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# NCPA Statement to FDA Compounding Session
- URL: https://www.fdaweb.com/ncpa-statement-to-fda-compounding-session/
- Published: 2024-05-01T12:00:00.000Z
- Updated: 2026-09-14T14:29:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156887

The National Community Pharmacists Association (NCPA) says there are many comments it has submitted to FDA over the years that still have not been addressed by the agency. The comment is included in the NCPA [statement](https://downloads.regulations.gov/FDA-2015-N-0030-8517/attachment%5F1.pdf?ref=fdaweb.com) submitted in advance of the agency’s 5/14 Drug Compounding Annual Listening Session. The NCPA comments and concerns are listed under these headings:

- concerns with patient access to cBHT;
- insanitary conditions overreach;
- any future memorandum of understanding;
- addressing drug shortages;
- demonstrably difficult to compound *Federal Register* notice;
- FDA draft report and plan for guidance documents, removing the public notice and comment period;
- draft guidance on wholesaling under Section 503B of the Federal Food, Drug, and Cosmetic Act;
- stability study delays for United States Pharmacopeia category 3 sterile compounding; and
- adverse event reporting.

“NCPA believes there is a path forward on these issues which can meet the needs of patients and compounding pharmacists while ensuring the safety goals of FDA,” the statement concludes…. “NCPA is committed to working with FDA and other stakeholders on these important matters.”