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ARLINGTON, Va. — Many proposed changes to policies governing pharmacy compounding are commendable, but some aspects of Senate legislation on the practice may have unintended consequences, says the National Association of Chain Drug Stores.
NACDS conveyed its position in a statement to the Senate Committee on Health, Education, Labor and Pensions in conjunction with a hearing titled “Pharmaceutical Compounding: Proposed Legislative Solution.”
NACDS emphasized the importance of distinguishing between traditional compounding and manufacturing, pointing out that traditional compounding is based on individual prescription orders for individual patients for products that are not commercially available.
The association supported the committee’s draft proposal for maintaining state board of pharmacy jurisdiction over traditional compounding, given that boards regulate functions that are the province of pharmacy. NACDS said that the Food and Drug Administration should regulate the manufacturing of prescription drugs.
Further, NACDS backed the legislation’s provision to foster collaboration between the FDA and state boards 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, the statement said.
“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 general support for the direction of the proposed legislation, NACDS provided an example showing that its 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.
