This temporary final rule amends provisions of the Food Drug and Cosmetic Act (FDC&A) section 412 related to the Anti-Drug Abuse Act of 1986. Section 412 of the FDC&A was established under the Infant Formula Act of 1980.
Current Good Manufacturing Practices, quality control processes, audits, quality factors, registrations, notifications, recordkeeping, and reporting
The current Good Manufacturing Practices require that infant formulas prevent contamination by microorganisms, mandate microbial testing at the final production stage for the presence of Cronobacter and Salmonella. Other requirements include the use of codes to identify packaging and the entire manufacturing process for traceability, approval of finished products for sale, and control to prevent contamination from various other sources during manufacturing or packaging.
Revised quality control process requirements mandate that both intermediate and finished products be tested to ensure they contain all necessary and added nutrients at appropriate levels. For instance, finished products must be tested for vitamins A, C, E, and thiamine before packaging.
Regular reviews must be conducted to ensure cGMP and quality control processes comply with the requirements.
The FDA has established two quality factors for manufacturers to continuously enhance research monitoring of infant formulas and to conduct protein efficiency ratio bioassays using rats to ensure biological protein quality.
This standard includes a registration requirement, allowing the FDA to obtain information about the entities distributing infant formula within the United States. It also requires entities to provide scientific data and information to demonstrate that a new infant formula contains all necessary nutrients and meets all requirements of the rule.
The standard also includes recordkeeping and reporting requirements to support the requirements listed in the rule, such as microbial testing requirements.
The public may submit comments until March 27, 2014, and the rule will take effect on July 10, 2014.