GroundRules
21 CFR 213.80: General requirements.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER C—DRUGS: GENERAL
- PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES
- Subpart E—Control of Incoming Designated Medical Gas, Components, and Medical Gas Containers and Closures
(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components, incoming designated medical gases, and medical gas containers and closures; such written procedures shall be followed.
(b) Components, incoming designated medical gases, and medical gas containers and closures shall at all times be handled and stored in a manner to prevent contamination and mix-ups.
(c) Lots of incoming designated medical gases or components, whether used directly as supply or commingled with an existing supply, shall be assigned a unique identification number.
Collected 2026-08-27T02:24:47Z. Source file · JSON