List of qualifying pathogens that have the potential to pose a serious threat to public health.
21 C.F.R. § 317.2
in effectEffective: 2024-07-01The 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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026