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# Woodcock Urges Better Drug Compounding Safety Reports
- URL: https://www.fdaweb.com/woodcock-urges-better-drug-compounding-safety-reports/
- Published: 2019-09-09T12:00:00.000Z
- Updated: 2026-09-15T01:48:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144953

CDER director **Janet Woodcock** is emphasizing the need for drug compounding outsourcing facilities to appropriately label their drugs with adverse event reporting information and to report events to FDA, or face regulatory and enforcement action if they do not. “We remind outsourcing facilities to develop thorough procedures to compile and investigate adverse event reports and share them with the FDA,” she says.

Woodcock co-authored a 9/9 *JAMA Internal Medicine* [viewpoint article](https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2749763?ref=fdaweb.com) to draw attention to a particular issue associated with compounded pellet hormones. “During an inspection in 2018 of BioTE Medical, our investigators uncovered information about 4,202 adverse events that had never been reported to the agency,” she says. “The adverse event information our investigators found suggested compounded hormone pellets were possibly associated with endometrial cancer, prostate cancer, strokes, heart attacks, deep vein thrombosis, cellulitis and pellet extrusion. However, because the reports lacked certain critical information, the FDA was able to attribute only a small percentage of the adverse events (61 reports), such as pellet extrusion and cellulitis, to the use of compounded hormone pellets containing testosterone.

Woodcock [says](http://s2027422842.t.en25.com/e/es?s=2027422842&e=251117&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=b664ae4ba0c44f6087bf3d2de3101915&elqaid=9395&elqat=1&ref=fdaweb.com) FDA is using the information it learned from this episode to take steps to improve adverse event reporting and analyses. “We will continue to work with outsourcing facilities to improve mechanisms for obtaining reports of adverse events associated with their products and for providing adverse event reports to the agency,” she says. “Furthermore, we continue to work with our state regulatory partners to finalize a standard memorandum of understanding under which states would agree to, among other things, investigate complaints of adverse events associated with certain compounded drugs from pharmacies operating under section 503A and report serious adverse events and serious product quality issues to the agency.”

Additionally, FDA has contracted with the National Academy of Sciences, Engineering, and Medicine (NASEM) to conduct a study on the risks associated with compounded hormone products. “Our collaboration with NASEM will also continue to examine the clinical utility of treating patients with compounded products and the available evidence of the safety and effectiveness of multi-ingredient compounded topical pain creams,” Woodcock says. The agency plans to share updates about the study with the public as information is available.