Start Usp 797 medium risk beyond use dating

Usp 797 medium risk beyond use dating

Two key criteria for immediate-use exemption are avoidance of touch contamination and administration within 1 hour.

The processing and packaging of ingredients as well as environmental storage and transport conditions are the main factors .

Different factors, such as contamination control (proper hand hygiene and garbing, material handling and proper conduct and aseptic technique of compounding personnel), sterilization procedures, and environmental cleanliness are the main .

All specific information on the handling of hazardous drugs was removed from the chapter and is now referenced in to provide more guidance on training, evaluation, and requalification of compounding personnel.

The frequency of certain environmental monitoring requirements was increased to promote better control over the compounding area.

A new term introduced in is the “in-use time” terminology, which refers to the time before which a manufactured product or CSP must be used after it has been opened or punctured.

Other changes include the addition of requirements for documentation including master formulation records and compounding records, guidance for sterility testing of CSPs prepared in batches of less than 40 units and guidance on establishing BUDs for Category 2 CSPs.

11 The risk was increased to 3.5-fold in nulliparous women.