21 CFR Part 317
Part 317—Qualifying Pathogens
Food and Drugs · Chapter I, Chapter I—Food and Drug Administration, Department of Health and Human Services · Subchapter D
21 CFR Part 317 - Words
- 88
- Sections
- 2
- Last amended
- December 23, 2016
21 CFR Part 317
Text as published by eCFR on .
PART 317—QUALIFYING PATHOGENS
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.