Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Proposed Rule

Please see attached for our revised comments - The National Community Pharmacists Association (NCPA) appreciates the opportunity to provide feedback to FDA's Nonprescription Drug Product With an Additional Condition for Nonprescription Use proposed rule. NCPA represents America's community pharmacists, including 19,400 independent community pharmacies. Almost half of all community pharmacies provide long-term care services and play a critical role in ensuring patients have immediate access to medications in both community and long-term care (LTC) settings. Together, our members represent a $78.5 billion healthcare marketplace, employ 240,000 individuals, and provide an expanding set of healthcare services to millions of patients every day. Our members are small business owners who are among America's most accessible healthcare providers. NCPA support FDA's goal of improving patient access to needed medications. However, leaving out the pharmacist, and issues related to access create barriers to success of this initiative. Thank you again for holding a listening session on November 15 with us and the American Pharmacists Association, American Society of Consultant Pharmacists, National Association of Chain Drug Stores, and National Alliance of State Pharmacy Associations to hear our concerns. We hope you will take the recommendations discussed in the listening session and in our comment letters submitted to the docket into consideration as FDA works to finalize this proposed rule. While this proposed rule seems logical and easy to implement, there are significant issues related to operations, logistics for the patient and the pharmacist/pharmacies that need to be considered as FDA considers finalizing this rule. NCPA thanks FDA for the opportunity to provide feedback, and we stand ready to work with FDA to offer possible solutions and ideas. Should you have any questions or concerns, please feel free to contact me at steve.postal@ncpa.org or (703) 600-1178.

The National Community Pharmacists Association (NCPA) appreciates the opportunity to provide feedback to FDA's Nonprescription Drug Product With an Additional Condition for Nonprescription Use proposed rule. NCPA represents America's community pharmacists, including 19,400 independent community pharmacies. Almost half of all community pharmacies provide long-term care services and play a critical role in ensuring patients have immediate access to medications in both community and long-term care (LTC) settings. Together, our members represent a $78.5 billion healthcare marketplace, employ 240,000 individuals, and provide an expanding set of healthcare services to millions of patients every day. Our members are small business owners who are among America's most accessible healthcare providers. NCPA opposes FDA's proposed ACNU class of drugs given our concerns with its safety, administrative burden, and payment implications. NCPA thanks FDA for the opportunity to provide feedback, and we stand ready to work with FDA to offer possible solutions and ideas. Please see attached for our full comment letter.