The International Academy of Compounding Pharmacists (IACP) recently released its formal comments about its concerns over the proposed U.S. Food and Drug Administration (FDA) memorandum of understanding.
The organization’s main concerns are about patients having access to important medications.
“We believe the FDA’s draft guidance overreaches far beyond the intentions of Congress and contradicts the clear language of the DQSA and previous federal legislation -- to the point that, if left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,” Dr. David G. Miller, IACP executive vice president and CEO, said.
The FDA’s proposed agreement would create a new regulatory framework for pharmacy compounding. These changes are founded on the 2013 Drug Quality and Security Act (DQSA).
“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 “The fact that more than 3,000 individuals and organizations have commented on the draft guidance underscores that the agency has a great deal of work to do before finalizing this document and ensuring that it does not negatively impact patient access to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.”