§ 310.101 - FD&C Red No. 4; procedure for discontinuing use in new drugs for ingestion; statement of policy.

(a) Section 81.10(d) of this chapter published December 11, 1964 (29 FR 16983), terminated the provisional listing of FD&C Red No. 4 for use in drugs that may be ingested and canceled the effectiveness of certificates for this color additive and mixtures containing it as of June 9, 1965 (§ 81.30(c) of this chapter), insofar as ingested drugs are concerned. On August 19, 1965 (30 FR 10289), FD&C Red No. 4 was restored to provisional listing by amendment to § 81.1(a) of this chapter, which restricted the use of color to the terms of § 81.25 of this chapter. The use of FD&C Red No. 4 or mixtures containing it in the manufacture of ingested drugs (except for limited use as provided in § 81.25 of this chapter) will result in adulteration and may constitute grounds for withdrawing approval of drugs for which a new drug approval is in effect.

(b) An approved supplemental new drug application will not be required to provide for discontinuing the use of FD&C Red No. 4 in the manufacture of articles that are the subject of approved new drug applications, provided that the applicant submits to the Food and Drug Administration a written notice of the date on which the change in formulation will be put into effect.

(c) It will be the policy of the Food and Drug Administration to take no action against a drug or applicant where a permitted color additive is substituted for FD&C Red No. 4 in the manufacture of a drug prior to receipt of a written notice of approval of a supplemental new drug application, provided that the applicant submits a satisfactory supplemental application meeting all the following conditions:

(1) The applicant submits a full list of the components and a full statement of the composition of the drug.

(2) The date when the composition of the drug will be changed is stated.

(3) The applicant submits data showing that the change in composition does not interfere with any assay or other control procedures used in manufacturing the drug, or that the assay and other control procedures are revised to make them adequate.

(4) The data available to establish the stability of the revised formulation are included, and if the data are too limited to support a conclusion that the drug will retain its declared potency for a reasonable marketing period, a commitment from the applicant:

(i) To test the stability of marketed batches at reasonable intervals;

(ii) To submit the data as they become available; and

(iii) To recall from the market any batch found to fall below the approved specifications for the drug.

(d) When a supplemental application proposes the change prescribed in paragraph (c) of this section and the applicant informs the Food and Drug Administration that the changes have been put into effect, such notification will be regarded as an agreement by the applicant to an extension of the time for formal action on the supplemental application.

(e) Except as provided in paragraph (c) of this section, no provision of this statement of policy shall limit the authority of the Secretary of Health and Human Services or of the Commissioner of Food and Drugs to suspend or withdraw approval of a new-drug application as prescribed by section 505(e) of the act or to initiate any other regulatory proceedings with respect to a drug or applicant under the provisions of the act.