Within what time frame must the FDA and Board be notified of a wholesaler's inability to authenticate a drug's pedigree?

The answer indicating that notification must occur within 3 business days is aligned with the regulatory requirements set forth for wholesalers regarding the authentication of a drug's pedigree. In the context of drug distribution, maintaining the integrity of the supply chain is critical to prevent counterfeit medications from entering the market.

When a wholesaler is unable to authenticate a drug's pedigree, it has an obligation to inform both the FDA and the relevant state Board of Pharmacy within the specified timeframe. This requirement emphasizes the importance of promptly addressing any issues that could compromise public safety and patient health. The 3-business-day window allows for a balance between the urgent need for communication and the practical realities of conducting due diligence to resolve the authentication issue. The timely notification helps regulatory authorities to take necessary actions if potential breaches in the supply chain are detected.

Understanding this timeframe is crucial for pharmacists and wholesalers alike, as it underscores the regulatory expectations tied to drug distribution and the responsibilities that come with ensuring drug authenticity.