Title 21
SECTION 207.53
207.53 What listing information must a registrant submit for a drug that it repacks or relabels
§ 207.53 What listing information must a registrant submit for a drug that it repacks or relabels?Each registrant must provide the following listing information for each drug it repacks or relabels:
(a) NDC. The appropriate NDC(s), as described in § 207.33, that include the registrant's labeler code and all package code variations;
(b) Source NDC. The NDC assigned to each finished drug received by the registrant for repacking or relabeling, with the exception of medical gases. Each such NDC must be associated with the corresponding NDC(s) for repacked or relabeled drugs, reported under paragraph (a) of this section.
(c) Name and Unique Facility Identifier. For each drug identified by an NDC reported under paragraph (a) of this section, the name and Unique Facility Identifier of every establishment where repacking or relabeling is performed for the drug and the type of operation (repacking vs. relabeling) performed at each such establishment.
(d) Labeling. For each drug identified by an NDC reported under paragraph (a) of this section, except those human drugs repacked or relabeled exclusively for private label distribution and not distributed under the registrant's own name and label, provide the following:
(1) Human prescription drugs. All current labeling for the repacked or relabeled drug except that only one representative container or carton label need be submitted where differences exist only in the quantity of contents statement or the bar code. This labeling submission must include the content of labeling, as defined in section § 207.1(b).
(2) Human nonprescription drugs. (i) For each human nonprescription drug subject to section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, all current labeling, except that only one representative container or carton label need be submitted where differences exist only in the quantity of contents statement or the bar code. This labeling submission must include the content of labeling, as defined in § 207.1(b).
(ii) For each human nonprescription drug not subject to section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, the current label (except that only one representative container or carton label need be submitted where differences exist only in the quantity of contents statement or the bar code), the package insert (if any), and a representative sampling of any other labeling. This labeling submission must include the content of labeling as defined in § 207.1(b).
(3) Animal drugs. (i) For each animal drug that is subject to section 512 of the Federal Food, Drug, and Cosmetic Act, which includes but is not limited to, new animal drugs that have been approved, conditionally approved, or indexed under sections 512, 571, or 572 of the Federal Food, Drug, and Cosmetic Act, a copy of all current labeling (except that only one representative container or carton label need be submitted where differences exist only in the quantity of contents statement), including the content of labeling as defined in § 207.1(b);
(ii) For all other animal drugs, a copy of the current label (except that only one representative container or carton label need be submitted where differences exist only in the quantity of contents statement), the package insert, the content of labeling as defined in § 207.1(b), and a representative sampling of any other labeling;
(4) All other. For all other listed drugs, including unfinished drugs, the label (if any), except that only one representative label need be submitted where differences exist only in the quantity of contents statement.
(e) Advertisements. (1) A representative sampling of advertisements for a human prescription drug that is not subject to section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act;
(2) If we request it for good cause, a copy of all advertisements for a particular drug described in paragraph (e)(1) of this section, including advertisements described in § 202.1(l)(1) of this chapter. Such advertisements must be submitted within 30 calendar days after our request.
(f) Private label distributor products. A listing submission for a human drug distributed by a private label distributor described in § 207.41(c)(2) must include information specified in § 207.53(b) through (e) as applicable and:
(1) The appropriate NDC(s) (as described in § 207.33) that include the private label distributor's labeler code and all package code variations;
(2) The name, mailing address, telephone number, and email address of the private label distributor; and
(3) For drugs bearing the NDC(s) reported under paragraph (f)(1) of this section, labeling as described in paragraphs (d)(1) through (4) of this section, as applicable, that accompanies the private label distributor's product.