Human Drug Compounding: Information for States
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 Pharmacy Compounding, September 26-27, 2017
- Inter-governmental Working Meeting on Pharmacy Compounding, September 20-21, 2016
Draft Memorandum of Understanding
On September 7, 2018, FDA issued a revised draft standard Memorandum of Understanding (MOU). Once finalized, the MOU will describe the responsibilities of the state that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the state, and in addressing the interstate distribution of inordinate amounts of compounded human drug products.
FDA is developing the MOU in consultation with the National Association of Boards of Pharmacy, in accordance with section 503A(b)(3)(B) of the FD&C Act. This MOU will not affect distribution of drug products by entities that are registered with FDA as outsourcing facilities under section 503B of the FD&C Act.