FDA appropriations bill bears APC’s fingerprints

A little background for this story: Along with Congress’s appropriations bill are memos to various agencies affected by the bill. They aren’t laws or regulations — more like “This is how we expect you to act based on this bill.” The memos aren’t binding, but they do show Congressional intent. 

Thanks to a champ in Congress, APC was able to get several memos attached to the bill specifically giving to the FDA a number of directives related to compounding. For example, one memo addresses inspection delays of compounding pharmacies and facilities: “The Committee requests a report within 180 days of enactment of this Act detailing inspections and addressing resolution timelines for observation and warning letters.”

And then there’s the makeup of the FDA’s Pharmacy Compounding Advisory Committee and the need for expertise: “The Committee encourages FDA to appoint qualified voting members with actual and diverse experience in the preparation, prescribing, and use of compounded medications.”

Other memos address how compounding can alleviate drug shortages, the risks of counterfeit meds, access to compounded hormones, and veterinary compounding. You can click here to read all the memos attached to the bill — they’re in alphabetical order starting with “503A Pharmacy and 503B Outsourcing Facility Inspections.”

The bill is currently moving from the House to the Senate, so it obviously hasn’t passed yet. We’re hopeful our memos will remain in the final version, and of course we’ll keep you updated.