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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2018]
[CITE: 21CFR317.2]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE

PART 317 -- QUALIFYING PATHOGENS

Sec. 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.

(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.

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