FDA Issues Guidance on Non-Standard Infant Formula Requirements
The Food and Drug Administration on April 14 posted a guidance document on current good manufacturing practices, quality control procedures, conduct of audits and records and reports for infant formulas exempt from normal requirements (here). Infant formulas are exempt from…
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FDA’s standards if they are labeled for use by an infant with metabolism errors, low birth weight or other unusual medical or dietary problems. Despite the exemption, manufacturers should attempt to follow standards for non-exempt formula “to the extent practicable,” said FDA in the guidance. Comments on the guidance may be submitted at any time, said FDA (here).