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Abstract
Compounded drugs gained significant attention following the 2012 New England meningitis outbreak. In response, the Federal Food, Drug, and Cosmetic Act established 503A and 503B compounding facilities, distinguishing between traditional neighborhood pharmacies requiring prescriptions and large-scale outsourcing facilities. The project investigates the justification for tightening regulations on 503A compounding facilities by comparing violation trends between 503A and 503B facilities. To do this, publicly available warning letters and form 483’s released within the years of 2012 to 2022 will be accessed from the U.S. Food and Drug Administration official website. The violations on these forms will be noted and codified. The hypothesis is violations between the facilities will not follow similar trends due to differences in regulations. Though the violations have been on a decreasing trend in the past decade, further transparency in adverse event reporting is encouraged to mitigate risks to patient health and provide more data for future research.