AAPC OIG: Compounded Drugs Should be Tracked

 

May 6th, 2014

A study conducted by the Office of Inspector General (OIG) found that neither the Centers for Medicare & Medicaid Services (CMS) nor Medicare administrative contractors (MACs) have a way to track the number of claims they process for compounded drugs under Part B or how much they pay for such claims. As such, the OIG recommends CMS make some changes that could affect the way providers report compounded drugs on claims.
Compounded drugs are medications customized to meet specific needs of patients. These specialized drugs pose significant health risks if not produced correctly by licensed pharmacists in accordance with the Federal Food, Drug, and Cosmetic Act. An outbreak of fungal meningitis and other fungal infections in late 2012 was linked to contaminated injectable compounded drugs.
Medicare doesn’t pay for compounded drugs knowingly produced in violation of the Act, as determined by the Food and Drug Administration (FDA), but has no way of knowing if it is or not. The OIG contends in the April 29 report, Compounded Drugs Under Medicare Part B: Payment and Oversight, that the ability for CMS to track claims payment of compounded drugs, as well as who produced the drugs, would reduce improper payments.
Based on findings from the study, the OIG recommends in the report that CMS:

1. Establish a method to identify Part B claims for compounded drugs;
2. Explore the possibility of requiring providers to identify on the Part B claim the pharmacy that produced the compounded drug; and
3. Explore the possibility of conducting descriptive analyses of Part B claims for compounded drugs.

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Pharmacy owner serves jail time for Medicaid fraud

ALBANY, N.Y. (AP) — A pharmacy owner has been sentenced for his part in a scheme that drained $16 million from the state Medicaid program.

Attorney General Eric Schneiderman said Monday that 41-year-old Raheel Pervez of Dix Hills will serve one to three years for his part in a scheme that billed Medicaid for

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Des Moines pharmacy owner's trial delayed - Washington Times

Des Moines pharmacy owner's trial delayed - Washington Times

Louis Romanet has reaffirmed the IFHA's commitment to horse welfare and medication control

Romanet spoke of the IFHA's commitment to both issues during the session, which also featured a presentation from world sports medicine expert Dr Perikles Simon, under the heading 'Leveling the Doping Field'.
"The IFHA must be proactive. The integrity of racing and horse welfare are absolute priorities," Romanet said before detailing two significant elements of IFHA policy which he said had been universally endorsed.
"The first is agreement on control of medications including international screening limits and detection times. The second is a commitment to the detection of doping agents and prohibited practices in and out of competition. The IFHA supports a total ban on raceday medication and bans on anabolic agents throughout a horse's career," Romanet said.
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FDA Seeks Input On Limiting Interstate Shipment Of Compounded Drugs

FDA met privately with stakeholders from states in late March to seek input on how to regulate interstate shipment of compounded drugs.

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Medication Health Fraud Public Notification: Natural Body Solution Contains Hidden Drug Ingredient

Medication Health Fraud Public Notification: Natural Body Solution Contains Hidden Drug Ingredient

Medication Health Fraud Public Notification: Slim Trim U Contains Hidden Drug Ingredient

Medication Health Fraud Public Notification: Slim Trim U Contains Hidden Drug Ingredient

California Board of Pharmacy Disciplinary Action against Indio Medical Pharmacy

Indio Medical Pharmacy, PHY 21267, Administrative Case AC 4569
Indio, CA
Through a disciplinary action of the Board, the license is revoked, the revocation stayed, and the license is placed on probation for five years and is subject to the terms and conditions in the attached decision.
Decision effective 5/1/2014.
View the decision

Louisiana Board of Pharmacy Revised Board Meeting Agenda for May 7, 2014

05-07-2014     Board Meeting   (revised 05-05)             Public Meeting Binder

05-07-2014     Reinstatement Committee

Second Question of the Day May 6, 2014 Are we any closer to a federal or state indictment in the NECC outbreak?

World's Largest Racing Conference Begins in Hong Kong

The Asian Racing Conference (ARC) got under way in Hong Kong May 5 with a full agenda of seminars focused on the business of racing, featuring topics such as the future landscape for wagering, the use of cutting edge technology in sports broadcasting, the issue of drug control, the community impact of racecourses, and the international movement of elite horses. A first-time participant at the conference was the executive council of the International Federation of Horseracing Authorities.


Read more on BloodHorse.com: http://cs.bloodhorse.com/blogs/around-the-globe/archive/2014/05/05/world-s-largest-racing-conference-convenes-in-hong-kong.aspx#ixzz30wmq66Vq

Racing Authorities have the conviction to enforce stringent drug rules

Mr Louis Romanet, Chairman of the International Federation of Horseracing Authorities (IFHA) reaffirmed his organisation's commitment to horse welfare and medication control on Tuesday at the session titled ‘Fair Competition and Drug Control’ at the 35th Asian Racing Conference in Hong Kong.

Romanet spoke of the IFHA’s commitment to both issues during the session, which also featured a presentation from world sports medicine expert Dr Perikles Simon, under the heading 'Leveling the Doping Field'.

"The IFHA must be proactive. The integrity of racing and horse welfare are absolute priorities,” Romanet said before detailing two significant elements of IFHA policy which he said had been universally endorsed.

"The first is agreement on control of medications including international screening limits and detection times. The second is a commitment to the detection of doping agents and prohibited practices in and out of competition. The IFHA supports a total ban on raceday medication and bans on anabolic agents throughout a horse's career," Romanet said.

Delegates heard that it is vital to the credibility of horse racing that everything is done to keep the sport ‘clean’ and retain the confidence of its participants, its fans and, crucially for racing’s finances, those who wager on horseracing - while noting that racing is far from the only sport facing this issue.

Dr Simon, from Johannes Gutenberg University in Germany, is a sports medicine and molecular biologist who is at the cutting edge of the fight against doping in sport. He was one of the original seven-member ‘Gene Doping’ group of experts within the World Anti-Doping Agency (WADA), charged with developing strategies for the prevention and detection of non-therapeutic use of gene protein in sport.
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2014 Griffith Dairy 4/22/14

2014 Griffith Dairy 4/22/14

2014 Greer Laboratories Inc 4/21/14

2014 Greer Laboratories Inc 4/21/14

CVM Updates FDA Approves HALAMID Aqua to Treat Disease in Freshwater Fish

CVM Updates FDA Approves HALAMID Aqua to Treat Disease in Freshwater Fish

Of Pills and Profits: In Defense of Big PharmaJuly/August 2006

By Peter W. Huber

THE MORE our health depends on their little pills, the more we seem to hate big drug companies. In The Constant Gardener (2000), John le Carre assigns to the pharmaceutical industry the role played by the KGB in his earlier novels. A villainous pharmaceutical company is using Kenya as a testing ground for a lethally defective drug, and people who find out about it die, too. Four recent, non-fiction indictments of the industry tell a similar story.[1] Conflating the four into one, one might tide them collectively How Big Pharma Deceives, Endangers, and Rips Us Off, with the Complicity of Doctors.

Two of these books are by former editors of the prestigious New England Journal of Medicine. Slamming the drug companies, Marcia Angell argues that Big Pharma, as it has come to be called, "uses its wealth and power to co-opt every institution that might stand in its way, including the U.S. Congress, the Food and Drug Administration, academic medical centers, and the medical profession itself." Slamming the medical profession, academics, and professional organizations, Jerome P. Kassirer, Angell's former boss, labels them Big Pharma's "whores."
The bill of particulars, drawn from the books cited above, goes something like this. Most of what people believe about Big Pharma is just "mythology spun by the industry's immense public-relations apparatus." Forget miracle drugs—Big Pharma is not a "research-based industry," it is "an idea-licensing, pharmaceutical-formulating-and-manufacturing, clinical-testing, patenting, and marketing industry." As for "the few innovative drugs that do come to market," these "nearly always stem from publicly supported research" or are developed by small biotech firms. Big Pharma simply goes "trolling small companies all over the world for drugs to license." At most tweaking the chemistry of drugs developed by others, it advances medicine by "waiting for Godot."
Moreover, these me-too drugs "usually target very common lifelong conditions—like arthritis or depression or high blood pressure or elevated cholesterol." Many just aren't needed, because older drugs already work as well or better, or because the new drugs are peddled to people who aren't sick. Big Pharma is thus "primarily a marketing machine to sell drugs of dubious benefit."
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Obamacare Will Bring Drug Industry $35 Billion In Profits

Despite expiring patents on blockbuster drugs and a wave of new regulation from the Affordable Care Act that will cost drug makers, the pharmaceutical industry will reap between “$10 billion and $35 billion in additional profits over the next decade,” a new analysis shows.


The health law, which will bring millions of uninsured Americans health benefits beginning in January 2014, will be a critical boon to pharmaceutical industry balance sheets, increasing revenue by one-third by the end of the decade, according to a new report from research and consulting firm GlobalData of London. That means the U.S. pharmaceutical industry’s market value will mushroom by 33 percent to $476 billion in 2020 from $359 billion last year.
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Big Pharma stands to profit by cleaning out its medicine chests

(Reuters) - Leading global pharmaceutical companies have started to view their vast portfolios of older, established prescription drugs as vehicles for raising large sums of cash to fuel development of new medicines with far higher profit margins.
France's Sanofi (SASY.PA) and U.S. drugmakers Merck & Co (MRK.N) and Abbott Laboratories (ABT.N) are exploring selling off their mature drugs that have lost patent protection, Reuters reported this week, citing people familiar with the plans. Officials at the three companies declined to comment.
The divestments could bring in more than $7 billion for Sanofi, north of $15 billion for Merck and over $5 billion for Abbott, the sources said, giving them considerable firepower to develop, or buy, promising experimental medicines.
Such a shift would also remove a source of pricing pressure, since many of the older medicines are sold in emerging markets, where governments are increasingly demanding lower prices.
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Bayer wins Merck & Co's $14 billion consumer unit auction

Reuters) - Germany's Bayer AG has trumped rival bidders for Merck & Co Inc's consumer care business in a $14.2 billion deal, adding to a string of major cross-border deals in the healthcare industry.
"This acquisition marks a major milestone on our path towards global leadership in the attractive non-prescription medicines business," Bayer's chief executive Marijn Dekkers said in a statement on Tuesday.
Merck said it expects after-tax proceeds of between $8 billion and $9 billion from the sale, which is expected to close in the second half of 2014.
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Must Read! Pharmacy Marketing Quarterly-Spring Issue--Interview with David Miller, Executive Vice President and CEO, and Cynthia Blankenship, Vice President of Government Affairs

Pharmacy Marketing Quarterly – Spring Issue

Read the latest issue of Pharmacy Marketing Quarterly. In this issue, PMQ  Publisher, Scot Maitland, interviewed David Miller, Executive Vice President and CEO, and Cynthia Blankenship, Vice President of Government Affairs, about being prepared for IACP’s Compounders on Capitol Hill.

Read the Current Issue Online

In wake of botched execution, pharmacies pressured to halt lethal drug sales to states: Fair?

By John Luciew | jluciew@pennlive.com The Patriot-News
Email the author | Follow on Twitter
on May 01, 2014 at 7:20 AM, updated May 01, 2014 at 9:54 AM

The battle over capital punishment in America has moved from the prison gates to the pharmacy aisle. It is here that anti-death penalty groups are pressuring pharmacies and drug companies to refuse to supply lethal drugs for executions in the U.S. And in wake of yesterday’s botched execution in Oklahoma, in which a new lethal drug mix resulted in an inmate’s agonized and prolonged death, the pressure is only intensifying.
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May 6, 2014, 9:15 a.m. EDT

Pharmagen Recruits Frederick W. Mundt as Senior Vice President of Sales

SILVER SPRING, Md., May 6, 2014 /PRNewswire/ -- Pharmagen, Inc. (otcpink:PHRX) (the "Company" or "Pharmagen") today announced that Frederick W. Mundt has accepted the position of Senior Vice President of Sales.  Frederick ("Fred") begin on May 2, 2014.  Fred's addition is key to building out the Pharmagen Team.  Fred brings a wealth of knowledge and experience in sales, business development and operational leadership.  Highlights of Fred's experience includes: nine years with Astellas Pharmaceuticals, ten years with Ortho Biotech Inc., and most recently he served as Director, Commercial Deployment and Alignments with Quest Diagnostics.
"Fred's rich experience in direct sales organizations as well as his most recent role at Quest Diagnostics where he was integral in building out their sales capacity and processes made Fred the clear leader amongst a strong talent pool provided by Tim Tolan, Senior Partner at Sandford Rose Associates – The Toland Group.  We conducted an intricate selection process and Fred's skills and professionalism, especially his detailed understanding in how to build a sales organization were the determinate factors in his selection," says Boyd Relac, Chief Operating Officer.  Relac continued, "We have a plan built for Fred to hit the ground running immediately gaining incremental sales momentum for Pharmagen so we can quickly begin hiring field sales professionals to call across and expand our customer base of hospitals, and physicians who conduct in-office dispensing of non-script pharmaceuticals as well as prescription based referrals.  I really want to thank Tim Tolan who sourced a strong field of candidates which we are continuing to consider as we build a professional sales capacity and especially for bringing Fred to Pharmagen."
Commenting on his new role, Mr. Mundt stated, "This is a very exciting time to be joining Pharmagen as they are poised for growth. The executive team is taking all of the necessary steps to be the leader in specialty drug, compounding and admix delivery. This is a great opportunity for me to leverage my experience building and developing commercial sales teams and to drive incremental sales growth for company. Joining the leadership team is truly an honor and I look forward to our bright future."
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Question of the Day May 6, 2014 How many humans take compounded preparations made for animals? How many humans give their animals compounded preparations made for animals? Are there only isolated incidents or is the abuse widespread?

In Email Exchanges, Oklahoma Officials Joked About Trading Lethal Injection Advice For Football Tickets

National attention turned to Oklahoma’s death penalty protocol last week after Clayton Lockett was slowly tortured to death during an execution gone awry. But the execution was the latest development in a long-running battle to continue putting people to death, even when the only way to do to is using unknown, untested drugs for lethal injections.
Emails recently obtained by the Colorado Independent reveal Oklahoma officials joking about their success in securing legal access to the controversial execution drugs. After Texas lawyers sought help from Oklahoma in arguing that they were justified in using new, untested drugs for executions, Oklahoma officials quipped in a 2011 email chain they would help them out exchange for coveted football tickets and a “commemorative plaque at halftime recognizing Oklahoma’s on-going contributions to propping up the Texas system of capital punishment.”

Among those involved in the emails was Stephen Krise, who is now General Counsel of the state’s Department of Public Safety. The head of that Department, Michael Thompson, was selected to lead an independent investigation into the botched execution of Lockett. While it is not clear whether Krise will be directly involved in the investigation, the American Civil Liberties Union points out that his affiliation calls into question the neutrality of the investigation.
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Recent Health Policy Briefs: Regulating Compounding Pharmacies and Basic Health Program Update by Tracy Gnadinger

Gnadinger points out that "compounding pharmacy industry initially catered to patients with specialized needs. Since the 1990s, many compounding pharmacies have also begun engaging in what is now called nontraditional compounding: manufacturing certain drugs in large quantities for sale to doctors’ offices and hospitals."  Read her blog here 

5/6/14 - TherapeuticsMD to Showcase the Design of Its Replenish Trial at the International Menopause Society's 14th World Congress [Professional Services Close - Up]

TherapeuticsMD, Inc., a women's healthcare company, will detail the design of its Replenish Trial, a large-scale pivotal phase 3 clinical trial to evaluate TX-001HR, the first oral combination for FDA approval of 17estradiol and progesterone in a single capsule for the treatment of menopausal symptoms, at the session on May 2 of the International Menopause Society's 14th World Congress. According to a release, the investigational combination product being studied in the phase 3 Replenish Trial uses SYMBODA, an advanced technology developed and patented by the Company for solubilizing bio-identical hormones estradiol and progesterone. TherapeuticsMD will present the study plan for its proprietary formulation at this year's gathering of the International Menopause Society, the leading global, nonprofit association dedicated to promoting women's health education and research. "The combination of the bio-identical hormones 17estradiol and natural progesterone in a single oral dose represents a novel alternative for treating menopausal vasomotor symptoms in women with a uterus," said Sebastian Mirkin, M.D., Chief Medical Officer of TherapeuticsMD, who will present the study design for TX-001HR, the Company's investigational combination drug candidate. Hormone therapy (HT) combining estrogen with a progestogen is considered to be the most consistently effective treatment for menopause symptoms for non-hysterectomized women. Currently there is no single FDA-approved product combining these two natural hormones. While compounding pharmacies produce unapproved combinations, the variable purity and potency have led many medical societies to choose not to recommend them. TX-001HR is an oral agent that, if approved, will be the first FDA approval of an oral combination of 17estradiol and progesterone in a gelatin capsule, representing a significant advancement in treatment options. "We are encouraged by the potential of our SYMBODA technology to deliver an exciting first for HT dosing. If approved, our lowest combination dose containing 0.25 mg 17estradiol and 50 mg natural progesterone could prove to be the lowest available dose of both hormones administered orally," Dr. Mirkin said.

6-month stay sought in delayed Oklahoma execution

Sean Murphy Associated Press

Updated:   05/05/2014 06:12:57 PM EDT

OKLAHOMA CITY (AP) — Attorneys for an Oklahoma inmate who was to be put to death the same night as a botched execution asked the Oklahoma Court of Criminal Appeals on Monday to grant a stay for at least six months pending a review into what went wrong last week. Lawyers for Charles Warner cited last Tuesday's execution of Clayton Lockett, who writhed on the gurney, gritted his teeth and moaned before being pronounced dead of an apparent heart attack 43 minutes after the execution began.
The stay should be granted "until evidence can be provided to counsel for Warner that the state of Oklahoma can carry out a humane, constitutional execution," according to the emergency application for a stay.Warner's attorney, Susanna

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ABA CLE Anti-Kickback Law Basics May 8, 2014

Anti-Kickback Law Basics The AKS impacts a broad range of transactions, arrangements, and relationships in the health care industry. Nearly any arrangement involving federal health care program business (e.g., Medicare and Medicaid) necessitates at least a basic analysis under the AKS. Attendees of this program will hear panelists focus on: The Fundamental knowledge necessary to analyze arrangements under the AKS Exceptions and Safe Harbors to the AKS Key distinctions between the AKS and other fraud and abuse laws The impact of the Affordable Care Act and other recent legislative changes Thursday, May 8, 2014 12:00 PM - 1:30 PM ET Webinar 1.5 CLE credits requested $115 Section Members $150 ABA Members $195 General Public Special Government Pricing Available: $115 for the first registrant and $50 for each additional registrant at the same location. Sponsors Health Law Section Young Lawyers Division    Register for the latest CLE specialty program from the American Bar Association Too busy to attend? Pre-purchase the recorded program now. Audio CD-ROM Ships 5/29/14 Available at ShopABA.org Also from the ABA Fundamentals of Medicare/Medicaid(Audio CD-ROM) Audio CLE 1.5 credit requested $175 General Public $125-145 ABA Members Health Care Fraud National Institute May 14-16, 2014 Hotel Nikko San Francisco, CA $1,375 General Public $1,095 - $1,255 ABA Members Civil False Claims Act and Qui Tami Enforcement National Institute June 4-6, 2014 Park Hyatt Washington, DC $1,285 General Public $965 - $1,095 ABA Members

FDA Law Blog: May 05, 2014

Favorable Ruling for Companies Defending Off-Label Promotion Cases

By Anne K. Walsh –
Most news involving the False Claims Act reports that a company paid large sums of money to the government and relators to settle allegations of off-label promotion.  Not so in this post about a recent decision dismissing a relator’s complaint.  Not only did the company win, for now, but the court made some helpful statements to support dismissal of other complaints with similarly defective allegations.
The relator, Laurie Simpson, worked for seven years at Bayer Corporation, during which tenure she helped market and promote Trasylol, a prescription drug approved by FDA for patients undergoing coronary artery bypass graft using a cardiopulmonary bypass pump to prevent excess bleeding.  Simpson alleged that Bayer violated the False Claims Act by “engag[ing] in a campaign of concealment and disinformation concerning Trasylol’s safety and efficacy.”  At the heart of Simpson’s Eighth Amendment of the 131-page Complaint containing 30 causes of action, is the allegation that Bayer promoted Trasylol for other types of surgeries and failed to provide safety and efficacy information about those other uses, resulting in the drug being misbranded under the Federal Food, Drug, and Cosmetic Act (“FDC Act”). 
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Asian Racing Conference opens in Hong Kong

The Chief Executive of the Hong Kong Special Administrative Region (HKSAR), Leung Chun-ying, struck a ceremonial gong to signal the start of the 35th Asian Racing Conference (ARC) during a stunning opening ceremony and gala dinner at the Hong Kong Convention and Exhibition Centre Monday night.
The regional flag of the Hong Kong Special Administrative Region hung proudly alongside those of the Asian Racing Federation's member nations and regions as Hong Kong Jockey Club Chairman T. Brian Stevenson welcomed a record number of almost 800 delegates, as well as media and invited guests, gathered from around the globe. The guests included Louis Romanet, Chairman of the International Federation of Horseracing Authorities, and Ingmar de Vos, Secretary General of the International Equestrian Federation.
Stevenson spoke of Hong Kong's "amazing vibrancy and blend of cultures" as he addressed those present ahead of what is the world's largest and most significant horseracing industry conference

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Horse Racing Industry Must Act Diligently, Says RCI Chief

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FDA Regulation of Compounding Pharmacies: Unsolved Mysteries: BakerHostetler

The U.S. Food and Drug Administration (FDA) has been busy since the passage of the Drug Quality and Security Act (DQSA) in November 2013. In just five short months, the FDA has issued six warning letters referencing the DQSA’s outsourcing facility provisions, published three draft guidance documents outlining its authority and enforcement priorities under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA) and conducted an “Inter-Governmental Working Meeting on Pharmacy Compounding” with officials from state boards of pharmacy and national trade organizations to discuss implementation of the DQSA. The FDA also welcomed the addition of almost 40 newly registered “outsourcing facilities” that have voluntarily registered with the FDA in exchange for the opportunity to compound drugs without a prescription for office use and to ship compounded drugs across state lines without restriction. But this flurry of activity also has resulted in several important unanswered questions under the DQSA, particularly as to where certain entities fit in relation to Section 503A, which governs traditional compounding pursuant to identifiable patient prescriptions, and Section 503B, which governs the newly created outsourcing facilities.

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US FDA asks Indian pharma leaders to make quality, their top priority

By Soma Das, ET Bureau | 5 May, 2014, 01.18PM IST

Read more at:
http://economictimes.indiatimes.com/articleshow/34679309.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

Another Job Opending for Pharmacy Marketing/Sales Representative

Pharmacy Marketing/Sales representative

Job Description:

Pharmacy Marketing/Sales Representative background in either pharmaceutical sales or a Pharmacy Tech who has experience with compounding who has either worked in sales or who is outgoing and would like to call on physicians offices promoting specialty pharmacy and compounding services in manhattan. Position is Full time with benefits. Paid vacation, holidays, medical insurance 401k and bonus potential. Pharmacy is located on the upper west side of manhattan. We require pre employment drug testing, criminal background check etc.

Click below to apply. If you can't click the link, copy and paste it into your browser.

http://dd2eb22d.dxjob1.com/004cfd3a

• Principals only. Recruiters, please don't contact this job poster.
• do NOT contact us with unsolicited services or offers

Tougher pharmacy rules eyed

Hune: Proposed legislation could have prevented meningitis deaths

Bills requiring out-of-state medical compounders to have one accountable pharmacist could have prevented a fungal meningitis outbreak that claimed eight Livingston County lives, state Sen. Joe Hune, R-Hamburg Township, said.
Last week, Hune’s legislation placing new regulations on compounding pharmacies in Michigan and those doing business in Michigan was approved in the Senate Health Policy Committee.
The bills were in response to the 2012 fungal meningitis outbreak linked to tainted steroids from the New England Compounding Center, or NECC, in Massachusetts. The tainted pain injections were administered at multiple Michigan clinics, including Michigan Pain Specialists in Genoa Township.
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Indiana Adopts Model Racehorse Drug Rules; Group has Doubts

Indiana Adopts Model Racehorse Drug Rules; Group has Doubts

Asmussen: PETA Allegations 'Completely False'

Asmussen: PETA Allegations 'Completely False'

Sunshine and Slaughter: Horse racing: dying to win

If the Kentucky Derby and other horse races conjure up images of fancy hats and mint juleps, it’s time to take off the blinders.
Horse racing is big business, with no regard for the well-being of the horses.

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World racing body reaffirms horse movement pledge

World racing body reaffirms horse movement pledge

Biggest Success? DCF Overhaul--What Florida Legislators Accomplished

By Carol Gentry       
Compounded Drugs: HB 7077 closes a loophole in Florida law that posed a significant danger to the public from out-of-state compounding pharmacies, which make drugs and ship them to hospitals and clinics in Florida.  Current law allows the Department of Health to license and inspect only those compounders based in Florida, but hundreds of compounders in other states also have Florida licenses.
DOH took a survey after the New England Compounding Pharmacy in 2012 caused an outbreak of fungal meningitis that killed scores of patients in many states, including Florida. Hearings and work by the Board of Pharmacy determined that pharmacies that make “sterile” drugs – usually liquid drugs that must be kept sterile because they enter the bloodstream – must be required to get a permit.
But while the Board of Pharmacy could require that of pharmacies in-state, the loophole eliminated the requirement for those based out-of-state. (See: Time to Fix Glitch in Pharmacy Law?)

quoted from here

CMS Doubts Power Of Purse To Stem Public Health Crises With Compounded Drugs

 

By Sue Sutter / Email the Author / View Full Issue
Reimbursement / Word Count: 1193 / Article # 00140505010 / Posted: May 5 2014 12:00 AM

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Executive Summary

Medicare agency disagrees with HHS Office of Inspector General recommendation that providers be required to identify the source of compounded drugs submitted for Part B payment.

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Compounding User Fees Reinforce Inspections As Central To FDA

 

By Sarah Karlin / Email the Author / View Full Issue
Regulatory Update / Word Count: 1568 / Article # 00140414010 / Posted: May 5 2014 12:01 AM

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Executive Summary

Guidance serves as reminder that inspections are at heart of FDA mission, particularly when it comes to quality enforcement; fees are bargain compared to GDUFA, PDUFA, but come with penalties for reinspection.

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Benefits of Veterinary Compounding

Drug compounding has found effective applications in formulating veterinary medications. It can prepare the exact medicines by modifying the dosage or flavour to make them suitable to treat specific health conditions of pets. Find out the major benefits of veterinary compounding in this article read article here

Medicated Feeds

Medicated Feeds

FDA Previously Inspected Weatherford Compounding Pharmacy 10/3-5/11; 10/13/11; and 2/3/12; FDA 483 from those inspections Can Be Viewed Here

Weatherford Compounding Pharmacy FDA 483  Page 1
Weatherford Compounding Pharmacy FDA 483 Page 2

Hospira and Cubist Pharmaceuticals Recall Medications Due to Presence of Particulate Matter

April 30, 2014 4:00 PM Topics: Fda

Hospira, Inc, of Lake Forest, IL, and Cubist Pharmaceuticals, Inc, of Lexington, MA, are voluntarily recalling products due to the presence of particulate matter. The recalled products are:

Cubist Pharmaceuticals

• CUBICIN^® (daptomycin for injection) 500 mg (Lot Number 280453F).

Hospira, Inc

• 0.25% Marcaine^TM (bupivacaine HCI Injection, USP) 10 mL, single-dose vial – Preservative Free (Lot Number 34-440-DD).
• 1% Lidocaine HCI Injection, USP, 10 mg/mL, 30 mL single dose, Preservative Free (Lot Number 31-427-DK).
• Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL). Lot Numbers:
  • 29-614-DJ, 29-615-DJ, 29-616-DJ, 26-617-DJ
  • 29-628-DJ, 29-629-DJ, 29-630-DJ

Depending on size, if undetected, particles could block administration of the drug to a patient, causing a delay in therapy. Other complications could include local inflammation and phlebitis. Health care providers should stop use and distribution, quarantine the products, and follow the instructions in the appropriate recall announcement, available in the Recalls, Market Withdrawals, and Safety Alerts section of FDA’s website. Adverse reactions may be reported to FDA’s MedWatch Adverse Event Reporting Program.

quoted from NABP found here

Brown’s Compounding Center Expands to Serve Montana Residents | Brown's Compounding Center

Brown’s Compounding Center Expands to Serve Montana Residents | Brown's Compounding Center

Press Release: Brown’s Compounding Center Hires Peter M. Campanella to Oversee Operation of World-Class Sterile Compounding Facility | Brown's Compounding Center

Press Release: Brown’s Compounding Center Hires Peter M. Campanella to Oversee Operation of World-Class Sterile Compounding Facility | Brown's Compounding Center

Research Roundup: Compounding Pharmacies; Marketplace Details; Changes In Insurance Coverage

read the Kaiser Health Report here

Yesterday at 1:53 AM State takes action against Canadian online pharmacy In a unanimous ruling Thursday, the state ruled that Canadadrugcenter.com is violating state law by marketing low-cost prescription drugs By Eric Russell erussell@pressherald.com Staff Writer

The Maine Board of Pharmacy has directed the Attorney General’s Office to send a cease-and-desist letter to a Canadian company that has been marketing low-cost prescription drugs to Mainers since last fall.

The board also has directed the attorney general to launch a formal investigation of the actions of Canadadrugcenter.com.

“We are pleased with the board’s decision. We think it was the right course of action,” said Kenneth “Mac” McCall, president of the Maine Pharmacy Association, who filed a complaint with the board in January.

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