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HHS/FDA | RIN: 0910-AI31 | Publication ID: Fall 2019 |
Title: Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food Drug and Cosmetic Act | |
Abstract:
Both sections 503A and 503B require compounded drug products to satisfy several conditions to qualify for the statutory exemptions from the FD&C Act listed under each section. One of those conditions is that the compounded drug product is not a drug product that presents demonstrable difficulties for compounding. FDA is proposing to establish the criteria by which drug products and categories of drug products will be evaluated for inclusion on the Difficult to Compound List for section 503A and the Difficult to Compound List for section 503B. Based on the results of its evaluation of nominated difficult to compound drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. |
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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: No | Unfunded Mandates: No |
EO 13771 Designation: Regulatory | |
CFR Citation: 21 CFR 216.25 | |
Legal Authority: 21 U.S.C. 353a 21 U.S.C. 353b 21 U.S.C. 371(a) |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Alexandria Fujisaki Regulatory Counsel Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, Building 51, Room 5169, Center for Drug Evaluation and Research, Silver Spring, MD 20993 Phone:240 402-4078 Email: alexandria.fujisaki@fda.hhs.gov |