21 C.F.R. § 369.3 Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1)(C).
Title 21 - Food and Drugs
Drugs exempted from prescription-dispensing requirements under section 503(b)(1)(C) of the act are subject to the labeling requirements prescribed in §310.201(a) of this chapter. Although, for convenience, warning and caution statements for a number of the drugs named in §310.201 of this chapter (cross-referenced in the text of this part) are included in subpart B of this part, the inclusion of such drugs in §§369.20, 369.21, 369.22 in no way affects the requirements for compliance with §310.201(a) of this chapter, or the provisions of an effective application pursuant to section 505(b) of the act.
Title 21: Food and Drugs
PART 369—INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
Subpart A—Definitions and Interpretations
§ 369.3 Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1)(C).
