Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
other · Food and Drug Administration · Rule · Published 2018-09-12 · Effective 2018-09-12 · 83 FR 46104
Document
Document number
2018-19855
Federal Register citation
83 FR 46104
CFR reference
21 CFR 110
Type
Rule
Action
Final rule; partial withdrawal.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2018-09-12
Effective date
2018-09-12
HHS docket
Docket No. FDA-2011-N-0920
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is removing instruction 13 from the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food) regulation. Instruction 13 directs the Federal Register to remove and reserve as of September 17, 2018, the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (Human Food CGMP) regulation. Removal of instruction 13 is necessary because the compliance dates for certain facilities subject to the modernized current good manufacturing practice requirements in the Preventive Controls for Human Food regulation have been extended. Retaining the Human Food CGMP regulation will maintain the status quo while these facilities prepare for compliance with the new CGMP requirements and will avoid an unintended gap in public health protection.