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§213.196. Distribution records.

21 C.F.R. § 213.196

Distribution records shall contain the name of the medical gas, lot or batch number, name and address of the consignee, and date and quantity shipped. For medically appropriate combinations of designated medical gases, the distribution record shall include the percentage of each gas.
Notes, amendments, and revision history

Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360b, 360ddd, 360ddd-1, 371, 374.

Source

Source: 89 FR 51770, June 18, 2024, unless otherwise noted.