C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 369—INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE › Subpart A—Definitions and Interpretations

21 C.F.R. § 369.1

Purpose of issuance

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

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.

Notes of Decisions
Cited in 1 case, 1979–1979 · leading case: Porter & Dietsch, Inc. v. Fed. Trade Comm'n, 605 F.2d 294 (7th Cir. 1979).
Sort: Relevance Newest Treatment
Porter & Dietsch, Inc. v. Fed. Trade Comm'n, 605 F.2d 294 (7th Cir. 1979). “9 A warning to this effect is printed on the back of the X-ll package in compliance with FDA Regulations, 21 C.F.R. § 369.1 , et seq. *304 The erroneous impression that X-ll is safe for use by all potential consumers is created by the statement, “No dangerous drugs,” the effect…”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.