The chapter is divided into the following main sections: Compounding personnel are responsible for ensuring that CSPs are accurately identified, measured, diluted, and mixed; and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed.
These performance responsibilities include maintaining appropriate cleanliness conditions and providing labeling and supplementary instructions for the proper clinical administration of CSPs.
Porta Fab specializes in the turn-key design and construction of modular clean rooms including applications specifically requiring USP 797 compliance.
Monographs for dietary supplements and ingredients appear in a separate section of the USP. A monograph includes the name of the ingredient or preparation; the definition; packaging, storage, and labeling requirements; and the specification.
3/14/2013 We have been informed by the Pharmacy department of our medical center that all (including individual) immunotherapy mixes MUST be re-formulated every 30 days according to JACHO. If so, how does one advance the dose if there is a new mix every 30 days? Unfortunately, if your extracts are compounded in a hospital or university pharmacy, the answer to your question is “yes.” This is because you pharmacy is under the aegis of the USP chapter 797 guideline.
The individual allergist who componds vaccines in the office is not under these guidelines but under the recommendtions of the Joint Task Force who is responsible for our Allergy Parameters.
For the purposes of this chapter, CSPs include any of the following: The sections in this chapter are organized to facilitate practitioners understanding of the fundamental accuracy and quality practices of CSPs.
They provide a foundation for the development and implementation of essential procedures for the safe preparation of CSPs in the three risk levels, which are classified according to the potential for microbial, chemical, and physical contamination.