IACP First to Issue Comments on for FDA's Draft Guidance: Implementation of 503A & 503B
Your Academy was the first to submit comments to the FDA on its Draft Guidance regarding the implementation for both Section 503A and 503B of the Federal Food, Drug and Cosmetic Act.
IACP is ensuring that the voice of our pharmacy compounding members is heard!
IACP Comments to FDA for your Review
Please click here to view IACP's Comments on FDA's Draft Guidance on the Implementation of Section 503A.
Please click here to view IACP's Comments on FDA's Draft Guidance on the Implementation of Section 503B.
Please click here for IACP's Comparison Chart of 503A and 503B - The Drug Quality and Security Act of 2013.
Complete List of Stakeholder Comments to the FDA
Please click here for a List of All Comments Submitted to the FDA.
IACP is Making Sure the FDA Plays by the Rules Congress Established
IACP also sent a letter to FDA Commissioner Margaret A. Hamburg, MD, expressing our specific concerns regarding what we believe is the premature nature of FDA's communication to stakeholders and State Boards, promoting conducting business with only 503B registered facilities.
"IACP continues to support increased communications between the States and FDA. However, we have strong reservations with FDA sending a letter to State stakeholders encouraging conducting business only with facilities registered as outsourcing facilities when FDA has not yet finalized guidance, restrictions, and quality standards for these 503B outsourcing facilities."
Click here to read letter to FDA Commissioner Hamburg. Please email IACP with any questions at firstname.lastname@example.org.