Saturday, August 2, 2014

HORSE DOPING – SEGMENT 4 NONPROFIT DRUG TESTING PROGRAMS – PROS & CONS

 


By Rick Dennis
Aug. 1, 2014

In the article “Horse Doping – Segment 3,” I discussed whether or not nonprofit equine drug-testing programs were fair and balanced. In Segment 4, I will provide a brief history of employee drug-testing programs in a general comparison to equine nonprofit drug-testing programs, especially in lieu of the recent announcement of the Federation Equestre International (FEI) saying, “The human athlete is subject to drug testing in equine showing disciplines as well as the horse.”  This article will also detail the pros and cons of several nonprofit equine drug-testing policies in use in the industry today as well as the perceived short falls of each.

continue to read here

16 NRHA “MILLION-DOLLAR’ TRAINERS PROPOSE CHANGES TO NRHA DRUG POLICY--- Proposal Could Eliminate Compounded Animal Drugs--read: “For the purpose of this rule a forbidden substance should be considered any substance that is not FDA approved for equine use and prescribed by a licensed veterinarian.”

 

 

FROM THE EDITOR


By Glory Ann KurtzJuly 31, 2014The National Reining Horse Association (NRHA) is planning on putting into effect a new drug and medication policy in 2015 that is more in line with the Federation Equestre International (FEI) and the United States Equestrian Federation (USEF) – International events that the NRHA Open horses and riders compete in, including the Olympics. FEI is the leader with the others following suit, as they recently announced they can also test the “human athlete” at their shows.

THE TRAINER PROPOSAL
Recently 16 of the 19 well-known NRHA trainers, known by many as the “Million-Dollar Gang,” proposed a replacement to Section 7 Equine Medications, The Therapeutic Substance Provisions in the General Rules and Regulations of the NRHA Rule Book that was recently put into effect. These trainers are not disputing the method of collecting samples, but are disputing what a forbidden substance is.  Three of the Million-dollar Gang, who were from European countries, refused to join in on the proposed rule change.

continue to read here

Third Question of the Day August 2, 2014 Should the Federal Trade Commission take a more active role in advertsising by compounding pharmacies?


Second Question of the Day August 2, 2014 How many compounding pharmacies violate these IACP Guidelines for Marketing Compounded Medications Responsibly (Remember your state laws may be more strict on advertising)? How many in fact claim compounded medications are better than commerically available drugs or that commerically available drugs are bad for you (i..e., Disparaging other products, including manufactured drugs and synthetic hormones)

Imprimis Pharmaceuticals is Hiring a Regulatory Corporate Counsel

Regulatory Corporate Counsel


Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a San Diego-based specialty pharmaceutical company focused on the development and commercialization of proprietary and novel sterile and topical drug formulations. Certain of Imprimis’ patent-pending drug formulations are available today and are being prescribed by physicians. For more information, please visit www.imprimispharma.com
 Job Summary
Responsibilities will include counseling and reporting requirements on regulatory issues such as FDA and State Pharmacy laws and regulations, guidance documents relating to pharmaceutical advertising and promotion, scientific exchange, handling adverse events including regulatory actions and violations; and regulatory agency strategy on inspectional and safety issues, communications, and quality issues. Responsibilities also include counseling on fraud and abuse issues relating to sales and marketing activities, including the Anti-kickback Statute and False Claims Act, as well as contract and pricing strategies such as discounts, rebates, and bundling methodologies. Researches FDA, FTC, DEA, DOJ, CBP, and State BOP regulations, case law and statutes pertaining to regulatory agencies and the administrative process. Supports business processes concerning specific legal-FDA regulatory matters and issues. This position reports to the Vice President of Accounting and Public Reporting.
The successful candidate must have the demonstrated ability to build and maintain relationships, trust, and respect with clients and peers, as well as the ability to proactively identify and manage significant legal issues.  Strong leadership, technical knowledge, business acumen, and excellent communication skills are required. Candidate has a track record of effective decision-making and the proven ability to assess, calibrate, and effectively communicate legal risk.  You must have the managerial courage required to counsel senior leaders, manage relationships with outside counsel and several regulatory agencies, including but not limited to, state boards of pharmacy and the FDA, and provide effective coaching and constructive feedback, as well as the organizational savvy and diplomatic sensitivities necessary to effectively collaborate with cross-functional client teams.
Position Responsibilities: 
  • Correspond with the State Pharmacy Boards, FDA, other regulatory agencies, customers, suppliers, and division personnel as needed both orally and in writing to address regulatory inquires, problems, or requests.
  • Identify, recommend and implement where possible, corrective actions for regulatory and other related processes.
  • Review promotional information and product literature to ensure FDA and FTC regulatory compliance.
  • Review governmental rulings to determine changes and probable effects on facility activities.
  • Draft and negotiate a broad range of contracts related to all aspects of the organization, including license agreements, collaboration agreements, clinical trial agreements, sponsored research agreements, material transfer agreements, supply agreements, master services agreements, consulting agreements and confidentiality agreements.
  • Oversees legal services provided by the practice group and helps ensure consistency of legal advice on healthcare law issues, including healthcare fraud and abuse, FDA regulations on clinical trial conduct, labeling, advertising and pharmacovigilance, product liability, reimbursement, antitrust, privacy, and other matters relevant to the development, manufacture and commercialization of formulations and products.
  • Help execute and maintain HIPAA and security compliance across all business units
  • Collaborate with all necessary parties to achieve desired business outcomes, works closely with Vice President of Pharmacy Operations.
  • Excellent organization and time-management skills required. Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure.
  • Assist on other matters within the legal department as needed.
  • Perform duties in accordance with established company procedures and policies; perform other duties as assigned.
  • Coordinate with outside counsel as appropriate.
  • Develops and manages budgets for assigned legal matters.
  • Resolve contract disputes.
  • Contribute to the constant improvement of the internal contracting process.
Requirements: 
  • J.D. degree from an accredited law school, exceptional academic credentials and bar membership. Licensed to practice law in the United States and currently admitted to practice and in good standing as a lawyer in the state of California.
  • Licensed pharmacist preferred
  • 5 or more years of relevant experience in FDA regulatory law area and state boards of pharmacy
  • Knowledge of DQSA
  • Strong written, verbal and presentation communication skills.
  • Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and Microsoft Office) required.
  • Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.
  • Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards.
  • Team player with a positive, can-do attitude.
  • Ability to complete tasks with little direction or need for supervisory follow-up.
  • Ability to travel up to 10% of the time. Must be able to travel independently as an Imprimis Pharmaceuticals, Inc. representative.
Work Environment/Physical Demands:
  • The employee may frequently be required to sit and talk or hear.
  • The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch.
  • The employee must occasionally lift and/or move up to 25 pounds.
  • Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Imprimis believes in creating long-term relationships by being responsive and relevant and by consistently delivering value to our community of customers. Specifically with our employees, we focus on attracting, developing and retaining the best talent for our business, challenging our people, demonstrating a “can-do” attitude and fostering a collaborative and mutually supportive environment.
Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
Imprimis Pharmaceuticals, Inc. is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.

Question of the Day August 2, 2014 What duty ethically and legally does a compounding pharmacy employee have to report illegal compounding? Does it matter the title of the employee? For example PIC vs. acccountant vs. compounding sales or marketing representative? Who should be liable for false advertising? Who should be liable if illegal compounds are advertised, promoted and sold by the compounding pharmacy? Does it matter if the employee attends meetings of the compounding pharamcy and is allowed to freely speak his or her mind even though he or she is not an officer of the company? In other words doesn't a close relatonship with the officers of the companyeffect criminal and civil liabile of the employee?


Health Care Is "The New Oil" Says Bush-Family Entrepreneur

I’m sitting on Amtrak distracted by a passenger two rows back, yakking on the phone to her doctor’s office. She’d like to transfer her records to another doctor down the street, and alas, such an enormous undertaking cannot be completed in only two days. “Please,” she begs, “Could you make an exception?” After half an hour of this, she succeeds. Hallelujah.
Nobody could be surprised by this conversation. When it comes to health care, we are accustomed to pointless bureaucracies and record systems dating from the Mad Men era. But think how shocked the entire train of passengers would have been if this passenger was instead cajoling her bank into allowing her to withdraw cash. Banks have allowed consumers instant access to their money 24 hours a day, on every street corner in the world, for decades. But in health care, it’s a major project to move a file down the street.
This is an embarrassing problem for the health care industry. But one businessman sees it as something else: a beautiful opportunity with dollar signs attached. That’s the message of a new book, Where Does It Hurt? by Jonathan Bush, CEO and founder of an innovative health care company called athenahealth.

continue to read here

Permalink to Veterinary Medicine Mobility Act heads to the White House

Permalink to Veterinary Medicine Mobility Act heads to the White House

Friday, August 1, 2014

Want to know Approximately how Much Money Your Compounding Pharmacy is Making a Year! Results from Dun and Bradstreet--Here is a random search of some compounding pharmacies in TX (Abrams Royal, Fry's Pharmacy, and Richie's Pharmacy and Medical Supply, Inc. Feel Free to go to link at the bottom and search your compounding pharmacy and get an estimate of their revenue

Royal Abrams Pharmacy Inc

          
8220 Abrams Rd Dallas, TX 75231-1402
Get Directions

 

Business Info

  • Founded 1980
  • Incorporated --
  • Annual Revenue $ 2,100,000.00
  • Employee Count 20
  • Industries Drug Stores
  • Contacts Bob G Scarbrough
 
 
 
Company Summary

Royal Abrams Pharmacy Inc was founded in 1980, and is located at 8220 Abrams Rd in Dallas, TX
 

Abrams Royal Pharmacy II

CLAIM THIS BUSINESS
4909 W Park Blvd Ste 165 Plano, TX 75093-2337
Get Directions

Business Info

  • Founded 2008
  • Incorporated --
  • Annual Revenue $ 400,000.00
  • Employee Count 5
  • Industries Drug Stores And Proprietary Stores
  • Contacts Lark Swofford
 
 
Company Summary

Abrams Royal Pharmacy Ii has been serving customers in the Plano area for over 6 years. Since 2008 the company has been providing Drug Stores And Proprietary Stores.



Fry's Pharmacy

     


311 N Sam Houston Blvd San Benito, TX 78586-4656
Get Directions

Business Info

  • Founded 1980
  • Incorporated --
  • Annual Revenue $ 1,900,000.00
  • Employee Count 15
  • Industries Drug Stores
  • Contacts Ben Fry
 
 
Company Summary

Since 1980, Fry's Pharmacy has been providing Drug Stores from San Benito.
 

RICHIE'S PHARMACY AND MEDICAL SUPPLY, INC

CLAIM THIS BUSINESS
12820 HIGHWAY 105 W CONROE, TX 77304-1574
Get Directions
Founded 1999
  • Incorporated Texas

  • Annual Revenue $ 13,571,958.00

  • Employee Count 40

  • Industries Wholesale - Medical Equipment And Supplies

  • Contacts RICHIE RAY

  •  
    +

    Company Summary

    Richie's Pharmacy And Medical Supply, Inc is located at 12820 Highway 105 W in Conroe and has been in the business of Wholesale - Medical Equipment And Supplies since 1999. It employs 40 employees and is generating approximately $ 13,571,958.00 in annual revenue. Additional information is available at www.richiespharmacy.com or by calling (877) 231-8386.


    Search Here to find out about your compounding pharmacy:  Dun and Bradstreet https://www.dandb.com/ or search here

    http://www.dandb.com/businessdirectory/search/?keyword=it+professionals&page=9


    13th Question of the Day August 1, 2014 How many compounding pharmacies will have to file bankruptcy once the effects of insurance companies and PBMs etc. covering less api and compounded drugs is felt?


    12th Question of the Day August 1, 2014 Anyone remember this prosecution regarding compounding? Is this the type of criminal prosecutions we will see in the near future regarding illegal activity relating to compounding pharmacies? In 2002, this fraud cost the taxpayers $15 million? Wonder what the cost of the fraudlent activity today is?

  • Two physicians, two licensed pharmacists, and four pharmacy and durable medical equipment (DME) owners were convicted in the largest Medicare fraud conspiracy trial in the Southern District of Florida. As part of the conspiracy, the defendants paid patients for their Medicare cards and for signing blank delivery receipts without receiving any medication. The physician defendants issued fraudulent prescriptions to the patients, ordered unnecessary tests, medical equipment and medication, and thereafter the DME defendants forwarded the prescriptions to co-conspirator pharmacies and submitted false bills to Medicare in excess of $15 million for medication and medical equipment that was never delivered. Additionally, the pharmacist and pharmacy owner defendants, who were unwilling to buy expensive medications approved by the FDA in the volumes necessary to fill prescriptions, manufactured unnecessary, non-FDA approved medications through a process called "compounding," and provided the DME companies with documentation reflecting full deliveries of FDA-approved medications even though "compounded" medications were supplied and often times only half or none of the medication was actually delivered to the DME companies. Following a 5 ½ month trial, a jury convicted the eight defendants of conspiracy to defraud the United States and additionally convicted one defendant of filing false claims, paying kickbacks, and conspiracy to commit money laundering; a second defendant of paying kickbacks; and a third defendant of filing false claims and paying kickbacks. Eighteen co-defendants entered guilty pleas prior to trial. 
  • quoted from here 
  • Growth Hormone Schemes and Scams by Stephen Barrett M.D.

    This older article at Quackwatch is still very relevant today

    Growth Hormone Schemes and Scams

    Stephen Barrett, M.D.

    Human growth hormone (HGH) is a substance secreted by the pituitary gland that promotes growth during childhood and adolescence. Growth hormone acts on the liver and other tissues to stimulate production of insulin-like growth factor I (IGF-I), which is responsible for the growth-promoting effects of growth hormone and also reflects the amount produced. Blood levels of circulating IGF-I tend to decrease as people age or become obese [1]. Many marketers would like you to believe that boosting HGH blood levels can reduce body fat; build muscle; improve sex life, sleep quality, vision and memory; restore hair growth and color; strengthen the immune system; normalize blood sugar; increase energy; and "turn back your body's biological clock." This article traces the history of these claims and why you should disregard them.

    Marketing "Milestones"

    The drive to popularize growth hormone began about 20 years ago with publication of the book Life Extension: A Practical Scientific Approach, by Durk Pearson and Sandy Shaw [2]. The book's central premise was large amounts of vitamins, minerals, amino acids, and and other substances would cause people to add muscle, burn fat, and live much longer. Although their advice had no scientific basis [3,4], Pearson and Shaw made hundreds of talk-show appearances that boosted sales of the substances they recommended.
    Soon after the book's publication, many amino acid products were claimed to cause overnight weight loss by increasing the release of growth hormone. So called "growth-hormone releasers" were also marketed to bodybuilders with claims that they would help build muscle. Such claims are unfounded because amino acids taken by mouth do not stimulate growth hormone release. These formulations are based mainly on misinterpreted studies of intravenous arginine, which can increase HGH blood levels for an hour or so. Taking it by mouth has no such effect. The FTC [5-9], and the New York City Department of Consumer Affairs [10] attacked some companies making "growth-hormone release" claims, but these actions had very little effect on the overall marketplace.
    In 1990, The New England Journal of Medicine published a study that attracted mainstream media attention. The study involved 12 men, aged 61 to 81, who were apparently healthy but had IGF-I levels below those found in normal young men. The 12 men were given growth hormone injections three times a week for six months and compared with 9 men who received no treatment. The treatment resulted in a decrease in adipose (fatty) tissue and increases in lean body (muscle) mass and lumbar spine density [11]. An accompanying editorial warned that some of the subjects had experienced side effects and that the long-range effects of administering HGH to healthy adults were unknown. It also warned that the hormone shots were expensive and that the study had not examined whether the men who received the hormone had substantially improved their muscle strength, mobility, or quality of life [1].

    What You Need to Know About the FDA's Push to Regulate Laboratory Developed Tests - Bio-IT World

    What You Need to Know About the FDA's Push to Regulate Laboratory Developed Tests - Bio-IT World

    Eleventh Question of the Day August 1, 2014 How many animal compounding pharmacies compound medications for convenience (i.e., it is easier to give a cow one shot of a drug than three shots as required by a commerically available etc.) Does this violate the law? Should there be an exception for this? If there is an exception made won't compounders always try to argue it was to make giving the medciation easier? How is this fair to the manufacturer who has followed the rules, invested the money done the studies and trials, gotten FDA approval for the three shot method and how do we know the one shot is just as effective as the three shot method since compounders haven't invested the money, haven't done the studies, haven't sought FDA approval etc.?

     

    FDA Publishes Compounding Guidance, but Where Are the Regulations?

     

    Executive Summary
    The Food and Drug Administration ("FDA") released five regulatory and guidance documents pertaining to compounding in an effort to provide clarity to pharmaceutical stakeholders.  The documents, issued pursuant to the Drug Quality and Security Act ("Act"), describe expectations regarding compliance with current good manufacturing practices ("cGMPs") for compounding outsourcing facilities and standards for compounding pharmacies, request nominations to the lists of bulk drug substances that can be used in compounding in those facilities and propose to update the list of drugs withdrawn from the market for safety or efficacy reasons.
    Background
    The FDA recently released five documents related to compounding pharmacies and outsourcing facilities pursuant to the Act.  The documents focus on Sections 503A and 503B of the Food, Drug, and Cosmetic Act, which was amended by the Act.  Section 503A places restrictions on compounding pharmacies that generally sell their products to specific patients within a single state.  The Act adds Section 503B that creates "outsourcing facilities," which do not face the same geographic restrictions as 503A compounding pharmacies but must register with the FDA and meet strict operational requirements.

    continue to read here

    Arizona Needed 15 Drug Doses to Execute Joseph Wood

    read here

    Recalls, Market Withdrawals, & Safety Alerts New England Greens, LLC dba Vibrant Health Recalls Green Vibrance and Rainbow Vibrance Because of Possible Health Risk

    Recalls, Market Withdrawals, & Safety Alerts New England Greens, LLC dba Vibrant Health Recalls Green Vibrance and Rainbow Vibrance Because of Possible Health Risk

    Tenth Question of the Day August 1, 2014 What impact. if any, will the new FDA rules relating to labs have on compounding pharmacies who use one or two main labs to do all their hormone testing?


    Medical labs to get new FDA oversight

     

    Published: Thursday, Jul. 31, 2014 - 1:00 am
     
    read here

    Read more here: http://www.sacbee.com/2014/07/31/6597538/medical-labs-to-get-new-fda-oversight.html#storylink=cpyThe Food & Drug Administration on Thursday announced it would step up its regulation of a class of lab tests that have been key in ushering in an era of personalized medicine - a step the agency has long considered against strong opposition by small labs. The FDA's proposal would tighten the agency's oversight of laboratory-developed tests, which are designed, manufactured and used within a single lab. Most of the tests that would now come under more stringent review are used by physicians and hospitals to help diagnose and treat patients, and they have been widely used to detect certain types of gene-based cancers and guide their treatment.
    As medical practice has grown increasingly dependent on genomic analysis, many small or specialized labs have gotten into the business of devising diagnostic tests, tailoring them to the needs of specialized practices, and providing laboratory services to hospitals and physicians.

    Read more here: http://www.sacbee.com/2014/07/31/6597538/medical-labs-to-get-new-fda-oversight.html#storylink=cpy

    Drug companies oppose India's move to slash prices of 50 drugs

    Drug companies oppose India's move to slash prices of 50 drugs

    Scrutiny flares as next Missouri execution looms

    Time appears to be running out for convicted Missouri killer Michael Worthington, who is scheduled on Wednesday to become the country’s first person executed since last month’s prolonged and problematic lethal injection of an Arizona inmate.
    For nearly 120 minutes on July 23, Joseph R. Wood III snorted and gasped “like a fish out of water” before dying.
    His execution, the country’s third this year described as “botched,” has prompted renewed calls for a halt to all lethal injections.
    On Monday, the American Civil Liberties Union suggested a nationwide suspension of the death penalty. It and other death penalty opponents say that what happened during the botched executions violates Eighth Amendment protection against cruel and unusual punishment. continue to read here

    Read more here: http://www.kansascity.com/news/local/crime/article863263.html#storylink=cpy

    Judge Approves New England Compounding Settlements


    Daily Bankruptcy Review ,
    Jacqueline Palank,
    August 01, 2014,
    (c) 2014 Dow Jones & Company, Inc.
    Victims of a deadly meningitis outbreak will share as much as $100 million under settlements that won court approval Thursday in the bankruptcy case of the Massachusetts pharmacy tied to the outbreak. ...
    continue to read here

    Veterinarian Says Compounding is Not Hard for Him to Do: Compounding medications at Stonebridge Animal Hospital - Star Local: Voices

    Compounding medications at Stonebridge Animal Hospital - Star Local: Voices

    Do You Make These Five Mistakes with Your Pharmacy Benefit? The burchfield group

    These are tough times. No corporation can afford to conduct business as

    usual; and most CFOs in America are desperately looking for ways to

    reduce costs. Yet there is one area that is often overlooked. Your

    pharmacy benefit cost.

    We all know health care costs are continuing their steady rise, and

    pharmacy benefit cost makes up 10% to 20% of your total health care

    costs. Pharmacy costs are expected to rise between 6% and 7% in 2009.

    Unfortunately these costs are often hidden and neglected.

    A quick way to calculate your potential pharmacy benefit savings is as

    follows. Take your number of employees in thousands and multiply it by

    $100,000. For example, a company with 11,000 employees has the

    potential for savings of $1.1million. Ask yourself if this is a significant

    enough opportunity that you want to do something about it.

    For corporations with retiree medical benefits, the ruling under FASB 106

    requires accrual for these benefits. The Board believes that failure to

    recognize an obligation prior to its payment impairs the usefulness and

    integrity of the employer's financial statements. Failure to manage these

    costs has a compounding effect.

    Here are five pharmacy benefit mistakes your organization may be

    making that could cost the company millions.


    1. Allowing Human Resources to negotiate with Pharmacy




    Benefit Manager (PBM) companies without the clout of

    pharmacy benefit specialists.



    HR has its hands full with other priorities, is often understaffed and can

    lack the scale required to get the best deal when negotiating with PBMs.

    PBMs often come to your HR/Benefits team with offers to extend the

    contract for incremental savings. While many HR departments have

    some staff and expertise, chances are they only see PBM contracts once

    every two or three years. Are they up-to-date on the latest pharmacy

    pricing, trends and definitions of terms? Why take this risk when millions

    could be at stake


    continue to read here

    Reminder: The first official registration period opens and fee collection starts for compounding pharmacies registering as outsourcing facilities with the FDA


    Must READ! Lot of Valuable Information! FDA Reveals Expectations of Conditions at Outsourcing Facilities

    Cheryl A. Thompson
    BETHESDA, MD 01 Aug 2014-A document from FDA offers clues as to the extent that sterile drug products from outsourcing facilities will be made under conditions different from those described in the United States Pharmacopeia (USP) standards for pharmaceutical compounding.
    Fifty-one sites as of July 25, according to the agency, had registered as compounding outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act.
    The sites have been able to register without paying a fee.
    But come October 1, the first official registration period opens and fee collection starts.
    In preparation, FDA on July 1 issued a draft of "Current Good Manufacturing Practice - Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act" (PDF) and invited comments from the public.
    According to pharmacy consultant E. Clyde Buchanan, pharmacists can expect sterile drug products from FDA-registered outsourcing facilities "to be made under conditions more stringent" than those specified in USP chapter 797.
    That is because FDA drafted current good manufacturing practice (CGMP) requirements that impose "a higher level of quality control and quality assurance activities," he explained.
    Buchanan runs an eponymous consulting firm and is a coauthor of Compounding Sterile Preparations, Third Edition, published by ASHP.

    continue to read here

    Important Read! Very Good Explanation: Advisers and PBMS are Closing Costly Health Care Loopholes

    Posted August 1, 2014 by Craig Hasday at 09:05AM. Comments (0)
    In 2012, in an effort to promote cost transparency, new regulations were issued requiring pharmacies to list all drugs included in a compounded medicine when seeking reimbursement. Previous protocol required that only the most expensive drug be listed, and reimbursement was based on the cost of that drug.

    continue to read here

    More and More added to the list: Updated 7/30/2014 Compounding Registered Outsourcing Facilities

    Compounding Registered Outsourcing Facilities

    Ninth Question of the Day August 1, 2014 How many millions/billions of tax dollars have compounding pharmacies, pharmacists, doctors etc. cost taxpayers with fraudlent deductions, underreported income, etc. while at the same time collecting illegal medicare, medcaid, and insurance payments?


    Eighth Question of the Day August 1, 2014 When will the FDA start cracking down on those compounding pharmacies in the 5th Circuit (Texas, Louisiana and Mississippi) that compound animal drugs from bulk beyond small, necessary amounts? When will compounding organizations and groups stop distorting and misrepresenting what the caselaw actually holds (see prior post with actual 5th Circuit case that trumps what the district court said? Should pharmacies receive warning letters first? What if they have already recevied a warning letter in the past?


    Seventh Question of the Day August 1, 2014 Should full disclosure of all conflicts of interest to be made to a patient before a doctor prescribes compounded medications and a pharmacists makes a compounded medication? For example if the pharmacist also works for the company that supplies the API shouldn't this be disclosed? If the pharmacist works for the company that does the testing on the compounded preparations shouldn't this be disclosed? What should be the legal ramification if it is not disclosed to the patient?


    Sixth Question of the Day August 1, 2014 Sometimes "mom and pop" business can be fronts for illegal activities, If mom and pop compounding pharmacies who are doing illegal compounding where given the choice today to close their doors or go to jail how many would opt to close their doors rather than have their families and employees go to jail?


    Fifth Question of the Day August 1, 2014 How many compounding pharmcists take family vacations, do a little "business" recruiting doctors for their compounds etc. and then write off all or part of the trip as as business expense for tax purposes?

     

    Fourth Question of the Day August 1, 2014 Are the compounding pharmacists organizations, associations etc. getting the support from patients they had hoped for on all their campaigns to perserve a patient's rights to compounded medications? If not, why not?


    Third Question of the Day August 1, 2014 Interesting Mugshot of Pharmacist charged with Unlawful dispensing, compounding, and sales of drugs. Will we be seeing more of these?

    click here

    Second Question of the Day August 1, 2014 Do compounding pharmacies who focus on and make a large amount of money from compounded pain creams think they are on touchable since the FDA is focused on outsourcing facilities? Should the FDA also ramp up its enforcement action against those" manufacturer" compounded pain creams? Should this be something DOJ/FBI/DEA should focus on prosecuting and recovering ill gotten gains?


    Moody's revises PharMEDium's rating outlook to negative after FDA warning letter; affirms B3 CFR


    Global Credit Research - 31 Jul 2014                

     

    Approximately $635 million rated debt affected

    New York, July 31, 2014 -- Moody's Investors Service changed PharMEDium Healthcare Corporation's ("PharMEDium") rating outlook to negative from stable, while affirming its ratings including the B3 Corporate Family Rating and B3-PD Probability of Default Rating. Moody's also affirmed the B1 rating on the first lien senior secured facilities and Caa2 rating on the second lien term loan.

    The change of outlook to negative follows the company's disclosure of receipt of a warning letter from the Food and Drug Administration ("FDA") in late July based on observation made during FDA inspection of PharMEDium's facilities in early 2013. The letter cited that PharMEDium violated certain quality requirements under the applicable Good Manufacturing Practices ("cGMPs") and demanded corrective actions within fifteen days upon receipt of the letter. Moody's believes the issuance of a warning letter indicates an escalation of regulatory and compliance risk facing the company and the entire drug compounding industry. The negative outlook contemplates the increased uncertainty on the company's operation and liquidity from the warning letter, if not resolved appropriately and timely, could lead to potential product recalls, or other enforcement actions or customer losses.

    The affirmation of the B3 CFR, however, reflects Moody's expectation that the company will proactively manage the risks in order to resolve the issue and alleviate the FDA's concern in the near term. In addition, Moody's anticipates management will use its best effort to avoid service disruptions to customers while working through this issue. Barring potential disruption from the FDA letter, Moody's also expects the company to continue to grow its revenue and earnings, remain on-track with its deleveraging plan and maintain a good liquidity.

    Ratings affirmed as follows:

    Corporate Family Rating at B3

    Probability of Default Rating at B3-PD

    First lien senior secured credit facilities at B1, LGD3

    Second lien senior secured term loan at Caa2, LGD5

    RATING RATIONALE

    The B3 CFR incorporates the business risk arising from PharMEDium's singular focus on the sterile compounding outsourcing service industry and heightened regulatory risk in light of increasing regulatory oversight of the industry. These upcoming changes, as contemplated in the Drug Quality and Security Act (DQSA) and recently proposed interim guidance on applicable Good Manufacturing Practices ("cGMP") for drug compounding industry (subject to final approval) by the FDA, could materially impact the company's operations and financial results. The rating also incorporates the company's small size, fragmented industry characteristics and aggressive financial leverage deployed in the capital structure as a result of the LBO transaction. Moody's expects debt/EBITDA to remain materially above 5.5x in the next 12-18 months.
    continue to read here

    Question of the Day August 1, 2014 Ever since the indictment regarding compounded pain creams in California, the compounding industry has appearedr to ramp up training, advertising and promoting compounded pain creams, gels, etc. Is this going to turn out to be just the move the FDA and law enforcement was needing and wanting the industry to make? Doesn't it appear the industry thought the end of these type of compounded medications might be near or in danger so they have been pushing hard to keep the billion dollar industry producing as much money as possible?


    Any Comments on this compounding pharmacy rep job in Dallas? Claims Transdermal pain therapy is a 30 billion dollar industry and growing.



    Compound Pharmacy Reps, Stop and Look now!

    Company Description ClinicalCorp, (with our partner Greg Normans 500 million dollar Great White Shark Opportunity Fund) is now looking for physician's with your specialty to participate in our Clinical Corp Coordinator program. Average physician's in our program generate approximately $4,000 - $8,000 a month in additional income for moments of their time. Simply put, patients fill out a HIPPA compliant 10 question survey, where by your desk manager takes about 60 seconds to upload 4 of these responses to our system. Compensation is 15 minutes of time at a rate of $150.00 per hour. If you have 200 patients a month who come through your doors, and they each fill a survey, you would be compensated $7,500.00 for your time. ClinicalCorp is employed by compounding pharmacies to report on Related Health Problems (ICD Classifications) where certain medications are used for treatment. It is important that the Physician have practical application and knowledge in these areas for their participation in our programs. Job Description Transdermal pain therapy is a 30 billion dollar industry and growing. It is an alternative non-addictive, non-narcotic and non-sedating pain therapy for patients of all ages. Take advantage of this exciting opportunity which offers the highest commissions in the industry through established pharmacies, compounding with only he highest quality PCCA based formulations. o Non-Narcotic o Non-Addictive o Non-Sedating o Targets to Site of Pain o Customized to Patient Needs o Made to Order o Minimal Systemic Concentration o Minimal Drug Interaction Risk o Customizable Formulations o Odorless o Private/Commercial insurance accepted Responsibilities: -Leverage existing physician relationships to market the products -Target and develop new customer opportunities to continually drive market penetration -Maintain a high level of product and technical knowledge -Keep strong relationships in order to easily bring other products/services/devices in the future Requirements: Already marketing transdermal pain, wound, scar or other compounded therapies If so, we'd like to speak with you if you are experiencing any of the following: Not able to offer your physicians a professional services agreement Compensation: Commission Only - You should be able to make a six figure income even at a part time status if you have the relationships, experience and drive. Reps take home $80,000 per year on the low end . . . Top reps take home $50K+ per month. Scripts adjudicate from $1,000.00 to $13,000.00 (per script) No compensation cap Our tiered compensation plan based on sales is ultra competitive Near Real-Time sales portal offering updates on a per script basis Click here to apply.

    • ID#: 216083066
    • Location: Dallas, TX         

    Read more at http://dallas-tx.geebo.com/jobs-online/view/id/216083066-compound_pharmacy_reps_stop/#YzfytBQasU0wFzEH.99

    Attorney General Holder: Condemned Should Know Lethal Drugs

    By Pete Williams

     

    Attorney General Eric Holder said Thursday that condemned prisoners have a right to know the composition and sources of the drugs to be administered in carrying out the death penalty.
    His comments, during an interview with Gwen Ifill on the PBS NewsHour, come as the Justice Department is working to complete a study, ordered by President Obama in May, on the growing controversy over lethal injection.
    continue to read here

    FDA Outsourcing Fee Rates for 2015

    http://regulations.justia.com/regulations/fedreg/2014/08/01/2014-18111.html

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    This chat board will make you feel real confident about sterile compounding--NOT!

    Thought you were gonna link this story. A compounding pharmacy is responsible for at least 5 deaths due to contaminated intratheical methylpred
    Click to expand...
    Sterile compounding is sooooo high risk. Scary. We are getting a clean room put in. We dont know the first thing about sterile compounding. Gonna hire an experienced compounding pharmacist.
     
    read more of the comments here

    Very Interesting: MUST READ!! What Compounding Pharmacies Want From Greg Abbott: Compounding pharmacies' interests run far deeper than secrecy over the lethal injection drug supply--Richie's Specialty Pharmacy--one of his specialties is a pain cream

    What Compounding Pharmacies Want From Greg Abbott

     
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    And then there’s the money.
    A week before Abbott’s ruling, the Austin-based watchdog Texans for Public Justice released a report on Abbott’s fourth-most-generous donor in the last year, Conroe compounding pharmacist Richie Ray. As TPJ notes, Ray catapulted into the top tier of Abbott-backers with a $250,000 donation in January—a few months after the mess in The Woodlands, and days after the first of this year’s wave of botched executions.
    Because Ray’s pharmacy isn’t certified as a “sterile” facility that can produce drugs for injection, his pharmacy couldn’t be Texas’ latest source. And, in a statement provided to the Observer, Ray is unequivocal that his business has nothing to do with lethal injections: “Richie’s Specialty Pharmacy has never compounded drugs that were used for executions, and we never will. Furthermore, in my 17 years as a licensed pharmacist, I have never compounded drugs that were used for executions, and I never will.”
    But as a national leader in pharmacy trade groups, and a major donor to pharmacists’ political allies, he’s taken an active role on behalf of the entire industry. So was Ray hoping to buy Texas’ secrecy, and protect a fellow compounder?
    Mother Jones suggested as much in a piece that ran May 28, one day before Abbott’s office ruled to keep Texas’ drug source anonymous. And sure, any time a compounding pharmacy is outed as a source for death row, it’s bad press for the whole industry—but Ray’s political agenda is surely bigger and more complex than the death penalty drugs.
    Compounding pharmacies are already locked in a bigger fight—one that more directly affects their bottom line—over how they’ll be regulated by the FDA. That fight involves lawmakers and lobbyists at the state and federal levels, and Ray and his staff have been instrumental in bankrolling compounders’ interests.
    Until now, the FDA had oversight of big drug manufacturers, but compounding pharmacies—which had long been little mom-and-pop shops that made drugs for pets or lollipop medications for kids—were left to state regulation. As compounders have grown, so have horror stories about tainted drug batches shipped from compounders to customers nationwide. In its report TPJ recalled the case of Dallas-based ApotheCure, whose drugs killed three patients in Oregon in 2007. Cedar Park-based Specialty Compounding was linked to infections last year in more than a dozen patients. And most notoriously, tainted drugs from the New England Compounding Center killed at least 64 people and infected more than 700 more with meningitis.
    That outbreak prompted a quick response from Congress: for the first time, large-scale compounding pharmacies are set for federal regulation, with standards similar to drug manufacturers. But which businesses will fall under federal watch as “outsourcing pharmacies,” and how much that’ll cost them, is all up to rule makers at the FDA.
    “That’s kind of the issue that is still unresolved,” says Robert Floyd, an Austin lobbyist for the Alliance of Independent Pharmacists. “At what level does a compound pharmacist have to make a decision to be an outsourcing facility and meet federal licensing, pay federal fees … where is that line going to be drawn?”
    That may explain why so many on Ray’s pharmacy staff bet so generously on support from U.S. Sen. John Barrasso of Wyoming in 2012, or why Ray has employed top lobbyists like Craig Chick, a former adviser to House Speaker Joe Straus, and David Marwitz, who also lobbies for the Texas Pharmacy Association. In his statement to the Observer, Ray said he’s worked for years to educate the public, and lawmakers, “about what appropriate quality evidence-based compounding services should look like and how they can best serve the public safely.”
    Richie’s Specialty Pharmacy, isn’t a high-volume producer likely to be caught up in the outsourcing regulation—one of its specialties is a pain cream—but it’d be important to Ray to spread a message about compounding that’s less about meningitis outbreaks or lethal injections.
    Floyd provided the Observer with a statement he says “reflects the position of most compounding pharmacies” on execution drugs. In brief, this is one fight the industry wants to be left out of:
    While we have no formal position on compounding pharmacies’ preparation of drugs used in executions, the pharmacy profession recognizes an individual practitioner’s right to refuse to dispense a medication based upon his or her personal, ethical and religious beliefs. In a very few cases, compounding pharmacies have been asked by a state government to prepare drugs used in executions because pharmaceutical manufacturers have unilaterally restricted distribution. We believe state corrections agencies should work first with the pharmacy services providers—the companies that provide medications to prisoners within their systems—to source or compound drugs for executions before soliciting a traditional compounding pharmacy.
    Before the twin controversies over some compounding pharmacies’ dangerous products—whether accidentally or intentionally lethal—the industry got little attention and light federal regulation. What the industry likely wants, most of all, is to keep it that way.