FDA Approves Temporary Importation of Amino Acids

The FDA Drug Shortages Program has informed ASPEN that Baxter Healthcare Corporation has received approval for the temporary importation of amino acids products from Baxter manufacturing facility in the United Kingdom. These products are:

SYNTHAMIN 17 without Electrolytes, a 10% amino acids product
CLINIMIX Solution for Infusion, 2.75% Amino Acid in 7.5% Glucose with Electrolytes, 1000 mL
CLINIMIX Solution for Infusion, 2.75% Amino Acid in 10% Glucose with Electrolytes, 1000 mL 
CLINIMIX Solution for Infusion, 4.25% Amino Acid in 15% Dextrose with Electrolytes, 2000 mL

Limited quantities will be available in the next few weeks. Baxter will provide further updates as more product becomes available.

Different brands of amino acids products are not always directly substitutable, especially for total nutrient admixture (3-in-1) vs. dextrose/amino acids (2-in-1) PN formulations. They may have different pHs, different calcium-phosphorus solubilities, different amounts of phosphorus, as well as other characteristics that should be considered. See the full ASPEN Drug Shortage Considerations for Amino Acids. Continue to conserve as much as possible until the shortage is resolved. 

ASPEN will continue its ongoing monitoring of the situation. As always, ASPEN is in an advocacy role on this issue. The ASPEN staff has had many conversations and meetings with key stakeholders, including manufacturers and the FDA Drug Shortages staff to address this situation and develop feasible strategies to resolve shortages of parenteral nutrition components.