NABP Supports Federal Legislation Creating New Category of Manufacturer Under FDA Oversight, While Maintaining Board of Pharmacy Authority Over Compounding Pharmacies

In testimony presented at a United States Senate Committee Hearing, NABP expressed its support of draft legislation that would create a new category of manufacturer to include entities that engage in large-scale production of sterile non-patient-specific drugs for distribution. The Senate Health, Education, Labor, and Pensions (HELP) committee’s proposed legislation distinguishes between pharmacies engaged in the practice of traditional drug compounding, a practice that would continue to be regulated by the state boards of pharmacy, and facilities producing non-patient-specific medications, designated as “compounding manufacturers,” to be regulated by the Food and Drug Administration (FDA). NABP supports the clear separation of traditional pharmacy compounding from the activities of a “compounding manufacturer,” although the Association indicates that not including “compounding” in the latter term is preferable in order to avoid the association with “traditional compounding and the confusion that could result.” The Association stresses that “the provision of the proposed legislation that specifies a compounding manufacturer cannot be licensed as a pharmacy is essential to distinguishing from state-regulated compounding and FDA-regulated manufacturing.”

In its testimony, NABP also raised some concerns for the consideration of the Senate HELP Committee. The Association noted that granting FDA access to pharmacy records for activities, including compounding, that are regulated by the states could create jurisdictional conflicts and impede the states from investigating or prosecuting a case if the FDA has seized needed evidence. NABP encourages the use by FDA and the states of its developing information sharing network that will provide, at no cost to the state boards of pharmacy, pertinent information about all pharmacies. Available information will include inspection reports and other related information submitted to the NABP network by the states. NABP also indicated that if the new legislation is adopted, allowing an appropriate transition period for implementation will allow states sufficient time to alert pharmacists and practitioners in order to ensure that patient care is continued and “not halted by new requirements that may no longer allow certain activities that were previously permitted under state laws.” Further, NABP stressed its concern that provisions in the proposed legislation would grant an exemption allowing the in-state distribution of non-patient-specific sterile compounded products. NABP emphasizes its findings that non-patient-specific, sterile prepared products “distributed intra-state bear the same risk levels to patients as products that are introduced into interstate commerce.”

The full testimony (PDF) presented by NABP on May 9, 2013, is available on the Web site of the Senate HELP Committee.