USPUSP-NF
This is a preview of
USP-NF/PF content.
Subscriber?
Access here!
Not a subscriber?
Learn more!
〈1041〉 Biologics

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.

This is a preview of
USP-NF/PF content.
Subscriber?
Access here!
Not a subscriber?
Learn more!