Extension of the Period Before the Food and Drug Administration Intends To Begin Enforcing the Statutory 5 Percent Limit on Out-of-State Distribution of Compounded Human Drug Products
other · Food and Drug Administration · Rule · Published 2022-10-21 · 87 FR 63947
Document
Document number
2022-22876
Federal Register citation
87 FR 63947
CFR reference
21 CFR 216
Type
Rule
Action
Notification; extension of period before enforcement.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2022-10-21
HHS docket
Docket No. FDA-2015-N-0030
Abstract
The Food and Drug Administration (FDA or the Agency) is extending the period before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that have not entered into a standard memorandum of understanding (MOU) with FDA addressing certain distributions of compounded human drug products. FDA is extending the period, which was scheduled to end on October 27, 2022, until the effective date of a final rule regarding certain distributions of compounded human drug products and publication of an updated standard MOU.