Thursday, May 30, 2013

NABP Testifies at US House Subcommittee Hearing Regarding Support for Federal Legislation to Distinguish Between Compounding and Manufacturing May 29, 2013 6:15 pm

Topics: Compounding

NABP expressed its support for federal legislation that would distinguish between compounding and manufacturing, in testimony (PDF) presented at a United States House subcommittee hearing on May 23, 2013. The hearing, “Examining Drug Compounding” was held to provide US Committee on Energy and Commerce Health Subcommittee members an opportunity to hear testimony from Food and Drug Administration (FDA) and health care experts regarding the importance of drug compounding to patients and the current regulation of compounding on the federal and state levels. In its testimony, NABP noted that the clarifications in the proposed Pharmaceutical Compounding Quality and Accountability Act (S 959) regarding the distinction between compounding and manufacturing “provide a safe and equitable environment for both compounding and manufacturing to occur in the best interest of the patient.” The Association stressed that the distinction between compounding and manufacturing is “critical to maintain the present authority of the states and address one of the contributing factors to the NECC [New England Compounding Center] crisis, specifically, the ambiguous authority between the states and FDA.”  The proposed legislation also specifies that a “compounding manufacturer” cannot be licensed as a pharmacy, and NABP notes that this provision is “essential to distinguishing between state-regulated compounding and FDA-regulated manufacturing.”
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