News & events

FDA has identified the following list of drugs for the purpose of the temporary enforcement policies described in 503B guidance and 503A guidance during the COVID-19 public health emergency.  503B guidance establishes revised cGMP standards and allows outsourcing facilities to compound and distribute drugs needed to treat COVID-19 patients that hospitals cannot obtain from an FDA drug manufacturer due to

Andrew Taylor, Microbiology Lab Supervisor Celsis rapid sterility testing is an alternative test method to USP Chapter <71>, which allows for shortened incubation times compared to the traditional sterility testing method. Where USP <71> requires between 14 and 18 days of incubation before a final test result, a Celsis rapid sterility test result can be

Kathy Heatherly, MSFS, Technical Sales  As a compounder, protecting yourself and your staff from exposure to hazardous drugs should be important both from a safety and monetary perspective.  USP <800> applies to sterile and non-sterile compounding pharmacies and anywhere that hazardous drugs are received, stored, or administered.   It is also designed to prevent compounders from

Which one is the most reliable for sterility testing? According to USP <71> Sterility Tests, membrane filtration is the sterility test method of choice for filterable pharmaceutical products. Membrane filtration refers to either an open membrane filtration (OMF) or closed membrane filtration system. Not all sterility test systems are the same. It is important pharmacists

Kathy Heatherly, MSFS, ARL Technical Sales A bulk substance, also known as an active pharmaceutical ingredient (API), is often the starting point of a compounded preparation.   Prior to use, compounding pharmacies and outsourcing facilities should confirm the quality of an active pharmaceutical ingredient to ensure consistency of the material as received from the supplier and suitability for use

Andrew Taylor, ARL Bio Pharma Microbiology Lab Supervisor Pyrogens are a group of fever causing substances which can be found in compounded sterile preparations (CSPs) if appropriate actions are not taken to reduce or remove them. One of the most widely known groups of pyrogens are bacterial endotoxins.  Bacterial endotoxins are: USP <797> requires a