Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the FD&C Act

The American Pharmacists Association (APhA) appreciates the opportunity to submit comments on the "Interim Policy on Compounding Using Bulk Drug Substances Under section 503A of the Federal Food, Drug, and Cosmetic Act," Guidance for Industry. APhA is the only organization advancing the entire pharmacy profession. Our expert staff and strong volunteer leadership, including many experienced pharmacists, allow us to deliver vital leadership to help pharmacists, pharmaceutical scientists, student pharmacists, and pharmacy technicians find success and satisfaction in their work while advocating for changes that benefit them, their patients, and their communities. We offer the following comments developed with input from our members, including feedback from APhA's Compounding Core Group, consisting of over 3,400 members. FDA proposes in the draft guidance to retain the policy related to nominated substances currently appearing in 503A Category 1 until the substances are addressed in a final rule or removed based on additional information (e.g., safety risks). In addition, FDA proposed that any substances nominated from now on cannot be used until a determination is made following rulemaking. Upon reviewing the draft guidance, we have identified several areas that would benefit from increased transparency, data retention, and data sharing. General Recommendations •Retain the existing lists of nominated substances in Categories 2 and 3 on the FDA website. •Provide the criteria or the evaluation process for substances nominated for the bulks list that raise significant safety risks. •Publish a list of all substances nominated on or after the date of publication of this guidance on the FDA website. See, attached .PDF for full comments. Thank you for the opportunity to provide our perspective and recommendations to the FDA. We look forward to working with FDA to ensure patients have access to the safe and effective compounded medications they need.