March 18, 2022

APC to USP: “Where’s the science?”

APC submitted formal comments this week regarding USP’s proposed changes to beyond-use dates in General Chapters <795> and <797>.

The detailed, 92-page document, largely formulated by APC’s BUD Task Force, not only laid out in detail our comments on the language of the proposals, but provided the rationale behind each change we believe must be made.

Most notably, we strongly urged USP to remove any references to batch size restrictions:

APC requests that USP remove any batch-size limits for CSPs and allow Category 3 CSPs to be assigned BUDs of up to one year, regardless of sterilization method or storage temperatures, as supported by data from stability-indicating studies, until USP can:

  1. Demonstrate that its proposed batch-size limitation and BUD restrictions are rooted in objective, replicable science and provide clear patient benefit; and

  2. Provide guidance as to stakeholder concerns over the effects of colder storage temperatures on compounded preparations, packaging, and patients themselves and the effects on patient access of cost-prohibitive stability studies

“USP has always had a reputation for relying on hard data and solid evidence, and we hope to see that continue,” said Tenille Davis of Civic Center Pharmacy in Scottsdale, Ariz., chair of the BUD Task Force. “All the concerns we’ve raised result from the lack of evidence to support the proposed language of the chapter. I’m confident the Compounding Expert Committee will appreciate the importance of continuing to base its standards and recommendations on solid science.“

Almost a year of work went into studying the USP proposal and developing APC’s comments. We’re grateful to the task force for their efforts.

Tenille Davis, Chair — Civic Center Pharmacy, Scottsdale, AZ

Dr. Loyd V. Allen — IJPC, Edmond, OK

Mitchell Bell — Innovation Pharmacy, Kennesaw, GA

L. Rad Dillon — ACHC, Loveland, CO

Nikki Feagin — Integrity Compounding Pharmacy, Sandy Springs, GA

Casey Greene — Innovation Compounding, Kennesaw, GA

Anthony Grzib, Wedgewood Pharmacy, Swedesboro, NY

Shawn Hodges — Innovation Pharmacy, Kennesaw, GA

Rebecca Johnson — Innovation Compounding, Kennesaw, GA

Kathleen Kane — University of Chicago Medical Center, Chicago, IL

Matt Martin — PCCA, Crestwood, KY

Renee McCarthy — Cape Drugs, Annapolis, MN

Peter Mihalik — NCPA, Alexandria, VA

David J. Miller — Keystone Pharmacy, Grand Rapids, MI

Courtney Miros — Reed’s Compounding Pharmacy, Tucson, AZ

Rich Moon — Innovation Pharmacy, Jamestown, NY

Philip Smyth — Medisca, Lebanon, OH

Trey Tietz — Cleveland Clinic, Cleveland, OH