viernes, 29 de septiembre de 2017

New report lists compounded drugs produced by FDA-registered outsourcing facilities - Drug Information Update

Compounding > Outsourcing Facilities

The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA.

For the first time, the FDA is posting a new report that provides a list of the drugs that entities registered as outsourcing facilities have produced. Under the Drug Quality Security Act (DQSA), outsourcing facilities are required to report to the FDA, upon initial registration and each June and December, the drug products that they compounded during the previous six months. We are making the list public, among other reasons, to help the medical community in their efforts to identify and access specific compounded drug products from facilities that are required to follow current good manufacturing practice standards. The first report list compounded drug products that outsourcing facilities reportedly produced between December 2016 and May 2017.
See FDA Commissioner Scott Gottlieb’s September 26, 2017, statement on new efforts to encourage compounding of better quality drugs under DQSA and help health care professionals access compounded medications needed for patient care from outsourcing facilities.
See the FDA’s website for additional information on Human Drug Compounding.

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