FDA Looks to Extend IV Fluid Expiration Dates

On Jan. 16, 2018, FDA published another update on the drug shortages that are occurring because of the impact of Hurricane Maria on Puerto Rico. The agency states the shortages of IV fluids should continue to improve and the agency is working with manufacturers to ensure facilities are operating at full capacity. FDA warns, however, that it might take some time for efforts to be felt in the marketplace.

Potential import sites for both small and larger volume IV saline bags are also being looked into by the agency. FDA also expects to approve product from additional companies in the next several weeks. Additionally, the agency is asking companies to submit data to extend expiration dates, if safe. This would allow product nearing expiry to be used by hospitals.

FDA is continuing to monitor the situation and the impact of mitigation strategies. According to the agency, some institutions have a very limited supply of IV fluids on hand. “We believe that as more supply enters the market, these challenges will start to diminish,” Commissioner Scott Gottlieb, MD, said in a statement.

The agency is looking at how hospitals may be using empty IV containers as an alternative to filled bags. These containers are regulated by FDA as class II medical devices. “We understand that, with the shortage of filled bags, hospitals and other healthcare providers are turning to the repackaging or compounding of IV saline fluids and utilizing empty IV containers. This is resulting in diminished supplies of these containers and concerns that supplies of empty bags could tighten further,” Gottlieb stated.

The demand caused by the flu may have further impact on the shortage, according to Gottlieb. The agency is encouraging healthcare organizations and hospitals to contact FDA directly if they experience a shortage in supply. Hospitals should also consider recommendations issued by the American Society of Health-System Pharmacists (ASHP) and the University of Utah, as well as the Small-Volume Parenteral Solutions Shortage guidance.

Source: FDA