View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
HHS/FDA | RIN: 0910-AI71 | Publication ID: Spring 2022 |
Title: ●Distribution of Compounded Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act(Section 610 Review) | |
Abstract:
The Food and Drug Administration is proposing rulemaking regarding statutory requirements for certain distributions of compounded human prescription drug products. The proposed rule, if finalized, will include provisions regarding a standard memorandum of understanding (MOU) that describes the responsibilities of a State Board of Pharmacy or other appropriate State agency that chooses to sign the standard MOU in investigating complaints related to drug products compounded in such State and distributed outside such State and in addressing the interstate distribution of inordinate amounts of compounded human drug products. It will also, if finalized, include provisions regarding the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that do not sign the standard MOU, and may address adverse event reporting, product quality reporting, and communication with State boards of pharmacy. |
|
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 |
RFA Section 610 Review: Section 610 Review | |
CFR Citation: 21 CFR 216 | |
Legal Authority: 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353a 21 U.S.C. 353a-1 21 U.S.C. 353b 21 U.S.C. 355 21 U.S.C. 371 |
Legal Deadline:
None |
||||||
Timetable:
|
Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: State |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: Yes | |
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 |