USFDA seeks comments on definition of outsourcing plants by industry

June 13, 2016: There has been a need for clarity in terms of definition of outsourcing facilities as the industry had received several warnings on the basis of it. There are 584 USFDA approved facilities in India.


The Cosmetic Act (FD&C Act), Section 503B, provides the definition of outsourcing facility at each geographical location. The section was added to the FD&C Act by the Drug Quality and Security Act in 2013, which created a new category for outsourcing facilities. It provides the conditions that must be satisfied for human drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility. This would help in qualifying for exemptions from three sections of the FD&C Act: section 502(f)(1) providing for labeling requirements; section 505 specifying drug approval requirements; and section 582 related to Drug Supply Chain Security Act. The above are very important and significant as outsourcing facilities have to adhere to current good manufacturing practice (CGMP) requirements.


The CGMP regulations specifies requirements in terms of facility design, staff training ,competency testing, control of incoming components, aseptic processing, air quality, environmental monitoring, and related specifications  required to ensure the quality of the finished product.


Also in continuation with its efforts to ensure quality of drugs, the Central Drug Standards Control Organization (CDSCO) will be recruiting 147 drug inspectors to improve inspections of manufacturing units. The Union Public Service Commission (UPSC) would be submitting the list of the selected candidates to the Union Ministry of Health to start the process for the appointments soon.  


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