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What is the ASR rule?

April 26, 2017ASR rule

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What is the ASR rule?

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Posted

This guidance document refers to three regulations as “the ASR rule.” Published in 1997, the regulations define and classify ASRs (21 CFR 864.4020), impose restrictions on the sale, distribution, and use of ASRs (21 CFR 809.30), and establish requirements for ASR labeling (21 CFR 809.10(e)).