Title 21 CFR reference
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United States • Title 21 CFR • Part 317
Part 317 — PART 317—QUALIFYING PATHOGENS
Part 317 establishes a list of qualifying pathogens that pose a serious threat to public health, as defined by the Federal Food, Drug, and Cosmetic Act.
What this part covers
- Defines "qualifying pathogen" as per section 505E(f) of the Federal Food, Drug, and Cosmetic Act.
- Lists specific bacterial, fungal, and other microbial species and complexes that qualify.
- Includes Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Coccidioides species, Cryptococcus species, Enterobacteriaceae, Enterococcus species, Helicobacter pylori, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, Neisseria meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, and Vibrio cholerae.
Sections in Part 317
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: Acinetobacter(a) species. Aspergillus(b) species. Burkholderia cepacia(c) complex. Campylobacter(d) species. Candida(e) species. Clostridium difficile.(f) Coccidioides(g) species. Cryptococcus(h) species. (i) Enterobacteriaceae. Enterococcus(j) species. Helicobacter pylori.(k) Mycobacterium tuberculosis(l) complex. Neisseria gonorrhoeae.(m) Neisseria meningitidis.(n) (o) Non-tuberculous mycobacteria species. Pseudomonas(p) species. Staphylococcus aureus.(q) Streptococcus agalactiae.(r) Streptococcus pneumoniae.(s) Streptococcus pyogenes.(t) Vibrio cholerae.(u)
Regulatory Context
This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.
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