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.

quoted from here

FDA this month signed a nearly $80,000 contract with Eastern Research Group to do an industry profile of pharmacy compounding operations, according to government spending records

Source found here FDA Seeks Contractor's Help In Profiling Drug Compounding Industry

(Daily News - 05-23-2013)

CBO Says House Rx Tracing Bill Would Generate $24 Million Over 8 Years

(Daily News - 05-31-2013)

The House version of drug tracing legislation would increase federal revenue by $24 million from 2015 to 2023 because of licensing fees, according to an analysis released Friday (May 31) by the Congressional Budget Office. The full House will consider the bill Monday under suspension of the rules alongside legislation reauthorizing animal drug user fees, according to the majority leader's schedule.

FDA MedWatch – Olympia Pharmacy Sterile Compounded Products: Recall – Concerns About Sterility Assurance | HRPP/IRB | Vanderbilt University

FDA MedWatch – Olympia Pharmacy Sterile Compounded Products: Recall – Concerns About Sterility Assurance | HRPP/IRB | Vanderbilt University

Press Release : The Illinois Department of Public Health (IDPH) is investigating two additional reports of adverse events among patients in Illinois who received injections of the steroid methylprednisolone acetate produced by Main Street Family Pharmacy, LLC in Newbern, Tennessee. All seven Illinois cases received injections at the Logan Primary Care clinic in downstate Herrin, located in Williamson County.

FOR IMMEDIATE RELEASE May 31, 2013	CONTACT: Sabrina L. Miller (312) 814-8194 www.idph.state.il.us
State Public Health Department Investigating Two Additional Steroid Injection Complications Cases Associated with Tennessee Compounding Pharmacy
CHICAGO – The Illinois Department of Public Health (IDPH) is investigating two additional reports of adverse events among patients in Illinois who received injections of the steroid methylprednisolone acetate produced by Main Street Family Pharmacy, LLC in Newbern, Tennessee. All seven Illinois cases received injections at the Logan Primary Care clinic in downstate Herrin, located in Williamson County. Initially five Illinois patients were reported to have developed abscesses after receiving injections of methylprednisolone acetate (MPA), an anti-inflammatory steroid used to treat a range of conditions including asthma and allergic reactions. The two additional cases were confirmed this week following public reports of a multistate outbreak involving more than 20 patients in Florida (13), North Carolina (2) and Illinois (7) who received injections of MPA from a shipment that originated from Main Street Family Pharmacy. IDPH is conducting a joint investigation with the Food and Drug Administration, Centers for Disease Control and Prevention and officials from other states that received shipments of MPA from Main Street Family Pharmacy. “The Illinois Department of Public Health continues to work with local and federal officials investigating these adverse events,” said IDPH Director Dr. LaMar Hasbrouck. “Our priority continues to be ensuring that all patients who might have received MPA injections have been contacted, and that they see a health care provider immediately if suffering any symptoms.” The seven Illinois cases received injections between January 3 and February 21. Investigation into the cause of the adverse events is ongoing. To date, no reports of meningitis or other life-threatening infections have been reported. Main Street Family Pharmacy has voluntarily initiated a recall of all sterile products, including MPA, in cooperation with state and federal authorities. Nearly 20 states received recalled MPA from Main Street Family Pharmacy since December 1, 2012. Main Street Family Pharmacy, LLC, is currently licensed by the Illinois Department of Financial and Professional Regulation, which is also investigating.

Illinois Department of Public Health 535 West Jefferson Street Springfield, Illinois 62761 Phone 217-782-4977 Fax 217-782-3987 TTY 800-547-0466 Questions or Comments