The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act



This guidance is intended for facilities planning to register or renew registration as human drug compounding outsourcing facilities (outsourcing facilities).

Go back

GMP Conferences by Topics