RX South DBA RX3 Compounding Pharmacy LLC – FDA Warning Letter, Feb 21, 2014

An FDA inspection of RX South (dba RX3 Compounding Pharmacy) from January 24 to February 21, 2014, following a complaint of particulate matter in a hydroxyprogesterone caproate injection, revealed serious deficiencies. The firm was found to be producing drug products without valid prescriptions for individually-identified patients, violating Section 503A of the FDCA. This makes these drugs misbranded under Section 502(f)(1) and subject to CGMP regulations.

The inspection also uncovered significant insanitary conditions and poor sterile practices, leading to adulterated sterile drug products under Section 501(a)(2)(A) and 501(a)(2)(B). Observed violations included: operators not routinely wiping down materials with sterile disinfectant before transferring them into cleanrooms and ISO 5 areas, failure to demonstrate adequate protection of ISO 5 areas by hoods, inadequate systems for maintaining equipment controlling aseptic conditions, inadequate facility design to prevent contamination, failure to establish and follow written procedures to prevent microbiological contamination and validate aseptic processes, and inadequate environmental monitoring in aseptic areas.

This is a recurring issue, as a December 2012 inspection also noted poor sterile practices and lack of individual prescriptions. The firm's compounded 17-hydroxyprogesterone caproate (17-P) appears to be an "essentially copy" of the commercially available drug Makena, potentially not qualifying for Section 5