NCPA joined APhA, ASCP, NASP and NACDS in signing onto a letter calling for FDA to extend the comment deadline for the Nonprescription Drug Product With an Additional Condition for Nonprescription Use proposed rule by at least 90 days to allow stakeholders to appropriately respond. Since comments are due Oct. 26, the extension, if granted, would allow comments to be submitted until about Jan. 26. Additionally, the above groups requested that a public listening session for the record be held to identify and discuss patient safety considerations. The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an additional condition for nonprescription use that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a health care practitioner. NCPA opposes this proposed rule and will submit additional comments by the existing Oct. 26 deadline.
NCPA
