Drugs made by compounders, including those made at outsourcing facilities, are not FDA-approved. This means that they have not undergone the same premarket review as approved drugs.

Are you willing to take the risk?

ADDITIONAL RESOURCES

News Stories

Individuals left blind by Tainted Compounded Drugs

https://www.wfaa.com/article/news/local/investigates/dozens-say-they-lost-eyesight-after-routine-surgery-using-compounded-pharmacy-drugs/287-5f002ed3-e110-4063-9959-a2e5f54b5097

Pioneer Drug Maker Throws First Punch at Pharmacy Outsourcing Facilities (503Bs)

https://www.troutman.com/insights/pioneer-drug-maker-throws-first-punch-at-pharmacy-outsourcing-facilities-503bs.html

Defenders: Central Texas man’s story added to growing list highlighting dangers of compounded drugs

https://www.kvue.com/article/news/investigations/defenders/austin-central-texas-compounding-pharmacies-compounded-drugs-dangers/269-8f03b797-5fcc-457b-9bb7-dbc517aafa4f

 

FDA Information on Compounding

https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding

https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities

https://www.fda.gov/drugs/human-drug-compounding/fdc-act-provisions-apply-human-drug-compounding

https://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions 

Take a look at FDA’s guidance concerning compounding drugs that are essentially copies of approved drugs:

https://www.fda.gov/media/98964/download.

List of Registered Outsourcing Facilities and their Facility inspection status:

https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities

 

Serious risks associated with poor quality compounding

PEW Charitable Trusts

https://www.pewtrusts.org/en/research-and-analysis/data-visualizations/2020/us-illnesses-and-deaths-associated-with-compounded-or-repackaged-medications-2001-19

https://www.pewtrusts.org/en/research-and-analysis/reports/2018/02/state-oversight-of-drug-compounding

https://www.pewtrusts.org/en/research-and-analysis/reports/2020/06/market-for-compounded-drugs-needs-greater-transparency-and-regulatory-certainty

Market for Compounded Drugs Needs Greater Transparency and Regulatory Certainty

https://www.pewtrusts.org/en/research-and-analysis/reports/2020/06/market-for-compounded-drugs-needs-greater-transparency-and-regulatory-certainty

Institute of Safe Medication Practices (ISMP)

https://www.ismp.org/sites/default/files/attachments/2017-11/Guidelines%20for%20Safe%20Preparation%20of%20Compounded%20Sterile%20Preperations_%20revised%202016.pdf