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Wednesday, April 30, 2014

FDA Officials are Frequent Visitors to White House, Data Show

FDA Officials are Frequent Visitors to White House, Data Show

Facing Dire Shortage of IV Saline, FDA Again Turns to Enforcement Discretion Approach

Facing Dire Shortage of IV Saline, FDA Again Turns to Enforcement Discretion Approach

In Unusual One-Two Punch, FDA Follows 'Extensive' Warning Letter With Safety Communication

In Unusual One-Two Punch, FDA Follows 'Extensive' Warning Letter With Safety Communication

Behind Oklahoma's Bungled Execution, a Crisis of Globalization for Lethal Injections

By
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The New Yorker Witnesses to a Botched Execution April 30, 2014


Three More Laboratories Receive RMTC Accreditation April 30, 2014

Twenty-Three States Now Using RMTC-Accredited Laboratories
The Horseracing Testing Laboratory Committee of the Racing Medication and Testing Consortium (RMTC) has approved full accreditation of three laboratories under the RMTC Laboratory Accreditation Program. The newly accredited laboratories are: 
  • Industrial Laboratories in Wheat Ridge, Colo.
  • Ohio Department of Agriculture laboratory in Columbus, Ohio, and
  • Truesdail Laboratories in Tustin, Calif.  
RMTC-accredited laboratories are responsible for the testing of samples for 23 of the 34 racing jurisdictions in the United States, including AR, AZ, CA, CO, DE, ID, IN, KY, MA, MD, ME, MN, ND, NE, NJ, NM, NV, OH, OK, OR, VA, WA and WY. With the addition of these three laboratories there are now a total of five laboratories that are fully accredited by the RMTC – the UC Davis Kenneth L. Maddy Equine Analytical Chemistry Laboratory and the LGC Sports Science Laboratory were accredited in 2013. 
“We applaud these laboratories for expending significant time and resources to achieve compliance with the RMTC Laboratory Accreditation standards for expertise and proficiency,” said RMTC Chair Alex Waldrop. “RMTC Accreditation is built upon protocols established by the World Anti-Doping Agency – the gold standard in human competition.”
“While the goal remains to have 100% of the laboratories that are testing horse racing samples RMTC-accredited, we are encouraged by having the majority of racing jurisdictions working with RMTC-accredited laboratories,” said Dr. Dionne Benson, executive director and COO of the RMTC.
Each laboratory receiving RMTC Accreditation has first been ISO 17025 certified, which is the international standard for analytical laboratories. Additionally, they must:
  • Submit an application which is reviewed by an independent auditor;
  • Successfully complete a multi-day laboratory site inspection with an internationally recognized expert in the field; and
  • Pass two rounds of the RMTC External Quality Assurance Program proficiency sample testing, which measures the ability of the laboratory to identify, detect and quantify (where appropriate) substances of concern in horse racing.
“We are gratified by the news of RMTC’s accreditation of our horseracing laboratory,” said Truesdail Laboratories Director Dr. Norm Hester. “We extend a formal "Thank You" to RMTC for recognizing us as compliant with their high standards for testing and allowing us to join the ranks of the relatively few organizations that share their approval. We are thrilled to be part of their goal of having 100% of racing laboratories accredited to their comprehensive requirements.”
“Industrial Laboratories is honored to have achieved RMTC Accreditation, and we thank our staff for their wonderful work,” said its director of drug testing services, Petra Hartmann. “Our laboratory looks forward to working with the RMTC and other industry partners for positive changes in the field of pari-mutuel drug testing – which will ultimately strengthen the integrity of the sport and protect the health and welfare of horses and jockeys.”
The RMTC consists of 23 racing industry stakeholders and organizations that represent Thoroughbred, Standardbred, American Quarter Horse and Arabian racing. The organization works to develop and promote uniform rules, policies and testing standards at the national level; coordinate research and educational programs that seek to ensure the integrity of racing and the health and welfare of racehorses and participants; and protect the interests of the racing public.
For additional information, visit the RMTC website at rmtcnet.com or contact Hallie Lewis, RMTC director of communications, at (859) 224-2848.
- See more at: http://www.ntra.com/en/news-media/press-releases/2014/4/30/three-more-laboratories-receive-rmtc-accreditation/#sthash.BqQpwy4l.dpuf

Horse Racing Groups Denounce Top Trainer Over Animal Mistreatment

By Ernie Smith / Apr 30, 2014
READ ARTICLE HERE

DeLauro Statement on Inspector General Report on Compounded Drugs

Issued By
April 30, 2014
Urges Centers for Medicare & Medicaid Services to Implement Recommendations WASHINGTON, DC-Congresswoman Rosa DeLauro (D-CT) released the following statement today on a new report from the Health and Human Services (HHS) Inspector General, Compounded Drugs Under Medicare Part B: Payment and Oversight. DeLauro is the senior Democrat on the subcommittee responsible for funding HHS and is the former chairwoman of the subcommittee responsible for funding the Food and Drug Administration (FDA), which has responsibility for overseeing compounded drugs.
"As the tragic outbreak of 2012-2013 demonstrated, our current system of tracking and ensuring the safety of compounded drugs is systemically flawed.  The Inspector General's recommendations make clear that we need to do far more to track compounded drugs, particularly in the Medicare program as seniors are more susceptible to becoming seriously ill or dying from an infection than the general public. I am disturbed that we could be wasting millions of taxpayer dollars on unsafe drugs, with no way of knowing for sure. While I introduced legislation which would have made FDA registration mandatory for companies that mass produce compounded drugs, the bill signed into law unfortunately made that registration only voluntary.  The current system still leaves our seniors and general population vulnerable and we need to change it. HHS should use the IG recommendations to take step to better protect our seniors from potentially dangerous compounded drugs."                                           
The Inspector General issued three recommendations:
·         Establish a method to identify Medicare Part B claims for compounded drugs
·         Explore the possibility of requiring providers to identify the pharmacy that produced the compounded drug on the Medicare Part B claim
·         Explore the possibility of conducting descriptive analyses of Medicare Part B claims for compounded drugs. Such analyses could include calculating how much Medicare Part B is paying for compounded drugs, determining where compounded drugs are being produced and determining which compounded drugs are being billed for.

With Long History Of Flawed Executions, New Debate Over Lethal Injections

watch video and read story here

Department of Health and Human Services OFFICE OF INSPECTOR GENERAL on Medicare Part B Compounded Drugs Payment and Oversight April 2014

PharMEDium Launches “I.D. Your I.V.®”

FOR IMMEDIATE  RELEASE
Contacts:       

Amy Langan, alangan@pharmedium.com, 847-457-2327

Molly Watson,  molly.watson@ritzcommunications.com, 413-454-3926 
 
LAKE FOREST, Ill., APRIL 30, 2014— PharMEDium Healthcare Corp., the nation’s leading provider of hospital pharmacy-outsourced, sterile admixture services, launched I.D. Your I.V.® solution today, which includes innovative, U.S.-Patented labeling that helps clinicians easily and quickly confirm the identity of medications to improve administration accuracy and reduce the risk of errors.
I.D. Your I.V.® is more than just a redesigned label, but rather a patient-safety focused solution from PharMEDium that includes the compounded service, its clearVIEW overwrap bag, an all-inclusive bar code for better patient traceability, an easy-to-read dual-labeled bag and IV tubing labels. The labels, a first of their kind, are removed from the back of the bag at the point of administration and folded around the tubing to offer clinicians an additional opportunity to reconfirm the correct medication is being delivered. This solution is easily integrated into medication use workflows and fully supports the “5 rights” of medication administration so the right medication is delivered to the right patient with the right dosage using the right route at the right time.
Responding to the industry
I.D. Your I.V.® is based on input from more than 1,000 critical care nurses, nurse educators, clinical pharmacists, and patient safety professionals responsible for IV therapy. Although the solution is being formally introduced today, PharMEDium began reaching out to its customers earlier this year to inform them of the enhancements and offering educational resources to clinicians to help communicate the changes around their organizations.
“This effort demonstrates PharMEDium’s decade-long understanding of the complex environment where multiple IV medications are used frequently, as well as the company’s continued dedication to providing important tools to clinicians at the point of care,” said Rich Kruzynski, RPh, president, PharMEDium.

North Carolina Bord of Pharmacy Has Opening for Entry Level Investigator/Inspector

FRIDAY, APRIL 25, 2014 - Open Investigator/Inspector Position at the NC Board of Pharmacy
The NC Board of Pharmacy has an opening for an entry level Investigator/Inspector. The primary duties of the position will be to conduct inspections and investigate complaints of pharmacies in the central part of North Carolina. CLICK HERE for a job description and instructions for sending the Board a cover letter of interest and resume.

Tougher injury penalties, longer rests for endurance

Tougher injury penalties, longer rests for endurance

FDA Oversight By House To Focus On User Fees, Compounding Law

18:25 EDT 29 Apr 2014 | Elsevier Business Intelligence
more information found here

American Academy of Ophthalmology Honors Eight Members of Congress for Their Dedication to Healthy Vision

WASHINGTON, April 29, 2014 /PRNewswire-USNewswire/ -- The American Academy of Ophthalmology - the world's largest association of eye physicians and surgeons - is honoring eight members of Congress for their outstanding legislative efforts to advance the quality of eye care available in the United States.

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Access to Compounded Drugs Sen. Tom Coburn, M.D. (R-Okla.), Sen. Johnny Isakson (R-Ga.), Sen. Chris Murphy (D-Conn.), Sen. Rand Paul, M.D. (R-Ky.) and Rep. Morgan Griffith (R-Va.), for supporting patients' continued convenient access to compounded drugs. Safe, sterile compounded medications have long been essential tools available to ophthalmologists for urgent treatment of eye diseases and conditions, benefitting millions of patients.

more information found here

Inmate dies of heart attack after execution is interrupted


Glance: Execution drug secrecy in 5 states

By Associated Press                  

    An Associated Press survey of the nation's 32 death penalty states found that the vast majority refuse to disclose the source of their execution drugs.
Some states with laws shielding information about execution drugs and policies and the challenges to those laws:  continue to read here

Tuesday, April 29, 2014

Zoetis Hiring Territory Business Manager in Oklahoma City

Territory Business Manager Zoetis US - Oklahoma City, OK
These activities include a large direct sales field force, strategic account team that helps veterinarians better run and grow their business, aligned...
Easily apply
6 days ago -  

Diamondback Drugs continues to expand: hiring Territory Manager

Territory Manager Diamondback Drugs 2 reviews - San Diego, CA
Diamondback Drugs is the leader in custom compounding for veterinary prescribers and patients nationwide. We pride ourselves on world class customer service and...
CareerBuilder - 18 days ago -  

Job Opening for new Compounding Pharmacy Opening in Weatherford, Texas

Compounding Pharmacy Tech (Full-time/2+ yrs exp)
PharmPro RX - Weatherford, TX
Looking for experienced compounding technicians in the DFW/Weatherford, TX area looking to work in a new start-up closed door pharmacy in Weatherford, TX! (West...
Easily apply
Sponsored by PharmPro RX - 13 days ago

Oklahoma inmate dies after execution is botched

McALESTER, Okla. (AP) — A botched execution using a disputed new drug combination left an Oklahoma inmate writhing and clenching his teeth on the gurney on Tuesday, leading prison officials to halt the proceedings before the inmate's eventual death from a heart attack.
Clayton Lockett, 38, was declared unconscious 10 minutes after the first of the state's new three-drug combination was administered. Three minutes later, though, he began breathing heavily, writhing on the gurney, clenching his teeth and straining to lift his head off the pillow.
The blinds were eventually lowered to prevent those in the viewing gallery from watching what was happening in the death chamber, and the state's top prison official eventually called a halt to the proceedings, although it didn't save Lockett.
"It was a horrible thing to witness. This was totally botched," said Lockett's attorney, David Autry.
continue to read here

Horse racing suffers from a perception problem

Oklahoma Postpones Execution After First Is Botched



McALESTER, Okla. — What was supposed to be the first of two executions here Tuesday night was halted when the prisoner, Clayton D. Lockett, began to writhe and gasp after he had already been declared unconscious and called out “oh man,” according to witnesses.
The administering doctor intervened and discovered that “the line had blown,” said the director of corrections, Robert Patton, meaning that drugs were no longer flowing into Mr. Lockett’s vein.
At 7:06 p.m., Mr. Patton said, Mr. Lockett died in the execution chamber, of a heart attack.
Mr. Patton said the governor had agreed to his request for a stay of 14 days in the second execution scheduled for Tuesday night, that of Charles F. Warner.
 
continue to read here

Texas Board of Pharmacy Inspection of out-of-state sterile compouning pharmacies--bidding

Inspection of Sterile Compounding Pharmacies

Bid Date & Time: 05/07/14 5:00 PM
Owner Solic Number: RFQ515-4-0004  Status: bidding  Report: 5545201
Country :United States   State: TX  County:
Location: Austin
Scope: Inspections of out-of-state sterile compounding pharmacies.
Plans: From Owner, see linked file.
Update Notes: Q&A file attached.
Owner Type: Public
 
Buyer: Texas State Board of Pharmacy
Buyer Address: William P. Hobby Building, Tower 3, Suite 600 333 Guadalupe Street
Buyer City: AustinBuyer State: TXBuyer Zip: 78701
Buyer Phone: 512-305-8000Buyer Fax: 512-305-8082
Website: http://www.tsbp.state.tx.us
Buyer Contact Name: Dave Hardy
Buyer Contact Phone: 512-305-8023
 
Bid Pkg Source: Texas State Board of Pharmacy
Bid Pkg Source Address: William P. Hobby Building, Tower 3, Suite 600 333 Guadalupe Street
Bid Pkg Source City: AustinBid Pkg Source State: TXBid Pkg Source Zip: 78701
Bid Pkg Source Phone: 512-305-8000Bid Pkg Source Fax: 512-305-8082
Website: http://www.tsbp.state.tx.us
Bid Pkg Source Contact Name: Dave Hardy
Bid Pkg Source Contact Phone: 512-305-8023
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California Board of Pharmacy Temporaily suspends Greenfield Pharmacy

Greenfield Pharmacy, PHY 37480, Administrative Case AC 5155
Vista, CA
Interim Suspension Order issued on 4/11/2014. Greenfield Pharmacy is temporarily suspended and prohibited from engaging in the practice of pharmacy. This Interim Suspension Order shall remain in effect pending further order of the Office of Administrative Hearings.
Effective April 8, 2014
View the decision

California Board of Pharmacy files Accusations Against California Pharmacy and Compounding Center

California Pharmacy and Compounding Center, LSC 99542, Administrative Case AC 4628
Newport Beach, CA
Accusation Filed 03/27/2014; Case Pending.
View the accusation
California Pharmacy and Compounding Center, PHY 49828, Administrative Case AC 4628
Newport Beach, CA
Accusation Filed 03/27/2014; Case Pending.
View the accusation
As Derby Week Begins, Racing at the Crossroads

SARATOGA SPRINGS, NY, April 28, 2014—From the backside to the executive offices to the press box, the racing community often laments the lack of meaningful media coverage of the sport.

The biggest stories are usually the saddest, the most embarrassing: the Fix Six scandal, the animal cruelty of Ernie Paragallo, the Barbaro and Eight Belles tragedies, the sudden equine death syndrome mystery and, most recently, the PETA/Asmussen tapes.

In the case of the latter, outside events unwittingly took some of the heat off racing created by the undercover sting operation. The NCAA Tournament was in high gear when the story broke. No foul, no harm.

But now, with Derby Week upon us, the sports world is mired in a new obsession; the hideous, hurtful Donald Sterling tapes. However, don’t expect the fallout from the “scandalous” PETA video to disappear anytime soon.

It’s Monday and the Asmussen story already has been dredged up by the New York Daily News, Newsday and a Lexington, KY-based business website.

But whatever coverage this story gets the rest of this week, it will pale in comparison to what will be learned by the general public during the highly rated network broadcast of Saturday’s Kentucky Derby.

New York Times Oklahoma Set for Double Execution Amid Storm Over Lethal-Drug Secrecy


McAlester, Okla. — Attempts by two condemned Oklahoma men to delay their lethal injections over the state’s refusal to disclose the source of the drugs were set to end Tuesday evening in the first double execution in Oklahoma in eight decades.
The appeals for disclosure, supported by a state court in March, threw Oklahoma’s highest courts and elected officials into weeks of conflict and disarray, with courts arguing over which should consider the request for a politically unpopular stay of execution, the governor defying the State Supreme Court’s ruling for a delay, and a legislator seeking impeachment of the justices.
The planned executions of Clayton D. Lockett, 38, and Charles F. Warner, 46, dramatized the growing tension nationally over secrecy in lethal injections as drug companies, saying they are fearful of political and even physical attack, refuse to supply drugs, and many states scramble to find new sources and try untested combinations. Several states have imposed secrecy on the suppliers of lethal injection drugs, leading to court battles over due process and the ban on cruel and unusual punishment.
continue to read here

North Dakota approves regulations for horse doping

North Dakota approves regulations for horse doping

Akin Gump Grows Health Industry Practice with Addition of Former FDA Advisor Nathan Brown who helped draft DQSA

(Washington, D.C.) – Akin Gump is pleased to announce that Nathan A. Brown, former U.S. Food and Drug Administration (FDA) lawyer and Senate Health, Education, Labor and Pensions (HELP) Committee advisor, has joined the firm as a health care and life sciences partner in the firm’s Washington, D.C. office.
At Akin Gump, Mr. Brown will provide regulatory, compliance and policy advice to health industry participants with regard to drugs, biologics and medical devices as well as cosmetics and food products regulated by the FDA. Prior to joining the firm, he served in several prominent roles with the FDA. Most recently, he was detailed to serve as health policy advisor to the Senate HELP Committee to cover FDA issues.
“Nate is a great addition to our health care practice, which has been routinely noted as among the best in the country,” said Akin Gump chairperson Kim Koopersmith. “With his extensive background and experience, we look forward to the great work he will do on behalf of our clients.”
Jorge Lopez Jr., head of the firm’s health industry practice, added “The health care industry continues to change rapidly, and throughout we have remained focused on building a team that can advise clients across the spectrum of issues they may encounter. Nate’s arrival adds to our already strong bench, and his experience—particularly with the FDA—makes him an ideal fit for Akin Gump. I am thrilled to have him with us.”
Mr. Brown has substantial experience in drug legislation matters including, on behalf of HELP Committee Chairman Tom Harkin, playing a lead role negotiating and drafting the Drug Quality and Security Act of 2013—which addresses compounded drugs and establishes a nationwide track and trace system for the pharmaceutical supply chain—as well as in coordinating passage of the Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013.
Mr. Brown has also advised FDA’s Center for Devices and Radiological Health on a wide range of matters, including software and health IT regulation, device review program reform, third-party review, laboratory developed tests and appeals issues. He served as counsel on the medical device user fee reauthorization negotiation team (“MDUFA 3”) and represented the FDA in providing assistance to Congress on device reform for the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA).
Mr. Brown said, “Working with Akin Gump is an incredible opportunity for me. It has always been a known industry leader in the health care industry, and I am looking forward to working with this impressive team and putting my skills to work on behalf of the firm’s clients.”

About Nathan A. Brown

Before going to the Senate HELP Committee, Mr. Brown served in two roles at FDA. As special assistant to the chief counsel, he counseled FDA leadership on high priority and cross-cutting matters involving drugs, devices, and other FDA-regulated products, emerging public health issues, high-profile enforcement cases and congressional investigations. He also served as senior counselor to the associate commissioner for regulatory affairs (ACRA) in the Office of Regulatory Affairs, where he advised the ACRA on compliance, enforcement and policy matters.
Prior to his work at FDA, Mr. Brown was a lawyer in private practice, where he focused on providing regulatory, legislative and litigation counsel relating to Medicaid, Medicare and other health programs to national associations, hospitals and other health care providers. He represented clients before the Centers for Medicare & Medicaid Services, the Department of Health and Human Services Departmental Appeals Board and various state agencies and in litigation in federal and state courts. He also advised clients on election law and lobbying law requirements.
Mr. Brown has been a vice-chair of the Montgomery County (Md.) Board of Social Services and previously served as co-chair of the Maryland Health Benefit Exchange Advisory Committee on Financial Sustainability.
Mr. Brown received his J.D., cum laude, from Harvard Law School and his B.A., summa cum laude, in government and politics from the University of Maryland.

About Akin Gump’s Health Care and Life Sciences Practice

Akin Gump combines the knowledge and experience of its health industry, food and drug law, intellectual property, public law and policy, corporate and tax practices to assist health industry clients in navigating the complex array of policies and regulations to which their industry is subjected. The firm represents participants in all aspects of health care and life sciences, including: hospitals and health care systems; pharmaceutical companies; medical device and technology manufacturers; health plans and managed care organizations; and lenders, investors and underwriters involved in health industry transactions.
The practice has been regularly recognized for its accomplishments and quality of service, including, most recently, as a Law360 Practice Group of the Year for 2011, 2012 and 2013.
Founded in 1945, Akin Gump Strauss Hauer & Feld LLP is a leading international law firm with more than 850 attorneys in offices throughout the United States, Europe, Asia and the Middle East.
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To Register or Not to Register – Compounding Pharmacy Dilemma


Written by Robert Moore and Bob Pollock • April 28, 2014

For Compounding Pharmacies, there is a new law (Compounding Quality Act) and a sheriff (the FDA) to enforce the law.  The new law is an amendment to the Food, Drug& Cosmetic Act (FDCA), which (amongst other things) requires that the drugs must be compounded in compliance with Current Good Manufacturing Practices (CGMP) by or under direct supervision of a licensed pharmacist in a registered facility.
Under this new law, some compounding pharmacies will be categorized as “outsourcing facilities”.  Those pharmacies that compound sterile drugs, among others, must register with the FDA as an “outsourcing facility”.
If the pharmacy compounds a solution or suspension using a non-sterile active pharmaceutical ingredient (API or, aka, drug entity) and then, by further processing, renders the final drug product as “sterile”, it must register with the FDA.  If the pharmacy performs “sterile to sterile” transfers or “sterile admixing”, it must register with the FDA.  If by any means the pharmacy compounds a sterile product, it must register with the FDA as an “outsourcing facility”.
continue to read here

American Bar Association Health Law Section The Health Lawyer

The American Bar Association Health Law Section April 2014, Vol 26, Number 4,  Edition of the Heath Lawyer has an article entitled Pharmacy Compounding After the Drug Quality and Security Act written by Erika Lietzan, Esq. and Mingham Ji, Esq. both of Covington and Burling, Washington, D.C. that I highly recommend reading. Membership is required.  More information can be found here,

VERY IMPORTANT WARNING LETTER: 2014 Americare Compounding, LLC. 4/22/14

2014 Americare Compounding, LLC. 4/22/14

Drug Compounding--A Veterinarian's Comments-Dr Colleen Currigan

Drug compounding is not new, but there have been some recent high profile events, both in the human and the veterinary world, that have brought the issue back into prominence. These include the 2009 deaths of 21 polo ponies at the U.S. Open Polo Championship in Florida after an error was made when mixing a compounded medication for the ponies, and most recently the 2012 outbreak of human fungal meningitis, when contaminated medication was dispensed to physicians around the country from New England Compounding Center. These events may lead to legislative changes that affect the compounding of medications in veterinary medicine and those changes could impact the prescribing of medications for cats.
What exactly is ‘compounding’? My recent involvement on the American Veterinary Medical Association’s (AVMA) Clinical Practitioners Advisory Committee has taught me a lot about the ins and outs of compounding. The AVMA is working hard to educate veterinarians and pet owners about compounding by posting information on their website, www.avma.org, as well as holding educational webinars for veterinarians. Much of the information that I am including in this blog article came from the AVMA. Below are some compounding facts:

The Impact of the Drug Quality and Security Act on Compounding Pharmacies is the Subject of May 13th Seminar in Boston

The Impact of the Drug Quality and Security Act on Compounding Pharmacies is the Subject of May 13th Seminar in Boston

Monday, April 28, 2014

Insurer Must Defend Claims that Radiologists Injected Tainted Drug Purchased from New England Compounding Pharmacy, Court Rules

A federal district court in West Virginia has ruled that a medical professional liability insurance company was obligated to defend two radiologists and their employer against claims that they had injected patients with an allegedly tainted drug purchased from New England Compounding Pharmacy, Inc.
more information here

Ohio Legislation SB 18 Relating to non-patient specific compounding for office use

Update on Current LegislationSB 18: Compounding. Sen. Wachtmann (R-Napoleon). This bill will allow pharmacists to do non-patient specific compounding for office use. The legislation passed unanimously out of the House Health Committee and now waits signature by the Governor. The Ohio Pharmacists Association supported this bill, and worked with the sponsor as well as the Board of Pharmacy to see it through to a successful conclusion.

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JURIST - Oklahoma Appellate Courts Wrestle Over Death Penalty Secrecy Statute

JURIST - Oklahoma Appellate Courts Wrestle Over Death Penalty Secrecy Statute

Pew Foundation Timeline for Drug Supply Chain and Security Act

Timeline for the Drug Supply Chain and Security Act

The Drug Supply Chain and Security Act (Title II, Drug Quality and Security Act, ... MOUs to address inordinate interstate shipment of compounded drugs; use of ...

Sunday, April 27, 2014

Florida Legislature Holds Fate of Racehorse Drug Reforms

Florida Legislature Holds Fate of Racehorse Drug Reforms

FDA

FDA Powerpoint:  Fees Associated with Human. Drug Compounding By. Registered Outsourcing. Facilities. Webinar: Overview of Fees and Information for. Small Businesses ...

Fees Associated with Human Drug Compounding By ...

 

For 2013, Pharmacist Salaries Rise Yet Again For This Family-Friendly Occupation

Time for our exclusive annual analysis of pharmacist salaries, based on the Bureau of Labor Statistics’ (BLS) latest 2013 Occupational Employment Statistics (OES).

Once again, pharmacist salaries grew faster than overall U.S. wages. The highlights:
  • In 2013, the average gross salary for a pharmacist at a retail, mail, and specialty pharmacy was $117,500—up 1.1% from 2012.
  • Average salaries for pharmacists at mass merchants climbed above $121,000.
  • Of the 820 detailed occupations that BLS lists in the OES survey, the “pharmacist” classification ranked 29th in compensation.
  • Retail, mail, and specialty pharmacists’ salaries are 57% higher than the average healthcare figure.
Details below. I also highlight a neat paper that analyzes how the growth of national chains turned pharmacy into a family-friendly, female-majority profession with a very small gender wage gap. It's a new twist on how free-market industry evolution can lead to positive social outcomes.

continue to read here

Inside Specialty Drug Dispensing at Physician Practices

As I discuss in Chapter 8 of the 2013-14 Economic Report on Retail, Mail, and Specialty Pharmacies, the growth in oral oncology products is encouraging physicians to dispense these products from offices and clinics. These practice-affiliated pharmacies act as “closed door” pharmacies by dispensing only to the practice’s patients

continue to read here

SouthCoast lawmakers question report's premise

Bad medicine: Over 450 pharmacies selling spurious drugs in Lahore

The Federal Investigation Agency (FIA) has identified more than 450 drug stores selling spurious drugs in the provincial capital, according to a report of the agency available with The Express Tribune.
The drugs include medicine manufactured by local and multinational pharmaceutical companies including life-saving drugs. Along with the FIA report, the names of the spurious drugs and the medical stores selling them have been shared with the provincial health authorities, including the Punjab health minister and the provincial health secretary, FIA Punjab Director Dr Usman Anwar said.
The Punjab chapter of the FIA had launched an operation in early April after several complaints were made about the sale of substandard medicine in Lahore. Over the last two weeks, the FIA identified and raided 10 establishments which engaged in the manufacture, bulk supply and distribution of spurious drugs to hundreds of drug stores in Lahore. The record confiscated at the 10 establishments jointly raided by the FIA personnel and drug inspectors of the Health Department included invoices documenting the sale of spurious drugs to more than 450 drug stores in Lahore. In random checks, the adulterated medicines supplied by the 10 establishments were recovered from the cited drug stores.
Pulling together
The schedule of offences that the FIA covers includes spurious drugs. However, the agency can only proceed against spurious drugs in coordination with the Health Department. Before initiating the crackdown, the FIA had held meetings with officials of the Health Department, the Quality Control Board, the drug testing laboratory and the pharmaceutical association, and requested their assistance. All four had agreed to support the action, according to FIA officials.
The FIA report said that the medicine found during raids included fake drugs in forged packing, unregistered drugs, drugs sold without manufacturer's warranty, expired medicine which had been repacked, drugs stolen from government or armed forces institutions, homeopathic or herbal products containing allopathic ingredients and drugs smuggled into Pakistan.
A taste of their own medicine
continue to read here

Stronger pharmacy laws could save lives

About 18 months ago, Michigan became "ground zero" in a fungal meningitis outbreak that claimed 19 lives and injured more than 260 patients in our state alone.
The culprit: tainted steroid drugs manufactured in Massachusetts by a compounding pharmacy and distributed in spinal injections at various medical facilities in four Michigan counties, including a pain clinic in Brighton.
Compounding pharmacies mix and assemble pharmaceuticals to create medicine needed by a patient but not commercially available in the dose or format required.
Meanwhile, a new federal law was passed to ensure greater oversight, but its rules are still being written. In Michigan, a Brighton-area lawmaker is leading the charge to tighten state rules through its own pharmacy board.
As Chris Gautz reports on Page 29, if patients are injured or die because the new rules aren't followed, the proposed law would impose felony charges and possible prison sentences.
Compounding pharmacies can offer many patients a safe alternative to stronger doses or ingredients they may be allergic to that are found in commercially available drugs. They can also create medications that are found to be in short supply.
The proposed legislation would require inspections and a "pharmacist-in-charge" responsible for quality control.
Reputable businesses should have no problems with the proposed legislation.
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Seminar on the DQSA by Microtest Laboratories

 

The Impact of the Drug Quality and Security Act on Compounding Pharmacies Is the Subject of May 13th Seminar in Boston      
AGAWAM, MASS. — April 29, 2014 — A seminar focusing on the impact of HR3204 — the Drug Quality and Security Act — on compound pharmacies and manufacturers is the subject of a seminar set for May 13, 2014 in Dedham, Mass., near Boston.

Meeting the new guidelines will require substantial changes for many compounders. The seminar is designed to explain the stepping stones needed to comply with the new legislation as well as review USP <797> in its current state.

The seminar will provide pharmacies and compounders that do business as compounding manufacturers and outsourcing facilities with the knowledge they need to know about how the new regulatory expectations will affect their businesses.

Seminar topics will include:
·         Becoming a compounding manufacturer
·         Manufacturing under cGMP requirements
·         Meeting current USP <797> requirements

The seminar will be presented by Microtest Laboratories, a leader in testing services for the medical device, pharmaceutical, and biotechnology industries, on Tuesday, May 13, 2014, from 9 a.m. to 3 p.m. at the Endicott House in Dedham, Mass., just outside Boston. Registration is at 8:30 a.m. A continental breakfast, break refreshments, and a luncheon are included.

To register, visit http://www.microtestlabs.com/seminar or contact Julie Adamski 1-800-631-1680, ext. 192, or jadamski@microtestlabs.com. Advance registration is $149.
 
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AHLA In-House Counsel Program and Annual Meeting June 29-June 2, 2014 in NYC to Including Laura A. Carpenter Speaking on Compounding

Pharmacy Compounding: What Hospitals Need to Know when Purchasing


Compounded Preparations from Specialty Pharmacies (not repeated)




Laura A. Carpenter


Pharmacy compounding serves an important health need when a patient needs a

product that is not commercially available. This program will address:

❯❯ The risk factors involved in outsourcing pharmacy compounding

❯❯ The difference between manufactured drugs and compounded preparations

❯❯ The United States Pharmacopoeia (USP) standards for compounding and monographs.

❯❯ The FDA’s position on when a drug is “compounded” or “manufactured”

❯❯ The impact of the federal Compounding Quality Act, which was enacted in



November 2013

❯❯ Different state law scenarios for regulating compounding preparations and purchasing



them by hospitals, clinics, outpatient treatment centers, and physician offices

more information found here

State legislation would tighten controls on compounding pharmacies

Compounding pharmacies in Michigan may soon operate under a system of tighter controls and regulations, and employees could face felony charges and prison sentences if patients are injured or die because the new rules are not followed.
The aim behind Senate bills 704 and 904, sponsored by Sen. Joe Hune, R-Hamburg, is to prevent the kind of injuries and deaths suffered in the state two years ago when the Framingham, Mass.-based New England Compounding Center allegedly sent tainted medicine to clinics around the country.

Michigan was the hardest hit when the tainted steroids were delivered to clinics in the state, resulting in 264 infections and 19 deaths. Nationwide, the death count hit 64 with 751 cases of fungal infections or meningitis, according to the Centers for Disease Control and Prevention.

"Hearing from constituents that have been so adversely impacted by these tainted steroids, it's the least we can do," Hune said.

Compounding pharmacies mix and assemble pharmaceuticals to create a drug or form of medicine needed by a patient.

Hune's bills would add a series of requirements for these businesses, including that accurate records of its procedures are maintained, that the pharmacies are subject to a physical state inspection once every two years and that all compounding pharmacies designate a "pharmacist-in-charge" responsible for making sure the business follows the state regulations.

The criminal penalties for violating the rules that result in personal injury include a maximum of a four-year prison sentence. A violation that resulted in a patient death would carry a maximum 15-year sentence.

The legislation would also give the state the ability to immediately suspend the pharmacy license of the business if notice was received by the CDC or the Food and Drug Administration of imminent risk to public health or safety.

Attorney General Bill Schuette's office has been working with Hune on the bill, and supports the legislation he says will protect patients and hold pharmacists accountable
continue to read here

Saturday, April 26, 2014

Pharmacist Pleads To Fraud Charge

OLD FORGE — A pharmacist from Lackawanna County is facing insurance fraud charges.
Authorities say Peter Capitano, owner of Capitano’s Pharmacy on South Main Street in Old Forge, submitted false insurance claims for fake prescriptions between 2007 and August of 2013.
According to federal investigators, a plea agreement has been filed requiring Capitano to pay back as much as $200,000.

quoted from here

Florida Board of Pharmacy Conference Call Agenda for May 1, 2014 Regarding Compounding Rule

10:00a.m. Conference Call Meet Me # 1(888) 670 - Florida ...

floridaspharmacy.gov/Meetings/Agendas/.../050114-board-agenda.pdf
13 hours ago - legally distributed in the State of Florida by a drug manufacturer or wholesaler. (1) Compounding includes: (a) The preparation of drugs or devices in anticipation ...

States Raise Legal Issues With FDA's Compounding Info-Sharing Plan

FDA is weighing how to encourage state officials to enter information-sharing agreements for drug compounding oversight after state stakeholders expressed concerns that some agency requirements, such as those that conflict with some state sunshine laws, pose major legal hurdles, according to recently released minutes of an FDA meeting with state regulators and stakeholders.

Friday, April 25, 2014

How Hong Kong's On-Track Pharmacies Work

How Hong Kong's On-Track Pharmacies Work

In this video, David G. Miller, RPh, executive vice president and CEO of the International Academy of Compounding Pharmacists (IACP), discusses changes in insurance reimbursement for compounded medications.

view video here

PharMEDium Announces Updated Core Values

Our Core Values represent what the company is and where it is headed.  Please click here, or go to the About Section - Core Values Tab, to read more.                           

Oklahoma Legislators Want to Impeach Justices Who Suspended Death Sentences

The state of Oklahoma narrowly avoided a constitutional crisis over the death penalty on Wednesday evening, after the governor moved to defy a state Supreme Court order and legislators called for impeachment of several justices.
This constitutional stand-off began on Monday, when the court issued an order halting two executions. Gov. Mary Fallin (R) responded with an executive order saying the state might proceed with the executions, despite the court order. Rep. Mike Christian (R) ordered articles of impeachment drafted on Wednesday, claiming the justices engaged in a “willful neglect of duty” by halting the executions of Clayton Lockett and Charles Warner. After this pushback from the political branches, the court lifted its order on Wednesday and allowed the executions to proceed.

The court initially stopped the executions because the inmates had sued to find out the source of the state’s lethal drugs. Oklahoma law says, “The identity of all…persons who supply the drugs…for the execution shall be confidential.” The Oklahoma Supreme Court ultimately rejected the inmates’ argument that they needed this information to assert their right to avoid “cruel and unusual” punishment under the Eighth Amendment.

continue to read here