Which regulation outlines the FDA's Current Good Manufacturing Practices for bulk liquid oxygen?

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The regulation that outlines the FDA's Current Good Manufacturing Practices (CGMP) for pharmaceuticals, including the production of bulk liquid oxygen, is found in 21 CFR 210 and 21 CFR 211.

21 CFR 210 provides the general regulations applicable to the manufacturing, processing, packing, or holding of drugs, while 21 CFR 211 specifies the requirements for production and quality control of pharmaceutical products. These parts ensure that manufacturers adhere to adequate standards to ensure the quality and safety of the drug products they produce, which includes bulk liquid oxygen, particularly when it is used in medical applications.

In the context of bulk liquid oxygen, adherence to CGMP is crucial for ensuring that the product is consistently produced and that the quality is controlled according to established standards. This regulatory framework is vital for maintaining the integrity of products that are critical for patient care in a healthcare setting.

The other regulations mentioned do not cover the manufacturing practices for bulk liquid oxygen specifically; rather, they relate to different aspects of drug manufacturing or different categories of substances.

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