§207.41. Who must list drugs and what drugs must they list? — Inbound Citations

(16) Listing submissions described in § 207.41(c)(2) for human drugs manufactured for private label distribution must include all information specified in § 207.49(a)(2) through (14) and:

(i) The appropriate NDC(s) (as described in § 207.33) that include the private label distributor's labeler code and all package code variations;

(ii) The name, mailing address, telephone number, and email address of the private label distributor; and

(iii) For drugs bearing the NDC(s) reported under paragraph (a)(16)(i) of this section, labeling as described in paragraph (a)(15) of this section that accompanies the private label distributor's product.

(f) 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.