ACNU Final Rule and Potential Implications for Future OTC Birth Control Switches

In 2022, the Biden-Harris Administration issued a comment period for a proposed rule that would establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). The proposed rule sought to enable pharmaceutical companies to safely market nonprescription drug products by implementing an ACNU that would ensure appropriate self-selection and/or use by consumers without the supervision of a healthcare provider.

Free the Pill coalition members submitted a comment, citing additional considerations for implementation including tailoring any ACNU to ensure minimal burden on consumers and streamlining the application process to avoid lengthy and expensive rounds of testing, which can delay access to nonprescription products. These considerations are essential for the proposed rule to ensure expanded access and prevent unintentional barriers to medications that can be used safely and effectively without a prescription.

The ACNU Final Rule was published to the Federal Registrar on Thursday, December 26, 2024 and is scheduled to go into effect starting March 21, 2025.

Free the Pill staff compiled an overview of the ACNU Final Rule, provided insight into possible impacts on future OTC birth control products, and shared resources related to the federal rulemaking process, which can be read below.