IACP Issues Nominations for FDA's Request for Bulk Drug Substances - for Both 503A & 503B Facilities
Your Academy was the first pharmacy association to submit comments to the U.S. Food and Drug Administration (FDA) under the recently enacted Drug Quality and Security Act for Active Pharmaceutical Ingredients (APIs) commonly used by compounding pharmacists to ensure the appropriate treatment of patients.
“The compounding community is working diligently to ensure that the FDA has all the information the agency needs to move forward with the implementation of the Drug Quality and Security Act,” said Pat Stephens, PharmD, IACP President. “We identified our list of bulk drug substances through a poll of our membership, as well as a review of the latest scientific and medical literature related to compounding pharmacy. Additionally, we are indebted to the IACP Foundation for its tireless work in helping identify as much information about each bulk ingredient as possible through the medical and scientific literature.”
Click here to access IACP's letters and bulk drug lists regarding 503A and 503B IACP submitted to FDA.
IACP Issues Press Release Announcing Submission to FDA of its 2,403-Bulk Drug Substances List
This week, IACP issued a press release on its efforts to seek FDA approval on a 2,403-bulk drug substances list for both 503A and 503B. Click here to read the IACP press release. IACP is working to Protect, Promote and Advance Pharmacy Compounding!