www.hhs.gov U.S. Department of Health and Human Services
Activity Outline
FDA Grand Rounds: Technical and Logistical Considerations for Interdicting Compromised FDA-Regulated Products and International Mail Facilities using Handheld and Field-Portable Analytical Devices.
November 14, 2019
WO Bldg 2, Rm 2047
Activity Coordinator
Devin Thomas
Devin.Thomas@fda.hhs.gov
 
Series Description

The FDA Grand Rounds is webcast monthly to highlight cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.


Lecture Description
On October 26, 2017, the President of the United States declared a public health emergency to address the ongoing opioid crisis. The FDA has recently 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). Shortly thereafter, FDA was 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 objectives 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 and therefore prevent them from reaching the US supply chain. This presentation will focus on details regarding FCC's responsibilities for this endeavor.
References
  • Adam Lanzarotta, Michael Thatcher, Lisa Lorenz and JaCinta Batson. Detection of Mitragynine in Mitragyna Speciosa (Kratom) using Surface Enhanced Raman Spectroscopy with Handheld Devices. Manuscript under review
  • Adam Lanzarotta, Martin Kimani, Michael Thatcher, John Lynch, Moseley Fulcher, Mark Witkowski and JaCinta Batson. Detection of Counterfeit Controlled Substance-Containing Pharmaceutical Tablets using Handheld Raman Spectrometers. Manuscript under review
  • Adam Lanzarotta, JaCinta Batson and Mark Witkowski. Identification of Opioids and Related Substances using Handheld Raman Spectrometers. Submitted for publication in Journal of Forensic Sciences. August, 2019
  • Lisa M. Lorenz, Valerie M. Toomey, Adam C. Lanzarotta, Rick A. Flurer, Travis Falconer. Identification of the Designer Steroid Androsta-3,5-diene-7,17-dione in a Dietary Supplement. Drug Testing and Analysis. 2019, 11, 1109-1115
  • Adam Lanzarotta, Lisa Lorenz, Sara Voelker, Travis M. Falconer and JaCinta S. Batson. Forensic Drug Identification, Confirmation, and Quantitation using Fully Integrated Gas Chromatography with Fourier Transform Infrared Detection and Mass Spectrometric Detection. Applied Spectroscopy. 2018, 72, 750-756
  • Adam Lanzarotta, Lisa Lorenz, JaCinta S. Batson and Cheryl Flurer. Development and Implementation of a Pass/Fail Field-Friendly Method for Detecting Sildenafil in Suspect Pharmaceutical Tablets using a Handheld Raman Spectrometer and Silver Colloids. Journal of Pharmaceutical and Biomedical Analysis. 2017, 146, 420-425
Series Objectives
  • Discuss the research conducted at the FDA
  • Explain how FDA science impacts public health
Learning Objectives After completion of this activity, the participant will be able to:
  • Describe FDA’s proposal to increase the number of packages annually screened at IMFs
  • Describe the type of products FDA will target for chemical analyses at IMFs
  • Describe handheld and field-portable devices that have historically been used by FDA for detecting active pharmaceutical ingredients at IMFs and for other field operations
  • Describe previously executed FDA field operations where handheld and field-portable analytical instruments have been successfully employed
  • Describe 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
  • Describe 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
Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency external scientific communities.
Agenda

Lecture 1 November 14, 2019
Time Topic Speaker
12:00 - 1:00 PM Technical and Logistical Considerations for Interdicting Compromised FDA-Regulated Products and International Mail Facilities using Handheld and Field-Portable Analytical Devices. Adam Lanzarotta, PhD
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1.00 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-19-012-L04-P for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Pharmacists will need their NABP e-profile ID number as well as their DOB in MMDD format in order to claim CE credit.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 10 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Lanzarotta, Adam, PhD, Chemist, Forensic Chemistry Center - nothing to disclose

Planning Committee
  • Dinatale, Miriam, Team Leader, Food and Drug Administration - nothing to disclose
  • Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose
  • KEMPF, LUCAS, MD - nothing to disclose
  • Lee, Christine, PharmD, , PhD, General Health Scientist, FDA - nothing to disclose
  • Pfundt, Tiffany, PharmD, Pharmacist, FDA - nothing to disclose
  • Wheelock, Leslie, MS, RN, Director, OSPD, FDA, OC, OCS, OSPD - nothing to disclose

CE Consultation and Accreditation Team
  • Bryant, Traci, M.A.T., CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
  • Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration Fee and Refunds
Registration is complimentary, therefore refunds are not applicable.
ACCME Joint Accreditation
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