§ 211.150 Distribution procedures

Written procedures shall be established, and followed, describing the distribution of drug products. They shall include:

(a) A procedure whereby the oldest approved stock of a drug product is distributed first. Deviation from this requirement is permitted if such deviation is temporary and appropriate.

(b) A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.

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What FDA inspectors cite under § 211.150

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).

• Written distribution procedure 112
• Recall facilitation 83
• Distribution Recall System 64
• Distribution of oldest approved drugs 7
• Distribution of oldest stock first 4

Warning letters citing § 211.150

5 FDA warning letters since 2017 cite this section :

• Lexia LLC 7 Apr 2026
• Maison Terre, LLC 1 Apr 2021
• Herbal Doctor Remedies 4 Oct 2019
• Phase 4 Pharmaceutical LLC 18 Apr 2018
• C. O. Truxton Inc. 19 Dec 2017

FDA guidance that cites § 211.150

• 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