Biological products and related terms.

CFR · 2024-01-01 · US · Title 9

When used in conjunction with or in reference to a biological product, the following terms shall mean: (a) (b) (c) (d) (e) (f) (g) (h) (i) (j) (k) (l) (m) (n) (o) (1) A suspension of organisms, representing a whole culture or a concentrate thereof, with the toxic growth products from the culture which has been inactivated without appreciable loss of antigenicity as measured by suitable tests, the inactivation of organisms and toxins being demonstrated by acceptable tests written into the filed Outline of Production: (2) A combination product in which one or more toxoids or bacterin-toxoids is combined with one or more bacterins or one or more bacterin-toxoids. (p) (q)

official document · source cfr-2024 · id 9:§ 101.3