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HHS/FDA RIN: 0910-AF16 Publication ID: Fall 2007 
Title: Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as Health Care Entities; PDMA of 1987; PDA of 1992; Policies, Requirements, and Administrative Procedures 
Abstract: FDA is amending certain limited provisions of the implementing regulations of the Prescription Drug Marketing Act (PDMA) of 1987, as modified by the Prescription Drug Amendments (PDA) of 1992 and the FDA Modernization Act of 1997. Certain provisions of that final rule that published on December 3, 1999 (64 FR 67720), would not allow registered blood establishments or hemophilia treatment centers that provide health care services to concurrently distribute drugs, including blood derivatives. The effective date of those provisions of that rule is delayed until December 1, 2008, as published on November 13, 2006 (71 FR 66108)--final rule; the applicability date was delayed in order to consider comments on the proposed rule published in the Federal Register February 1, 2006 (71 FR 5200). FDA is amending the final rule to allow registered blood establishments that provide health care services related to their activities as blood establishments and certain hemophilia treatment centers to also distribute certain products, including blood derivatives. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 203.3(q)    21 CFR 203.22(h)    21 CFR 205.3(h)   
Legal Authority: 21 USC 351 to 353    21 USC 371    21 USC 374   
Legal Deadline:  None
Action Date FR Cite
NPRM  02/01/2006  71 FR 5200   
NPRM Comment Period End  05/02/2006    
Delay of Applicability  11/13/2006  71 FR 66108   
Final Action  09/00/2008    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Kathleen E. Swisher
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-10),
Rockville, MD 20852
Phone:301 827-0372

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