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HHS/FDA

RIN: 0910-AF16

Publication ID: Fall 2006

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 December 1, 2006, as published on February 23, 2004 (69 FR 8105). FDA intends to delay the effective date of those provisions while FDA is considering comments on the proposed rule. FDA is amending the final rule to allow registered blood establishments and certain hemophilia treatment centers that concurrently provide health care services related to their activities as blood establishments or 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

Timetable:

Action	Date	FR Cite
NPRM	02/01/2006	71 FR 5200
NPRM Comment Period End	05/02/2006
Final Action	10/00/2007

Additional Information: Delayed effective date of portion of rule to 12/01/06, effective date of non-stayed portion of final rule, 64 FR 67720, December 3, 1999
Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Federalism: No
Included in the Regulatory Plan: 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