FDA Adds Intravenous Fluids to List of Drug Shortages

The FDA added 3 new drugs to the Drug Shortage Database, including Dextrose 70% intravenous (IV) solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution, due to the impact of Hurricane Helene on Baxter manufacturing and facilities. The agency stated the products are not “commercially available in adequate supply to meet national demand.”¹

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On October 11, 2024, the FDA also released a guidance that took immediate effect. The guidance includes the FDA’s regulatory and enforcement policies for the compounding of the drugs that are currently in shortage due to Hurricane Helene and Hurricane Milton. In the guidance, the FDA said that the policy remains in effect for the duration of the supply disruption related to the public health emergence, or for another duration of time if the FDA announces it.²

According to the FDA, compounding drugs are important for patient needs, but there is also a risk to patients because compounded drugs are not FDA approved, which can establish safety, efficacy, and quality before reaching the patient. Outsourcing facilities are required to register with the FDA, be inspected according to a risk-based schedule, and are subjected to Current Good Manufacturing Practice (CGMP) requirements. However, in the guidance, the FDA is taking a temporary measure with no intention to take action against a state-licensed pharmacy that is not registered as an outsourcing facility and provided a compounding drug to a hospital or health system without obtaining patient-specific prescriptions or for compounding a drug that is a copy of the commercially available drug. This includes hospital or health system pharmacies.²

Furthermore, the FDA, “encourages hospitals and health systems to provide to the pharmacy, to the extent allowed by applicable laws, records that identify the patients to whom the drugs were administered. Such records may be important to allow follow-up if there are adverse drug events or product quality issues associated with drugs the pharmacy has provided.”²

Furthermore, as a temporary measure, the FDA does not intend to take action against an outsourcing facility for compounding a drug that is a copy of an approved drug for use in bulk, even if the drug is not listed on the FDA’s 503B Bulks List or not meeting CGMP requirements. The FDA is encouraging the reporting of adverse events from compounding drugs to the outsourcing facility that provided the product as well as to the MedWatch Safety Information and Adverse Event Reporting Program.²

The FDA has also made note that additional products may be added to the FDA shortage list if the total supply decreases below the national demand. They also acknowledged. Concerns about discarding expired IV fluid products. They stated that a request for expansion of expiry needs to be submitted by the manufacture with stability data for the FDA to review. As of October 18, 2024, the FDA states that they “do not have data from the intravenous and renal fluid product manufacturers to support extension of expiry.”¹

However, they said that if data is received and supports the extension, the information will be updated on the agency’s drug shortage webpage.¹

REFERENCES

1. FDA. Hurricane Helene: Baxter's manufacturing recovery in North Carolina. Updated October 11, 2024. Accessed October 18, 2024. https://www.fda.gov/drugs/updates-2024-hurricane-season/hurricane-helene-baxters-manufacturing-recovery-north-carolina

2. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Temporary Policies for Compounding Certain Parenteral Drug Products Guidance for Industry. FDA. October 2024. Accessed October 18, 2024. https://www.fda.gov/media/182632/download