Baxter Resources for Products Authorized for Temporary Importation
Baxter’s North Cove manufacturing site was significantly impacted by the rain and storm surge from Hurricane Helene. Supporting our employees in the impacted communities, bringing the North Cove facility back online and helping to ensure ongoing supply to patients are our top priorities.
While healthcare practitioners should continue to use their professional judgement in assessing the needs and resources of their individual organizations and patients, this site is intended to help support product management and conservation strategies and efforts. Our Medical Affairs team is also available at [email protected].
Products Authorized for Temporary Importation
In order to help with the supply issue resulting from Hurricane Helene, the FDA authorized temporary importation into the United States (U.S.) of certain foreign-approved Baxter products that are manufactured in other countries. Temporary authorization allows for temporary, controlled importation of foreign-approved drugs to help mitigate U.S. drug shortages and differs from emergency use authorization (EUA), which provides an expedited approval pathway for products used in an emergency situation to protect against chemical, biological, radiological and nuclear threats, including infectious diseases. Additionally, Baxter manufactures and distributes FDA-approved products—some of which may be manufactured in foreign countries. As part of our FDA approval for the products, we import and distribute those products in the U.S. market.
This report contains Baxter product code and lot information and the associated Dear Healthcare Provider (DHCP) letters for products that have received temporary importation authorization from FDA as they become available in the U.S. market. The product codes and lot numbers that appear on this document are the only products that are authorized for both importation and distribution by Baxter.
Dear Healthcare Professional Letters
Dear Healthcare Professional (DCHP) letters for each Baxter product authorized for temporary importation in the U.S. are listed below by solution type and product code as they become available in the U.S. market. These will be added as new Product Codes/Lots become available.
For additional information beyond what is available in the letter, please refer to Baxter U.S. Medical Information Online: https://medinfo.baxter.com. Self-service portal intended for Healthcare Professionals to search and download frequently requested product information.
Side-by-Side Comparisons for Clinical Use
For Baxter products authorized for temporary importation in the U.S., available side-by-side comparisons are listed below by solution type and product code as they become available in the U.S. market. These will be added as new Product Codes/Lots become available.
Order Entry & Compounders
Educational material on how to add concentrated glucose to the Baxter order entry software (Abacus) and automated compounding device (ExactaMix). Additional information on the differences between glucose and dextrose can be found in Webinars & Videos.
Webinars & Videos
WEBINAR - Dextrose, USP vs Glucose: Part 1 – What Are The Differences?
Presented by:
Jeff Brittain, PharmD, BCPS, BCMAS, Senior Manager, Baxter Medical Affairs
Watch this educational webinar, provided by Baxter Medical Affairs, for information on differences between dextrose, USP and glucose.
WEBINAR – Dextrose, USP vs Glucose: Part 2 – Baxter Hurricane Helene Recovery Resource
Presented by:
Allison Blackmer, PharmD, BCPS, BCPPS, FCCP, FASPEN, Associate Director Medical Affairs, Clinical Nutrition and Pharmacy Tools
Watch this non-promotional educational webinar, provided by Baxter Medical Affairs, for additional differences between dextrose, USP and glucose, specifically pertaining to aspects related to compatibility/stability, concentration, and energy content.
VIDEO – Handling, Setting Up, and Spiking the VIAFLO Container
Watch this video to learn how to handle, set up, and spike the Viaflo container.
VIDEO – Handling, Setting Up, Spiking and Unspiking the VIAFLO Container with Dripless Accessory Component (DAC)
Watch this video to learn how to handle, set up, spike, and unspike the Viaflo container with a Dripless Accessory Component (DAC).
Additional Resources
- ASPEN Practice Tool on Use of Imported Glucose 50% Injection
- Fluid Shortage Update—Safeguard Imported Products – ISMP & ECRI
- Fluid Shortage: Importation Risk Mitigation Strategies - ASHP
- Note: ASHP recommends using with the below “Imported Fluid Product Checklist” by ISMP & ECRI
- Imported Fluid Product Checklist – ISMP & ECRI
- Weathering the Storm—Safety Considerations During Fluid Shortages – ISMP & ECRI
Baxter U.S. Medical Information Online: https://medinfo.baxter.com
Self-service portal intended for Healthcare Professionals to search and download frequently requested product information.