In the January 22 and January 25, 2016, Federal Registers,
FDA corrected and amended a final rule published in the September
17, 2015, Federal Register amending the regulation for
CGMPs in manufacturing, packing, or holding human food to modernize
it and add requirements for domestic and foreign facilities
required to register under the U.S. Food, Drug, and Cosmetic Act
("FDCA") to establish and implement hazard analysis and
risk-based preventive controls. The final rule also revised certain
definitions in the regulation to clarify the scope of the exemption
from registration requirements provided by FDCA for
"farms." The January 22 and 25, 2016, notices correct
editorial and inadvertent errors in the final rule.
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