White Paper: Labeling Over the Counter (OTC) Drugs – 6 Best Practices for FDA Compliance

• By: ComplianceOnline
• Date: July 10, 2014

A recent study showed that US consumers spent USD 23 billion on OTC drugs in 2010. The huge market for these drugs spurs companies to create and launch more products. The market growth has, however, also forced the FDA to crack the whip on regulatory violations. While a number of manufacturers of OTC drugs are warned for CGMP violations, many also face enforcement action for shoddy labeling and branding. Considering that consumer trust is vital for the sales of an OTC drug, news that a manufacturer has been fined or warned for mislabeling can lead to a significant drop in consumer confidence, affecting the company bottom line. This White Paper explains six best practices that manufacturers can follow to ensure that they comply with the FDA’s stringent OTC drug and drug-cosmetic labeling regulations.

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