After input from stakeholders the FDA posted a notice announcing a change in inspections of 503 (A) Human Drug Compounding Facilities effective August 1, 2016. The investigations will consist of an initial assessment to see if the pharmacies are operating as a 503 (A) facility. If it is concluded that the facility is not operating as a 503 (A) facility the investigator will place the pharmacy on the list of non-compliance 483 and require the pharmacy to meet CGMP requirements. “The FDA investigators now will make a preliminary assessment regarding the firms compliance with certain conditions of section 503A before closing an inspection” as a response to the stakeholders input.
To read the entire notice click here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM510684.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery