently, the agency is looking to revive the MOU effort despite the fact that, since then, Congress created 503B outsourcing facilities, which effectively solved the problem the MOU was supposed to tackle.

And that’s why APC’s Scott Brunner wrote a letter to Matthew Lash, interim director of the FDA’s Office of Compounding Quality and Compliance, with a simple request: How about creating an MOU that actually sticks to the law — one that covers distribution of compounded drugs, not dispensing? One that the pharmacy compounding industry doesn’t need to waste its time fighting. (Side note: We’ve won those fights.)

If FDA does that, Scott wrote, “APC will commit to actively assist in encouraging and persuading state boards of pharmacy (or other state authorizing agencies) to sign it.”

As Scott succinctly put it, with an MOU that actually adheres to Congress’s intent and that compounding pharmacies and facilities can live with, “industry can turn to more productive matters.”