Distribution of Certain Drug Products by Registered Blood Establishments and Comprehensive Hemophilia Diagnostic Treatment Centers That Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements and Administrative Procedures
hospital-facility · Food and Drug Administration · Rule · Published 2008-10-09 · Effective 2008-11-10 · 73 FR 59496
Document
Document number
E8-24050
Federal Register citation
73 FR 59496
CFR reference
21 CFR 203
Type
Rule
Action
Final rule.
Category
hospital-facility
Sub-agency
Food and Drug Administration
Publication date
2008-10-09
Effective date
2008-11-10
HHS docket
Docket No. FDA-2005-N-0345
Abstract
The Food and Drug Administration (FDA) is amending its regulations to allow certain registered blood establishments and comprehensive hemophilia diagnostic treatment centers that are also health care entities to distribute certain drug products. The final rule amends limited provisions of the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA). These regulations, among other things, restrict the sale, purchase, or trade of, or the offer to sell, purchase, or trade, prescription drugs purchased by hospitals and other health care entities.