Infant formula, fentanyl and rural hospital bills

Protect Infant Formula from Contamination Act

• Require faster reports of formula problems: Manufacturers would have to notify the FDA within one business day after learning that formula they processed, but no longer control, may lack required nutrients or may be adulterated or misbranded
• Report positive microorganism tests: A manufacturer would have to notify the FDA within one business day of a confirmed positive test for a microorganism covered by the testing rules, even if the product remains under the manufacturer’s control. The manufacturer would consult with the FDA about isolating the product, stop distribution and dispose of it if the FDA requires, and provide test results and isolates or genome-sequence data
• Require FDA follow-up and review: Within one business day of a positive-test notification, the FDA would respond and begin discussing investigation and corrective action with the manufacturer. Within 90 days of a notification, the FDA would confirm whether the manufacturer performed or is performing an appropriate investigation and corrective action, if applicable

1. Introduced
2. In committee
3. Reported
4. Passed Senate
5. Passed House
6. Law

What’s next: Passed the Senate. Next step: the House.