Analysis of Drug Products by an International Mail Facility Satellite Laboratory Equipped with Rapid Screening Devices

The Food and Drug Administration’s (FDA) National Forensic Chemistry Center (NFCC) Satellite Laboratory Branch has oversight of handheld and field portable devices used for the rapid screening and detection of active pharmaceutical ingredients (APIs) in unknown drug products entering the US through International Mail Facilities (IMFs). Phase I of the program (nationwide mail blitz) demonstrated that an effective set of instruments for a rapid screening “toolkit” included a handheld Raman spectrometer, transportable mass spectrometer, and a portable Fourier transform infrared (FT-IR) spectrometer. Phase II of the program (pilot study) demonstrated the reliability of the toolkit at an on-site IMF satellite laboratory by comparing results to those generated by a full-service laboratory. Phase III of the program (production mode) demonstrated that the FDA satellite laboratories yielded confirmatory chemical identifications for about 85 % of the products examined. The remaining 15 % of products examined required additional full-service laboratory analyses due to inconclusive results. Overall, 95 % of the products examined by this study were either refused entry or destroyed under FDA's administrative destruction authority based on the presence of undeclared APIs that were verified or confirmed by the satellite laboratory or full-service laboratory and/or based on the presence of a labeling violation or other violation of FDA laws and regulations. The satellite laboratory program is currently in Phase IV, which involves continuing production mode examinations, expanding to other IMF locations, supporting investigators with field operations, developing methods to identify new APIs not previously detected using the toolkit, and continually updating the toolkit instrumentation to overcome limitations of the existing devices. This presentation will describe the current progress of Phase IV and will introduce future goals of the program.