(a) Identity and specifications.(1) The color additive FD&C Red No. 40 shall conform in identity and specifications to the requirements of § 74.340(a)(1) and (b).
(2) Color additive mixtures for drug use made with FD&C Red No. 40 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(3) The listing of this color additive includes lakes prepared as described in §§ 82.51 and 82.1051 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by §§ 82.51 or 82.1051 of this chapter.)
(b) Uses and restrictions.(1) FD&C Red No. 40 and FD&C Red No. 40 Aluminum Lake may be safely used in coloring drugs, including those intended for use in the area of the eye, subject to the restrictions on the use of color additives in § 70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice.
(2) Other lakes of FD&C Red No. 40 may be safely used in coloring drugs, subject to the restrictions on the use of color additives in § 70.5 of this chapter, in amounts consistent with current good manufacturing practice.
(c) Labeling. The label of the color additive and any lakes or mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.
(d) Certification. All batches of FD&C Red No. 40 and lakes thereof shall be certified in accordance with regulations, in part 80 of this chapter.
[42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994]
Title 21 published on 2012-04-01
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