Urges continued distinction between prescription compounding and manufacturing
May 9, 2013 (Arlington, Va.) — The National Association of Chain Drug Stores (NACDS) today commended a Senate committee for many of its proposed changes to policies governing compounding, and urged caution regarding potential unintended consequences of some aspects of its draft legislation.
NACDS conveyed its position in a statement to the U.S. Senate Committee on Health, Education, Labor and Pensions in conjunction with a hearing titled “Pharmaceutical Compounding: Proposed Legislative Solution.”
“NACDS supports the mission and work of FDA in ensuring that Americans receive only safe and effective prescription medications. Safeguarding the health and welfare of our patients remains our highest priority,” NACDS said in its statement. “Pharmacist compounding services are the only source of critical medications for millions of patients who each have their own unique health care needs. For these patients, there are no commercially-manufactured preparations available. Accordingly, we agree with FDA that pharmacist compounding services are a valuable and important part of our nation’s healthcare system.”
NACDS emphasized the importance of distinguishing between traditional compounding and manufacturing, noting that traditional compounding is based on individual prescription orders for individual patients for products that are not commercially available.
NACDS noted support for the Committee’s draft proposal for maintaining state board of pharmacy jurisdiction over traditional compounding, given that these entities regulate functions that are the practice of pharmacy. NACDS said that the Food and Drug Administration (FDA) should regulate the manufacturing of prescription drugs.
Further, NACDS indicated support for the draft legislation’s provision to foster collaboration between the FDA and state boards of pharmacy to investigate any questionable practices so that compounding is regulated in the best interests of patients.
“Despite best efforts, there still may be entities that seek to circumvent patient safety measures as well as federal and state regulation. We support state and federal joint efforts to root out rogue entities that seek to use a state pharmacy license as a shield from federal oversight,” NACDS said.
Despite general support for the direction of the proposed legislation, NACDS provided an example showing that the legislation’s definition of “compounding manufacturer” may inadvertently group into this category those pharmacies that repackage a drug using sterile preservative-free single-dose vials or by pooling sterile drugs.
“Pharmacies that perform these types of functions, such as for Total Parenteral Nutrition (TPN) for home-infusion purposes, would lose their status as pharmacies and would no longer be able to provide these critical services to many of the sickest patients,” NACDS explained. “ We urge the Committee to further review this language, as it appears to be over-broad and would hinder patient access to critical sterile compounded medications. We welcome the opportunity to work with the Committee to amend the language so that it addresses the Committee’s concerns without having negative impacts on patient access.”
NACDS’ statement can be accessed on the NACDS website.