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U.S. Department of Health and Human Services

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Number of state referral letters issued concerning compounders

Dictionary: FDA is continuing surveillance and for-cause inspections of compounders, including compounders registered under section 503B of the Act, and FDA plans to take action, including enforcement actions, as appropriate to protect the public health. Since the fungal meningitis outbreak began, FDA has been conducting inspections of compounders for cause (in response to serious adverse event reports and reports of quality problems), and surveillance, to proactively identify pharmacies with deficient sterile compounding practices. Numerous recalls of sterile products have been conducted, and numerous compounders chose to stop sterile operations after FDA identified problems with their sterile compounding processes.

Information is current as of December 31, 2017.

Fiscal Year - 2017

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Oct 2016N/A1
Nov 2016N/A1
Dec 2016N/A0
Jan 2017N/A7
Feb 2017N/A4
Mar 2017N/A4
Apr 2017N/A5
May 2017N/A3
Jun 2017N/A4
Jul 2017N/A6
Aug 2017N/A7
Sep 2017N/A3

FY 2017 Total: 45


  • CDER began reporting on this measure in January 2014.

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.