42 CFR 7.3 - Definitions.

§ 7.3 Definitions.

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.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 42 published on 19-Apr-2017 03:51

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 7 after this date.

  • 2013-09-18; vol. 78 # 181 - Wednesday, September 18, 2013
    1. 78 FR 57293 - Distribution of Reference Biological Standards and Biological Preparations
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (HHS/CDC)
      Confirmation of effective date of direct final rule.
      The Direct Final Rule published at 78 FR 43817, July 22, 2013, will become effective on September 20, 2013.
      42 CFR Part 7