What is the required reporting timeframe for manufacturers after an occurrence?

The required reporting timeframe for manufacturers after an occurrence is 5 days. This is specified in the guidelines for the 340B Drug Pricing Program. Within this timeframe, manufacturers must report any significant changes or occurrences that may affect their compliance with the program or the pricing of covered drugs. This timeframe ensures that any potential issues are addressed swiftly, minimizing any adverse impact on covered entities that rely on the 340B program for access to affordable medications.

It's important for manufacturers to adhere to this timeline to maintain transparency and accountability, which are key aspects of the program. Timely reporting helps ensure that all stakeholders, including covered entities, can make informed decisions based on the most current information available.