21 CFR 114.5 - Current good manufacturing practice.

§ 114.5 Current good manufacturing practice.
The criteria in §§ 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the criteria in part 110 of this chapter, apply in determining whether an article of acidified food is adulterated (1) within the meaning of section 402(a)(3) of the act (21 U.S.C. 342(a)(3)) in that it has been manufactured under such conditions that it is unfit for food, or (2) within the meaning of section 402(a)(4) of the act (21 U.S.C. 342(a)(4)) in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
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§ 114.5 Current good manufacturing practice.

The criteria in §§ 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the criteria in parts 110 and 117 of this chapter, apply in determining whether an article of acidified food is adulterated:

(a) Within the meaning of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it has been manufactured under such conditions that it is unfit for food; or

(b) Within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

[80 FR 56144, Sept. 17, 2015]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 21 - FOOD AND DRUGS
U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 114 after this date.

  • 2015-11-18; vol. 80 # 222 - Wednesday, November 18, 2015
    1. 80 FR 71934 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; clarification of compliance date for certain food establishments.
      The compliance date under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (published on September 17, 2015 at 80 FR 55908) for grade “A” milk and milk products covered by NCIMS under the PMO is September 17, 2018.
      21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211