503B Outsourcing Facilities Exposed to Civil Liability for Allegedly Compounding “Essential Copies” of Commercially Available Drugs September 19, 2017 | By: Jason M. McLaren, Esq., Pharm.

503B Outsourcing Facilities Exposed to Civil Liability for Allegedly ...

https://www.frierlevitt.com/.../503b-outsourcing-facilities-exposed-civil-liability-alleg...

5 hours ago - An outsourcing facility may use a bulk drug substance in compounding only if it appears on a list to be developed by FDA “for which there is a clinical need” (also known as the “503B Bulks List”) or, alternatively, “the drug compounded from such bulk drug substance” appears on the FDA's drug shortage list at the time ...