21 CFR § 317.2 - List of qualifying pathogens that have the potential to pose a serious threat to public health.

---
identifier: "/us/cfr/t21/s317.2"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 317.2 - List of qualifying pathogens that have the potential to pose a serious threat to public health."
title_number: 21
title_name: "Food and Drugs"
section_number: "317.2"
section_name: "List of qualifying pathogens that have the potential to pose a serious threat to public health."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "317"
part_name: "QUALIFYING PATHOGENS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 355f, 371."
regulatory_source: "79 FR 32480, June 5, 2014, unless otherwise noted."
cfr_part: "317"
---


# 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.*