(a) Definition. The following definition applies to this section:

(1) Additional condition for nonprescription use (ACNU) means one or more FDA-approved conditions that an applicant of a nonprescription drug product must implement to ensure consumers' appropriate self-selection or appropriate actual use, or both, of the nonprescription drug product without the supervision of a practitioner licensed by law to administer such drug if an applicant demonstrates and FDA determines that labeling alone is insufficient to ensure appropriate self-selection or appropriate actual use, or both.

(2) [Reserved]

(b) Separate application required for a nonprescription drug product with an ACNU. Notwithstanding § 310.200(b) of this chapter, an applicant must submit a separate application for a nonprescription drug product with an ACNU. Initial approval for a nonprescription drug product with an ACNU cannot be obtained through a supplement to an approved application.

(c) Specific requirements for an application for a nonprescription drug product with an ACNU. The applicant must submit an application that complies with the following requirements:

(1) New drug application (NDA). When fulfilling the content and format requirements under § 314.50, an NDA for a nonprescription drug product with an ACNU must include—

(i) A statement regarding whether the purpose of the ACNU is to ensure appropriate self-selection or appropriate actual use, or both, by consumers of the nonprescription drug product with an ACNU without the supervision of a practitioner licensed by law to administer such drug;

(ii) A statement regarding the necessity of the ACNU;

(iii) A description of how the ACNU ensures appropriate self-selection or appropriate actual use, or both;

(iv) A description of the key elements of the ACNU, including:

(A) The additional condition implemented by the applicant to be fulfilled by the consumer to obtain the nonprescription drug product with an ACNU;

(B) The labeling specifically associated with the ACNU; and

(C) The criteria by which the consumer would successfully fulfill the ACNU, including a description of the specific actions to be taken by a consumer or required responses to be provided by a consumer;

(v) Adequate data or other information that demonstrates the necessity of the ACNU to ensure appropriate self-selection or appropriate actual use, or both;

(vi) Adequate data or other information that demonstrates the effect of the ACNU on the appropriate self-selection or appropriate actual use, or both; and

(vii) A description of the specific way(s) the ACNU is operationalized.

(2) Abbreviated new drug application (ANDA). When fulfilling the content and format requirements under § 314.94, an ANDA for a nonprescription drug product with an ACNU must include:

(i) A statement regarding whether the purpose of the ACNU is to ensure appropriate self-selection or appropriate actual use, or both, by consumers of the nonprescription drug product with an ACNU without the supervision of a practitioner licensed by law to administer such drug, which must be the same as the purpose of the ACNU for its reference listed drug (RLD);

(ii) Information demonstrating that the key elements of the ACNU are the same as the key elements of the ACNU for its RLD; and

(iii) A description of the specific way(s) the ACNU is operationalized. If an applicant believes the ACNU is operationalized in the same way as the RLD, include information demonstrating that the ACNU is operationalized in the same way as the RLD. If a different way to operationalize the proposed ACNU is used, include information to show that this different way to operationalize the proposed ACNU achieves the same purpose as the ACNU for its RLD and that the differences from the RLD are otherwise acceptable in an ANDA.

(d) Simultaneous marketing of nonprescription and prescription drug products. An ACNU constitutes a meaningful difference between a nonprescription drug product and a prescription drug product, such that a prescription drug product and a nonprescription drug product with an ACNU may be simultaneously marketed even if there is not another meaningful difference between the two products that makes the nonprescription drug product safe and effective for use without the supervision of a healthcare practitioner licensed by law to administer such drug (e.g., a different active ingredient, indication, strength, route of administration, dosage form, or patient population).