Wednesday, April 24, 2013

Is this on Average How Much A Compounding Pharmacist Makes--86 percent higher than average salaries for other jobs nationwide?

Average Salary of Jobs Matching Your Search

In USD as of Apr 24, 2013		45k	90k	135k
Compounding Pharmacist owner	$125,000

Average Compounding Pharmacist owner salaries for job postings nationwide are 86% higher than average salaries for all job postings nationwide.

Compounding Pharmacist owner Salary Trend

Average Salary of Jobs with Related Titles

In USD as of Apr 24, 2013		45k	90k	135k
Pharmacist	$111,000

Berger v. New England Compounding Pharmacy, Inc. et al

Indianapolis-Based Compounding Pharmacy Issues Multi-State Recall of Nearly 100 Products

Kroger Pharmacy Expansion Is Contaminated By A Compounder

The compounding pharmacy scandal has caused still more collateral damage and this time, it involves one of the largest supermarket chains in the US. Who are we talking about? Kroger KR -0.23%, which owns Axium Healthcare Pharmacy, a specialty operator that the food and pharmacy retailer purchased last year in a bid to broaden its already large and fast-growing pharmacy business (look here and here).

Last month, however, the FDA issued a 483 inspection report to an Axium unit called Balanced Solutions Compounding Pharmacy for a host of manufacturing violations. And earlier this week, the compounder recalled all lots of its sterile, unexpired products due to a lack of sterility assurance and concerns with product quality controls (here is the recall announcement).

continue reading here

http://www.bna.com/fdas-responsibilities-continue-n17179873557/

13).
The overall FY 2014 request is $821 million, or 21 percent, above the 2012 enacted level, according to the budget proposal. Of the $821 million increase, only $52 million is from budget authority. Industry user fees would fund 94 percent of the proposed budget increase.

New Responsibilities Under FDASIA
Hamburg said the Food and Drug Administration Safety and Innovation Act (FDASIA) gave FDA new responsibilities, which, among others, require the agency to speed medical product reviews and reduce drug shortages.
Under FDASIA, FDA also is required to consider patient views on treatments, Hamburg said.
She said FDA is launching a patient network website that is meant to encourage patients to share ideas.
FDA also “has nearly completed an implementation plan” for FDASIA and “you can look for that in the near future,” Hamburg said.

Drug Shortages
Hamburg said the agency has seen some quality lapses in recent years that have caused drug shortages. “Drug shortages have increased fivefold since 2006,” she said.
Hamburg said quality is a major concern for the agency, and quality depends on the companies that manufacture drugs and devices.
“Quality has to be built into products,” she said. “Quality that's built into a product prevents problems.”
Hamburg said, “We've made progress in correcting and heading off drug shortages.” She noted, however, that quality issues continue.

Compounding Pharmacies
Quality issues also caused the recent fungal meningitis outbreak that is linked to 53 deaths, Hamburg said. The outbreak was caused by contaminated drugs produced by a compounding pharmacy.
“This terrible tragedy must be a wake-up call to our nation,” she said.
Hamburg said FDA recently completed a series of inspections of compounding pharmacies and in some facilities found sterility problems and other issues that could cause contamination. For instance, Hamburg said inspectors found that some technicians were handling sterile products with their bare hands.
FDA inspectors “ran into resistance” from some compounding pharmacies, Hamburg said. “These obstacles are not new, and this is why I've asked Congress for additional authorities.”
Under these new authorities, nontraditional compounding would be subject to federal standards, Hamburg said. Traditional compounding pharmacies typically produce a small amount of custom-made medications for consumers who have a prescription. Nontraditional ones manufacture without prescriptions large quantities of drugs that are sometimes shipped over state lines.
Hamburg said under the new authorities, nontraditional compounding pharmacies would be required to report adverse reactions to FDA, and the agency would have clear authority to examine their records.
Hamburg said FDA's current authorities over compounding pharmacies “are limited and lack clarity.”
“New legislation is needed to address safety concerns and to provide a more tailored approach for compounding,” she said.
By Bronwyn Mixter

source found here

Question of the Day: 4/24/2013 With Constant Talk About All the Illegal Kickbacks Offered at Conventions by Both Human and Animal Compounders Why Are There Not More Health Fraud Prosecutions by

the Department of Justice in this area especially when Health Care Fraud is one of the Number One Priorities of DOJ? Why aren't states that have health care fraud statues prosecuting cases that the federal governement does not have jurisdiction to prosecute? How much does this illegal behavior of kickbacks and fraud effect good compounders and eventually run the good compounders out of business?

All Sterile Compounded Products by Nora Apothecary And Alternative Therapies: Recall - Lack of Sterility Assurance April 23, 2013

Posted 04/23/2013]
ISSUE: Nora Apothecary & Alternative Therapies announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection
BACKGROUND: The recall includes sterile products that Nora Apothecary & Alternative Therapies supplied to patients and offices of licensed medical professionals. Specifically, the recall includes approximately 95 dosage units of sterile compounded products that the pharmacy supplied to offices of twelve licensed medical professionals located within Indiana. Some patients that received products from those medical professionals may be live in states other than Indiana. The recall also includes approximately 400 prescriptions compounded for patients within Indiana and four other states: four prescriptions for patients in Illinois; and one prescription each for patients in Ohio, Florida and Tennessee. See the firm press release for a list of products.
The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. To date, Nora has received no reports of injury or illness associated with the use of our sterile products.
RECOMMENDATION: Consumers or health care providers with questions regarding this recall may contact Nora Apothecary & Alternative Therapies by phone at 800-729-0276 or 317-251-9547 from the hours of 9:30AM- 6:00PM Eastern Daylight Time Monday through Friday, or at the following e-mail address: pharmacist@noraapothecary.com. Patients who have received any product furnished by Nora Apothecary & Alternative Therapies and have concerns should contact their healthcare provider.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/22/2013 - Firm Press Release - Nora]

Senators Release Draft Bill to Create National Drug Track-and-Trace System Wednesday, April 24, 2013

By Bronwyn Mixter

Members of the Senate Health, Education, Labor, and Pensions (HELP) Committee April 19 released a discussion draft of a bill that would create a national traceability system for pharmaceuticals.
Sens. Michael Bennet (D-Colo.), Richard Burr (R-N.C.), Tom Harkin (D-Iowa), and Lamar Alexander (R-Tenn.) said in a press release that their draft bill would improve patient safety by replacing the “patchwork of state product tracing laws with a strong, uniform standard that would ultimately result in electronic, interoperable unit level product tracing for the entire country.” Harkin is chairman of the HELP Committee and Alexander is the ranking member.
“Ensuring the integrity and security of our prescription drug distribution system is critically important. To ensure consumers know that the medications they take are safe--not adulterated, counterfeit, or otherwise compromised, it is important to know where these drugs have been at every step of the way--from the manufacturer to the pharmacy,” Harkin said. “There is bipartisan consensus that we must improve the oversight of our prescription drug supply chain. This draft legislation reflects the work of Senators Bennet, Burr, and Alexander, along with my office, and I look forward to seeking further input as we move towards a final bill for introduction and Committee consideration.”
Track-and-trace provisions were taken out of the Food and Drug Administration user fees bill before it was passed by the Senate in 2012. At that time, Burr, Bennet, and Harkin said they would continue to work to get a track-and-trace bill passed.
This legislation does not deal with safety issues at compounding pharmacies, the senators said. The HELP Committee expects to release draft legislation on compounding “sometime” this week, they said.
Meanwhile, the House Energy and Commerce Committee has scheduled an April 25 hearing on the topic of securing the prescription drug supply chain.

Supply Chain
The draft Senate bill would require moving from a lot-level tracing system to a unit-level tracing system over the course of a decade, the senators said. It would require the entire drug supply chain, including manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers, to pass along transaction information, transaction history, and transaction statements, as applicable, when there is a change of ownership. Additionally, no one in the supply chain would be allowed to accept drugs if this information is not provided as part of a transaction, they said.
The proposal also strengthens licensure requirements for wholesale distributors and requires FDA to keep a database of wholesale distributors that will be available to the public on FDA's website, the senators said. “This empowers both consumers and members of the pharmaceutical distribution supply chain to identify appropriately licensed wholesalers,” they said.
The senators said they are asking stakeholders to provide feedback, including their level of support for the overall proposal, in addition to any comments regarding the feasibility of this framework, and any technical feedback to help improve the draft bill.
Comments on the draft bill are due April 26, the senators said. Comments may be sent to drugdistributionsecurity@help.senate.gov. A spokesman for Bennet told BNA April 22 that the senators hope to introduce the bill “soon.”
In October 2012, the Senate HELP Committee released a similar discussion draft bill for a national drug traceability system.

Stakeholders Respond
The Pharmaceutical Distribution Security Alliance (PDSA) April 19 applauded the senators for moving forward with the draft legislation. PDSA is a coalition of more than 25 stakeholders spanning the supply chain spectrum, including biopharmaceutical manufacturers, distributors, pharmacies, and logistics providers. The Pharmaceutical Research and Manufacturers of America (PhRMA) is a member of PDSA.
“We commend this bipartisan commitment to better protecting American patients and consumers through a single, uniform and national pharmaceutical distribution supply chain solution, and we are encouraged by this latest development,” PDSA said in a statement. “The release of this draft bill is an important step forward and demonstrates the commitment by many in Congress to enacting a supply chain solution now.”
PDSA said it “looks forward to thoroughly reviewing this draft and to working with lawmakers and other stakeholders to protect the health of patients and consumers by further safeguarding the pharmaceutical distribution supply chain.”

The draft bill is at http://www.help.senate.gov/imo/media/TAM13064.pdf.Source found at http://www.bna.com/senators-release-draft-n17179873564/

Services for George Malmberg

GEORGE J., RPh, FACA, FACVP, Co-founder and Chief Executive Officer of Wedge-wood Pharmacy, passed away on April 22, 2013 in Wilmington DE, following a brief illness. A resident of Sarasota FL, he was 64. With his loving wife of 39 years, Lucy Malmberg, RPh, FACA, FACVP, he transformed a New Jersey community pharma-cy they purchased in 1981 into one of the largest specialized compounding pharmacies in the United States, with more than 230 employees serving tens of thousands of prescribers and millions of people and animals.
Mr. Malmberg was an icon in the compounding pharmacy profession, a friend and beloved mentor to many who lead and will lead the industry. He was a passionate advocate for the rights of prescribers and pharmacists to develop custom-ized medicines for people and animals. He was generous with his time, money and talent, frequently leading efforts to defend the legal rights of compounding pharmacists and patients who need access to personalized medications. His leadership, wisdom and clarity will be sorely missed at Wedge-wood Pharmacy, on the national stage and on Capitol Hill.
He is survived by his wife, Lucy Malmberg; his sister-in-law, Gloria (Bruce) Bartow and his siblings, Karen (Thom) Cole, Steve, Richard, Paul and Kim Malmberg.
Celebrate Mr. Malmberg's life on Saturday, April 27, 2013, at Brandywine Valley Baptist Church, Seven Mount Lebanon Road, Wilmington DE. Friends and family may call from 9 to 11 A.M., followed by Celebration of Life at 11 A.M. A reception follows the Service. In lieu of flowers, please support one of Mr. Malmberg's favorite causes: The University of the Sciences, General Scholarship Fund 600 S. 43rd St. Philadelphia PA 19104 and Sunday Breakfast Mission 110 N. Poplar St. Wilmington DE 19801.
For online condolences visit:

www.mccreryandharra.com
302-478-2204

Published in Philadelphia Inquirer & Philadelphia Daily News on April 24, 2013

APhA-ASP Summer Leadership Institute -

July 12-14, 2013 in Washington, DC

Read more about APhA-ASP Summer Leadership Institute - Traveling to Washington, DC

SLI Registration and Program Information

APhA--Markey report: More FDA oversight of compounding pharmacies needed in light of state ‘deficiencies

Five House Democrats sent letter to boards of pharmacy requesting information

Rep. Ed Markey (D-MA) yesterday released a report that argued for more FDA authority over certain compounding pharmacies based on findings that show they are “largely untracked, unregulated, and under-inspected by states across America,” according to a news release from his office.
The report, State of Disarray: How States’ Inability to Oversee Compounding Pharmacies Puts Public Health at Risk, resulted from a letter sent by Reps. Markey, Henry Waxman (D-CA), John Dingell (D-MI), Frank Pallone Jr. (D-NJ), and Diana DeGette (D-CO) to boards of pharmacy in all states, territories, and Washington, DC, requesting answers to six questions. All boards of pharmacy—except Rhode Island, Guam, Puerto Rico, and the U.S. Virgin Islands—responded to the letter.
These Members of Congress are Democratic members of the House Energy & Commerce Committee, and all but Pallone are members of its Subcommittee on Oversight and Investigations (with Dingell as a nonvoting member). Markey’s report came before today’s House Energy & Commerce Subcommittee on Oversight and Investigations hearing, with FDA Commissioner Margaret A. Hamburg as the only scheduled witness.
“Deficiencies associated with state record-keeping, communication, resources, and specialized expertise combined with the inability of any single state to monitor the adequacy of compounding pharmacy safety in 49 other states appear to be systemic barriers to relying solely on the states to assure the safety of compounded drug products,” according to the report. “The FDA needs clear, unambiguous authority that would enable it to set and enforce safety standards for the riskiest and largest compounding pharmacies, as well as those that sell compounded drugs across state lines.”

Continue reading here

APhA- House hearing: FDA seeks stronger authority over compounding pharmacies: Republicans not so sure new legislation needed; Democrats’ request for IACP testimony rejected by Republicans

At today’s hearing held by the House Energy & Commerce Subcommittee on Oversight and Investigations, FDA Commissioner Margaret A. Hamburg, MD, repeatedly argued for new legislative authority over the highest-risk compounding pharmacies even as questions posed by the Republican majority conveyed skepticism about the need for new legislation.

The 3-hour investigative hearing, A Continuing Investigation into the Fungal Meningitis Outbreak and Whether It Could Have Been Prevented, featured testimony under oath primarily by one witness—Hamburg—as well as a lawyer at FDA. Throughout the hearing, Hamburg often responded that she could not answer questions because of the ongoing criminal investigation.

Hamburg’s introductory testimony barely dipped into her written testimony, which referred to the 1997 law that added section 503A to the Food, Drug, and Cosmetic Act, and to subsequent conflicting court decisions interpreting the law differently for different parts of the country.

Continue to read here

Viewing Countries Continues to Grow—Added Guatemala, Finland, and Holland

Algeria

Argentina

Australia

Austria

Azerbaijan

Bahamas

Bangladesh

Barbados

Belgium

Bosina & Herzegovina

Brazil

Bulgaria

Cayman Islands

Canada

Chile

China

Columbia

Costa Rica

Croatia

Cyprus

Czech Republic

Denmark

Ecuador

Egypt

Estonier

Finland

France

Tuesday, April 23, 2013

Hamburg: Resource Constraints Limit Compounding Inspection Push

FDA Commissioner Margaret Hamburg said the agency needs more money and authority to keep its recent spate of surprise compounding pharmacy inspections going, but GOP House leaders rejected the request during a confrontational committee hearing last week.

SC pharmacist-lawmaker frequently authors bills that affect his industry By Watchdog Staff / April 23, 2013 /

By Rick Brundrett | The Nerve

COLUMBIA – Country music star Kenny Chesney’s planned concert on May 4 in Columbia apparently was important enough for state Rep. Kit Spires to sponsor a formal resolution last week on the House floor welcoming Chesney back to the Capital City.

It wasn’t the Lexington County Republican’s first attempt at introducing frivolous legislation.
When it comes to serious legislation, though, Spires, a licensed pharmacist and pharmacy owner, has spent a great deal of his time on bills affecting his industry. A review by The Nerve found that of 22 general bills sponsored by Spires since joining the General Assembly, seven, or nearly a third, were pharmacy-related.
Spires has two pharmacy-related bills this session: H. 3161, which would establish new regulations for “compounding” pharmacies, or pharmacies that mix or modify medications to fit the particular needs of patients; and H. 3151, dubbed the “Pharmacy Patient Protection Act,” which, among other things, would ban pharmacy benefits managers from discriminating in certain areas when contracting with pharmacies.
Read more at The Nerve.

Medical Quack: Branded Solutions Compounding Pharmacy Recalls All...

Medical Quack: Branded Solutions Compounding Pharmacy Recalls All...: The FDA was at work inspecting another compounding facility after the nightmare that occurred in New England with the deaths related to bact...

FDA 2013 Pharmacy Inspections--listed by dated 483 was issued through 4/17/20113

2013 Pharmacy Inspections

Persons with disabilities having problems accessing the PDF file(s) may call 301-796-3900 for assistance.

Updated List of 483 from FDA website

2013

Anazaohealth Corporation, Tampa, FL

483 Issued 2/22/2013 (PDF - 857KB)

ApothéCure, Inc., Dallas, TX

483 Issued 4/17/2013 (PDF - 1.6MB)
Firm Press Release: ApothéCure, Inc. Recalls All Lots of All Sterile Products Compounded, Repackaged, and Distributed by ApothéCure, Inc. Due to Sterility Assurance Concerns (4/15/2013)

Avella of Deer Valley, Inc, Phoenix, AZ

483 Issued 2/25/2013 (PDF - 1010KB)

Axium Healthcare Pharmacy (dba Balanced Solutions Compounding), Lake Mary, FL

483 Issued 3/15/2013 (PDF - 638KB)

Balanced Solutions Compounding Pharmacy, LLC.

Firm News Release: Balanced Solutions Compounding Pharmacy, LLC. Announces a Voluntary Nationwide Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (04/17/2013)

Central Admixture Pharmacy Services, Inc. (CAPS), Woburn, MA

483 Issued 1/29/2013 (PDF - 11.7MB)

Central Admixture Pharmacy Services, Inc. (CAPS), Wallingford, CT

483 Issued 2/19/2013 (PDF - 8MB)

Central Admixture Pharmacy Services, Inc. (CAPS), Homewood, AL

483 Issued 3/7/2013 (PDF - 600KB)

Central Admixture Pharmacy Services, Inc., (CAPS), Kansas City, MO

483 Issued 2/28/2013 (PDF - 697KB)

Central Admixture Pharmacy Services, Inc., (CAPS), Livonia, MI

483 Issued 2/28/2013 (PDF - 790KB)

Central Admixture Pharmacy Services, Inc., (CAPS), Chicago, IL

483 Issued 2/22/2013 (PDF - 974KB)

Clinical Specialties Compounding Pharmacy, Augusta, GA

483 Issued 4/2/2013 (PDF - 5.4MB)
Firm News Release: Clinical Specialties Compounding Pharmacy Recalls All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance (03/20/2013)

College Pharmacy Incorporated, Colorado Springs, CO

483 Issued 3/15/2013 (PDF - 1.3MB)

The Compounding Shop St. Petersburg, FL

Amended 483 Issued 3/25/2013 (PDF - 10MB)
483 Issued 3/22/2013 (PDF - 1.3MB)

Custom Compounding Center, Los Alamitos, CA

483 Issued 12/13/2012 (PDF - 577KB)

Drugs are Us, Inc. (dba Hopewell Pharmacy), Hopewell, NJ

483 Issued 3/21/2013 (PDF - 1.5MB)

Foundation Care LLC, Earth City, MO

483 Issued 3/19/2013 (PDF - 867KB)

FVS Holdings, Inc. (dba Green Valley Drugs), Henderson, NV

483 Issued 3/15/2013 (PDF - 4.9MB)

Green Valley Drugs, Henderson, NV

Firm Press Release: Green Valley Drugs Announces Voluntary Nationwide Recall of All Lots of All Sterile Products Compounded, Repackaged, and Distributed by Green Valley Drugs Due to Quality Control Concerns (4/5/2013)

Home Intensive Care Pharmacy, Inc., San Antonio, TX

483 Issued 3/1/2013 (PDF - 1.1MB)

IV Solutions of Lubbock, Lubbock, TX

483 Issued 3/20/2013 (PDF - 3.7MB)

JCB Labs, LLC, Wichita, KS

483 Issued 2/27/2013 (PDF - 1.9MB)

Lee and Company dba Lee Pharmacy, Inc., Fort Smith, AR

483 Issued 2/21/2013 (PDF - 2.6MB)

Lowlite Investments, Inc. (dba Olympia Pharmacy), Orlando, FL

483 Issued 3/21/2013 (PDF - 717KB)

Lowlyn Pharmacies, Inc., Blanchard, OK

483 Issued 3/8/2013 (PDF - 732KB)

Medaus, Inc., Birmingham, AL

483 Issued 3/22/2013 (PDF - 712KB)

Medi-Fare Drug & Home Health Center, Inc., Blacksburg, SC

483 Issued 1/18/2013 (PDF - 3.5MB)
Warning Letter issued 3/07.2013

MedPrep Consulting, Tinton Falls, NJ

483 Issued 4/3/2013 (PDF - 6.9MB)
FDA Press Release: FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey (03/18/2013)
Firm News Release: Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/20/2013)
Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/17/2013)
Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of Magnesium Sulfate 2gm In Dextrose 5% In Water, 50ml For Injection Due To Mold Contamination (03/16/2013)

Nora Apothecary and Alternative Therapies, Inc., Indianapolis, IN

483 Issued 3/21/2013 (PDF - 309KB)

NuVision Pharmacy, Dallas TX

483 Issued 4/17/2013 (PDF - 1.2MB)
Firm Press Release: NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility Assurance Concerns (4/15/2013)

Oakdell Pharmacy, Inc., San Antonio, TX