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| HHS/FDA | RIN: 0910-AF16 | Publication ID: Spring 2008 |
| Title: Distribution of Certain Drug Products by Registered Blood Establishments and Comprehensive Hemophilia Diagnostic Treatment Centers That Qualify as Health Care Entities; PDMA of 1987; PDA of 1992 | |
| 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 drug activities as blood establishments and certain hemophilia treatment centers to also distribute certain drug 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 203.22(i); 21 CFR 205.3(h) | |
| Legal Authority: 21 USC 351 to 353; 21 USC 371; 21 USC 374 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: No | |
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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 Fax:301 827-0440 |
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