Hurricane Helene: Baxter's manufacturing recovery in North Carolina - Pill Pals®

On this page: Drugs in shortage | Information on compounding | Previous FDA Communication | Communication from Baxter International

Drugs in Shortage

FDA has not declared any new shortages related to products produced at Baxter’s North Cove facility. The following products are currently in shortage and may be further impacted until North Cove resumes operations:

Information on Compounding

Compounded drugs might be appropriate if a patient’s medical need cannot be met by an FDA-approved drug or the FDA-approved drug is not available. However, compounded drugs are not FDA-approved, which means they are not reviewed by FDA for safety, effectiveness or quality before they are marketed for patient use.

Compounders may make a compounded version of a drug on FDA’s drug shortages list if they meet the conditions in federal law.

The compounded drug has to meet other conditions in section 503A or 503B.

The agency has received some questions about its draft guidance for industry on hospital and health system compounding under section 503A. In 2021, FDA revised its draft guidance to, among other things, remove a provision about the distribution of the compounded drug beyond a one-mile radius. There is no one-mile radius policy.

FDA will continue to review its policies in light of Hurricane Helene’s impact on patients and on the availability of these drugs.

Visit FDA’s webpage Compounding when Drugs are on FDA’s Drug Shortages List for more information.

Previous FDA Communication

[10-1-2024] FDA is aware of the devastating impact Hurricane Helene had to Baxter International’s North Cove manufacturing facility in Marion, North Carolina. Our thoughts go out to the community and to Baxter’s employees during this difficult time.

This facility is one of the largest manufacturers of intravenous and peritoneal dialysis solutions in the United States. FDA is actively working with Baxter and our colleagues in HHS and across government to confirm how much product was recently released for distribution, or may be available at wholesalers, and provide any resources and assistance we can during this time. This could include reviewing potential temporary imports or expediting reviews of the cleaned and restored manufacturing lines.

As of October 1, 2024, FDA has not declared any new shortages related to products produced at the North Cove facility. While Baxter is taking new steps to manage inventory of their North Cove presentations to assure equitable access, FDA is also working with Baxter’s additional facilities to increase supply and reduce the risk of new shortages until Baxter can resume manufacturing the impacted products. FDA will also be working with alternative suppliers, as needed, to manage gaps/shortages in supply of critical products.