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Title 21

Displaying title 21, up to date as of 9/23/2021. Title 21 was last amended 9/21/2021.

Title 21

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PART 317 - QUALIFYING PATHOGENS
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.