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HHS/FDA | RIN: 0910-AH09 | Publication ID: Spring 2014 |
Title: ●Current Good Manufacturing Practice for Outsourcing Facilities | |
Abstract: This rule would set forth the minimum current good manufacturing practice (cGMP) requirements for human drug products compounded by an outsourcing facility. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: Undetermined |
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.) | |
Legal Authority: 21 USC 351 PL 113-54, 127 Stat 587 21 USC 371 |
Legal Deadline:
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Overall Description of Deadline: Section 104 of the Drug Quality and Security Act (DQSA) requires that in promulgating any regulations to implement the DQSA (e.g., section 503B of the FD&C Act), at least 60 days be provided for comments on a proposed regulation and the final regulation be published not more than 18 months following publication of the proposed rule and not less than 30 calendar days before the effective date of such final regulation. |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Federalism: Undetermined | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Ashley Boam Health Science Administrator Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, Building 51, Room 4192, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-6341 Email: ashley.boam@fda.hhs.gov |