Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an ACNU that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner. The proposed 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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Parts 201 and 314 [Docket No. FDA-2021-N-0862] RIN 0910-AH62 AGENCY: Food and Drug Administration, Department of Health and Human Services (HHS). ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an ACNU that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner. The proposed 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. DATES: Either electronic or written comments on the proposed rule must be submitted by October 26, 2022. Submit comments (including recommendations) on information collection issues under the Paperwork Reduction Act of 1995 by July 28, 2022. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 26, 2022. Comments recei…
Other Federal Register documents from the same docket.
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Extension of Comment Period
Citation: 87 FR 38313
