21 CFR 211.86
Use of approved components, drug product containers, and closures. This section left the CFR when the QMSR took effect on Feb 2, 2026; the text below is as of Feb 1, 2026.
- Inspections citing it: 8
- Of those classified, ended OAI: 43%
- Last cited: FY2018
Inspections Citing It by Fiscal Year
Sites in and outside the US, FY2017 to Oct 20, 2026.
Regulation Text
eCFR, as of Feb 1, 2026Components, drug product containers, and closures approved for use shall be rotated so that the oldest approved stock is used first. Deviation from this requirement is permitted if such deviation is temporary and appropriate.
Counts are inspections with posted citations that cite any paragraph of the section, once per inspection, from FDA's Data Dashboard. OAI share is over inspections FDA finally classified. Text from eCFR, the official online CFR. FDA Data Dashboard and eCFR