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United States
21 CFR Part 317 — Qualifying Pathogens
21 CFR Part 317 — Qualifying Pathogens
law://us/cfr/21/317@2026-11-12
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United States
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· 1 version
Version from 23 Dec 2016
2016
today
23 Dec 2016
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Key facts
Type
CFR part
· 21 CFR Part 317
Made by
Chapter I—Food and Drug Administration, Department of Health and Human Services
Topics
Food and Drugs
This text since 23 Dec 2016
Contents
317.1
[Reserved]
317.2
List of qualifying pathogens that have the potential to pose a serious threat to public health.
In force
317.1
[Reserved]
#
317.2
List of qualifying pathogens that have the potential to pose a serious threat to public health.
#
The term “qualifying pathogen” in section 505E(f) of the Federal Food, Drug, and Cosmetic Act is defined to mean any of the following:
(a)
Acinetobacter species.
(b)
Aspergillus species.
(c)
Burkholderia cepacia complex.
(d)
Campylobacter species.
(e)
Candida species.
(f)
Clostridium difficile.
(g)
Coccidioides species.
(h)
Cryptococcus species.
(i)
Enterobacteriaceae.
(j)
Enterococcus species.
(k)
Helicobacter pylori.
(l)
Mycobacterium tuberculosis complex.
(m)
Neisseria gonorrhoeae.
(n)
Neisseria meningitidis.
(o)
Non-tuberculous mycobacteria species.
(p)
Pseudomonas species.
(q)
Staphylococcus aureus.
(r)
Streptococcus agalactiae.
(s)
Streptococcus pneumoniae.
(t)
Streptococcus pyogenes.
(u)
Vibrio cholerae.
United States Government work; public domain under 17 U.S.C. § 105.