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Food and Drug Administration and Compliance Issues
Sunday, May 12, 2013
NACDS hails Federal Compounding Legislation
ARLINGTON, Va. – The National Association of Chain Drug Stores hailed a Senate committee for proposed changes to policies governing pharmacy compounding yet urged lawmakers to exercise caution regarding possible unintended consequences of some parts of its draft legislation.
NACDS said Thursday that it expressed its praise and concern in a statement to the Senate Committee on Health, Education, Labor and Pensions for 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 to the committee. "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 health care system."
As the legislation proceeds, lawmakers must distinguish between traditional compounding and manufacturing, NACDS pointed out, explaining that traditional compounding is based on individual prescription orders for individual patients for products that aren't offered commercially.
NACDS also noted support for the committee's draft proposal for maintaining state board of pharmacy jurisdiction over traditional compounding, since the state boards regulate functions that are the practice of pharmacy. The association added that the Food and Drug Administration should regulate the manufacturing of prescription drugs.
NACDS, too, indicated support for the draft legislation's provision to promote collaboration between the FDA and state boards of pharmacy to investigate any questionable practices so that compounding is regulated in patients' 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," NACDS stated. "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."
Despite its general support for the proposed legislation, NACDS gave an example showing that the measure's definition of "compounding manufacturer" may inadvertently be applied to 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 said in its statement. "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."