Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter C - DRUGS: GENERALPart 213 - [Effective 12/18/2025] [Effective 12/18/2025] CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES
Subpart E - [Effective 12/18/2025] CONTROL OF INCOMING DESIGNATED MEDICAL GAS, COMPONENTS, AND MEDICAL GAS CONTAINERS AND CLOSURES
Section 213.89 - [Effective 12/18/2025] Rejected components, incoming designated medical gases, and medical gas containers and closures

21 C.F.R. § 213.89

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Current through October 31, 2024
Section 213.89 - [Effective 12/18/2025] Rejected components, incoming designated medical gases, and medical gas containers and closures

Rejected components, incoming designated medical gases, and medical gas containers and closures shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable and shall be documented and assessed.

21 C.F.R. §213.89

89 FR 51770 , 12/18/2025