Code of Federal Regulations · Section

§ 7.3 — Definitions

42 C.F.R. § 7.3

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Biological standards means a uniform and stable reference biological substance which allows measurements of relative potency to be made and described in a common currency of international and national units of activity.

Biological preparations means a reference biological substance which may be used for a purpose similar to that of a standard, but which has been established without a full collaborative study, or where a collaborative study has shown that it is not appropriate to establish the preparation as an international standard.

42 C.F.R. § 7.2 42 C.F.R. § 7.4

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