IACP Issues Comments on FDA's Draft Guidance: Implementation of 503A & 503B
Your Academy is the first pharmacy association to submit comments to the FDA on its Draft Guidance regarding the implementation of Section 503A and 503B of the Federal Food, Drug and Cosmetic Act.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! We urge our members to use our language or positions in submitting your own comments to the FDA, which are due, February 4, 2014.
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Please click here to view IACP's Comments on FDA's Draft Guidance on the Implementation of Section 503A.
Please click here to view IACP's Comments on FDA's Draft Guidance on the Implementation of Section 503B.
IACP is Making Sure the FDA Plays by the Rules Congress Established
Today, IACP also is sending 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 today's letter to FDA Commissioner Hamburg.