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Small personal quantities often pass through uninspected

The enhanced oversight comes with enhanced capabilities

This 503C designation would require enhanced quality controls beyond 503A standards but less infrastructure than 503B facilities

According to FDA inspection data, only 72 outsourcing facilities maintained active registration as of December 2025, compared to thousands of 503A pharmacies. This concentration reflects the significant investment required for 503B compliance

Enhanced State-Federal Coordination : The FDA and state pharmacy boards are developing information-sharing protocols to coordinate enforcement