Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Iron final rule

This article was originally published in The Tan Sheet

Executive Summary

Blister packs will not be mandatory for iron supplements as of Oct. 17, agency announces in same-day 1Federal Register notice. In January, a three-judge Court of Appeals panel overturned a previous decision supporting FDA's requirement for unit-dose packaging because the agency did not show that "iron-containing supplements may be adulterated without such packaging" (2"The Tan Sheet" Jan. 27, 2003, p. 9). Nutritional Health Alliance first filed suit in August 1997 alleging FDA "did not have the authority...to issue and enforce regulations for the purpose of poison prevention"...

You may also be interested in...



Iron-Containing Supplement, Drug Unit-Dose Packaging Rule Invalid – Court

FDA's reliance on current Good Manufacturing Practice regulations under the FD&C Act to justify requirement of unit-dose packaging for iron-containing dietary supplements and drugs is "misplaced," a New York federal appeals court concludes

Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker

Vaccination Health Next Stop For Dentovations’ Self+ Immunity Supplement Line

Vacci Prep is first “supplement to establish a standard of care for consumers when preparing their immune system for vaccinations,” Dentovations says.

Topics

UsernamePublicRestriction

Register

OM017175

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel