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

How Makena, a Controversial Drug to Prevent Preterm Birth, Made a Comeback (lot of discussion about compounding 17P)

By STEPHANIE GLEASON

K-V Pharmaceutical Co., KVPHQ +21.97%a small drug maker, landed in bankruptcy court last year amid disappointing sales of its flagship medicine Makena and an outcry over the drug's high price.

Today, sales of Makena, used to prevent preterm birth, are surging.

K-V slashed the price of the drug by half. But a bigger reason for the gains, say many doctors, is an aggressive K-V campaign touting Makena as a safe alternative to cheaper versions of the drug made by compounding pharmacies.

Compounders, lightly regulated pharmacies that custom-mix drugs, have long provided a less expensive version of the main ingredient in Makena. But a string of meningitis deaths late last year linked to pain medicine from a Massachusetts compounding pharmacy medicine raised concerns about the safety of such drugs. Compounded medicines aren't approved by the Food and Drug Administration.

Doctors say K-V representatives have been pressing them to switch to Makena by reminding them of the potential for malpractice lawsuits should their patients fall ill after taking a drug formulated by a compounder.

"They've been in doctors' faces a lot more about the possible harm of compounded medications," said Armando Fuentes, a maternal-fetal medicine specialist at Children's Hospital Central California. "They've really ratcheted up their marketing," he said.

K-V in a statement said the recent "tragic cases" highlighted a need for information about the differences between compounded medicines and those that carry FDA approval. The St. Louis-based company added, "K-V is taking all responsible approaches to educate health-care providers to help avoid costly and painful unintended consequences" for patients and providers.

Compounders, for their part, say the compounded version is as safe as Makena. "We cannot conclude that there is  any disparity in quality between this manufactured drug and the compounded alternative," said a representative of the International Academy of Compounding Pharmacists, David Ball, citing a June 2012 FDA analysis that tested 16 samples of the compound and found them potent and pure.

continue reading here

Virginia HAS Enacted a compounding law which requires a current inspection report before an out-of-state compounding pharmacy can be registered!

Fox Business- DANGERS OF COMPOUNDING PHARMACIES Video

view here

CDC: ‘Multistate outbreak’ from drugs linked to Tenn. pharmacy

By Chelsea Conaboy, Globe Staff
May 31, 2013 2:13 p.m.

This isn’t deja vu. The Centers for Disease Control and Prevention sent out a press release today about a “multistate outbreak of infections following steroid injections.” This time it’s not related to New England Compounding Center, the Framingham pharmacy that produced tainted drugs officials say sickened more than 700 people, and killed 55.

Federal and state regulators announced last week that seven people had developed infections after receiving a steroid made at a Tennessee compounding pharmacy. The total is now up to 20 cases in three states, and the CDC has labelled it an outbreak.

The agency said on its website that most reports were of “skin and soft tissue infections of unclear etiology.” There have been no reports of meningitis or life-threatening infections.

The new outbreak is far less severe than the one involving New England Compounding, but there are commonalities. Both were caused by injectable methylprednisolone acetate, used to treat pain and inflammation, and both involved compounding pharmacies that are supposed to make sterile, individualized drugs for patients who need special doses or formulations.

New England Compounding was operating beyond that scope by producing large batches, more like a drug manufacturer, and in unclean facilities, regulators found. Tennessee was among the states hardest hit by that outbreak, with 15 deaths.

The latest issue, involving Main Street Family Pharmacy, in Newbern, Tenn., has affected patients in Florida, Illinois, and North Carolina. The Tennessean reported that the company has surrendered its license to operate in North Carolina, where patients have had skin abscesses.

No issues have been reported regarding other drugs produced at Main Street Family Pharmacy, but the company has recalled all products which were supposed to be made with sterile processes.

“Since this matter surfaced, Main Street Family Pharmacy has done everything in its power to ensure that all potentially affected compounded medicines are recalled and no longer used by consumers or health care providers,” a company statement sent by spokesman Joe Grillo said.

quoted form here 

The Essentials of Hospital Pharmacy Compounding Conference Friday, May 31, 2013 8:30am - 3:45pm MHA Conference Center at Executive Park Burlington, MA

PROGRAM OVERVIEW

With the increased federal and state focus on regulating and monitoring compounding practices at retail-based pharmacies - hospital based pharmacies need to continue their own due diligence to ensure they are meeting both federal, state, and national standards. What is not clear is the extent of the guidelines and standards that are being used by state regulators to review hospital based pharmacies. This program will provide a comprehensive look at best practices that hospitals should be using. We will also look at the proposed state law and current regulatory practices, providing examples of best practices hospitals should be considering when conducting internal audits of their own operations. To ensure that all hospitals are meeting national standards for quality and saftey, we have also invited both legislative and regulatory agency staff to discuss their latest efforts and to hear their expectations for providers' practice. We will conclude with a reactor panel to generate further discussion and provide an opportunity for dialogue.
AGENDA
8:30am      Overview of Current Legislation & Regulatory Initiatives                    Rep. Jeffrey Sanchez
                    Member of Massachusetts House of Representatives
9:00am       Hospital & Retail Compounding Pharmacies:
                    Expectations & Best Practices                    Madeleine Biondolillo, M.D., Director, Bureau of Health
                    Care Safety & Quality, Commonwealth of MA -
                    Dept. of Public Health
9:45am       BREAK
10:00am    The Essential Quality & Safety Elements for
                    Hospital Compounding Pharmacies                    Eric Kastango, MBA, RPh, FASHP, Principal
                    CLINICALIQ, LLC & CriticalPoint, LLC
11:30am    BREAK
11:45am     Infection Prevention in Hospital Compounding Pharmacy                  
                    Keith H. St. John, MS, CIC, Director, Clinical Epidemiology,
                    Pharmacy OneSource/Wolters Kluwer Health
12:30 pm    LUNCHEON
1:15pm       Best Practices for Audits, Internal Processes,
                    and Infection Control                    William Churchill, MS, R.Ph., Chief of Service,
                    Department of Pharmacy Services
                    Brigham & Women’s Hospital
2:30pm      Break
2:45pm      Update from the National Front                   Gary Kerr, PharmD, MBA, Chief Pharmacy Officer
                   Baystate Health, Inc., & President, Massachusetts Society
                   of Health-System Pharmacists
                    Reactor Panel: What if there is an Audit at Your Hospital?                    Moderator: Gary Kerr
                    Panelists will be the speakers from the program.
                    There will be time for audience interaction, Q&A
3:45pm       PROGRAM ADJOURNS