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USP 800 describes practice and quality standards for the handling of HDs involving but not limited to the receipt, storage, compounding, dispensing, administration, and disposal of sterile and non-sterile products. This chapter applies to any personnel who may be exposed to HDs.
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.
USP establishes documentary (written) and reference (physical) standards for medicines, food ingredients, dietary supplement products, and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.
Contact plates or sterile swabs can also be used to test for microbes on a surface when compounding sterile products to ensure compliance with USP 797. [ 5 ] As an alternative to traditional methods (membrane-filtration and plate count method) there are rapid microbiological methods (RMM) that correlate to plate counting and give results in ...
USP grade meets the purity levels set by the United States Pharmacopeia (USP). USP grade is equivalent to the ACS grade for many drugs. NF grade is a purity grade set by the National Formulary (NF). NF grade is equivalent to the ACS grade for many drugs. British Pharmacopoeia: Meets or exceeds requirements set by the British Pharmacopoeia (BP ...
A closed system drug transfer device or "CSTD" is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into a system and the escape of hazardous drug or vapor concentrations outside the system.
The standard can be compared visually to a suspension of bacteria in sterile saline or nutrient broth. If the bacterial suspension is too turbid, it can be diluted with more diluent. If the suspension is not turbid enough, more bacteria can be added. McFarland nephelometer standards:{2}