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.
Iron warnings
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 28, 1997
Recommended
Machinery Basics
Pharmaceutical Innovations Report
Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.
Learn More
Break out of the ordinary: see what’s new in packaging & processing!
At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us this September to experience a breakthrough in packaging and processing.
REGISTER NOW AND SAVE
