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  5. Technical and Logistical Considerations for Examining FDA-Regulated Products at International Mail Facilities using Handheld and Field-Portable Analytical Devices - 11/14/2019 - 11/14/2019
  1. FDA Grand Rounds


Event Title
Technical and Logistical Considerations for Examining FDA-Regulated Products at International Mail Facilities using Handheld and Field-Portable Analytical Devices
November 14, 2019

November 14, 2019
12:00 PM - 1:00 PM ET
Organized By:

Presented by

Adam Lanzarotta, PhD
Chemist, Office of Medical Products, Tobacco, and Specialty Laboratory Operations
Office of Regulatory Affairs

About the Presentation:

On October 26, 2017, the President of the United States declared a public health emergency to address the ongoing opioid crisis. In response, FDA vowed to help combat this epidemic by increasing the number of packages screened annually for dangerous goods at international mail facilities (IMFs) and express courier hubs (ECHs). FDA was then granted destruction authority at these locations for ‘articles of concern’, including unlawful FDA-regulated products that contain active pharmaceutical ingredients. Since the FDA’s Forensic Chemistry Center (FCC) has extensive experience analyzing violative FDA-regulated products, this laboratory was tasked with three main responsibilities to support FDA’s efforts regarding this initiative: 1) purchasing field-deployable instruments and developing methods to detect active pharmaceutical ingredients (APIs) in suspect samples, 2) participating in mail blitzes and other field operations to evaluate the performance of these methods on intercepted samples and 3) providing logistical and technical recommendations to senior FDA leadership regarding requirements of effective, efficient and robust IMF-based field laboratories. Successful completion of these three responsibilities will be followed by the implementation of field-based miniature laboratories at IMFs with the ability to provide analytical results to support the destruction of dangerous FDA-regulated products on site so that these products do not reach the US supply chain. This presentation will focus on details regarding FCC’s responsibilities for this endeavor.

About the Speaker: 

Adam Lanzarotta earned a B.S. in forensic science from Eastern Kentucky University in 2005 and a Ph.D. in analytical chemistry from Miami University in 2010. Research interests include developing methods for the analysis of violative FDA-regulated products (e.g. counterfeit finished dosage forms, counterfeit contact lenses, silicone in human autopsy tissue) resulting from tampering, counterfeiting, adulteration and/or product diversion using a wide variety of vibrational spectroscopic instrumentation that includes macro, micro and imaging infrared and Raman spectrometers. Current projects include 1) developing field friendly methods for handheld and field-portable vibrational spectroscopic instrumentation for detecting active pharmaceutical ingredients (APIs) in violative FDA-regulated products, 2) using fully integrated gas chromatography with Fourier transform infrared detection and mass spectrometric detection (GC/FT-IR/MS) to identify and quantify analytes that co-elute and yield nearly identical electron ionization fragmentation patterns such as diastereomers, positional isomers, designer drugs, etc., 3) using FT-IR spectroscopic imaging to determine the composition of multi-component samples that are challenging to do so using conventional analytical instrumentation and 4) employing surface enhanced Raman scattering (SERS) spectroscopy with handheld devices to detect low-concentration APIs in violative FDA-regulated products.


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