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USP 800 (Hazardous Drugs—Handling in Healthcare Settings) is a guideline created by the United States Pharmacopeia Convention (USP), as one of their General Chapters through which the USP "sets quality standards for medicines, dietary supplements and food ingredients".
USP 800 is an example of a publication created by the United States Pharmacopeia. Prescription and over-the-counter medicines available in the United States must, by federal law, meet USP-NF public standards, where such standards exist.
Current regulating bodies include ISO, USP 800, US FED STD 209E (previous standard, still used). Drug Quality and Security Act (DQSA) created in Nov. 2013 in response to drug compounding deaths and serious adverse events. The Federal Food, Drug, and Cosmetic Act (FD&C Act) created specific guidelines and policies for human compounding.
The USP Controlled Room Temperature is a series of United States Pharmacopeia guidelines for the storage of pharmaceuticals; [1] the relevant omnibus standard is USP 797. [2] [3] Although 100% compliance remains challenging for any given facility, [4] the larger protocol may be regarded as constituting a form of clean room [5] which is included in a suite of best practices.
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