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.