0910-AH62 202404 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Nonprescription Drug Product With an Additional Condition for Nonprescription Use

The final rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers. The final rule would establish requirements for a drug product that could be marketed as a nonprescription drug product with an additional condition for nonprescription use (ACNU) that an applicant must implement to ensure appropriate self-selection, appropriate actual use, or both by consumers.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 201.67 21 CFR 314.56 21 CFR 314.81 21 CFR 314.125 21 CFR 314.127 21 U.S.C. 321 21 U.S.C. 352 21 U.S.C. 355 21 U.S.C. 371 42 U.S.C. 262 42 U.S.C. 264 ... Yes NPRM 06/28/2022 87 FR 38313 NPRM Comment Period End 10/26/2022 NPRM Comment Period Extended 10/24/2022 87 FR 64178 NPRM Comment Period Extended End 11/25/2022 Final Rule 10/00/2024 No Businesses None No No No No Angela Mtungwa Program Coordinator 0910 Food and Drug Administration FDA 301 796-9329 angela.mtungwa@fda.hhs.gov 10903 New Hampshire Avenue, Building 22, Room 4393, Silver Spring MD 20993