§314.56. Nonprescription drug product with an additional condition for nonprescription use (ACNU). — Inbound Citations

(1) Sections 314.50 through 314.72;

(20) For an NDA for a nonprescription drug product with an additional condition for nonprescription use under § 314.56, if FDA has determined the application failed to meet the requirements in § 314.56 applicable to NDAs.

(15) For an ANDA for a nonprescription drug product with an additional condition for nonprescription use under § 314.56, if FDA has determined the application failed to meet the requirements in § 314.56 applicable to ANDAs.

(a) An applicant may ask the Food and Drug Administration to waive under this section any requirement that applies to the applicant under §§ 314.50 through 314.81. An applicant may ask FDA to waive under § 314.126(c) any criteria of an adequate and well-controlled study described in § 314.126(b). A waiver request under this section is required to be submitted with supporting documentation in an NDA, or in an amendment or supplement to an NDA. The waiver request is required to contain one of the following:

(1) An explanation why the applicant's compliance with the requirement is unnecessary or cannot be achieved;

(2) A description of an alternative submission that satisfies the purpose of the requirement; or

(1) The key elements of the ACNU under § 314.56(c)(1)(iv) of this chapter for NDAs or § 314.56(c)(2)(ii) of this chapter for ANDAs; and

(i) The key elements of the ACNU under § 314.56(c)(1)(iv) of this chapter for NDAs or § 314.56(c)(2)(ii) of this chapter for ANDAs; or

(A) An ACNU failure occurs upon either of the following events:

(1) A failure associated with the implementation of a key element of an ACNU under § 314.56(c)(1)(iv) or (c)(2)(ii); or

(2) A failure associated with the operationalization of an ACNU under § 314.56(c)(1)(vii) or (c)(2)(iii).

(2) The operationalization of the ACNU under § 314.56(c)(1)(vii) of this chapter for NDAs or § 314.56(c)(2)(iii) of this chapter for ANDAs.

(ii) The operationalization of the ACNU under § 314.56(c)(1)(vii) of this chapter for NDAs or § 314.56(c)(2)(iii) of this chapter for ANDAs.

(A) An ACNU failure occurs upon either of the following events:

(1) A failure associated with the implementation of a key element of an ACNU under § 314.56(c)(1)(iv) or (c)(2)(ii); or

(2) A failure associated with the operationalization of an ACNU under § 314.56(c)(1)(vii) or (c)(2)(iii).

(1) The key elements of the ACNU under § 314.56(c)(1)(iv) of this chapter for NDAs or § 314.56(c)(2)(ii) of this chapter for ANDAs; and

(i) The key elements of the ACNU under § 314.56(c)(1)(iv) of this chapter for NDAs or § 314.56(c)(2)(ii) of this chapter for ANDAs; or

(A) An ACNU failure occurs upon either of the following events:

(1) A failure associated with the implementation of a key element of an ACNU under § 314.56(c)(1)(iv) or (c)(2)(ii); or

(2) A failure associated with the operationalization of an ACNU under § 314.56(c)(1)(vii) or (c)(2)(iii).

(2) The operationalization of the ACNU under § 314.56(c)(1)(vii) of this chapter for NDAs or § 314.56(c)(2)(iii) of this chapter for ANDAs.

(ii) The operationalization of the ACNU under § 314.56(c)(1)(vii) of this chapter for NDAs or § 314.56(c)(2)(iii) of this chapter for ANDAs.

(A) An ACNU failure occurs upon either of the following events:

(1) A failure associated with the implementation of a key element of an ACNU under § 314.56(c)(1)(iv) or (c)(2)(ii); or

(2) A failure associated with the operationalization of an ACNU under § 314.56(c)(1)(vii) or (c)(2)(iii).