October 17, 2024
FDA issues IV fluids emergency guidance
On Friday, FDA published emergency guidance that empowers pharmacies to help address the nationwide IV solutions shortage. APC leaders had met with FDA officials in advance of the agency’s issuing this emergency guidance to brief them on what would be needed for compounders to help fill gaps and meet local needs.
We believe some sterile compounding pharmacies may be able to help meet the needs of smaller, local hospitals in a limited but important way. (Limited because not all 503A pharmacies are able to prepare these kinds of IV bags because of the complexity involved, but those that can will be able to provide some support to local hospitals.)
That’s why, following the release of the temporary guidance, we gave FDA some practical suggestions that could better equip those 503As to help:
- We’ve proposed allowing the emergency importation of essential supplies, such as empty IV bags, sterile containers, and bulk ingredients that meet USP standards. This could help bypass the current supply chain bottlenecks.
- We’ve also suggested issuing emergency guidance enabling pharmacies to compound IV solutions like normal saline, sterile water for injection (SWFI), and 5% dextrose using alternative or non-USP ingredients. This could provide flexibility in meeting immediate local needs (e.g., starting with other USP grades of water).
One of the most pressing challenges is the lack of available SWFI as a starting ingredient. We welcome your input on any additional suggestions or experiences you may have regarding this issue.
We’ll keep you informed as we continue our discussions with the FDA.
