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HHS/FDA RIN: 0910-AG15 Publication ID: Spring 2011 
Title: Revision of the Requirements for Constituent Materials 
Abstract: Constituent materials include ingredients, preservatives, diluents, adjuvants, extraneous protein, and antibiotics that are contained in a biological product. This action will allow flexibility for manufacturing biological products, including innovative lifesaving products, that do not currently comply with the requirements for constituent materials but have been demonstrated to be safe, pure, and potent products. FDA is amending the regulation for constituent materials to allow the Director of the Center for Biologics Evaluation and Research (CBER) and the Director of the Center for Drugs Evaluation and Research (CDER) to approve an exception or alternative to the requirements under section 610.15, when the exception or alternative is sufficient to ensure the safety, purity, and potency of the biological product. This final rule will provide manufacturers of innovative biological products and manufacturers of currently approved products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protection. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 610.15   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351    21 USC 352    21 USC 353    21 USC 355    21 USC 360    21 USC 360c    21 USC 360d    21 USC 360h    21 USC 360i    21 USC 371    21 USC 372    21 USC 374    21 USC 381    42 USC 216    42 USC 262    42 USC 263    42 USC 263a    42 USC 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/30/2010  75 FR 15639   
NPRM Comment Period End  06/28/2010    
Final Action  04/13/2011  76 FR 20513   
Final Action Effective  05/13/2011    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Paul E. Levine Jr.
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike,
Rockville, MD 20852
Phone:301 827-6210