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Friday, February 28, 2014

IACP Provides Members with Legal Information on Which States Allow Office Use-No answer from Georgia, Illinois, and New Jersey. Also No Answer as to whether allowed in Puerto Rico, Guam and America Samoa

IACP Introduces the First Installment of its New Member Resource – the IACP Law Library

As part of our ongoing development of tools, programs and materials that help our members improve their professional and business practice, IACP is launching its IACP Law Library. As conceived, this law library will provide pharmacists with a comprehensive analysis of state pharmacy law and regulation that affect many day-to-day decisions.
Our first installment in the new IACP Law Library—Compounding for Office-Use is now available for purchase! Click here for purchase information.
Working in collaboration with the National Alliance of State Pharmacy Associations (NASPA), IACP created this resource after a lengthy and detailed review of the pharmacy statutes and regulations of the 50 states as they pertain to the sales of prescription drugs for office use to practitioners by pharmacies and compiled. That included checking wholesaler licensure laws and regulations (state PDMA laws), controlled substance regulations when referenced by the Boards of Pharmacy, as well as individual states’ labeling statutes and regulations. Once that was completed, the Boards of Pharmacy were contacted to confirm and obtain information, especially, for those states whose laws and regulations were not clear as to whether sales for office use is allowed and what the requirements are. Follow-up phone calls and emails were made to nearly 40 states. Only three states did not respond to our request for a formal review (Georgia, Illinois, and New Jersey). As an added check, several state pharmacy associations also reviewed the final chart.
Overview of Results
The majority of the states (42) allows pharmacies to sell any non-controlled prescription drug and compounded drugs to practitioners for office use. Six states specifically prohibit that activity, and two states appear to be silent. Silent means the statutes and regulations do not specifically say whether it’s allowed. As our phone calls to the states Boards revealed, silent does not necessarily mean it is not allowed. Many of the states Boards confirmed that although the statutes or regulations don't say office use is specifically permitted, the Boards allow by broad interpretation, board policy, or by common practice covered by a pharmacy’s license the provision of office-use prescriptions.
For the most part, those states that do specifically prohibit office-use prescriptions provide for a “sales” process instead and require that in lieu of a prescription, orders from practitioners must be placed via an invoice. Several of these states limit the amount of product that a pharmacy can sell to a practitioner for office use to either 5% of the total annual sales or 5% of the total dosages in a consecutive 12-month period. This five percent figure appears in many of the states controlled substances laws and is being applied by the Boards to sales for office use in general.
The percentage limitation is from the federal DEA Controlled Substances Act and rules. The five percent language was placed into some of the states PDMA laws – which deal with wholesaler licensure -- where the allowing of sales for office use also is found in an exemption provided in the definition of wholesale drug distribution. In these states, sales to practitioners are not wholesale drug distribution and do not require a wholesaler license. Many of the states providing the exemption limit the sales to 5%. If sales exceed 5%, then a pharmacy would be required to obtain a wholesale drug distributor license.
Unanswered Questions
Even the best research has limitations. Three states did not respond to our numerous phone calls and emails for clarifications and additional information. They are: Georgia, Illinois, and New Jersey.
  • Based on our review of the statutes and regulations, Georgia allows the sale to practitioners for legend drugs but is not clear as to whether such is allowed for compounded products.
  • Illinois and New Jersey allow the sale of compounded products for office use but appear to be silent as to whether legend drugs may be sold to a practitioner for office use.
IACP members doing business in those states should confer with the Board of Pharmacy if they have any questions.
Toward the end of our research, we were asked to determine whether Puerto Rico, Guam, and America Samoa allowed sales for office use. Phone calls have been made and emails sent; however, we have not received any response. Once received and confirmed, IACP will update our Law Library.
Quoted from and More information found here

Reminder the National Conference of State Legislators (NCSL) Has great Resources including links to all the current state compounding laws and the proposed legislation

found here

NCSL Meeting Session - Fall Forum, Dec. 6, 2013
Tracking Tracing and Compounding: An Update on Pharmaceutical Legislation

  • Jane Axelrad, Food and Drug Administration (FDA) - View slidesPresentation 
  • I. Bernstein, Food and Drug Administration (FDA)- View slides: Presentation 
  • Elizabeth "Scotti" Russell, Government Affairs Manager, National Association of Boards of Pharmacy (NABP), Illinois - View slides: Presentation 

A Prescription that Works for Pharmacy Risks--Compounding Pharmacy Insurance

A Prescription that Works for Pharmacy Risks
by Dan Springman

Once upon a time insurers would jump at the chance to provide a neighborhood pharmacy with a Business Owners Policy that included professional liability coverage by endorsement. But as the extent of this sector’s professional liability exposures has become apparent, many carriers have come to view the class as unattractive. Beazley’s approach is different. Working closely with pharmacies and their brokers to identify pharmacies’ exposures and ensure that appropriate risk management procedures are in place, we continue to provide competitive coverage while minimizing claims.


All pharmacies, from the largest national chains down to Main Street mom-and-pop shops, have substantial professional liability risks. Opportunities for human error are abundant. Since many medicines look alike, a prescription container may be mislabeled, or the wrong capsules may be grabbed off a shelf. Improperly securing medicine (not using child-proof caps, for example) can put a pharmacist at risk. It can be as simple as a cashier accidentally handing over the wrong bottle to a customer. Or as monumental as a pharmacist erring in transcribing a prescription for 21 polo horses, resulting in a fatal overdose of the animals.

Compounding the exposure Compounding drugs involves combining, mixing, or reconstituting existing pharmaceuticals to meet the unique needs of a patient. It may mean suspending and flavoring an antibiotic to make it child-friendly, or altering the dosage of medication capsules to accommodate a doctor’s prescription. Compounding elevates exposures. Consider the recent, high-profile case of a meningitis outbreak sparked by a widely-given steroidal injection that was contaminated during the compounding process.

While specific pharmaceuticals are regulated by the US Food and Drug Administration, compounded drugs are not. Change is in the wind, with Congressional passage late last year of the Drug Quality and Security Act, which opens the door for the FDA to develop voluntary regulations on compounding and traceability of prescription drugs.

Smaller pharmacies are especially vulnerable to many professional liability claims since they are less likely than their larger counterparts to have extensive procedural checks

continue to read here

GAO Study Finds FDA Actions Have Reduced New Drug Shortages, Recommends Additional Action

 

Topics: Fda
Steps taken by FDA have successfully reduced the number of new drug shortages, and a new study from the Government Accountability Office (GAO) urges the agency to take additional steps to reduce the number of overall drug shortages. The report acknowledges the impact of recent FDA actions, including implementation of FDA Safety and Innovation Act regulations and requirements previously recommended by GAO in 2011.
Continue reading here

Tennessee Board of Pharmacy Public Notice for Meeting March 11-12, 2014

March 11-12, 20149:00 amBoard Meeting
Iris Room 665 Mainstream Drive, MetroCenter
Public Notice

Tennessee Board of Pharmacy Minutes from December 2013 Meeting--Look at this new inspection form for compounding pharmacies

Testimony Underscores Global Threat of Counterfeit Drugs, Need for Greater Enforcement

 

February 27, 2014
Members and Witnesses Urge Increased Enforcement Measures to Detect and Punish Illegal, Counterfeit Drug Manufacturing and Distribution
WASHINGTON, DC – The House Energy and Commerce Subcommittee Oversight and Investigations, chaired by Rep. Tim Murphy (R-PA), today held a hearing to examine the ongoing threat of counterfeit drugs, in particular illegal drug supply chains. Witnesses and members discussed how advances in technology, a globalization of the drug supply, and the proliferation of rogue Internet pharmacies have all contributed to this growing threat of illegal, counterfeit drugs reaching Americans. The subcommittee today explored how to improve and update the enforcement and penalties for these crimes in this new era of counterfeiting.
“In the United States, a relatively comprehensive system of laws, regulations, and enforcement by federal and state authorities has kept drug counterfeiting incidents in the United States relatively rare, and FDA continues to believe – and works to ensure – that Americans can have a high degree of confidence in the drugs they obtain through legal channels,” said Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations and Policy at FDA. “Nonetheless, with the dramatic increase in the complexity of the global supply chain, FDA and its regulatory and law enforcement partners around the world face enormous challenges regarding supply chain security.”
Marcia Crosse, Director of Health Care at the Government Accountability Office explained, “Although the exact number of rogue Internet pharmacies is unknown, one estimate suggests that there were over 36,000 in operation as of February 2014, and these rogue sites violate a variety of federal laws. Most operate from abroad, and many illegally ship prescription drugs into the United States that have not been approved by the Food and Drug Administration, including drugs that are counterfeit or are otherwise substandard. … Foreign rogue Internet pharmacies use sophisticated methods to evade scrutiny by customs officials and smuggle drugs into the country. Their operations also often violate other laws, including those related to fraud and money laundering. Rogue Internet pharmacies are often complex, global operations, and federal agencies face substantial challenges investigating and prosecuting those involved.”
“Our biggest challenge is that criminals are now willing to counterfeit and market any product that will sell, regardless of whether it could result in serious and significant injury to consumers or the public,” said Lev Kubiak, Director of the National Intellectual Property Rights Coordination Center at the Department of Homeland Security. One reason for this is substandard penalties. Vice President and Chief Security Officer for the Global Security, Compliance Division at Pfizer Inc., John Clark explained, “Those who counterfeit medicines seem confident that even if they get caught, they will get a mere slap on the wrist.”
Murphy underscored the point, adding, “The penalties for drug-counterfeiting under the Federal Food Drug and Cosmetic Act have not been updated since 1938. As the FDA Commissioner has said, there is a steeper penalty for counterfeiting a designer purse under the Federal Criminal Code than a drug product under current FDA law.”
Subcommittee Vice Chairman Michael C. Burgess, M.D. (R-TX) further elaborated, “In my opinion, punishment for counterfeiting prescription medication is far from adequate. From fake flu vaccines to oncology drugs – counterfeit medications have been able to enter the supply chain and even been administered.”
Members and witnesses expressed bipartisan agreement that this threat is a top concern.
The Energy and Commerce Committee has been actively working for fortify the drug supply chain, and last year led the effort in drafting and passing the Drug Quality and Security Act, which became law in November 2013. This legislation, championed by Chairman Fred Upton (R-MI), established a track-and-trace pedigree system for drugs and marked a significant milestone for legal supply chain security and patient safety.  
- See more at: http://energycommerce.house.gov/press-release/testimony-underscores-global-threat-counterfeit-drugs-need-greater-enforcement#sthash.zTiClpsL.dpuf

HIGH IMPORTANCE! MUST READ! House Committee on Energy and Commerce Counterfeit Drugs: Fightling Illegal Supply Chains Hearing Held on February 27, 2014 Video, Agenda and Written Testimony

Witnesses: 
Panel I

Howard Sklamberg, J.D.
Lev Kubiak
  • Director
  • National Intellectual Property Rights Coordination Center
  • Department of Homeland Security
  • Immigration and Customs Enforcement (ICE)
  • Witness Testimony (Truth in Testimony CV)
Panel II

Marcia Crosse, Ph.D.
Prashant Yadav, Ph.D., M.B.A.
John P. Clark
Jean-Luc Moreau
Bruce Longbottom, J.D.
Elizabeth Jungman, J.D.M.P.H.,
- See more at: http://energycommerce.house.gov/hearing/counterfeit-drugs-fighting-illegal-supply-chains#sthash.qtNlOs3O.dpuf

Written Statement of Prashant Yadav, PHD on Falsified and Substandard Medicines before Subcommittee on Oversight and Investigations on February 27, 2014



FALSIFIED AND SUBSTANDARD MEDICINES


Statement of

Prashant Yadav, PhD

Director, Health Care Research Initiative, William Davidson Institute, University of Michigan

and

Member, Committee on Understanding the Global Public Health Implications of Falsified, Substandard, and Counterfeit Medicines and

Member, Committee on Regulatory Capacity Building in Developing Countries

Board on Global Health Institute of Medicine The National Academies

before the

Subcommittee on Oversight and Investigations

Committee on Energy and Commerce

U.S. House of Representatives

February 27, 2014
read written statement here

Second Question of the Day February 28, 2014 How many in Congress actually understand what office use of compounded medications is? How many in Congress actually know which states do and do not even allow it?


Griffith Addresses Counterfeit Drug and Compounded Drug Issues at hearing February 27, 2014 and ask about civil penalties and criminal charges that can be brought; Reminds FDA that he wanted status quo kept on office use

read and watch here

Will Courts Lift Veil of Secrecy Around Lethal Injections? by NBC Pete Williams

espite growing controversy over the use of anonymous pharmacies for lethal injections, the U.S. Supreme Court has thus far declined to block any executions based on 11th-hour appeals challenging the drug connections.
That includes the case of Michael Taylor, a convicted rapist and murderer who was put to death at 12:10 a.m. Wednesday in Missouri after a furious legal battle that stretched into the night.
It's worth nothing, however, that three high court justices wanted to block Taylor's execution and cited the words of an appeals judge who said so little was known about the source of the deadly dose of pentobarbital that it "could be nothing more than a high school chemistry class."
The strongly worded dissent from Eighth Circuit Court of Appeals Judge Kermit Bye — echoed by Justices Ruth Bader Ginsburg, Sonia Sotomayor and Elena Kagan — is giving some defense lawyers hope the veil of secrecy will be lifted by the judiciary.
"It seems that the issues raised in Judge Bye's dissent are starting to at least resonate with some members of the Supreme Court," said Allen Bohnert, a federal capital defender from Ohio.
continue to read here

Question of the Day February 28, 2014 How many medication errors relating to animals go unnoticed, unreported, or ignored? Read this person's story.

 
In December, my 4-year-old Labrador retriever was prescribed a medication to help with a condition related to her cancer. The pharmacist at a West Chester, Pa., Rite Aid mistakenly filled the medication at three times the prescribed dose, putting my dog’s life in danger. Fortunately, she recovered from the overdose after two nights at the emergency veterinarian.
Many states do not require pharmacies to report errors, and few do so voluntarily. While patients can report mistakes to state pharmacy boards, punishments are often light or nonexistent. In the absence of a legal judgment against it, a pharmacy is not required to reimburse a victim for damages incurred because of an error.
Even when a pharmacy does agree to pay for its mistake, it often requires the victim to agree to non-negotiable settlement terms. In my case, Rite Aid offered a settlement that included a clause forbidding me from ever talking about the incident. When the company rejected my request to remove the clause and refused to pay the veterinary bill without my agreement to it, I effectively paid $866 for the right to tell my story here.

CVM Updates FDA Announces New Program for State Animal Feed Regulators

CVM Updates FDA Announces New Program for State Animal Feed Regulators

Determination 101: You Have to Know Where to Look on these State Board of Pharmacy Website and Even Then You Might Not Find the Information in the Most Logical Place

Louisiana Board of Pharmacy has a number of tabs on its website indicating agendas, minute meetings etc. will be found there.  For example, on the main page there is Consumer Heading and underneath it is a heading for both Agendas and Public Notices. Clicking on either today got me no 2014 information.  Most people would probably stop looking and assume the 2014 information is not available, but if you click on the Public Library tab you will see an Agendas and Binders hyperlink and when you click on it--guess what you get?  You get the 2014 information as shown below. I have no idea why state boards of pharmacy do not do some major revamping and make information a lot easier for everyone to find.  As I have pointed out before, some states like Florida have done just that and made their websites a lot easier to view and to find information.  Until all states do so, if you are looking for a specific piece of information don't give up trying clicking on a number of tabs even if you think agendas is the most logical tab for agendas...you might just find them under the public library tab and not under the agenda tab.

2-25-2014     Application Review Committee

02-25-2014     Regulation Revision Committee

02-13-2014     Administrative Hearing   (revised 02-07)

02-12-2014     Board Meeting   (revised 02-07)          Public Meeting Binder

02-12-2014     Reciprocity Committee   (revised 02-11)

02-11-2014     Executive Committee   (revised 02-05)

02-11-2014     Impairment Committee   (revised 02-10)

02-11-2014     Reinstatement Committee   (revised 02-07)

02-06-2014     Regulation Revision Committee  (revised 02-04)

Louisiana Board of Pharmacy Publishes Second Draft of Regulations Relating to office use or non patient specific compounds; new term is "pharmacy-generated drug"

2014-C ~ Amends Chapter 25 of the Board's rules, more specifically Subchapter C - Compounding of Drugs. Act 168 of the 2013 Legislature introduced a new term "pharmacy-generated drug" to describe a drug made by a pharmacy in response to a non patient-specific order.  Compounding is used to describe the process whereby a pharmacy makes a drug in response to a patient-specific order.  In addition to incorporating the new legislatively-defined term, the proposal also retains the basic elements of the currently-pending emergency rule and also incorporates suggestions and comments offered during public hearings on the emergency rule.
               11-13-2013 - Committee reviewed Draft #1 and requested further changes and discussion.
               02-06-2014 - Committee discussed further changes and requested new draft; Draft #2 prepared.
               02-25-2014 - Draft #2 scheduled for review by the committee.

Thursday, February 27, 2014

Outside Sales Rep Opening for Midwest Veterinary Supply, Inc. in Oklahoma City

Outside Sales Representative - Oklahoma City, OK

Job ID2741
Company: Midwest Veterinary Supply, Inc.
Job Location Oklahoma City, OKAt least 2 years experience in veterinary sales, food, companion animal or equivalent selling experience in a competitive selling environment
*Demonstrates success in selling and overall territory management
*Team Player
*Limited overnight travel

Customer service, motivation for sales, meeting sales goals, closing skills, territory management, prospecting skills, negotiation, self-confidence, product knowledge, presentation skills, client relationships, and computer skills

Job Description

* Make sales calls to Equine veterinary clinics, tracks, universities, and research facilities within assigned territory.

* Sell Equine veterinary products, Midwest Equine Business Solutions and provide market information to clinics. Assist in growth of equine businesses throughout the Region by working with ISR’s and OSR’s, educational and marketing programs. Up to 35 to 40% travel is required.

* Establish and maintain working relationships with Equine vendor representatives in assigned geographic area.

* Plan calls including monthly organization of iPad, distribution of literature packets, analysis of sales calls for each clinic, send out advance notice cards, stay current with sales promotions, new products, email, mail, and industry trends.

* Attend educational meetings which include Equine vendor-sponsored veterinary meetings, Equine industry trade shows, regional and national Midwest Veterinary Supply meeting, and vendor educational training including conference calls and Webex training.

* Participate in corporate initiative requests to assist in the development of increasing equine presence within MVS including working directly with the Equine Business Development Manager, Regional Manager and National Sales Manager.

*Respond to all Management approved vendor requests for territory including surveys, territory analysis, etc.

If you have any issues applying through our website, please send your resume and cover letter to john.odorzynski@midwestvet.net
IndustryIndustry
TypeSales
Earningsnot provided at this time
Minimum Years Experience1 to 5
Travel25 to 50%
Minimum DegreeHigh School / GED
# of Openings1
Print Job
Please log in to apply for this job.



Second Question of the Day February 27, 2014 Is it legal for compounding pharmacies to perform saliva testing without a doctor ordering the test and then to refer the patient to specific doctors or provide a list to the patient of doctors who will prescribe compounded medications from the refering compounding pharmacy? Does it matter whether or not the patient ask the compounding pharmacist for a list of doctors?


Question of the Day February 27, 2014 How many insurance companies will pay for a salivary hormone test done by a compounding pharmacy? Does it matter whether it is ordered by a doctor as to whether the insurance company will pay for the test?

Lawyers warn that California Law Allowing Pharmacists to perform some medical services could put patients' health at risk and affect medical malpractice law

Debate Continues Over Calif. Law To Expand Role of Pharmacists


Some physician groups are raising concerns about a new California law that gives pharmacists more responsibilities, arguing that expanded scopes of practices could negatively affect patient safety, HealthyCal reports.
The law is aimed at addressing California's physician shortage (Richard, HealthyCal, 2/11).

Background

Only 16 of the California's 58 counties have the supply of physicians recommended by the federal government.
In addition, the Association of American Medical Colleges says that nearly 30% of California's doctors are nearing retirement age.
The California Legislature in September 2013 approved a bill (SB 493), by Sen. Ed Hernandez (D-West Covina), to expand the scope of practice for pharmacists to help boost access to health care (California Healthline, 9/17/13).
Once California State Board of Pharmacy protocols are approved, the law will allow pharmacists in the state to perform certain medical services, such as providing routine vaccinations and certain prescription drugs for travelers.

Law Draws National Attention

According to HealthyCal, the California law has drawn national attention.
Frank Ciesla, a New Jersey health care attorney, warned that treating pharmacists as primary care providers could put patients' health at risk and affect medical malpractice law.
continue to read  here

Understanding the role of pharmacists

Understanding the role of pharmacists

Pharmacists Increasingly Take On Clinical Roles, but Should They? Not Everyone Thinks It is A Good Idea and Not All State Laws Allow it. Where is the Line of What is Allowed By Law Drawn in Your State?

for more information read here

New Law in California Expanded role of pharmacists as health care providers

New law could expand role of pharmacists as health care providers ...

pharmacy.ucsf.edu › ... › News Archive
University of California, S...
 
Nov 12, 2013 - New law could expand role of pharmacists as health care providers ... The new law, pending California State Board of Pharmacy protocols, ...

North Carolina Wants New Drug For Death Row Executions, But Where Will It Come From?

Prosecutors in Wake County are selecting a jury in a first-degree murder trial this week. It is the fifth case in North Carolina this year where a defendant could face capital punishment. But a series of lawsuits have blocked the death penalty for years in this state. And now, a little-known drug could become another obstacle.
In 2007, executions were scheduled for four death row inmates: Archie Lee Billings, James Campbell, Allen Holman and James Thomas. Each of them had been convicted of murdering someone. One confessed to the crime. Another actually asked to be executed.
read and listen to story here

359 comments received by FDA so far for Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act, Concerning Outsourcing Facilities; Request for Nominations

source found here

14 comments received by FDA so far Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations

source found here

81 comments submitted to FDA so far Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Request for Nominations

source found here

The FDA Opens Its Vast Files on Drug Side Effects to the Public

Thousands of times each day, the U.S. Food and Drug Administration receives reports about unwanted side effects of the prescription and over-the-counter medications it oversees. They stream in from patients and doctors—and from drugmakers, which are required to relay accounts of problems. This data, cataloging reactions as mild as rashes and headaches and as serious as internal bleeding and death, help the agency monitor drug safety. With millions of records created since the system began in 1998, it’s the world’s most extensive record of how drugs interact with the human body.

continue to read here

More information from IACP on documents submitted to FDA and reminder of March 4, 2014 deadline to file your own nominations

There are four submission letters for each type of compounder – a pharmacy or an outsourcing facility. One is a nomination letter that submits all homeopathic medications. One is a nomination letter requesting acceptance of drug monographs and standards in alternative compendia (e.g., the British Pharmacopeia). One is a nomination letter requesting acceptance of all nutritional/dietary supplements and food chemicals that appear in USP publications other than the official USP/NF. One is a nomination letter and spreadsheet of more than 2,400 drug substances. That spreadsheet was created by the IACP Foundation leadership and without the Foundation’s expertise in research, education and quality, we could not have assembled such an extensive set of documentation in the very short timeline provided to us by the FDA.
What can YOU do? 
The more submissions the FDA and the Pharmacy Compounding Advisory Committee receives, the greater the likelihood that they will initiate a review of the nominated bulk ingredient. It’s simple.  We’ve done the hard work…all you have to do is take the language in our submissions, put it on your own letterhead, and follow the instructions further down on how to file your own nomination electronically with the FDA.
Remember, the deadline is before midnight on Tuesday, March 4, 2014.

quoted from and more information found here

Fresenius Kabi sets up new $47 million pharmaceutical manufacturing centre in Melbourne to provide lifesaving products to patients

Fresenius Kabi sets up new $47 million pharmaceutical manufacturing centre in Melbourne to provide lifesaving products to patients
 
Construction is set to begin on a state of the art Australian pharmaceutical manufacturing facility that will deliver lifesaving infusion therapies, irrigation solutions, I.V generic drugs and compounded oncology products to public and private hospital patients Australia wide.
 
The facility will be built on a 40,000 square metre site by Fresenius Kabi Australia, one of the major pharmaceutical and medical devices providers to hospitals in the country. The new site will create 120 jobs after entering full operation.
 
Marking the start of construction, Zita Peach, Managing Director of Fresenius Kabi Australia & New Zealand and Executive Vice President South Asia Pacific said, “The site will markedly change the landscape for IV products and oncology delivery in Australia. Up until now there has been limited choice for hospitals when it comes to choosing products that are manufactured locally. This site will see products being manufactured that have easy handling, drug compatibility, sterility and environmental characteristics.
 
“The investment in this site demonstrates the strength of our commitment to Australian manufacturing and is great news for patients, hospital staff and the greater community who will all benefit.” said Zita Peach.
 
It will also secure local manufacturing of IV solutions using the Fresenius Kabi freeflex® infusion bag, a high quality, flexible, DEHP-free, latex-free and PVC-free container, which means reduced exposure to patients and environment
 
“Fresenius Kabi Australia currently provides infusion therapies, irrigation solutions and compounded oncology products to patients in over 180 public and private hospitals and clinics throughout Australia. This new facility will enable the availability of more medicines to more people, ultimately improving patient outcomes,” said Zita Peach.
continue to read here

Intensive Scare

The US regulators increased scrutiny of Indian drug exporters is giving the pharmaceutical industry the jitters.
read here

Additional government enforcement authorities to speak at the 2014 Compliance Institute - News and Weather For The Quad Cities -

Additional government enforcement authorities to speak at the 2014 Compliance Institute - News and Weather For The Quad Cities -

VERY IMPORTANT: FDA "Counterfeit Drugs: Fighting Illegal Supply Chains"

"Counterfeit Drugs: Fighting Illegal Supply Chains"

Pharmacist must return $1 million to Medicare for unapproved drugs from abroad

— A local pharmacist owes Medicare $1 million after getting caught filling cancer prescriptions with drugs illegally purchased abroad.
According to a statement released by the United State’s attorney’s office, licensed pharmacist William Burdine, owner of the Alvarado Medical Plaza Pharmacy in San Diego, ordered drugs like Avastin and Rituxin from Quality Specialty Products of Canada and used them to mix infusion solutions “without advising the doctors that the drugs came from abroad and were not approved for use in the United States
continue to read here

SAN JUAN, Puerto Rico (AP) — Four people including the owners of two pharmacies have been arrested on federal health care fraud charges in Puerto Rico.

more information found here

Men in separate fraud cases allege misconduct by El Paso federal judge-Pharmacist's conviction for health care fraud vacated

A federal appeals court has vacated the conviction of a former West El Paso pharmacist convicted of healthcare fraud, while a defendant in the city's public corruption case is seeking to have his guilty plea withdrawn.
Both men claim misconduct by a federal judge in El Paso.
In 2012, U.S. District Judge Frank Montalvo sentenced Peter Victor Ayika, 58, to 63 months, or more than five years, in prison after he admitted to submitting fraudulent billings to Medicaid, the Federal Employees Health Benefit Program and private insurance providers for medicines and other pharmaceuticals he never dispensed. Montalvo also ordered Ayika to pay $2.5 million in restitution.
Ayika pleaded guilty to fraud after a jury convicted him on charges of possession with intent to distribute hydrocodone by a practitioner and of selling pseudoephedrine to an undercover Drug Enforcement Administration agent.
continue to read here

Pharmacist gets 7 years for $1.7M health care fraud

A north suburban pharmacist who operated a North Side store will spend seven years in prison for collecting more than $1.7 million in false health insurance claims “to finance a lavish lifestyle,” according to federal prosecutors.
Ronald Kielar, 76, of Mundelein was sentenced Friday to seven years in prison by U.S. District Judge Robert Dow Jr., according to a statement from the U.S. Attorney’s office. He was convicted last fall of 10 federal charges including health care fraud, obstruction of justice and aggravated identity theft.
Kielar operated the former Cartagena Pharmacy in the 1500 block of West Devon Avenue, Chicago, federal prosecutors said.
continue to read here

Washington State Pharmacy Commission Disciplinary Action February 4, 2014 Newsletter

read here

Pharmacy mistake leads to year-long criminal case for Burlington man, 82

Pharmacy mistake leads to year-long criminal case for Burlington man, 82

Three Pharmacists surrender licenses amid pending criminal charges

Three pharmacists surrender licenses amid pending criminal charges in Interstate Prescription Drug Distribution Ring involving Plainfield pharmacy
By:
NEWARK – The State Board of Pharmacy within the Division of Consumer Affairs has suspended the licenses of three pharmacists for their alleged participation in an illegal prescription drug distribution ring involving a pharmacy in Plainfield.
The multi-state investigation involving federal, state and local law enforcement agencies in New Jersey, New York and Florida, began with information developed by the Enforcement Bureau within the Division of Consumer Affairs, Acting Attorney General John Hoffman noted
continue to read here

Not guilty: Steroid doctor, pharmacist cleared on all counts

Not guilty: Steroid doctor, pharmacist cleared on all counts

MUST READ! The Register's editorial: Pharmacy Board forgets it's to serve the public

Iowa has dozens of state boards responsible for licensing everyone from cosmetologists and doctors to hearing aid technicians and athletic trainers. The primary mission of these boards is supposed to be protecting the public health and safety.
That means they are supposed to ensure licensed workers meet the state’s educational requirements and abide by the regulations the state establishes for these occupations. The boards are supposed to issue cease-and-desist orders to those not abiding by the rules and respond to complaints from consumers.
Though these complaints are not public when they are initially filed, if the board investigates and decides to file a “statement of charges” against the license holder, those charges become a public document. The board’s subsequent decision in the case — whether that is dismissal of charges, the imposition of sanctions or the revocation of the person’s state license — are also public documents.
continue to read here

Whistleblower Sheds Light on Pharmacy Mistakes

Prescription for Error? I-Team Investigates Pharmacy Mistakes

By Tisha Thompson
|  Monday, Feb 24, 2014  
read here

Are Pharmacies Overworking their Pharmacists?

Family Says Pharmacy Error Nearly Killed Boy

By Chris Coffey
|  Wednesday, Feb 26, 2014  |


Source: http://www.nbcchicago.com/investigations/Family-Says-Pharmacy-Error-Nearly-Killed-Boy--247413951.html#ixzz2uYB5IzoJ

The FDA is quietly testing some drugs for generic equivalency

Critics call for harsher treatment of foreign drugmakers who sell faulty drugs

NH Application for Non-Resident Pharmacy to Renew License--If shipping sterile compounded products to NH Residents--new requirements

Sterile Compounded Drugs * If shipping Sterile Compounded Products to NH Residents, you must attach items 1-5; additionally, by signing this renew



application you acknowledge that the pharmacy has item #6 on hand and available upon request:


1. Any and all GAP analysis reports related to the pharmacy done within the last twelve (12) months;

2. Any and all certification documents on compounding equipment done within the last six (6) months;

3. An inventory listing of any / all products shipped into the State of New Hampshire within the last six (6) months, including

product, quantity, location of shipment, and date of shipment;

4. Any Department of Health and Human Services, Food and Drug Administration Inspection Reports (Form FDA 483) issued

within the last twelve (12) months and any responses submitted to these agencies by the pharmacy;

5. Any state inspection reports issued within the last eighteen (18) months and any responses submitted to these agencies

regarding the inspection reports by the pharmacy; and

6. The pharmacy’s policies and procedures on sterile compounding. (Do not attach – but must be available upon request)

found here

The Law of Veterinary Medicine: Over One Year After My Inquiry to FDA I received ...

The Law of Veterinary Medicine: Over One Year After My Inquiry to FDA I received ...: Dear Ms. Richmond: This is in response to your e-mail communication dated January 22, 2013, inquiring why a December 8, 2004, warning lett...

Wednesday, February 26, 2014

USP PowerPoint for compounding pharmacies and outsourcing facilities

Why are drug dispensing firms supporting fee schedules for doc dispensed drugs?

Why are drug dispensing firms supporting fee schedules for doc dispensed drugs?

​Federal judge rips death penalty states for secretive execution methods Published time: February 27, 2014 03:24 Get short URL

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Be Careful What You “Like”: Healthcare Industry Should Consider Privacy, Adverse Events, and Promotional Issues in Social Media Interactions

Be Careful What You “Like”: Healthcare Industry Should Consider Privacy, Adverse Events, and Promotional Issues in Social Media Interactions

News on *PAWS* Mesa’s Topical Pain Medications Becoming More Popular!--Claims The Company is currently filling prescriptions for transdermal topical pain medications of approximately $400,000 dollars per day

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Question of the Day February 26, 2014 Is anyone seeing any signs that PCCA, IACP, and others who predicted that compounding pharmacies would close their doors is becoming a reality? In my opinion the exact reverse has happened--it is a expanding and rapidly growing area? How can Congress expect the FDA to even begin to keep up with the way it is now exploding? What are states doing to keep up? What can they do to keep up?


Compounding Sales Representative Opening in Abilene Texas

Medical Sales Representative
My Pharmacy - Abilene, TX
My Pharmacy and Compounding Lab
Regional Sales Representative
SA110
General Purpose
Promote compounding pharmaceutical product sales through effective interaction with health care professionals and organizations to increase the awareness and use of the company's pharmaceutical products in a specified territory.
Main Job Tasks and Responsibilities
  • Plan work schedules and timetables
  • Plan and implement an effective call plan
  • Build effective business relationships with health care partners and customers
  • Prospect for new business
  • Develop strategies to approach potential customers and increase sales
  • Cold calling health care professionals to set up appointments
  • Distribute information to health care professionals
  • Demonstrate product use
  • Answer questions from health care professionals
  • Organize and execute sales presentations
  • Develop and present educational programs
  • Organize group events and conferences for health care professionals
  • Maintain detailed records of all contacts, meetings, create reports on a daily basis and submit at the end of each week.
  • Keeping current with clinical data and presenting this data to health care professionals
  • Keeping informed about the activities of health care professionals and organizations in a specific area
  • Keeping current with the competition's products, service offerings and activity
  • Establish and maintain effective working relationships with all company support departments
  • Provide after-sales service
Requirements:
Bachelor’s degree from an accredited College or State University
2+ years in outside medical sales with hospitals and clinics
Ability to travel within a set region
Proven leadership and decision-making ability
Must have a consistent track record of accomplishments and success in sales
MS Word, Excel, PowerPoint
Benefits:
Medical
Dental
Vision

Indeed - 30+ days ago - save job - block
» Apply Now
Please review all application instructions before applying.

The Pharmacy Compounding Business Continues to Grow--Another Regional Sales Representative Opening

Regional Sales Representative for Compounded Pharmaceuticals - new Pharmacy Compounding Connection - Washington, DC - +1 location
ATTENTION EXPERIENCED PHARMACEUTICAL AND MEDICAL SALES PROFESSIONALS. Pharmacy Compounding Connection, (PCC) is seeking exceptionally talented Sales...
 

A Drug Company Tried to Block the Use of Pentobarbital in Executions, But U.S. States Are Finding Ways Around the Ban

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Oklahoma Death Row Inmates Sue Over Drugs' Secrecy

OKLAHOMA CITY February 26, 2014 (AP)

IACP touts being first pharmacy association to issue nominations for FDA's Request for Bulk Drug Substances for both 503A and 503B

Attention IACP Members: Your Academy is the first pharmacy association to issue nominations for FDA's Request for Bulk Drug Substances - for Both 503A & 503B Facilities. An IACP member alert is distributing now http://bit.ly/1hh8qfb . Please note that you will need to log into the Members only site to view the comprehensive list of IACP documents submitted to the FDA.              

Pharmacy Technician II- Sterile Compounding Job Opening

Wednesday, February 26, 2014


Pharmacy Technician II-

Pharmagen Laboratories is hiring Pharmacy Technician II- Sterile Compounding on Wed, 26 Feb 2014 17:03:25 GMT. Compounding Pharmacists in our state-of-the-art USP 797 sterile room. SUMMARY Responsible for sterile compounding under the supervision of a pharmacist, to...
more information found here

 

Iowa Board of Pharmacy Disciplinacy Records as of February 26, 2014

Compounding Pharmacy Business Manager (Bellevue) Job Opening

Compounding Pharmacy Business Manager (Bellevue)
compensation: DOE, benefit package avialable after 60 days
Paramount Pharmacy is looking for an outstanding full-time (100% FTE) Compounding Pharmacy Business Manager with pharmacy billing experience to join our Pharmacy team. This position requires Pharmacy Technician licensure and is responsible for assisting Paramount Pharmacy by performing non-professional/technical tasks related to delivery of pharmaceutical services.

These functions may include:
•Verification of Benefits with Patients prior to filling prescription
•Customer Service
•Pharmacy Billing (finalizing submission)
• Revenue Cycle Management
•Adheres to Paramount Pharmacy Services policies and procedures
• Performs related duties as required
•The successful candidate will build and manage a customer service team of pharmacy technicians

Paramount Pharmacy offers a comfortable work environment, excellent benefits, a competitive salary. This position provides opportunities to work in a fast-paced, challenging, diverse and rewarding environment.

Requirements:
•Compound Pharmacy Billing experience as a Pharmacy Technician or equivalent education/experience.
•Must pass background check and drug test

Legal Requirement:
•Pharmacy Technician licensure with State of Washington (Dept. of Health)
•Desired: More than 1 year of Compound Pharmacy Technician experience or significant customer service experience preferred.

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

Company that makes drugs for Ohio executions says it opposes lethal injection

CLEVELAND, Ohio -- The drug maker that manufactured the two drugs used for Ohio executions says it opposes lethal injection and makes products to save lives, not end them.
How the drugs got to Ohio underscores how far states will go to obtain drugs for executions.
Hospira Inc. of Lake Forest, Ill., made the midazolam and hydromorphone that Ohio received in late 2013 for its lethal injections, a state spokesman said. The two types of drugs were used in Dennis McGuire's execution Jan. 16.
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NEWS: Mesa Pharmacy prescription orders for February exceed $6.5 million. Sales continue to increase inline with expectations

The PAWS Pet Company, Inc. (OTCQB:PAWS), is pleased to announce that February orders at its Mesa Pharmacy, Inc. (Mesa) subsidiary have continued to increase inline with expectations and have generated gross revenues, excluding allowances for returns and discounts, exceeding $6.5 Million Dollars......

IRVINE, CA, Feb. 26, 2014 /PRNewswire/ - The PAWS Pet Company, Inc. (OTCQB:PAWS), is pleased to announce that February orders at its Mesa Pharmacy, Inc. (Mesa) subsidiary have continued to increase inline with expectations and have generated gross revenues, excluding allowances for returns and discounts, exceeding $6.5 Million Dollars.  "We are currently filling prescriptions for transdermal topical pain medications of approximately $400,000 dollars per day".  Stated Andrew Do, Mesa's President and Registered Pharmacist.

As controlled narcotic medications become more problematic and laws continue to limit options for physicians to control pain, other alternatives are being considered. Mesa's non-narcotic trans-dermal formulations for pain management are becoming more popular for managing pain suffered by injured workers.  Mesa is continuing its plan to increase staff for the surge in orders that has occurred as a result of its recent agreement with Trestles Pain Specialists LLC.

About The PAWS Pet Company, Inc.

The PAWS Pet Company, Inc. is undergoing a transition from the pet space to the pharmaceutical space. This exciting transition strategy has been developed to take advantage of the changes underway in traditional medical services. PAWS believes that great opportunities exist in pharmaceuticals and how they are delivered to the public.

About Mesa Pharmacy, Inc.

Mesa focuses on providing custom compounded non-narcotic, transdermal topical pain medications that are marketed to industrial health physicians and clinics. Mesa compounds a series of topical prescription medications, in different strengths, that provide the pain relief doctors seek and that have a very low propensity for addiction. As a result, physicians and insurers need not worry about treating an injured worker and winding up having to treat that worker's potential addiction to pain killing narcotics.

For more information on The PAWS Pet Company go to: www.thepawspetcompany.com

Forward-Looking Statements

The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements that are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995).

The actual results may differ materially from those described or contemplated and consequently, you should not rely on these forward-looking statements as predictions of future events. Certain of these risks and uncertainties are discussed in the reports we filed with the SEC.

SOURCE The PAWS Pet Company, Inc.

Michael Taylor executed by Missouri using compounded pentobarbital

State fends off legal challenges and goes ahead with lethal injection using unofficial version of drug from unnamed source

Missouri has gone ahead with executing a death-row prisoner using a drug from an unspecified source. The lethal injection of pentobarbital used to kill Michael Taylor, 47, who raped and murdered a teenage girl in 1989, was presumed to have been bought by the state from a compounding pharmacy – a supply arrangement that sparked legal challenges over the potential cruelty of using an unregulated drug.
Taylor offered no final statement. He mouthed silent words to his parents, two clergymen and two other relatives who witnessed his death. As the process began he took two deep breaths before closing his eyes for the last time.
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Pharmacist Sentenced to Seven Years in Prison for Obtaining $1.7 Million from Health Insurers for Drug He Never Dispensed


U.S. Attorney’s Office February 25, 2014
  • Northern District of Illinois (312) 353-5300
CHICAGO—A Chicago pharmacist was sentenced to seven years in federal prison after being convicted at trial of collecting more than $1.7 million through false claims he submitted to insurance companies for a drug that he never dispensed and stealing the identities of unsuspecting pharmacy customers to make that money, which he used to finance a lavish lifestyle. The defendant, Ronald Kielar, also created fake documents to make his false insurance claims appear legitimate.
Kielar, 76, of Mundelein, was a pharmacist at the former Cartagena Pharmacy, located in the 1500 block of West Devon Avenue, which was owned by his ex-wife. He was sentenced to five years in prison on six counts of health care fraud and one count of obstruction of justice and received a mandatory consecutive sentence of two years on three counts of aggravated identity theft. Kielar, who was convicted on all 10 counts he was charged with at a trial last fall, was ordered to begin serving the 84-month sentence on June 10.
U.S. District Judge Robert M. Dow, Jr., who imposed the sentence on Friday, also ordered Kielar to pay more than $1.725 million in restitution and to forfeit nearly $78,000 in proceeds from the sale of property he owned in Florida.
According to court documents, Kielar used patients’ insurance information, including their names and dates of birth, to bill for the drug Procrit, which stimulates the production of red blood cells. These patients, however, were never prescribed Procrit, Kielar never provided them with the medication, and the patients never authorized the use of their insurance information to submit claims for payment. After he was indicted, Kielar forged prescriptions, patient receipts, and false invoices to make the insurance claims look legitimate. Between November 2004 and August 2010, Kielar submitted 603 false claims and received more than $1.7 million from Blue Cross and Blue Shield of Illinois and the United Food and Commercial Workers Unions and Employers Midwest Health Benefit Fund.
“Each time [Kielar] hit the submit button on the pharmacy’s computer for a Procrit claim, he made a calculated choice: to lie to the victim insurance company who received, processed, and paid on the claim,” Assistant U.S. Attorney Heather McShain wrote in a sentencing memo. Kielar also betrayed a physician who had been his friend for 40 years and whose name and DEA registration number Kielar used without permission, as well as unsuspecting patients whose personal information he used.
Evidence showed that Kielar used proceeds from the fraud scheme to pay salaries to himself and his ex-wife and then used those funds to pay mortgages on his home in Illinois, as well as properties in Florida and Arizona.
The sentence was announced today by Zachary T. Fardon, United States Attorney for the Northern District of Illinois; Robert J. Holley, Special Agent in Charge of the Chicago Office of the Federal Bureau of Investigation; James Vanderberg, Special Agent in Charge of the U.S. Department of Labor Office of Inspector General in Chicago; and John Redmond, Special Agent in Charge of the Chicago Office of the U.S. Food and Drug Administration Office of Criminal Investigations.
The government was represented by Assistant U.S. Attorneys Heather McShain and Steven J. Dollear.

Around Iowa: Pharmacist's health care fraud trial starts--Allegations are that Michael Stein billed Wellmark for expensive drugs when his pharmacy actually did little work and only acted as a pass through entity for Florida compaines

IOWA CITY

A trial is starting for an Iowa pharmacist accused of fraudulently billing an insurance company for life-saving drugs sent to hemophilia patients.
Michael Stein, the owner of Pharmacy Matters in Iowa City, has pleaded not guilty to 15 counts of health care fraud. Jury selection began Monday in federal court in Des Moines.
Prosecutors contend Stein billed Wellmark for expensive drugs to treat hemophilia, when his pharmacy actually did little work in dispensing those drugs. They say his pharmacy acted as a “pass-through entity” for Florida companies, giving them access to the Blue Cross and Blue Shield network.
Stein’s attorneys say the case is a contract dispute between a pharmacist and an insurer.
quoted from here

Feds make Medicare fraud a top priority

By
Published:   |   Updated: February 23, 2014 at 08:51 AM
TAMPA — Four men set up four bogus medical clinics in Tampa.
They pay Medicare clients who allow the clinics to bill Medicare HMO insurance providers in their names for vein procedures they never undergo. Each clinic submits a separate bill for each patient, submitting multiple claims for the same procedures on the same individuals at the same time.
The scam went on for more than three years. Collectively, the men were able to steal more than $2.5 million from federal taxpayers.

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Warning Letters Usv Limited 2/6/14

Warning Letters Usv Limited 2/6/14

Warning Letters Bridgewater Dairy LLC. 2/18/14

Warning Letters Bridgewater Dairy LLC. 2/18/14

Tuesday, February 25, 2014

Tennessee gets new rules on compounding pharmacies February 25, 2014

More than six months after they were first approved, new rules governing the operation of compounding pharmacies in Tennessee have passed legal muster and gone into effect.
The rules, issued by the state Board of Pharmacy, were drawn up in reaction to a nationwide outbreak of fungal meningitis that hit particularly hard in Tennessee. Sixteen Tennessee patients died after being injected with fungus-tainted spinal steroids shipped from a Massachusetts drug compounding firm.
Reginald Dillard, executive director of the pharmacy board, said the final version of the rules won approval from the state attorney general and went into effect late last month
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Texas Board of Pharmacy Winter 2014 Newsletter and Winter 2014 Disciplinary Actions

Hamburg says FDA's focus on India reflects its place in the global supply chain