§7.3. Definitions.
42 C.F.R. § 7.3
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.
Notes, amendments, and revision history
Authority
Authority: Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); title V of the Independent Offices Appropriations Act of 1952 (31 U.S.C. 9701); and secs. 301(a) and 352 of the Public Health Service Act, as amended (42 U.S.C. 241(a) and 263).
Source
Source: 52 FR 11073, Apr. 7, 1987, unless otherwise noted.