Hurricane Helene really smacked Western North Carolina. Unfortunately, that included a major Baxter manufacturing plant.
From the FDA:
What’s New:
[10-9-2024] FDA is working to temporarily import some products in shortage to help meet patient needs. In this situation, we very carefully assess the overseas product for quality, making sure that it is safe for U.S. patients. Please see the table below for more information.
FDA’s Drug Shortages Staff is working with the manufacturer(s) to confirm each product’s availability and ordering information, and will update the table as the information becomes available.
On this page: Drugs in shortage | Information on compounding | Temporary importation sources to help mitigate shortages | Previous HHS and FDA Communication | Communication from Baxter International
Drugs in Shortage
The following products are currently in shortage and may be further impacted until North Cove resumes operations:
- Dextrose 5% IV solution – (shortage posted on 2/14/22)
- Dextrose 10% IV Solution – (shortage posted on 2/14/22)
- Sodium Chloride 0.9% IV Solution (Normal Saline) – (shortage posted on 6/21/18)
- Sodium Chloride 0.9% for Irrigation – (shortage posted on 4/28/23)
- Sterile Water for Injection – (shortage posted on 11/23/21)
- Sterile Water for Irrigation – (shortage posted on 4/28/23)
Additional products may be added to the FDA shortage list if FDA were to determine that the total supply, including importation of product from other Baxter facilities outside the US, dips below national demand.
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.
- Section 503A of the FD&C Act restricts compounding, regularly or in inordinate amounts, drugs that are essentially copies of commercially available drugs. FDA does not consider a drug to be commercially available if it is on FDA’s drug shortages list.
- Section 503B of the FD&C Act restricts outsourcing facilities from making essentially a copy of an FDA-approved drug. This condition does not prohibit outsourcing facilities from preparing compounded drugs that are identical or nearly identical copies of an FDA-approved drug on the FDA’s drug shortages list.
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.
Communications from Baxter International
- Baxter’s NewsroomExternal Link Disclaimer
- Dear Customer Letter: Update on Baxter’s North Cove, NC Facility (9-29-2024)
- Dear Customer Letter: Medical Information Letter for Healthcare Facilities (9-30-2024)
- Dear Customer Letter: Medical Information Letter for Home Dialysis Customers (10-1-2024)
Contact CDER
If you have a question about drug shortages, email drugshortages@fda.hhs.gov.
For all other questions, email druginfo@fda.hhs.gov or call (301) 794-3400 or (855) 543-3784.
