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

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

§ 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.

(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.

authority: 21 U.S.C. 355f,371

source: 79 FR 32480, June 5, 2014, unless otherwise noted.

cite as: 21 CFR 317.2