View Rule

Printer-Friendly Version Download RIN Data in XML

HHS/FDA

RIN: 0910-AF16

Publication ID: Fall 2003

Title: ●Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Derivatives of Blood
Abstract: FDA is proposing to amend the implementing regulation of the Prescription Drug Marketing Act of 1987, as modified by the Prescription Drug Amendments of 1992 and the FDA Modernization Act of 1997. The final rule (12/3/99; 64 FR 67720), does not allow a registered blood establishment that provides health care services related to its activities as a blood establishment to concurrently distribute derivatives of blood. The effective date of that rule is April 1, 2004. FDA is amending the final rule to allow a registered blood establishment that concurrently provides health care services to also distribute derivatives of blood.
Agency: Department of Health and Human Services(HHS)	Priority: Substantive, Nonsignificant
RIN Status: First time published in the Unified Agenda	Agenda Stage of Rulemaking: Prerule Stage
Major: Undetermined	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:

Action	Source	Description	Date
Other	Statutory	Effective date of final rule, 64 FR 67720, December 3, 1999	04/01/2004

Overall Description of Deadline: Date final rule takes effect: Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures."

Timetable:

Action	Date	FR Cite
ANPRM	07/00/2004

Regulatory Flexibility Analysis Required: Undetermined	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