Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?

On November 27, 2019 the Drug Supply Chain Security Act (DSCSA) requires wholesale distributors

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2 thoughts on “Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?”

  1. These are great points regarding VRS enforcement and I have been asked this same question by customers. My response is similar to one of the other Big-3, “I can speculate but I don’t have secret insight into what the FDA will do. Until a decision is clear, we will continue to work as if the deadlines will be enforced.” There are definitely concerns by industry participants but the risk of noncompliance can be significant.
    I think it is important to act as if the law will be enforced or, at a minimum, define a contingency plan (with trigger points/dates) on your company’s action plan if the FDA does (or does not) choose to enforce the law.

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