The International Academy of Compounding Pharmacists (IACP) has raised serious concerns about patient access to vital medications in formal comments submitted on July 20, 2015, to the U.S. Food and Drug Administration, as the agency develops a new regulatory framework for pharmacy compounding based upon the Drug Quality and Security Act (DQSA) of 2013.
“We believe the FDA’s draft guidance overreaches far beyond the intentions of Congress and contradicts the clear language of the DQSA and previous federal legislation – to the point that, if left intact, it will hinder patient access to compounded medications, limit patient choice of their pharmacist, and disrupt the essential physician-patient-pharmacist triad relationship,” said David G. Miller, RPh, the IACP’s Executive Vice President and Chief Executive Officer.
“Our organization, along with a diverse group of stakeholders in the health care industry, has worked cooperatively with the FDA as the agency implements the DQSA, and we urge the FDA to incorporate our feedback,” Miller said. “The fact that more than 3,000 individuals and organizations have commented on the draft guidance underscores that the agency has a great deal of work to do before finalizing this document and ensuring that it does not negatively impact patient access to compounded medications.”
The International Academy of Compounding Pharmacists (IACP) is an association representing more than 4,000 pharmacists, technicians, students, and members of the compounding community who focus upon the specialty practice of pharmacy compounding. Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians to create customized medication solutions for patients and animals whose healthcare needs cannot be met by manufactured medications.
IACP Comments to FDA
Click here to read IACP’s submitted MOU comments to the FDA.
IACP Press Release
Click here to read the IACP press release announcing its formal comments submitted to FDA.