On October 2, 2019, the United States Food & Drug Administration (FDA) announced that it awarded a cooperative agreement grant to the National Association of Boards of Pharmacy (NABP) to establish an information-sharing system for drug compounding activities conducted in accordance with Section 503A of the Federal Food, Drug, & Cosmetic Act (FDCA). With this three-year pilot project, FDA's stated hope is that it will improve the information available to federal and state regulators regarding the Agency's interpretation of the interstate distribution of compounded medications.
While FDA identifies public health and patient safety as its primary motivation for this new information-sharing system with NABP, the Agency has also represented that this system is its attempt to make it easier for States to sign on to the proposed memorandum of understanding agreement (MOU). FDA's current revised draft MOU limits interstate distribution of compounded drugs and triggers various reporting requirements for regulated State-entities. Many States have indicated that, due to the extensive reporting requirements in the draft MOU, they may choose not to sign on to a finalized MOU, which carries serious restrictions for compounding pharmacies located in States that decline to enter into an MOU.
The Agency has indicated in its announcement that it intends to finalize the MOU this year, so we encourage industry stakeholders to remain apprised of this new information-sharing system and closely watch for the issuance of the finalized MOU. With the year quickly drawing to a close, this pilot project is further indication that the Agency remains actively engaged in the regulation of drug compounding.
Should you have any questions or concerns regarding any of the issues raised in this alert, please do not hesitate to reach out to Rachael Pontikes, Emily Hussey, Kelly Kearney, or Allyson Wilson for further discussion.
This article is presented for informational purposes only and is not intended to constitute legal advice.