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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter D → Part 317


Title 21: Food and Drugs


PART 317—QUALIFYING PATHOGENS


Contents
§317.1   [Reserved]
§317.2   List of qualifying pathogens that have the potential to pose a serious threat to public health.

Authority: 21 U.S.C. 355f, 371.

Source: 79 FR 32480, June 5, 2014, unless otherwise noted.

§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.

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