Zdrowie i gospodarka · 19/02/2015

FDA Releases Draft Guidance on Repackaging of Human Drug Products by Pharmacies and Outsourcing Facilities

The FDA is announcing the availability of a draft guidance that outlines conditions under which the agency will not take action for violations of the FD&C Act when pharmacies or outsourcing facilities repack human drug products, potentially impacting guidance documents related to approved new drugs and hospital pharmacies.