21 CFR 317.2
§ 317.2 List of qualifying pathogens that have the potential to pose a serious threat to public health.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 317.2, § 317.2 List of qualifying pathogens that have the potential to pose a serious threat to public health, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86445
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.