NABP Testifies at US House Subcommittee Hearing Regarding Support for Federal Legislation to Distinguish Between Compounding and Manufacturing

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.”

Further, NABP noted its preference for not including “compounding” in the new proposed designation for a manufacturing entity because of the inference to traditional compounding and the confusion that could result, and its concern regarding the exemption for intrastate distribution of non-patient-specific sterile compounded medications, which the Association believes bear the same risk levels as non-patient-specific sterile compound products in interstate commerce. In its testimony, NABP provided information on actions taken by state boards of pharmacy and the Association in response to the fungal meningitis outbreak linked to contaminated drugs compounded by NECC. For example, the testimony included details on the NABP inspection program initiated on behalf of the Iowa Board of Pharmacy.

NABP also indicated the Association’s support for the Pharmaceutical Compounding Quality and Accountability Act in testimony presented at a US Senate Health, Education, Labor, and Pensions (HELP) Committee hearing on May 9, 2013, and in a letter (PDF) to the HELP Committee Chair, Senator Tom Harkin, and the Committee Ranking Member, Senator Lamar Alexander.