(a) Scope. This section sets forth labeling requirements for a nonprescription drug product with an ACNU.

(b) 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 the applicant demonstrates and FDA determines that labeling alone is insufficient to ensure appropriate self-selection or appropriate actual use, or both.

(2) [Reserved]

(c) General labeling requirements. (1) A nonprescription drug product with an ACNU must comply with applicable labeling requirements for nonprescription drug products under this part, including the format and content requirements for nonprescription drug product labeling under § 201.66 and the statements specified in § 201.130(a) and (b).

(2) A nonprescription drug product with an ACNU may also be approved with additional labeling that supplements the format and content requirements for nonprescription drug product labeling under § 201.66.

(d) Format requirements for the required statement about the ACNU. The statement about the ACNU specified in § 201.130(b)(1) must meet all format requirements as follows:

(1) The statement about the ACNU must appear on the principal display panel (see § 201.60) and the immediate container surface that the consumer is most likely to view when seeking information about the drug product. If the immediate container is a bottle, the statement about the ACNU must appear on the surface that the consumer is most likely to consider the front of the bottle. If the immediate container is a blister card (including a card that contains more than one blister unit), the statement about the ACNU must appear on the blister card surface that the consumer would most likely view when removing the drug product from the blister card. If the blister card contains more than one blister unit (e.g., perforated blister card where individual blister units can be separated from one another), the statement about the ACNU does not need to be included on each blister unit of a blister card. However, the statement about the ACNU must remain intact and be readable on the blister card when the drug product is removed from each blister unit.

(2) The statement about the ACNU must appear in boldface and black type.

(3) The statement about the ACNU must appear in a yellow background banner. No other information or statements may be included within the yellow background banner.

(4) The statement about the ACNU must be in one of the following font sizes, whichever is greater:

(i) At least 25 percent as large as the font size of the largest printed words on the principal display panel and immediate container; or

(ii) At least 12-point font (1 point = 0.0138 inches).

(5) An applicant may request an exception to the minimum font size requirement specified in paragraph (d)(4) of this section for containers where its size would render compliance with this requirement impractical. FDA may allow such an exception upon request by an applicant if FDA determines an exception is warranted.

(e) Misbranding. A nonprescription drug product with an ACNU is misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) if—

(1) It does not comply with the labeling requirements specified in paragraphs (c) and (d) of this section and § 201.130(a) through (c); or

(2) The ACNU is not implemented by the applicant in accordance with the following, as approved by FDA in the application:

(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

(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.