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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter KPart 1143 → §1143.13


Title 21: Food and Drugs
PART 1143—MINIMUM REQUIRED WARNING STATEMENTS


§1143.13   Effective date.

(a) Except as stated in paragraph (b) of this section, this part will take effect 24 months after May 10, 2016. The effective date will be with respect to the date of manufacture, provided that, in any case, beginning 30 days after the effective date, a manufacturer may not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with this part.

(b) The requirement to submit a warning plan to FDA under §1143.5(c)(3) will take effect 12 months after May 10, 2016.

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