November 14 FDA Grand Rounds discusses technical and logistical considerations for examining FDA-Regulated products at international mail facilities: Register Now!

A discussion of technical and logistical considerations for examining FDA-Regulated products at international mail facilities using handheld and field-portable analytical devices

Thursday, November 14, 2019

12:00 p.m. - 1:00 p.m. EST

 

Register here for webcast (public attendees and FDA staff)

CE Credit Available

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.

What you’ll learn from this FDA Chemist:

1. A description of FDA’s proposal to increase the number of packages annually screened at IMFs.
2. A discussion of the type of products FDA will target for chemical analyses at IMFs. 
3. A description of handheld and field-portable devices that have historically been used by FDA for detecting active pharmaceutical ingredients at IMFs and for other field operations.
4. A discussion of previously executed FDA field operations where handheld and field-portable analytical instruments have been successfully employed.
5. An explanation of in-lab and in-field evaluations of several handheld and field-portable devices to determine which ones are best suited for an IMF-based miniature laboratory.
6. A discussion of how lessons learned from previous field operations, sample analyses and instrument evaluations provided a blueprint for determining technical and logistical requirements for developing an IMF-based miniature laboratory.