What is the maximum percentage of annual gross sales of controlled substances that a pharmacy may distribute without special registration?

The maximum percentage of annual gross sales of controlled substances that a pharmacy may distribute without requiring special registration is indeed 5%. This regulation is outlined in the Controlled Substances Act, which governs the distribution of controlled substances and establishes thresholds to ensure that pharmacies operate within legal boundaries.

When a pharmacy exceeds the 5% threshold, it becomes classified as a wholesaler for the distribution of controlled substances, which necessitates additional registration requirements. This rule helps enforce proper monitoring of controlled substances, reduces the potential for diversion, and ensures that pharmacies primarily remain focused on dispensing medications to patients rather than engaging in wholesale distribution.

Understanding this limitation is crucial for pharmacy professionals to ensure compliance with both federal and state regulations regarding the handling of controlled substances.