Recent FDA Compounding Guidances to Pharmacies May Not Apply Everywhere

In the 2 guidances that FDA issued on January 18 regarding pharmacy repackaging and compounding, the most important part for hospitals and health systems may lie in a pair of footnotes.

“FDA is considering the applicability of the policies described in this guidance to hospitals and health systems and intends to address these issues in separate guidance,” reads footnote 5 in the guidance on mixing, diluting, or repackaging biological products in a manner not described in the labeling.

The same footnote, albeit introducing the possibility of FDA creating a regulation, appears in the guidance on compounding drug products that mimic commercially available drug products.

These footnotes echo one in FDA guidance on repackaging drug products issued last year [see April 1, 2017, AJHP News].

Jillanne Schulte Wall, ASHP’s director for federal regulatory affairs, commented, “I think [that] right now what’s most important is that hospitals and health systems don’t make any huge changes until we have the hospital- and health system–specific guidances.”

FDA, however, has not indicated when it will issue those documents. The agency’s 2018 Compounding Policy Priorities Plan mentions state-licensed pharmacies and federal facilities but not specifically hospitals and health systems.

“The good news here,” Wall said, “is that we know for sure that we are definitely going to be getting our own guidances on all these issues. And that’s important, because if we had been pulled in under these other guidances we would have seen real challenges to care delivery.”

In announcing availability of the guidance “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act,” FDA acknowledged being told of potential implications for inpatient care settings.

ASHP, for example, explained to FDA in 2016 that hospital pharmacies work with medication orders, not prescriptions. Thus, hospital pharmacies may not be able to document how providing a compounded drug product rather than a commercially available product makes a significant difference for a particular patient.

FDA also received comments explaining hospital pharmacies’ need to repackage biological products more than 4 hours before administration.

For example, Allina Health, a 13-hospital, 90-clinic health system based in Minnesota, informed FDA in 2015 that the proposed 4-hour beyond-use date (BUD) for biological products mixed, diluted, or repackaged in ways not described in the labeling “will have a significant, detrimental impact to patient care.”

“The 4-hour BUD forces bedside preparation, which poses a greater risk of contamination than if [a product is] repackaged by a pharmacy under USP 797 conditions,” wrote Ann E. Byre, then director of pharmacy services for Allina Health, referring to requirements stipulated in United States Pharmacopeia general chapter 797.

FDA retained both the significant-difference notation and the 4-hour limit in the respective documents.

In addition to the aforementioned footnotes, FDA’s senior science adviser Julie Dohm spoke of separate guidance for hospitals and health systems during an educational session at the ASHP Midyear Clinical Meeting in December 2017.

“She was very clear that [FDA] will in fact be doing separate guidances for repackaging and for hospitals and health systems on compounding,” said Wall, who moderated the session.

[This news story appears in the March 1, 2018, issue of AJHP.]