How Profound: No Difference in the Compound

Researcher Information

Mike Darvin
Lara Kachachi

Project Type


Start Date

2010 12:00 AM

End Date

2010 12:00 AM

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Jan 1st, 12:00 AM Jan 1st, 12:00 AM

How Profound: No Difference in the Compound

The purpose of this study was to compare generic versus brand name formulations of both prescription and over-the-counter (OTC) medications. FDA regulations require a bioequivalence of generic prescription drugs within 20% of the brand name product. OTC drugs are not subjected to the same criteria; the FDA has a list of approximately 800 approved ingredients that are combined in numerous ways to create over 10(),()0() OTC medications. To assess the level of variation between prescription and OTC generic formulas and their brand name counterparts, drug samples of each category were analyzed using gas chromatography-mass spectrometry (GC-MS). The brand name prescription drug, Darvocet- N, was compared with its generic counterpart; the brand name OTC acetaminophen medication, Tylenol, was compared with two different store brand generic formulations. The resulting GC-MS data indicated greater variance between OTC formulas than the prescription medications sampled.