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USP General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparations

Friday, April 6, 2018   (0 Comments)
Posted by: Elizabeth Maynard
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Millions of medications are compounded each year in the US to meet the unique needs of patient, including vulnerable populations such as seniors and children. Compounding provides tailored therapy to patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases.

Compounded drugs made without the guidance of standards may be sub-potent, super potent or contaminated, exposing patients to significant risk of adverse events or even death.

USP develops standards for compounding nonsterile drugs to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. USP General Chapter <795> provides standards for compounding quality nonsterile preparations. The chapter describes requirements for the compounding process, facilities, equipment, components, documentation, quality controls and training. General Chapter <795> also provides general guidelines for assigning beyond-use dates to nonsterile preparations.

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