Title 21

SECTION 369.3

369.3 Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1)(C).

§ 369.3 Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1)(C).

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 or 369.21 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.

[85 FR 72907, Nov. 16, 2020]

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