In June 2014, the FDA published its final rule on current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula. It is in effect from July 10, 2014 and there are two important dates for manufacturers to be aware of. By November 12, 2015 manufacturers must meet the requirements of 21CFR 106.96(a), 106.96(e), 106.96(i)(5), 106.100(p)(2) and 106.100(q)(2) related to quality factors for eligible infant formulas. The remaining provisions of this final rule must be met by September 8, 2014.
This final rule will help prevent the manufacture of adulterated infant formula, ensure the safety of infant formula and ensure that the nutrients in infant formula are present in a form that is bioavailable. The FDA are issuing this final rule to establish requirements for quality factors for infant formulas and good manufacturing practices, including quality control procedures, under section 412 of the Federal Food, Drug, and Cosmetic Act (the FD Act) (21 U.S.C. 350a).
The FDA had previously implemented certain of the provisions in the Infant Formula Act and 1986 amendments. This final rule implements the remaining provisions of the 1986 amendments, including provisions for cGMPs and quality factor requirements. It also generally affirms the IFR's changes to the FDA's regulations at 21 CFR parts 106 and 107 and provides additional modifications and clarifications to part 106.
The final rule in full can be found here. In our next blog, we will discuss a demonstration of the Quality Factor Requirements under 21 CFR 106.96 for eligible Infant Formulas