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US Extends Enforcement Discretion For Infant Formula Production With Guidance For Compliance

 
• By Malcolm Spicer

Guidance extends through Jan. 6 enforcement discretion for formula products cleared for sales under temporary guidance FDA announced in May. Further extensions possible for firms taking steps toward lawful marketing of products in US, agency says.

• Source: Shutterstock

Enforcement discretion for manufacturing to increase infant formula supplies in the US has been extended to early January as the Food and Drug Administration provides guidance for firms currently using temporary clearances to market their products to work toward becoming fully compliant.

“The guidance balances the need to ensure that infant formula products meet regulatory requirements with the need for a more resilient infant formula

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