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Wednesday, July 31, 2013

History of sterile compounding in U.S. hospitals: Learning from the tragic lessons of the past

History of sterile compounding in U.S. hospitals: Learning from the tragic lessons of the past

Senate should act efficiently on drug compounding bill

A Senate vote for legislation that would put some compounding pharmacies under the FDA's regulatory oversight would be a crucial step even if it's not yet clear how the House will act, according to this editorial. The bill's approval would show Congress is ready to help prevent events similar to last year's fungalmeningitis outbreak tied to the New England Compounding Center.
 Washington Post (tiered subscription model), The

Rep. Cummings and Tierney Release GAO Report on Drug Compounding

 

FOR IMMEDIATE RELEASE

Members Urge Action on Legislation to Protect Nation’s Drug Supply
 
Washington, DC (July 31, 2013)—Today, Rep. Elijah E. Cummings, the top Democrat on the House Committee on Oversight and Government Reform, and Rep. John Tierney, Ranking Member of the Subcommittee on National Security, Homeland Defense and Foreign Operations, released a report from the Government Accountability Office (GAO) on the oversight of pharmaceutical drug compounding.
 
Cumming and Tierney requested the report last year after a fungal meningitis outbreak from a contaminated compound drug led to more than 50 deaths and hundreds of illnesses.
You may read the full report on the Oversight Committee website by clicking here.

Congress should consider clarifying FDA's authority over compounding, GAO says--FDA officials said they had to obtain 11 warrants to gain access to drug compounders' facilities that had challenged FDA's inspection authority.”

By Jessica Zigmond 
Posted: July 31, 2013 - 7:15 pm ET


Congress should think about clarifying the Food and Drug Administration's authority to oversee drug compounding, the Government Accountability Office concluded in a report released on Wednesday.

A deadly outbreak of fungal meningitis linked to contaminated compounded drugs in 2012 led to a series of federal hearings on Capitol Hill last fall. In those heated discussions, FDA Commissioner Dr. Margaret Hamburg implored lawmakers for more clarity on her agency's authority over compounding, a process in which a pharmacist combines, mixes or changes ingredients to create a drug that is tailored to an individual's needs.


Read more: Congress should consider clarifying FDA's authority over compounding, GAO says | Modern Healthcare http://www.modernhealthcare.com/article/20130731/NEWS/307319946#ixzz2agWCkXAQ 
?trk=tynt 

Follow up to The Thriving Compounding Pharmacy Industry In Tampa Bay Post

Thank you to Kenneth N. Woliner, M.D., A.B.F.M for the following information:

1.  Previous post entitled The Thriving Compounding Pharmacy Industry In Tampa Bay  is a press release.  It was put out by Father David, LLC d/b/a "Maxcare Pharmacy" (http://ww2.doh.state.fl.us/IRM00PRAES/PRASINDI.ASP?LicId=18803&ProfNBR=2205) in an effort to promote their compounding pharmacy directly to patients, not just to doctors.  Actually, they are using this press release to promote SPECIFICALLY TO PATIENTS, not doctors.  BTW, MaxCare Pharmacy's website is: http://www.maxcare-pharmacy.com/
 
FATHER DAVID, LLC
LICENSE NUMBER: PH25823Printer Friendly Version

 
2.  The supervising pharmacist is Rita Shoukry, R.Ph.  She has only had a license since October 6, 2011.  Not exactly years and years of experience. 

3.  Dr. Scott Gottleib has nothing to do with this pharmacy.  He might be surprised that they are using his name (and quotes from him, supposedly from a Forbes magazine article), as a way of promoting their pharmacy.  Shouldn't he be "paid" for being a spokesman for this company?  If I found out that a private company was using quotes from me in this manner, I would have my lawyer send them a "cease and desist" letter, telling them to stop, and to remunerate for the false use of my name.

 
4. Father David, LLC d/b/a MaxCare Pharmacy is actually owned by its supervising pharmacist.  This is RARE IN FLORIDA.  Florida is one a few states that doesn't prohibit unlicensed persons from owning medical clinics (such as the pain clinics that have been pumping out Oxycontin, Oxycodone, Xanax and Soma - creating addicts from Florida to Kentucky to Ohio ...; such as "Rejuvination Clinics" that pump out steroids (testosterone) and Human Growth Hormone (HGH) to Major League Baseball Players such as Alex Rodriguez and Ryan Braun; such as diet clinics that pump out HCG and Phentermine ... etc.    http://search.sunbiz.org/Inquiry/CorporationSearch/ConvertTiffToPDF?storagePath=COR%5C2011%5C1019%5C40461724.tif&documentNumber=L11000119630

5.  The reason why I bring up the "corporate practice of ____" (medicine, pharmacy, etc) - is that Florida is a hotbed for criminal activity because unlciensed businessmen (a.k.a. the mafia) will start these clinics and pharmacies as an easy way to do Medicare/Medicaid fraud, and/or prescribe/dispense drugs without medical justification.  Florida is the laughing-stock of the country.

6.  Regardless, this pharmacy wants to break into the compounding pharmacy business because it is so lucrative, and because regulation and enforcement is so lax.  Hopefully, the U.S. Congress will not water down the Senate Bill going through the sausage-making machine.  Hopefully, Florida's Legislature will pass stricter laws, but actually enforce the laws they have.  I'm not as hopeful for Florida doing its part.  We don't have a good track record, and there are so many probems I've uncovered at the Florida Department of Health's Bureau of Enforcement (that are not being addressed), that I feel that Florida will feed poisonous drugs to the nation for a long time to come (just look at Franck's Compounding Lab, Signature Pharmacy, etc.).

California Board of Pharmacy Webcast, Agenda and Meeting Materials for July 30-31, 2013

July 30-31, 2013
Webcast 7/30/13
Webcast 7/31/13
Department of Consumer Affairs
1625 N. Market Blvd.
1st Floor Hearing Room
Sacramento, CA 95834
AgendaMeeting Materials
  source found here

Healthy Life Chemistry Supplement Product Contains Anabolic Steroids, FDA Warns


quoted from NABP

 Topics: Patient Safety
FDA is warning consumers not to use a product marketed as a Vitamin B dietary supplement due to the presence of potentially harmful anabolic steroids. The product, Healthy Life Chemistry by Purity First B-50, was found to contain methasterone, a controlled substance, and dimethazine, ingredients which are not listed in the product’s labeling and should not be in a dietary supplement, indicatesFDA. This product is sold online and in retail stores and FDA notes that the company, Purity First Health Products, has declined to voluntarily recall the product or to warn consumers about the potential for injury. The agency has received reports of 29 adverse events associated with use of the products, including reactions such as “fatigue, muscle cramping, and myalgia (muscle pain), as well as abnormal laboratory findings for liver and thyroid function, and cholesterol levels. Females who used this product reported unusual hair growth and missed menstruation, and males who used the product reported impotence and findings of low testosterone.” FDA advises that anyone experiencing such symptoms should consult a health care provider and warns that use of products containing anabolic steroids may cause acute liver injury and other serious long-term consequences. FDA advises health care providers to ask patients about their use of dietary supplements, particularly if patients are exhibiting symptoms that may be associated with the use of steroids or steroid-like substances. Adverse reactions should be reported to FDA’s MedWatch program either by completing and submitting an online report or by downloading, completing, and faxing the form to 800/332-0178.

Deceptive Practices By Illegal Online Drug Sellers Give Consumers a False Sense of Legitimacy and Safety, Reports NABP


Quoted from NAPB--

 Topics: Counterfeit Drugs and Buying Medicine Online
National Association of Boards of Pharmacy® (NABP®) recently issued a report emphasizing the deceptive practices that illegal online drug sellers use to make consumers believe that they are legitimate, safe, and trustworthy. As detailed in the Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: July 2013 (PDF), NABP discovered numerous examples of Web sites falsely claiming to be accredited through the Association’s VIPPS® (Verified Internet Pharmacy Practice SitesCM) accreditation program, sites selling counterfeit versions of brand-name drugs, and sites claiming to be Canadian that dispense prescription drugs without any prescription and sell counterfeit versions of brand-name drugs.
NABP reviews and monitors Web sites selling prescription drugs to patients in the United States and its findings are also presented in the report released last week – of more than 10,000 Web sites analyzed, nearly 97% operate out of compliance with pharmacy laws and practice standards established to protect public health in the US and many other developed countries.
Consumers in the US tend to be particularly trusting of online drug sellers purporting to be Canadian pharmacies, many of which sell drugs that are neither approved by Health Canada nor legal to sell in Canada or the US. In the last quarter alone, NABP discovered a cluster of so-called Canadian “pharmacy” sites that also offer counterfeit versions of brand-name drugs and offer to dispense prescription drugs without any prescription. NABP’s findings are supported by a July 2013 report from the US Government Accountability Office on Internet pharmacies that stated, “Many rogue Internet pharmacies seek to take advantage of this perception [of safe drugs obtained at an affordable price] by purporting to be located in Canada, or sell drugs manufactured or approved for sale in Canada, when they are actually located elsewhere or selling drugs sourced from other countries.” Furthermore, some of the medicines being sold on these Web sites may be too strong, too weak, fake, expired, stolen, diluted, or impure.
To help consumers in the US find the safest sources for purchasing medicine online, NABP developed the VIPPS accreditation program. Consumers are encouraged to look for the VIPPS Seal on an accredited site and check NABP’s list of accredited sites on its consumer protection Web site,www.AWARErx.org. The Web site is part of the AWARxE® Consumer Protection Program, provided by NABP and the state boards of pharmacy to help educate the public about the risks of Internet drug outlets, and includes news, tips, and links to relevant NABP resources.
The full news release is available in the Newsroom section of the NABP Web site.

Domperidone Not FDA Approved, Should Not be Marketed in the US, FDA Stresses



Quoted From NABP

 Topics: Compounding and Patient Safety

Food and Drug Administration (FDA) stresses that domperidone is not an FDA-approved drug, and that it may not be legally marketed in the US. In June 2004, FDA warned compounding pharmacies and firms that supply domperidone for use in compounding that it is illegal to compound domperidone. In addition, FDA put into place an import alert permitting FDA personnel to detain domperidone shipments of bulk ingredients and shipments of finished drug products offered for importation without an active investigational new drug application. These actions resulted from FDA's concern about the potential health risks associated with the use of domperidone in lactating women. These risks include cardiac arrhythmias, cardiac arrest, and sudden death.
Although domperidone is not FDA approved, FDA recognizes there are some patients with severe gastrointestinal motility disorders that are refractory to standard therapy who may benefit from the use of domperidone and in whom the benefits of the drug may outweigh its risks. Domperidone is available to these patients through an Expanded Access to Investigational Drugs program. Under this program, domperidone may be obtained only from certain specified suppliers and authorization must be obtained prior to the importation, interstate shipment, and administration of the drug. According to FDA, currently the only authorized supplier of the drug is Dougherty’s Pharmacy in Dallas, TX.
Boards observing that an entity may be obtaining or compounding domperidone under circumstances not in compliance with FDA regulations are encouraged by the agency to report any concerns. Pharmacists may direct any questions to the FDA Division of Drug Information by sending an e-mail todruginfo@fda.hhs.gov or by calling 855/543-3784 or 301/796-3400.

Texas Board of Pharmacy Agenda for August 6, 2013 Meeting Includes Final Report of Task Force on Compounding

Know What It Means To Be ‘On the Flagpole’?


July 30, 2013 | 6:45 p.m.

You don’t have to work on Capitol Hill too long to realize the place has its own language. Lawmakers become “members.” A short-term legislative solution becomes a “patch.” And issues get their own shorthand, from the “doc fix” to “net neutrality.”
Ever wonder how all this lingo takes root?
For answers, one might look to Sen. Lamar Alexander, R-Tenn., whose pet phrase “on the flagpole” appears to be gaining traction, at least among a small subset of Hill staffers, lawmakers, lobbyists, and officials.
The expression may puzzle you, especially if you’re not familiar with the debate surrounding pharmaceutical compounding, where it is most often—or even exclusively—used. You may feel the urge to e-mail a colleague who has covered health care issues for years to see if it’s a pharmaceutical term of art. It’s not. It’s an Alexanderism used to describe the person or agency responsible for something.
A fatal fungal-meningitis outbreak last fall—the result of tainted steroid injections—has spurred proposed legislation to tighten restrictions on the type of pharmacies that mix custom drugs, a process known as compounding. Alexander, the ranking member on the Senate Health, Education, Labor, and Pensions Committee, wants to make sure someone is accountable for overseeing those facilities—or, as he says, to make clear who is “on the flagpole.”
Alexander has been using the phrase for more than 30 years. “My experience in life is that if it’s clear who’s on the flagpole, the job usually gets done,” he told National Journal Daily.
He traces its origins to his time as governor of Tennessee. “In my first Cabinet meetings I would say, ‘Why don’t we do X?’ Everyone would agree, ‘Let’s all do X.’ A month later, X wasn’t done. I learned the hard way that everybody does nothing,” Alexander recalled in a 1986 memoir of his governorship, Steps Along the Way. “I developed a new procedure. When something was important, someone went ‘up the flagpole.’ ”
Alexander brought the phrase to Capitol Hill during the recent discussions on pharmaceutical compounding, using—and defining it—in several printed editorials that have run in Tennessee newspapers (one 484-word piece cited the term four times).
It’s catching on, as these things tend to do.
“We had advised that any compounding manufacturer would also have to hold a pharmacy license in the state in which they were located. And I understand the reason for not doing that was to make the flagpole clear,” said Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, at a May hearing.
Carmen Catizone, executive director of the National Association of Boards of Pharmacy, said at the same hearing, “We are concerned … that allowing the FDA access to pharmacy records for activities that are regulated by the states could create a confusing situation, could take people off the flagpole.”
Joseph Hill, director of federal legislative affairs for the American Society of Health-System Pharmacists, first heard the phrase at a HELP Committee hearing last year. “This regulatory gray area or legal gray area has been around for quite some time, so as soon as [Alexander] mentioned the phrase ‘on the flagpole, who is it going to be?’ I understood exactly what he was saying, because that’s been the problem,” he said. Now, ASHP uses the phrase internally, Hill says.
The popularization of the phrase among staffers and others gives Alexander hope. “I appreciate the fact that staff members listened to senators, and that senators were listening to each other and that the FDA was listening, too, and so maybe we’ll find the principle of accountability—well, it is the central feature of this solution to a really terrible public health tragedy,” he said.
But despite its spread, the neologism conjures different images among those who use it.
“I wasn’t sure whether it meant, frankly, like who’s on the flagpole—like someone’s sitting on top of the flagpole looking for something—or someone’s responsible for raising a flag, like flagpole duty,” said David Ball, president of Ball Consulting Group, which works with the International Academy of Compounding Pharmacists on media relations. “Growing up at school, there was always someone [on] flagpole duty.”
Hill had a different image in mind: “I kind of picture, you know, someone who didn’t do their job being tarred and feathered and tied to a string, and they raise this person up the flagpole for all to see they didn’t do their job,” he said.
Alexander pictures “somebody flapping in the wind, so it’s absolutely clear whose job it is to get it done.”
This article appears in the July 31, 2013, edition of National Journal Daily as Do You Know What ‘On the Flagpole’ Means?.
Get the latest news and analysis delivered to your inbox. Sign up for National Journal's morning alert,Wake-Up Call, and afternoon newsletter, The Edge. Subscribe here.



Mounting Opposition To Compounding Bill Plagues Efforts To Advance Legislation Before Recess

Groups this week launched competing efforts to save and defeat Senate compounding legislation after a manager's amendment emerged that lawmakers intended to quickly advance but did not address concerns raised by most pharmacy stakeholders.

The Thriving Compounding Pharmacy Industry In Tampa Bay

The Thriving Compounding Pharmacy Industry In Tampa Bay

DRUG COMPOUNDING: Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight GAO-13-702, Jul 31, 2013

50 page report is available http://www.gao.gov/products/GAO-13-702?source=rahere

What GAO Found

The authority of the Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), to oversee drug compounding is unclear. Two federal circuit court decisions have resulted in differing FDA authority in different parts of the country. According to FDA officials, these inconsistent decisions and the agency's limited inspection authority over pharmacies have created challenges in FDA's ability to inspect and take enforcement action against entities engaging in drug compounding. For example, from 2002 through 2012, in order to inspect some facilities engaged in drug compounding, FDA officials said they had to obtain 11 warrants to gain access to drug compounders' facilities that had challenged FDA's inspection authority. GAO also found that while FDA and national pharmacy organization officials generally agreed that states regulate the practice of pharmacy and FDA regulates drug manufacturing, there was no consensus on whether compounding drugs in large quantities--in anticipation of individual prescriptions or without prescriptions--and selling those drugs across state lines falls within the practice of pharmacy or is a type of drug manufacturing that should be overseen by FDA. This lack of consensus and differing FDA authority to oversee compounded drugs across the country has resulted in gaps in oversight of drug compounding.
FDA lacks timely and reliable information to oversee the entities that compound drugs, but has found problems through its limited oversight. Specifically, FDA's inspection database cannot identify all of the agency's inspections of compounding pharmacies, or the final classification of inspection results, for all of the inspections. Until 2013, FDA limited its inspections of compounding pharmacies to those conducted in response to complaints or adverse events. However, the agency recently inspected compounding pharmacies that it identified as posing a significant threat to public health from poor sterile drug production practices in the past and found problems, such as concerns about a lack of sterility, which resulted in recalls of compounded drugs. In addition, drug manufacturers are required to register with FDA and are subject to FDA's inspection and drug approval processes; pharmacies meeting certain requirements are generally exempt from registration. However, some compounding pharmacies may have registered with FDA to market themselves as "FDA-registered" which may lead some purchasers to assume that FDA has inspected or approved their compounded drugs; whereas, according to FDA officials, this is generally not the case.
The states GAO reviewed--California, Connecticut, Florida, and Iowa--have each taken actions to enhance their oversight of drug compounding. For example, Florida required all pharmacies--both those located in the state and out-of-state that sell drugs in Florida--to notify the board of their compounding activities. In addition, national pharmacy organizations have undertaken efforts to help states oversee drug compounding. For example, a national pharmacy organization is working with Iowa to inspect out-of-state pharmacies that ship drugs into the state. However, according to national pharmacy organizations and officials from state boards of pharmacy, some states do not have the resources to inspect pharmacies on a regular basis. Instead, these states inspect pharmacies only in response to a complaint or a reported adverse drug event.

Why GAO Did This Study

Drug compounding is the process by which a pharmacist combines, mixes, or alters ingredients to create a drug tailored to the medical needs of an individual. An outbreak of fungal meningitis in 2012 linked to contaminated compounded drugs has raised concerns about state and federal oversight of drug compounding. GAO was asked to update its 2003 testimony on drug compounding. Specifically, this report addresses (1) the status of FDA's authority to oversee drug compounding, and the gaps, if any, between state and federal authority; (2) how FDA has used its data and authority to oversee drug compounding; and (3) the actions taken or planned by states or national pharmacy organizations to improve oversight of drug compounding. GAO reviewed relevant statutes and guidance; reviewed FDA data; and interviewed officials from FDA, national pharmacy organizations, and four states with varied geography, population, and pharmacy regulations.

What GAO Recommends

To help ensure that the entities that compound drugs have appropriate oversight, Congress should consider clarifying FDA’s authority to oversee drug compounding. In addition, FDA should ensure its databases collect reliable and timely data on inspections associated with compounded drugs, and differentiate drug compounders from manufacturers. HHS's comments support the need to clarify FDA's authority, and stated that the information in its inspection database could be improved and that it would consider whether it can differentiate compounding pharmacies from manufacturers.

APIC | APIC endorses compounding oversight legislation

APIC | APIC endorses compounding oversight legislation

'Sunshine-ing' on Docs Signals End to Pharma Largesse

WASHINGTON -- There aren't many gifts physicians can take from drug companies after this week without it becoming publicly reported.
Maybe a low-cost breakfast or midday snack and coffee. The little knick-knacks given out at exhibit booths. (Drug companies don't give office supplies like pens and note pads any more.)
Starting Thursday, drug and device manufacturers and group purchasing organizations must report payments or gifts in excess of $10 made to physicians in a yearly basis under the Physician Payments Sunshine Act. Those payments will be displayed on a public website starting next fall.
"A lot of items are going to be reported," Tom Sullivan, president of the medical consulting group Rockpointe Corporation in Columbia, Md., told MedPage Today in a phone interview.
There are a few exceptions, according to the American Academy of Family Physicians:
  • Gifts or payments valued at less than $10 -- unless the aggregate amount paid to the physician exceeds $100 annually
  • General food and drinks offered to all participants at conferences or large-scale events
  • Educational materials and items intended for use by or with patients
  • Samples intended for patient use, including coupons and vouchers for obtaining samples
  • Payments or other transfers of value to residents

Medical groups also pushed hard for CMS to exempt speaker fees for accredited continuing medical education programs, which CMS granted. Publicly reporting such information would have a "chilling effect on doctors if they want to go to an accredited event that they'll show up on this public Open Payments database," Andy Rosenberg, JD, senior adviser at theCME Coalition, a group of CME sponsors and providers, told MedPage Today.
Pharmaceutical companies underwrite about a third of today's accredited CME programs, he said.
Programs approved by the Accreditation Council for Continuing Medical Education, the American Dental Association's Continuing Education Recognition Program, the American Academy of Family Physicians, the American Medical Association, and the American Osteopathic Association are exempt from public reporting.
Although data collection starts Thursday, CMS won't release the data on the public website till Sept. 20, 2014. Manufacturers must report the data to CMS by March 31, 2014. CMS will post the information on its website on June 30 in subsequest years.
But CMS will allow physicians 45 days to dispute the data before they are public, and doctors can seek corrections within a 2-year period. The agency and medical groups like theAmerican Medical Association are encouraging providers to take those steps and open a dialogue with patients about transparency.
Physicians can register with CMS starting Jan. 1 to receive a report on their activities each June before the public report is released. CMS also is pushing the smartphone application called "Open Payments Mobile for Physicians" which tracks payments and other value transfers manufacturers will report.
"Physicians can certainly access the website on which manufacturers report the information and see whether the information the manufacturers report matches the doctors' own understanding and then request revisions if they believe those are required," Alan Sager, professor of health policy and management at Boston University, told MedPage Today in a video interview.
Sullivan said he doesn't expect much to change in the doctor-drug company relationship, just more tracking and reporting on interactions between the two sides.
"I don't see pharma changing a whole lot of how they do business other than writing down who they do business with," Sullivan said.


 
 

Quesion of the Day July 31, 2013 Do organizations such as IACP which advocated in the past for its members to resist FDA inspections or PCAB which granted accrediation to compounding pharmacies have any civil or criminal liability in the deaths and illness from compounding medications?


Who lobbied for meningitis victims?


This interesting article on Livingston Daily.com  makes some key points about who is lobbying for those who became ill and those who died:
Is there a connection between the lack of congressional action and the amount of lobbying done by pharmaceutical interests? That would be an interesting topic for Congress to study while trying to deflect responsibility.

There may be no connection. This might have been a rogue company that was operating negligently with tragic results.

One thing is likely. It’s a good bet that none of the Livingston County residents who died had a lobbyist representing them when regulations were being discussed — or ignored — in Washington.
The article can be read here 
.

PEW Charitable Trust Letter dated July 29, 2013 to Support Senate Bill 959

Allan Coukell, senior director of drugs and medical devices, sent a letter to Senators Tom Harkin and Lamar Alexander in support of S.959, The Pharmaceutical Quality, Security and Accountability Act.
If passed, the bipartisan legislation would improve patient safety by enhancing the security of the drug supply chain.

July 29, 2013
The Honorable Tom Harkin
U.S. Senate
135 Hart Senate Office Building
Washington, DC 20510
The Honorable Lamar Alexander
U.S. Senate
455 Dirksen Senate Office Building
Washington, DC 20510
Dear Chairman Harkin, and Ranking Member Alexander,
I write on behalf of The Pew Charitable Trusts, an independent research and policy organization, to express support for S.959, The Pharmaceutical Quality, Security and Accountability Act. This bipartisan legislation will improve patient safety by meaningfully enhancing the security of the drug supply chain. This legislation will also take steps to improve federal oversight of certain aspects of pharmacy compounding.
Congress has been trying to address vulnerabilities in the U.S. pharmaceutical supply since it passed the Prescription Drug Marketing Act of 1987. S.959 is an important improvement over the status quo by ensuring there will be a national unit-level serialization and traceability system to track the movement of drugs throughout the entire supply chain in 10 years.
Congress has also long struggled with how to regulate the growing pharmacy compounding industry. This bill recognizes that the industry has changed significantly over the last several decades and attempts to mitigate the risks associated with large-scale production of sterile drugs by bringing under federal oversight any facility that produces (1) sterile products, (2) without, or in anticipation of, a prescription, and (3) sells those products into interstate commerce. This addresses certain high-risk facilities while leaving traditional pharmacy dispensing essentially untouched. The safety of compounded drugs is a critical public health issue, and the failure of the status quo is illustrated by numerous incidents, including the recent fungal meningitis outbreak that has cost so many lives. The time for Congress to act is now.
Thank you again for your bipartisan commitment to improving the safety of the U.S. drug supply by addressing gaps in both our drug distribution security system and the oversight of pharmacy compounding. We would also like to thank Senator Burr and Senator Bennet as leaders on drug supply chain security and Senator Roberts and Senator Franken as champions for the compounding provisions of the bill. We would also like to thank all of your staff for their dedication and professionalism. We applaud your efforts to date, and we look forward to continue working with you to make this legislation as strong as possible on behalf of all consumers.
Sincerely,
Allan Coukell
Senior Director, Drugs and Medical Devices
The Pew Charitable Trusts
- See more at: http://www.pewhealth.org/reports-analysis/issue-briefs/pew-letter-to-us-senate-in-support-of-s959-85899493884#sthash.MFTrhEeS.dpuf

Tuesday, July 30, 2013

Alliance for Natural Health Advocates Urgent Action Because Vote May Be Near

read here

Mixing track-and-trace, compounding: Would bill unfairly burden pharmacies? | Drug Store News

Mixing track-and-trace, compounding: Would bill unfairly burden pharmacies? | Drug Store News

Bringing compounding pharmacies under federal regulation

 

A FUNGAL meningitis infection last year that spread in contaminated vials of medicine distributed by the New England Compounding Center in Framingham, Mass., led to 749 people becoming ill and 61 deaths in 20 states. Without doubt, this outbreak could and should have been prevented. Now, Congress is making headway toward writing laws that would prevent similar occurrences.
This is not the first time Congress has attempted to tackle the problems of so-calledcompounding pharmacies, lightly regulated firms that mix and ship medicines to hospitals and clinics, but previous efforts were frustrated by lawsuits and ultimately were ineffective. A legacy of the 2012 outbreak must be hard and fast rules that would prevent another disaster.
continue to read here