The US Food and Drug Administration (FDA) declared a national shortage of Lactated Ringers IV Solution on October 11, 2024. The shortage is due to Hurricane Helene damaging bridges at Baxter’s North Carolina plant, which are needed to transport repair equipment and ship finished products. Baxter has not provided a timeline for reopening the plant, but CEO Alex Lucio estimates it will be out of commission for nine to 12 months. The FDA is considering temporary imports and expedited reviews to help meet patient needs. This is due to damage to the Baxter Manufacturing Facility. The shortage has led some hospitals to ration their supplies and postpone surgeries. Lactated Ringers IV Solution is used to rehydrate patients.

FDA has heard concerns about discarding expired intravenous fluid products and questions about possible expiration date extensions for those products. The request for extension of expiry must be submitted by the manufacturer and manufacturer-specific stability data must be reviewed by FDA. At this time, we do not have data from the intravenous and renal fluid product manufacturers to support extension of expiry. If we do receive data that supports an extension of expiry, we will update the information on our drug shortage webpage.

LETTER ISSUED BY BAXTER

Dear Valued Customer:
In follow-up to the communication issued on September 29, 2024 regarding Baxter’s North Cove, NC
facility and the disruption of site operations as a result of Hurricane Helene, below is information
from Baxter’s Medical Affairs team regarding immediate product management and conservation
actions.
Healthcare practitioners should use their professional judgment in evaluating the information in this
document and assessing the needs and resources of their individual organizations.
If you have questions related to the content of this letter, please email [email protected].

Suggestions for Management and Conservation
Please refer to the list of Product Codes manufactured at Baxter’s North Cove facility beginning on
page 2 of this document.
• Evaluate Inventory: Review your current stock levels, expiration dates, and the distribution of
IV and irrigation solutions (e.g., saline, dextrose, lactated Ringer’s) and impacted medications
to identify the most critical areas. Prioritize the use of fluids that are most essential for
patient care.
• Evaluate Clinical Needs: Work with clinical teams to identify which patients are in most
urgent need of impacted IV solutions, such as those undergoing surgery, critically ill patients,
or those with severe dehydration or shock. You may want to consider reevaluating protocols
for fluid administration to prevent unnecessary usage.
• Identify Alternative Sources of Solutions and Medications: Recommend the use of alternative
IV fluids or solutions when appropriate, such as oral rehydration for non-critically ill patients.
Consider using smaller volumes or concentrated forms of fluids, based on clinical guidelines.
Consider alternative sources or formats of equivalent medications including medications with
similar pharmacological actions and indications.
• Optimize Fluid Management: Implement evidence-based fluid management protocols to
optimize IV fluid administration and minimize waste. For instance, reducing IV fluid bolus
volumes for routine patients or switching to other therapies like enteral feeding. Consider
fluid conservation strategies, such as reducing maintenance IV fluids in less critical patients.
Consider changing medications and electrolytes to a clinically appropriate oral product
whenever possible.
• Assess Pharmacy Operational Strategies: Consider transitioning to commercially
manufactured premix medications, including multichambered parenteral nutrition bags, if
available. Consider changes in the electronic health record (EHR) to allow the use of either
dextrose or saline for admixture of drugs compatible with both solutions. This will help create
better flexibility based upon which products are available at the time. If your institution can
utilize syringe infusions pumps, consider preparing and dispensing non-IV push medications
in ready-to-administer syringes to be infused via syringe pump.
2

• Engage Clinical Teams: Provide education and training to healthcare providers on managing
fluid restrictions, medication and therapeutic changes and the potential risks. Regularly
update all staff on the status of the shortage and any changes to treatment protocols.
• Document and Monitor: Maintain thorough documentation of impacted fluid and medication
usage, patient needs, and any adverse effects or shortages encountered. Set up a
monitoring system to track fluid and medication consumption closely and ensure transparent
reporting to leadership.
Baxter is continuing to take immediate action so that we can resume production in North Cove as
quickly as possible to help mitigate the effect on product supply for patients. We thank you for your
partnership as we navigate this situation.
References
Suggestions for Management and Conservation. American Society of Health-System Pharmacists.
Drug Shortage Resource Center, 2022. https://www.ashp.org/drug-shortages/shortageresources/publications/fluid-shortages-suggestions-for-management-and-conservation

Product Codes Made in North Cove
Code Description NDC
10019055
61
BREVIBLOC PREMIX NACL INJ SOL 10MG/ML 250ML X 10 10019-0055-61
10019075
87
BREVIBLOC PREMIX INJ 2000 MG 100ML 20mg/mL DBL
STRG BAGS
10019-0075-87
2B0062Q DEXTROSE 5% INJECTION USP 250M L MIGRATED 00338-0017-02
2B0063Q DEXTROSE 5% INJECTION USP 500M L MIGRATED 00338-0017-03
2B0064X DEXTROSE 5% INJECTION USP 1000 ML MIGRATED 00338-0017-04
2B0162Q 10% DEXTROSE INJECTION USP 250 ML MIGRATED 00338-0023-02
2B0163Q 10% DEXTROSE INJECTION USP 500 ML MIGRATED 00338-0023-03
2B0164X 10% DEXTROSE INJ USP 1000ML 00338-0023-04
2B0296H 70% DEXTROSE INJECTION (2000ML ) USP 00338-0719-06
2B0304X STERILE WATER FOR INJ.USP 1000ML 00338-0013-04
2B0306 STER WATER FOR INJ. USP 2000 ML (PHARM BULK PKG) 00338-0013-06
2B0307 STERILE WATER FOR INJ. USP 3000 ML (PHARM BULK PKG) 00338-0013-08
2B0309 STERILE WATER FOR INJ. USP 5000 ML (PHARM BULK PKG) 00338-0013-29
2B1024X 2.5% DEX AND 0.45% SOD CHL INJ USP 00338-0073-04
2B1063Q 5% DEX AND 0.9% SOD CHL INJ, U SP 00338-0089-03
2B1064X 5% DEX AND 0.9% SOD CHL ING, USP 00338-0089-04
2B1073Q 5% DEX AND 0.45% SOD CHL INJ, USP 00338-0085-03
2B1074X 5% DEX AND 0.45% SOD CHL INJ, USP 00338-0085-04
2B1094X 5% DEX AND 0.2% SOD CHL INJ, USP 00338-0077-04
2B1134X 20 MEQ POT IN 5% DEX INJ-USP 00338-0683-04
2B1313Q 0.45% SODIUM CHLORIDE INJ USP 00338-0043-03
2B1314X 0.45% SODIUM CHL INJ, USP VIAFLEX PLASTIC CONTAINER 00338-0043-04
3
2B1322Q SOD CHLOR 0.9% INJ USP VIAFLEX PLASTIC 250ML
MIGRATED
00338-0049-02
2B1323N 0.9% SOD CHL INJ, USP 00338-0049-03
2B1323Q SOD CHLOR 0.9% INJ USP VIAFLEX PLASTIC 500ML
MIGRATED
00338-0049-03
2B1324X SOD CHLOR 0.9% INJ USP VIAFLEX 1000ML MIGRATED 00338-0049-04
2B1353Q 3% SODIUM CHLORIDE INJ, USP 00338-0054-03
2B1357X 20MEQ POTASSIUM CHLORIDE 0.45% SOD CHLORIDE INJ,
USP
00338-0704-34
2B1373Q 5% SODIUM CHLORIDE, INJ USP 00338-0056-03
2B1462X CARDIOPLEGIC SOLUTION SOL F/SLUSH 1000 ML X 14 00338-0341-04
2B1473Q 10MEQ POT CHL IN 5% DEX&0.33% SOD CHL INJ,USP 00338-0603-03
2B1614X 20MEQ POT CHL IN 5% DEX & 0.2% SOD CHL ING, USP 00338-0663-04
2B1644X 10 MEQ POT CHL IN 5% DEX%0.45% SOD CHL INJ-1000ML 00338-0669-04
2B1653Q 10 MEQ POT CHL IN 5% DEX 0.45% SOD CHL INJ,USP (500
ML)
00338-0671-03
2B1654X 20 MEQ POT CHL IN 5% DEX & 0.4 5% SOD CHL INJ, USP 00338-0671-04
2B1664X 30MEQ POT CHL IN 5%DEX & 0.45% SOD CHL INJ, USP 00338-0673-04
2B1674X 40 MEQ POT CHL IN 5% DEX&0.45% SOD CHL INJ, USP 00338-0675-04
2B1764X 20 MEQ POT CHL IN .9% SOD CHL INJ,USP 00338-0691-04
2B1984X 40 MEQ POT CHL IN 0.9% SOD CHL INJ 00338-0695-04
2B2073Q LACTATED RINGER’S AND 5% DEXTR OSE 00338-0125-03
2B2074X LACTATED RINGERS & 5% DEXTROSE INJ, USP 00338-0125-04
2B2103Q 5% DEXTROSE AND ELECTROLYTE NO 48 INJ. 00338-0143-03
2B2224X 20 MEQ POT CHL IN LACTATED RINGER’S AND 5% DEX 00338-0811-04
2B2322Q LACTATED RINGER’S INJ, USP 00338-0117-02
2B2323Q LACTATED RINGER INJ, USP VIA FLEX PLASTIC CONTAINER
500ML
00338-0117-03
2B2324X LACTATED RINGER INJECTION, USP 1000ML VIAFLEX
CONTAINER
00338-0117-04
2B2434X 20MEQ POT CHL IN 5% DEX&0.9% SOD CHL INJ, USP 00338-0803-04
2B2454X 40 MEQ PJOT CHL IN 5% DE1X&0.9 % SOD CHL INJ, USP 00338-0807-04
2B2534X PLASMA-LYTE 148 INJ (MULT ELECINJ TYPE 1, USP) 00338-0179-04
2B2543Q PLASMA-LYTE A INJECTION PH 7.4 (MULTIPLE 00338-0221-03
2B2544X PLASMA-LYTE A INJECTION PH 7.4 MULTIPLE 00338-0221-04
2B7114X STERILE WATER FOR IRRIG,USP 1000ML 00338-0003-44
2B7116 STER WATER FOR IRRIG USP,2000 ML UROMATIC 00338-0003-46
2B7117 STERILE WATER FOR IRRIG.USP. 3000mL UROMATIC CONT. 00338-0003-47
2B7124X 0.9% SOD CHL IRRIG, USP 1000 ML UROMATIC CONT 00338-0047-44
2B7126 0.9% NACL IRRIG USP 2000 ML UR OMATIC CONTAINER 00338-0047-46
2B7127 0.9% SOD.CHL.IRRIG. USP 3000ML UROMATIC CONTAINER 00338-0047-47
2B7207 0.9% SOD CHL PROCESSING SOL, 3 000 ML FLEXIBLE CONT 00338-0050-47
2B7231 0.9% SOD CHL IRRIGATION, USP I N BAXTER STER CONT 00338-0051-44
2B7231K 0.9% SOD CHL IRRIGATION, USP I N BAXTER STER CONT 00338-0051-44
2B7317 1.5% GLYCINE FOR IRRIG USP, 30 00 ML 00338-0289-47
2B7357 3% SORBITOL IN WATER, 3000 ML UROMATIC CONTAINER 00338-0295-47
2B7477 0.9% SOD CHL IRRIG, USP, 3000 ML ARTHROMATIC 00338-0047-27
2B7479 0.9% SOD CHL IRRIG, USP, 5000 ML ARTHROMATIC 00338-0047-29
2B7487 LACTATED RINGERS IRRIG, 3000 M L ARTHROMATIC 00338-0137-27
2B7489 LACTATED RINGERS IRRIG, 5000 M L ARTHROMATIC 00338-0137-29
4
2D5613Q 10% OSMITROL INJ (10% MANNITOL INJ, USP) 00338-0353-03
2D5632Q 20% OSMITROL INJ (20% MANNITOL INJ, USP) 00338-0357-02
2D5633Q 20% OSMITROL INJ (20% MANNITOL INJ, USP) 00338-0357-03
2J1416 BREVIBLOC INJ VIZIENT 2000MG IN 100ML PREMIX BAG,
SALINE
10019-0668-10
2J1417 BREVIBLOC INJ VIZIENT 2500MG IN 250ML PREMIX BAG,
SALINE
10019-0672-10
2J1419 BREVIBLOC INJ PREMIER 2500MG IN 250ML PREMIX BAG,
SALINE
10019-0670-10
2J1420 BREVIBLOC INJ PREMIER 2000MG IN 100ML PREMIX BAG,
SALINE
10019-0666-10

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

Compounding Guidances
FDA is working continuously to address the shortages and supply disruptions to ensure patients have access to certain parenteral drugs, including intravenous solutions. The agency has issued an immediately-in-effect guidance, Temporary Policies for Compounding Certain Parenteral Drug Products, for compounders to help fill the gaps from the impact of Hurricane Helene on Baxter International’s North Cove facility.

The guidance describes that, temporarily, FDA does not intend to take action against a pharmacy, including a hospital or health system pharmacy, that is not registered as an outsourcing facility for providing certain compounded parental drugs to a hospital without first obtaining a patient-specific prescription, provided certain conditions are met.

Additionally, FDA does not intend to take action against an outsourcing facility for not meeting current good manufacturing practice (CGMP) requirements pertaining to product stability testing of certain parental drugs, provided certain conditions are met.

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. In addition, the new guidance—Temporary Policies for Compounding Certain Parenteral Drug Products—does not include a condition for use within 24 hours.