FDA Oversight of Compounding Facilities The following table describes some of the documents and actions involved in FDA oversight of compounding facilities: Documents and Actions Description […]

How does registration as a human drug compounding outsourcing facility under section 503B work? To register as an outsourcing facility, a compounder must use the electronic […]

July 23,2018 Summary Cesium chloride (CsCl) is a mineral salt that is sometimes taken either by mouth, or by injection into the body, by cancer patients […]

Update: July 5, 2018 Introduction On July 28, 2017, FDA alerted health care professionals of adverse event reports concerning at least 43 patients who were administered […]

1. FDA will continue to explore options for sharing information with states that have sunshine laws, including whether a modified information sharing agreement could be developed. […]

Under section 503A of the FD&C Act, bulk drug substances used in compounding must either be components of FDA-approved drug products, the subject of an applicable […]

Submit Comments by 09/26/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]