The rule, which becomes effective on July 15, 1997, also requires that all solid oral dosage products containing any non-carbonyl iron or iron salts bear a warning label. A one-year exemption was granted for products containing carbonyl iron, based on the assertion that this form of iron is less toxic. Accidental overdoses of iron is the leading case of poisoning deaths of children under six years old. Unit dose packaging will be more dificult for children to open, said FDA, and will limit the number of doses a child may consume if access is gained.
Unit dose packaging is now required for any solid dosage product containing more than 20 milligrams of iron per dosage unit, under a new FDA regulation.
Feb 28th, 1997