FDA’s compounding program closely collaborates with state officials. FDA collaborates with state officials in a variety of ways, including by sharing information about compounders who engage in poor practices that could put patients at risk, sharing information about complaints and adverse events, and sharing findings from inspections. FDA also invites states to participate in inspections of compounders and supports state actions by offering testimony. Further, FDA holds annual intergovernmental working meetings with states to address issues of mutual concern, including continuous improvements to federal/state collaboration.
States are primarily responsible for day-to-day oversight over the vast majority of the thousands of compounders in the United States, most of which do not register with FDA. State officials are often the first to identify compounders that are operating like conventional manufacturers or that engage in poor drug production practices that could lead to patient harm. It is critical that FDA and the states continue to work together to identify and take appropriate action against compounders whose practices present the greatest risk to public health.
Section 105 of the Drug Quality and Security Act
Pursuant to section 105 of the Drug Quality and Security Act (DQSA), FDA may receive submissions from state boards of pharmacy concerning certain actions taken against compounding pharmacies or expressing concerns that a compounding pharmacy may be acting contrary to section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). States that wish to provide this information to FDA should submit the information by email to the following mailbox: StateCompounding@fda.hhs.gov. The DQSA also requires that FDA notify state boards of pharmacy when the agency receives certain state submissions or makes a determination that a compounding pharmacy is acting contrary to section 503A. FDA intends to follow up with states that provide this information and to notify other states about the receipt of the information in accordance with the law.
Federal law prohibits FDA from sharing certain non-public information with individuals and organizations unless an agreement is in place that permits FDA to share the information. FDA encourages states to enter into one or both of the following agreements:
- FDA Commissioning
- 20.88 Agreements
Inter-governmental Working Meetings on Pharmacy Compounding
- Inter-governmental Working Meeting on Drug Compounding, October 26-27, 2021
- Inter-governmental Working Meeting on Drug Compounding, October 27-28, 2020
- Inter-governmental Working Meeting on Drug Compounding, October 10-11, 2019
- Inter-governmental Working Meeting on Drug Compounding, September 25-26, 2018
- Inter-governmental Working Meeting on Pharmacy Compounding, September 26-27, 2017
- Inter-governmental Working Meeting on Pharmacy Compounding, September 20-21, 2016
Standard Memorandum of Understanding
In October 2020, FDA made a standard memorandum of understanding (MOU) available for signature by states. The standard MOU was developed in consultation with the National Association of Boards of Pharmacy (NABP) as described in section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The standard MOU is an agreement that is intended to address interstate distribution of inordinate amounts of compounded drugs and complaint investigation by a state regulator relating to compounded drugs distributed outside the state.
Soon after issuing the standard MOU, FDA was sued by several compounding pharmacies in the U.S. District Court for the District of Columbia. In September 2021, the court remanded the standard MOU to FDA to either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis.
To undertake this analysis more fully and ensure a robust framework for these important public health protections, the agency intends to engage in notice-and-comment rulemaking regarding the statutory provisions on certain distributions of compounded human drug products, including the MOU.
Please see FDA's webpage on the MOU for the most recent information.