FDA Removes Regulations for Unit-Dose Packaging Requirement for Iron-Containing Supplemennts and Drugs

The Food and Drug Administration (FDA) is removing a rule requiring unit-dose packaging for iron-containing dietary supplement and drug products that contain 30 milligrams (mg) or more of iron per dosage unit.

This action is a response to a Court ruling which concluded that the Food, Drug, and Cosmetic Act does not provide FDA with authority to require manufacturers of iron-containing dietary supplement and drug products to use unit-dose packaging for poison prevention purposes.


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