Standard: HHS - 21 CFR PART 369

INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE

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Scope:

Purpose of issuance.

The warning and caution statements suggested in subparts B and C of this part, for inclusion in the label or labeling of drugs and devices subject to section 502(d) and (f)(2) and other relevant provisions of the Federal Food, Drug, and Cosmetic Act are issued for the purpose of assisting industry in preparing proper labeling for these articles for over-the-counter sale and in meeting the legal requirements of the act that the label or labeling of drugs and devices bear adequate warnings, in such manner and form as are necessary for the protection of users. Only section 502(d) of the act requires use of the specific language included in these suggested warning and caution statements. These suggested warning or caution statements are illustrative of those that may be necessary or desirable. It is the responsibility of the manufacturer, packer, shipper, or distributor in interstate commerce to see that such statements are adequate for compliance with the provisions of the law. Omission of any article from this suggested list does not relieve drugs and devices subject to provisions of the act from bearing adequate warning or caution statements where such statements are necessary or desirable for the protection of the user.

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 369
Publish Date: 2014-04-01
Page Count: 8
Change Type: COMPLETE REVISION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
21 CFR PART 369 Change Type: COMPLETE REVISION Update Date: 2016-04-01 Status: ACTV
21 CFR PART 369 Change Type: COMPLETE REVISION Update Date: 2015-04-01 Status: ACTV

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