§ 211.86 Use of approved components, drug product containers, and closures

Components, 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.

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What FDA inspectors cite under § 211.86

Form FDA 483 observations citing this section, fiscal years 2009–2018 (Drugs).

• Rotation of components/containers/closures 8

FDA guidance that cites § 211.86

• BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry 1 Mar 2014

Amendment history

Federal Register documents that created or amended this section.

• 43 FR 45077 29 Sept 1978