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HHS/FDA | RIN: 0910-AG20 | Publication ID: Spring 2013 |
Title: Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Second Phase | |
Abstract: FDA will revise regulations for "current good manufacturing practice" for oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products. This revision will update and harmonize requirements and improve detection and response to emerging product safety and quality signals. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: Undetermined |
CFR Citation: 21 CFR 210 21 CFR 211 | |
Legal Authority: 21 USC 321 21 USC 351 21 USC 352 21 USC 355 21 USC 360b 21 USC 371 21 USC 374 42 USC 262 42 USC 264 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
RIN Data Printed in the FR: Yes | |
Agency Contact: Paula Katz Regulatory Counsel, Office of Compliance Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 4314, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-6972 Fax:301 847-8742 Email: paula.katz@fda.hhs.gov |