Products such as antitoxins, antivenins, blood, blood derivatives, immune serums, immunologic diagnostic aids, toxoids, vaccines, and related articles that are produced under license in accordance with the terms of the federal Public Health Service Act (58 Stat. 682) approved July 1, 1944, as amended, have long been known as “biologics.” However, in Table III, Part F, of the Act, the term “biological products” is applied to the group of licensed products as a whole. For Pharmacopeial purposes, the term “biologics” refers to those products that must be licensed under the Act and comply with Food and Drug Regulations—Code of Federal Regulations, Title 21 Parts 600-680, pertaining to federal control of these products (other than certain diagnostic aids), as administered by the Center for Biologics Evaluation and Research or, in the case of the relevant diagnostic aids, by the Center for Devices and Radiological Health of the federal Food and Drug Administration.

Each lot of a licensed biologic is approved for distribution when it has been determined that the lot meets the specific control requirements for that product as set forth by the Office. Licensing includes approval of a specific series of production steps and in-process control tests as well as end-product specifications that must be met on a lot-by-lot basis. These can be altered only upon approval by the Center for Biologics Evaluation and Research and with the support of appropriate data demonstrating that the change will yield a final product having equal or superior safety, purity, potency, and efficacy. No lot of any licensed biological product is to be distributed by the manufacturer prior to the completion of the specified tests. Provisions generally applicable to biologic products include tests for potency, general safety, sterility, purity, water (residual moisture), pyrogens, identity, and constituent materials (Sections 610.10 to 610.15 and see Safety Tests—Biologicals under Biological Reactivity Tests, In Vivo 88, Sterility Tests 71, Water Determination 921, and Pyrogen Test 151, as well as Bacterial Endotoxins Test 85). Constituent materials include ingredients, preservatives, diluents and adjuvants (which generally should meet compendial standards), extraneous protein in cell-culture produced vaccines (which, if other than serum-originating, is excluded) and antibiotics other than penicillin added to the production substrate of viral vaccines (for which compendial monographs on antibiotics and antibiotic substances are available). Additional specific safety tests are also required to be performed on live vaccines and certain other items. Where standard preparations are made available by the Center for Biologics Evaluation and Research (Section 610.20), such preparations are specified for comparison in potency or virulence testing. The U.S. Opacity Standard is used in estimating the bacterial concentration of certain bacterial vaccines and/or evaluating challenge cultures used in tests of them. (See also Units of Potency in the General Notices.)

The Pharmacopeial monographs conform to the Food and Drug Regulations in covering those aspects of identity, quality, purity, potency, and packaging and storage that are of particular interest to pharmacists and physicians responsible for the purchase, storage, and use of biologics. Revisions of the federal requirements affecting the USP monographs will be made the subjects of USP Supplements as promptly as practicable.