21 CFR Part 317 — Qualifying Pathogens
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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 (b) Aspergillus (c) Burkholderia cepacia (d) Campylobacter (e) Candida (f) Clostridium difficile. (g) Coccidioides (h) Cryptococcus (i) Enterobacteriaceae. (j) Enterococcus (k) Helicobacter pylori. (l) Mycobacterium tuberculosis (m) Neisseria gonorrhoeae. (n) Neisseria meningitidis. (o) Non-tuberculous mycobacteria species. (p) Pseudomonas (q) Staphylococcus aureus. (r) Streptococcus agalactiae. (s) Streptococcus pneumoniae. (t) Streptococcus pyogenes. (u) Vibrio cholerae.
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