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  1. Human Drug Compounding

Compounding Information for States

Collaborating with States

FDA’s compounding program closely collaborates with state officials in a variety of ways, including:

  • sharing information about compounders who engage in poor practices that could put patients at risk
  • sharing information about complaints and adverse events
  • sharing findings from inspections
  • inviting states to participate in inspections of compounders
  • supporting state actions by offering testimony
  • hosting an 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 U.S., 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 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 of the FD&C Act. 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.

Information-Sharing Agreements

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:


Inter-governmental Working Meetings on Pharmacy Compounding 

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 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.

FDA was sued by several compounding pharmacies in the U.S. District Court for the District of Columbia soon after issuing the standard MOU. 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.

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, to undertake this analysis more fully and ensure a robust framework for these important public health protections.

Visit FDA's webpage on the MOU for the most recent information.

FDA Sends Letters About Desiccated Thyroid Extract

FDA sent letters to the National Association of State Boards of Pharmacy and the Federation of State Medical Boards in 2022 regarding desiccated thyroid extract (DTE) products prepared by state-licensed pharmacies.

 

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