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Code · CFR · Title 21 — Food and Drugs · Part 213 — Current Good Manufacturing Practice for Medical Gases · § 213.208

§ 213.208. Salvaging of medical gases.

111 words·~1 min read·/us/cfr/t21/s§ 213.208·

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Medical gases in containers that have been subjected to improper storage conditions may be salvaged unless their containers have been subjected to adverse conditions that impact the identity, strength, quality, and purity of the gas or integrity of the container closure. Whenever there is a question whether medical gases have been subjected to such conditions, salvaging operations may be conducted only if there is evidence from laboratory tests that such gases meet all applicable standards of identity, strength, quality, and purity, and the integrity of the container closure system is not compromised.
Procedures for the holding, testing, and use of salvaged medical gases shall be in writing and shall be followed.
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