FDA Aims to Improve Oversight of Compounding Pharmacies with Data-Sharing System
The FDA has awarded a cooperative agreement grant to the National Association of Boards of Pharmacy to develop a 3-year pilot project for a data-sharing system to improve oversight of compounding pharmacies.
The FDA has awarded a cooperative agreement grant to the National Association of Boards of Pharmacy (NABP) to develop a 3-year pilot project for a data-sharing system to improve oversight of compounding pharmacies.1
The goal of the system is to improve data sharing between state boards of pharmacy on interstate distribution of compounded drugs, thereby encouraging states to enter into a memorandum of understanding agreement with the FDA. Sharing information between state boards of pharmacy and the FDA will reduce the potential resource burden associated with collecting and sharing information on interstate distribution of compounded drugs.1
The grant announcement comes amid increased discussion about compounding pharmacy oversight, following a segment on 'Last Week Tonight with John Oliver' in which the host said compounding pharmacies are under regulated and result in sometimes unsanitary conditions or fraudulent drugs.2
While some compounding pharmacists have disagreed with Oliver's characterization, interstate distribution regulation is of concern to the FDA.
State-licensed pharmacies are primarily overseen by states, and the interstate distributive growth of compounders operating under the exemptions in section 503(A) has been unexpected.3 The memorandum of understanding, expected to be finalized later this year, is an effort by the FDA to establish more effective regulation of these interstate distributors.
The data system will also improve patient safety by enabling the state boards of pharmacy to prioritize their resources in order to address the compounding pharmacies that pose the highest risk to patients.1
"Receiving this grant from FDA will allow NABP to collect, manage, and share compounding data beyond what is currently available," said NABP President Jack W. Campbell IV, JD, RPh, in a statement.4
- US Food and Drug Administration. FDA awards grant for compounding information-sharing system. FDA website. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-awards-grant-information-sharing-system-and-research-interstate-distribution?utm_campaign=FDA%20awards%20grant%20to%20the%20National%20Association%20of%20Boards%20of%20Pharmacy%20%28NABP%29&utm_medium=email&utm_source=Eloqua. Published October 2, 2019. Accessed October 3, 2019.
- Last Week Tonight with John Oliver. September 29 2019, Compounding Pharmacies. HBO website. https://www.hbo.com/last-week-tonight-with-john-oliver. Accessed 1 Oct. 2019.
- US Food and Drug Administration. Draft Standard Memorandum of Understanding (MOU). FDA website. https://www.fda.gov/media/92232/download Accessed October 3, 2019.
- National Association of Boards of Pharmacy. NABP Received FDA Funding…Develop Data-Sharing System for Improved Oversight of Compounding Pharmacies | National Association of Boards of Pharmacy. NABP website. https://nabp.pharmacy/newsroom/news/nabp-receives-fda-funding-to-develop-data-sharing-system-for-improved-oversight-of-compounding-pharmacies/ Published October 2, 2019. Accessed October 3, 2019.