U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
Exit search mode at current location
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.
