Viruses, Serums, Toxins, and Analogous Products; Definition of Biological Products and Guidelines
plant-animal-health · Animal and Plant Health Inspection Service · Rule · Published 1997-06-09 · Effective 1997-07-09 · 62 FR 31326
Document
Document number
97-14997
Federal Register citation
62 FR 31326
CFR reference
9 CFR 101
Type
Rule
Action
Final rule.
Category
plant-animal-health
Sub-agency
Animal and Plant Health Inspection Service
Publication date
1997-06-09
Effective date
1997-07-09
USDA docket
Docket No. 93-152-2
Abstract
We are amending the regulations by revising the definition of ``biological products.'' The amendment is necessary in order to reflect current usage and advances in scientific knowledge, and to clarify certain parts of the definition. We are also adding a definition of ``guidelines'' to the regulations. Guidelines are issued to assist manufacturers of veterinary biological products and others in understanding test procedures, standards, and regulatory requirements pertaining to such products. This addition clarifies the purpose and intent of guidelines.