Originally published by our sister publication Pharmacy Practice News
By Gina Shaw
With shortages of IV fluids expected to persist for an undetermined length of time due to the severe damage caused by Hurricane Helene to Baxter International’s manufacturing facility in North Carolina, which produces some 60% of IV fluids used in U.S. hospitals and health systems, the FDA has issued a temporary guidance giving compounding pharmacies that are not licensed as 503A outsourcing facilities flexibility in compounding certain drugs.
The guidance covers drugs including certain dextrose formulations, sodium chloride, sterile water, lactated Ringer’s solution and peritoneal dialysis solutions, and is intended to remain in place for the duration of the public health emergency (PHE) related to Hurricane Helene, which was declared on Oct. 10, 2024.
“To the extent that hospitals and health systems have a need for compounded drug products, FDA encourages them to obtain such products from outsourcing facilities,” the guidance cautioned. “However, [these facilities] may have difficulty obtaining adequate supplies of certain FDA-approved parenteral drug products or adequate supplies of comparable drug products made by an outsourcing facility.”
Therefore, the FDA guidance noted that the agency will not take action against a licensed pharmacy that provides a compounded drug without a patient-specific prescription or for compounding an essential copy of a commercially available drug, as long as it meets certain requirements, including:
• the drug must be on its temporary drug shortage list;
• it must be labeled with a default beyond-use date;
• the pharmacy has to notify the relevant state authority of its intention; and
• the compounder must comply with certain sanitary, strength, quality and purity requirements.
Help From USP
To help hospital and health-system pharmacies and other compounding pharmacies that may be doing such compounding during the PHE navigate the safety concerns involved, USP has issued an operational consideration document to support sterile compounding during PHEs and natural disasters. It includes operational strategies and regulatory considerations for compounding IV fluids; compounding practices and guidelines; and best practices for relevant leadership, training and certification, as well as additional information and resources.
“These IV fluids are lifeblood for health systems,” said Farah Towfic, PharmD, the senior director of USP’s healthcare quality and safety center of excellence. Because the shortage is so major, it is likely that there will be a significant volume of compounding that takes place under the flexibility given by the FDA guidance, which poses some risks, she noted. “When there’s a change in routine that takes place in a health system, it does create the opportunity for potential errors. That’s why we wanted to create this document, to help ensure that this isn’t going to cause a patient safety or quality issue.”
The document is not intended to be a stand-alone guide, Dr. Towfic stressed. “Rather, it’s designed to be a set of streamlined considerations that will complement what you have in your existing policies and procedures for sterile compounding within your health system, pulling out all the key issues that one needs to consider in this specific crisis.”
For example, she noted, because of the major shortage of sterile water, the document contains a flow diagram that lays out the different considerations regarding water for pharmaceutical purposes. “We have also made available some compounded preparation monographs and other documents that are intended to complement this document, again intended to help streamline areas of focus where quality and safety issues could arise,” she added.
Released on Oct. 17, the document may be updated based on feedback from the industry, Dr. Towfic said. “We are in listening mode, and we want feedback. What else could help us improve what this document offers, so that we can ensure quality and patient safety? This is an evolving situation. We know that health systems are really working hard to mitigate the impact of these shortages, particularly with injectable medicines that are so prone to shortage, and we want to hear from them as far as what other resources we can provide to strengthen their work.”
Dr. Towfic reported no relevant financial disclosures.
