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Prescription Drug Marketing Act Pedigree Requirements; Effective Date and Compliance Policy Guide; Request for Comment

other · Food and Drug Administration · Rule · Published 2006-06-14 · Effective 2006-12-01 · 71 FR 34249

Document

Document number
06-5362
Federal Register citation
71 FR 34249
CFR reference
21 CFR 203
Type
Rule
Action
Final rule; announcement of effective date; notice of availability; request for comment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2006-06-14
Effective date
2006-12-01
HHS docket
Docket Nos. 1992N-0297 (Formerly 92N-0297), 1988N-0258 (Formerly 88N-0258), 2006D-0226

Abstract

The Food and Drug Administration (FDA) does not intend to further delay the effective date of certain provisions of the final regulation published in the Federal Register of December 3, 1999 (64 FR 67720). The provisions will therefore go into effect on December 1, 2006. In addition, FDA is announcing the availability of a new compliance policy guide (CPG) 160.900 entitled "Prescription Drug Marketing Act Pedigree Requirements Under 21 CFR Part 203" for public comment. This CPG describes how the agency intends to prioritize its enforcement efforts during the next year with respect to pedigree requirements set forth in the Federal Food, Drug, and Cosmetic Act (the act) and certain FDA regulations.

Source

Authoritative
Federal Register document
Machine
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