21 C.F.R. § 317.2
List of qualifying pathogens that have the potential to pose a serious threat to public health.
Cite as 21 C.F.R. § 317.2 (2026)
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.