US FDA Announces Proposed Rule for Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU)

The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862).

The proposed rule is available for public comment for 120 days. Comments should be submitted to docket FDA-2021-N-0862 on Regulations.gov

Current situation concerning nonprescription drugs

Currently, nonprescription drug products are limited to drugs that can be labeled with sufficient information for consumers to appropriately self-select and use the drug product. For certain drug products, limitations of labeling present challenges for adequate communication of information needed for consumers to appropriately self-select or use the drug product without the supervision of a healthcare provider.

What is an Additional Condition for Nonprescription Use (ACNU)

An ACNU is 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 healthcare practitioner. For example, an applicant could propose an ACNU that requires a consumer to respond with specific answers to a set of questions on a self-selection test available by either a mobile application (“app”) or an automated telephone response system in order to purchase the nonprescription drug product.

About the proposed rule

Under the proposed rule, when labeling alone is not sufficient to ensure that the consumer can appropriately self-select, appropriately use, or both, a drug product correctly in a nonprescription setting, an applicant may submit an application proposing an ACNU that a consumer must successfully fulfill to obtain the nonprescription drug product with an ACNU.

The proposed rule:

  • if finalised, would establish requirements for a nonprescription drug product that has an additional condition for nonprescription use (ACNU).
  • is intended to increase options for the development and marketing of safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.

Source: FDA