Appendix A

Study Approach

In response to a request by the U.S. Food and Drug Administration (FDA), the National Academies of Sciences, Engineering, and Medicine’s Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams was charged with identifying and analyzing the available scientific data relating to the ingredients used in compounded topical pain creams and evaluating how these data translate to the safety and effectiveness of compounded topical pain creams with various combinations of those ingredients. The committee’s final report will summarize the current evidence on compounded topical pain creams and offer recommendations on their use.

COMMITTEE EXPERTISE

The National Academies appointed an 11-member committee of experts to address objectives in the Statement of Task. The resulting committee included experts in a variety of disciplines and fields, including drug research and development, pharmacology, toxicology, pain management and care, drug evaluation, epidemiology, and pharmaceutical compounding and manufacturing.

MEEETINGS AND INFORMATION-GATHERING ACTIVITIES

The committee deliberated from March 2019 to February 2020, during the course of which it held four in-person meetings (March, May, July, and September) and two half-day virtual meetings. The March, May, and

September meetings included portions open to the public. The committee meeting in July was held in closed session.

In the three open-session meetings, the committee heard presentations from content experts on a wide variety of topics related to the committee’s charge. These open-session meetings also included periods of public comment, to provide stakeholders with an opportunity to present the committee with any additional relevant information. The agendas for the three open-session meetings are presented in the section below.

In addition to the data collection efforts within the open-session meetings, the committee also received and reviewed a number of resources submitted by various stakeholders, including American Association of Poison Control Centers, American Chronic Pain Association, FDA, Massachusetts State Board of Pharmacy, National Association of Boards of Pharmacy, and Professional Compounding Centers of America. These resources include, but are not limited to, data on active pharmaceutical ingredients commonly used in compounded topical pain creams, literature reviews, findings from national surveys related to the cost and use of compounded topical pain creams, adverse event reports, and guidance on the federal and state regulations and oversight for compounded preparations.

First Committee Meeting

Open Session Agenda
March 25, 2019
National Academies Keck Building
500 Fifth Street, NW, Washington, DC 20001

Second Committee Meeting

Open Session Workshop Agenda
May 20, 2019
National Academies Keck Building
500 Fifth Street, NW, Washington, DC 20001

Fourth Committee Meeting

Open Session Agenda
October 1, 2019
National Academies Keck Building
500 Fifth Street, NW, Washington, DC 20001