June 24, 2022

APC, sister groups present to FDA

APC, APhA, NCPA, and PCCA were singing from the same sheet of music last week in FDA’s annual Pharmacy Compounding Listening Session.

In prepared remarks, each organization’s representatives were largely unified in the concerns they raised, from the final GFI on animal compounding to ambiguity in FDA’s insanitary conditions guidance to the implicit threat that FDA will restrict compounded hormone therapy.

Other issues raised with FDA were:

• The agency’s slowness to close 483 files after mitigation is completed.

• Next steps on the MOU regarding interstate shipping of compounded drugs.

• The desire to work with FDA in creating a coherent, state-based adverse events reporting framework for compounded medications.

• Problems with the PCAC process.

• The need for a pathway for 503As to compound shortage drugs for hospitals and clinics.

“We think there is common ground to be found in dealing with a range of pharmacy compounding issues,” APC’s Scott Brunner said in APC’s comments. “That common ground can help FDA achieve its policy objective of keeping patients safe, while also preserving patient access to essential compounded medications. And it’s a much better alternative than ongoing head-butting, overreach, and litigation.”

Most of the presenters—including those for APhA, NCPA, and PCCA—were APC members, including Natalie Young, Steve Hoffart, Cheri Garvin, Amy Shank, and AJ Day.