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Regulatory Focus™ > News Articles > FDA Allows Temporary Saline Imports to Deal With Shortages Caused by Hurricane Maria

FDA Allows Temporary Saline Imports to Deal With Shortages Caused by Hurricane Maria

Posted 11 October 2017 | By Zachary Brennan 

FDA Allows Temporary Saline Imports to Deal With Shortages Caused by Hurricane Maria

Baxter Healthcare said in letters to health care professionals dated Monday that it is working with the US Food and Drug Administration (FDA) to import sodium chloride and glucose intravenous infusion products from Ireland and Australia to address shortages because of Hurricane Maria.

The temporary imports are manufactured at Baxter facilities in Ireland and Australia and the company notes that at this time, "No other entity except Baxter is authorized by the FDA to import or distribute these products in the United States."

The allowance of the imports comes almost a month after the hurricane hit Puerto Rico, which is still struggling with power shortages and manufactures about 10% of the medical products that the US consumes. 

Last week, FDA noted there are currently about 40 pharmaceutical and biologic products that are at risk of a shortage and FDA Commissioner Scott Gottlieb said the agency in some cases is in daily communication with the companies to act quickly to prevent drug and device shortages.

"In urgent cases, when critical products are at issue, we’ve intervened over the last two weeks to help firms secure fuel to maintain production lines, get clearance to move logistical support into the island or finished goods to their recipients," he said.

Gottlieb told Reuters in an interview Tuesday that most of that manufacturing capacity has not come back online and that the US may start to see other drug shortages within two or three weeks due to delays.

All four of the letters sent by Baxter on Monday also noted some of the differences between the FDA-approved products and the imports.

"While the injection or medication ports are similar across the FDA-approved products and the imported products, the administration port protector on the imported products must be twisted off rather than pulled off," one of the letters says.

Letter to Healthcare Professional

FDA Drug Shortages

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