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“In 2016, when FDA published the final rule Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs ” (the Registration and Listing Final Rule), the Agency stated that when it runs out of 5-digit labeler codes, it will begin assigning 6-digit labeler codes (81 FR 60169 at 60187, August 31, 2016)

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