November 14, 2013 Webcast | Department of Consumer Affairs 1625 N. Market Blvd. 1st Floor Hearing Room Sacramento, CA 95834 | Agenda | Meeting Materials |
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Saturday, November 30, 2013
California Board of Pharmacy November 14, 2013 webcast of meeting--including DISCUSSION AND POSSIBLE ACTION TO INITIATE A RULEMAKING TO AMEND TITLE 16 CALIFORNIA CODE OF REGULATIONS SECTIONS 1715, 1735.2 AND 1784, TO UPDATE THE SELF‐ASSESSMENT FORMS FOR PHARMACIES, HOSPITALS, WHOLESALERS AND COMPOUNDING PHARMACIES
Judge Declines to Reinstate South Lyon Pharmacy's License
11/27/13 - The license suspension stands until at least January for a South Lyon pharmacy accused of mass-producing drugs for hospitals and clinics in violation of its license. The hearing was held yesterday before Administrative Law Judge David Cohen in Detroit, who ruled that the license suspensions of Specialty Medicine Compounding Pharmacy and its owner, Kenny Walkup Jr., will remain in place until at least January when a full hearing will take place. Attorney General Bill Schuette ordered the suspension after several of the pharmacy’s products at Henry Ford Hospital in Detroit were found to contain fungus. Tuesday’s hearing went late into the evening and hours of testimony centered on the whether or not the facility was sterile and whether Walkup and the pharmacy were licensed to mix products in bulk. The Detroit Free Press reports that inspectors for the state and the FDA testified that the pharmacy was not following proper procedures to ensure products were sterile. Walkup is said to have been acting as a drug manufacturer by distributing large amounts of medication to various hospitals and clinics even though the pharmacy is currently only licensed to fill individual prescriptions. He had applied for a license to manufacture drugs in October 2012, but that application was denied. Walkup’s attorney maintains that regulations allow pharmacists with that type of license to provide the service if it is less than 5% of the pharmacy’s business. A final decision will be made by the Michigan Pharmacy Disciplinary Subcommittee, which will be based on the judge’s recommendation. (JM)
quoted from here
Tarolimus Ointment v. Cyclosporine-- Compounded medications
Re: Tacrolimus Ointment.
Tacrolimus is a relative new drug to the veterinary world. It comes from a class of medications called "calcineurin inhibitors," and it is used most frequent for treating keratoconjunctivitis sicca (also known as KCS or dry-eye). Less commonly this medicine is used topically to treat for allergies (atopy) and for some of the autoimmune skin diseases (discoid lupus erythematosus, pemphigus erythematosus, etc.). In human medicine this medication is used orally for similar conditions at massively higher dosages.
The Most Dangerous Two Minute Sport--Doping in Horse Racing
by Michael Markarian, President of the Humane Society Legislative Fund — Our thanks to Michael Markarian for permission to republish this post, which originally appeared on his blog Animals & Politics on November 21, 2013. Racehorses are impressive, and it would be hard not to be awed by their power and grace. But there’s an important power they lack: unlike other athletes, they have no control over the drugs administered to them. That’s why groups such as The HSUS and HSLF and concerned legislators and citizens must be their voice. Horse race—image courtesy Humane Society Legislative FundThe House Subcommittee on Commerce, Manufacturing and Trade heard that voice today during a hearing on H.R. 2012, the Horseracing Integrity and Safety Act, a bill introduced by Reps. Joe Pitts, R-Pa., Ed Whitfield, R-Ky., Jan Schakowsky, D-Ill., and Anna Eshoo, D-Calif., to protect horses from pervasive race-day doping and other inhumane practices. (A companion bill, S. 973, is sponsored by Sen. Tom Udall, D-N.M.). The legislation would safeguard both the animal and human athletes who participate in the sport, as well as help the racing industry’s reputation recover from bad publicity about cheating and unfair - See more at: http://advocacy.britannica.com/blog/advocacy/2013/11/#sthash.fUr3sx4y.dpuf
Obamacare Winner: The Not-So-Hidden Industry Poised to Profit
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By Brian Orelli | More Articles
November 30, 2013 | Comments (0)
November 30, 2013 | Comments (0)
Drugmakers had to give up a big chunk of their profits when Obamacare, officially known as the Patient Protection and Affordable Care Act of 2010, was enacted. But the companies didn't seem to mind; well ahead of when the final law was written, the drug industry signed on to the law, giving seniors in Medicare Part D prescription coverage a discount on their drugs.
The rebates cover seniors as they hit the so-called doughnut hole after prescription drug coverage runs out but before catastrophic coverage kicks in. In the doughnut hole, senior were responsible for covering the full cost of their prescription drugs, but as part of Obamacare, the pharmaceutical industry agreed to offer seniors discounts.
For brand-name drugs, the discount started at 14% in 2012 and will eventually rise to 75% in 2020. Drugmakers with drugs that primarily treat seniors are disproportionally hurt by the legislation, but pretty much all drugmakers will end up losing profits from the discount to seniors. The only exceptions are drugs such as Dendreon's (NASDAQ: DNDN ) Provenge and Regeneron Pharmaceuticals' (NASDAQ: REGN ) Eyela that are administered by doctors because they're not covered by Medicare Part D.
The rebates cover seniors as they hit the so-called doughnut hole after prescription drug coverage runs out but before catastrophic coverage kicks in. In the doughnut hole, senior were responsible for covering the full cost of their prescription drugs, but as part of Obamacare, the pharmaceutical industry agreed to offer seniors discounts.
For brand-name drugs, the discount started at 14% in 2012 and will eventually rise to 75% in 2020. Drugmakers with drugs that primarily treat seniors are disproportionally hurt by the legislation, but pretty much all drugmakers will end up losing profits from the discount to seniors. The only exceptions are drugs such as Dendreon's (NASDAQ: DNDN ) Provenge and Regeneron Pharmaceuticals' (NASDAQ: REGN ) Eyela that are administered by doctors because they're not covered by Medicare Part D.
Obamacare also increased …
Yet the drug industry was largely in favor of implementing Obamacare despite the discounts that cut into drugmakers profits.
Now we know whyAs was widely suspected, it appears the drug industry is going to benefit substantially from Obamacare in the long run.
The IMS Institute for Healthcare Informatics ran some scenarios, including a full implementation of Obamacare and a botched implementation leading to a significant decline in health-care utilization, and found that the difference between the two could be as much as $140 billion in 2017.
Under IMS's rosy scenario, drugmakers stand to profit from U.S. drug spending between $420 billion and $460 billion in 2017. Much of that gain comes from "increased enrollment, screening, removal of caps, and management of existing conditions."
In non-insurance speak, that's more patients, better diagnosis, no maximum payouts, and more spending on chronic diseases, which all leads to an increase in spending on drugs.
If Obamacare isn't instituted, the situation is much bleaker. Drugmakers will only share U.S. spending between $300 billion and $320 billion, which sounds like a lot, but it's actually a decline from the $328 billion Americans spent on drugs in 2012.
In the worst-case scenario, IMS predicts that drug spending will decline because insurers will push back on spending for new medications with premium prices.
Somewhere in the middleIMS's actual prediction is somewhere in the middle. The analysts predict U.S. drug sales will hit $350 million to $380 million in 2017, producing an annual compounded growth rate of 1% to 4% from 2012 levels. The prediction assumes a third of the target levels of enrollment in Obamacare by the uninsured and some pushback from insurers resulting in having drugmakers compete on price.
In that scenario, companies that are developing drugs that treat unmet needs -- Vertex Pharmaceuticals (NASDAQ: VRTX ) in cystic fibrosis and Sarepta Therapeutics (NASDAQ: SRPT ) in Duchenne muscular dystrophy for example, should be good investment because of a lack of competition and therefore pricing pressure.
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Eighth Question of the Day November 30, 2013 Because a number of pharmacies, pharmacists and organizations representing them advocated that states should retain jurisdiction over compounding pharmacies and the Drug Quality and Security Act (DQSA) leaves jurisdiction over traditional compounding with the states will these organziations now advocate to its members to comply with the states laws and will they support state boards of pharmacy who take a strong enforcement stance against those traditional compounderes who fail to comply?
Seventh Question of the Day November 30, 2013 Was there more the Colorado State Board of Pharmacy could have done in the NECC outbreak? Did it really do all that it could have? I do think it deserves kudos for what all it did do, but are there Colorado state criminal laws that were broken? I pose this question because IACP's position is someone like NECC would not register under the DQSA. Assuming this is true, then states need to be prepared to take more aggressive enforcement action in the future to stop another NECC outbreak.
In 2011, a year before the outbreak, the Colorado State Board of Pharmacy detected problems with the NECC when it was determined that the company was distributing compounded drugs in our state that had been manufactured ahead of time without first obtaining patient-specific prescriptions. This left Colorado patients at risk for being given a medication not appropriate for their specific medical needs and necessary health requirements.
Our state board issued a cease-and-desist order to the NECC, and notified the Massachusetts Board as well. But that was all it could do; ultimately, it was not enough to stop the NECC’s actions and prevent the tragic outbreak that swept across the nation a year later. Despite Colorado’s warnings, the state of Massachusetts did not act and, because it was hamstrung by existing regulations, the FDA could not act, either.
quoted from here
quoted from here
Fifth Question of the Day November 30, 2013 What will it ultimately take for state boards of pharmacy to be willing to enforce the laws on the books? The state employees who are charged with investing and enforcing these laws can only do so much? Ultimately if a state board dismisses the charges, allows minor fines etc., it does not matter how hard the state employees work to rein in rogue compounders. Are state boards of pharmacy preparing to step up their enforcement action? Are is it going to be business as usual with the states now that the Drug Quality and Security Act has become law? Is there a chance when Congress revisits the issue in 2014 it will take all the authority from the states if they have not stepped up enforcement action? Everyone is aware that Congress will be watching the FDA and its activity, but what happens if the FDA is doing what it is suppose to do and the local pharmacy, pharmacists and state boards are not?
Third Question of the Day November 30, 2013 How many members of state boards of pharmacy currently have conflicts of interest (personal, financial, or ethical) on compounding matters? Are state boards of pharmacy capable and willing to address these issues? Does the federal criminal system need to address these issues?
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Key Report on the Veterinary Health Market Now available
11/29/13 - 2013 Report on the Veterinary Health Market
Dublin - Research and Markets (http://www.researchandmarkets.com/research/3x24vv/veterinary-health) has announced the addition of the "2013 Report on the Veterinary Health Market" report to their offering.
The range and complexity of animal health products continues to expand, encompassing anti-infectives, parasite controls, reproductive aids, metabolic drugs, feed additives, antibiotics, vaccines, topical solutions and imaging diagnostics as well as novel treatments for chronic conditions such as osteoarthritis, cardiovascular disease and even cancer.
This report also provides a thorough analysis of the companies known to be marketing, manufacturing or developing veterinary health products as well as detailed tables and figures covering veterinary health markets around the globe - including the following:
- Abaxis, Inc
- BASF
- Bayer Animal Health
- Boehringer Ingelheim Corp
- Cypress Diagnostics
- Dupont Qualicon
- Egyptian International Pharmaceutical Industries Company - Elanco Animal Health
- Gene Check, Inc
- Heska
- Huvepharma
- IWAKI & Co., Ltd
- Janssen Pharmaceutica
- Laboklin
- Merck
- Mosaic Company
- Neogen Corporation
- Novartis Animal Health
- OptiGen
- Orion Corporation
- Pfizer Animal Health
- Sanofi-Aventis
- Synbiotics Corporation
- Teva Pharmaceutical Industries Ltd
- VCA Antech, Inc
- Virbac SA
- WooGene B&G Co., Ltd
Key Topics Covered:
1. Overview
2. Animal Diseases: An Overview
3. Veterinary Medicines: An Overview
4. Global Livestock Production and Consumption: An Overview
5. Companion Animals: An Overview
6. Animal Health: Market Analysis
6.1 Role of Animal Health Industry
6.2 Evolution of Animal Health Market
6.3 Sub-Sectors of Animal Health Products
6.4 U.S. Veterinary Positions
6.5 U.S. Market for Veterinary Health
6.6 Veterinary Market in Brazil
6.7 Veterinary Market in Mexico
6.8 Animal Health Products Market in Europe
6.9 China's Booming Animal Health Domestic Market
6.10 Veterinary Market in India
6.11 Global Market for Veterinary Vaccines
6.12 U.S. Veterinary Vaccine Market
6.13 Veterinary Market for Companion Animals
6.14 U.S. Pet Care Market Trends
6.15 Expenditure on Companion Animals in Australia
6.16 Global Market for Animal Feed Additives
6.17 Global Market for Antibiotics in Animal Feeds
6.18 Exports of U.S. Micro-Ingredients and Supplements for Feed Additives 6.19 Global Market for Animal Feed Enzymes
6.20 Vitamins as Feed Additives
7. Company Profiles
For more information visit http://www.researchandmarkets.com/research/3x24vv/veterinary-health
CONTACT:
Research and Markets,
Laura Wood,
Senior Manager.
press@researchandmarkets.com
Fax from USA: 646-607-1907
Fax from rest of the world: +353-1-481-1716
Sector: Animal Healthcare/Veterinary (http://www.researchandmarkets.com/categories.asp?cat-id=346&campaign-id=3x24vv)
Dublin - Research and Markets (http://www.researchandmarkets.com/research/3x24vv/veterinary-health) has announced the addition of the "2013 Report on the Veterinary Health Market" report to their offering.
The range and complexity of animal health products continues to expand, encompassing anti-infectives, parasite controls, reproductive aids, metabolic drugs, feed additives, antibiotics, vaccines, topical solutions and imaging diagnostics as well as novel treatments for chronic conditions such as osteoarthritis, cardiovascular disease and even cancer.
This report also provides a thorough analysis of the companies known to be marketing, manufacturing or developing veterinary health products as well as detailed tables and figures covering veterinary health markets around the globe - including the following:
- Abaxis, Inc
- BASF
- Bayer Animal Health
- Boehringer Ingelheim Corp
- Cypress Diagnostics
- Dupont Qualicon
- Egyptian International Pharmaceutical Industries Company - Elanco Animal Health
- Gene Check, Inc
- Heska
- Huvepharma
- IWAKI & Co., Ltd
- Janssen Pharmaceutica
- Laboklin
- Merck
- Mosaic Company
- Neogen Corporation
- Novartis Animal Health
- OptiGen
- Orion Corporation
- Pfizer Animal Health
- Sanofi-Aventis
- Synbiotics Corporation
- Teva Pharmaceutical Industries Ltd
- VCA Antech, Inc
- Virbac SA
- WooGene B&G Co., Ltd
Key Topics Covered:
1. Overview
2. Animal Diseases: An Overview
3. Veterinary Medicines: An Overview
4. Global Livestock Production and Consumption: An Overview
5. Companion Animals: An Overview
6. Animal Health: Market Analysis
6.1 Role of Animal Health Industry
6.2 Evolution of Animal Health Market
6.3 Sub-Sectors of Animal Health Products
6.4 U.S. Veterinary Positions
6.5 U.S. Market for Veterinary Health
6.6 Veterinary Market in Brazil
6.7 Veterinary Market in Mexico
6.8 Animal Health Products Market in Europe
6.9 China's Booming Animal Health Domestic Market
6.10 Veterinary Market in India
6.11 Global Market for Veterinary Vaccines
6.12 U.S. Veterinary Vaccine Market
6.13 Veterinary Market for Companion Animals
6.14 U.S. Pet Care Market Trends
6.15 Expenditure on Companion Animals in Australia
6.16 Global Market for Animal Feed Additives
6.17 Global Market for Antibiotics in Animal Feeds
6.18 Exports of U.S. Micro-Ingredients and Supplements for Feed Additives 6.19 Global Market for Animal Feed Enzymes
6.20 Vitamins as Feed Additives
7. Company Profiles
For more information visit http://www.researchandmarkets.com/research/3x24vv/veterinary-health
CONTACT:
Research and Markets,
Laura Wood,
Senior Manager.
press@researchandmarkets.com
Fax from USA: 646-607-1907
Fax from rest of the world: +353-1-481-1716
Sector: Animal Healthcare/Veterinary (http://www.researchandmarkets.com/categories.asp?cat-id=346&campaign-id=3x24vv)
January 1st, 2012 Issued by: Rood and Riddle Equine Hospital Compounding Pharmacies: The Real Truth Bart Barber, DVM
“Being
admitted to the profession of veterinary medicine, I solemnly swear to
use my scientific knowledge and skills for the benefit of society
through the protection of animal health [and] the relief of animal
suffering…….” Veterinary oath
The
ability of the veterinarian to relieve animal suffering has made
enormous advances in the past 50 years. Our understanding of disease
processes, the development and refinement of surgical technique and our
diagnostic abilities have been vastly improved over recent decades.
Imagine what James Herrriot would think of digital radiography or MRI.
It’s a great day to be a veterinarian!
The
advancement that has probably had the broadest affect is the
improvement in our drug arsenal. Diseases that were death sentences for
animals a few years ago are now cured by a few simple injections or a
course of tablets. What can currently be done with pharmaceuticals is
nothing short of a miracle. It seems certain that the greatest
improvements that lie ahead of us will also come from this avenue.
One
of the resources that we have for obtaining medications is through
compounding. Compounding is defined as the manipulation of one or more
drugs to form a new one. Many times an animal may require a medication
that is not commercially available in the appropriate strength, in a
flavor for maximum palatability, or a suitable method of administration.
Compounding encompasses everything from something as simple as mixing
two injections, to far more complex formulas. It is an essential part of
our own human health care system as well as veterinary medicine.
Without this resource many of the tools we have to combat disease and
suffering would be unavailable to us and we would, in fact, be no better
off than we were 50 years ago.
continue to read here
Oklahoma Board of Pharmacy Update on Hydrocodone Refills
November 21, 2013
HYDROCODONE REFILL UPDATE (click to view full document):
- A pharmacy may partially fill a Hydrocodone prescription only if they are unable to supply the full quantity. The remaining portion must be filled within 72 hours, and no further quantity may be supplied after that time without a new prescription.
- Pharmacies may partially fill Hydrocodone prescriptions for terminally ill patients and/or patients in a Long Term Care Facility (LTCF) for up to 60 days. See OAC 475:30-1-7 for more detailed information about documentation.
- A Hydrocodone prescription may be transferred from one pharmacy to another only if it has never been filled at the original pharmacy (i.e. on hold). Examples of this may be when a prescriber has sent the prescription to the wrong pharmacy or a pharmacy does not have the medication in stock.
- If a patient has a prescription for a certain quantity of Hydrocodone and their insurance will only pay for part of that prescription, they may pay cash for the remainder but it must occur within the same transaction and the pharmacist should document on the back of the prescription.
- The OBNDD has interpreted OAC 475:30-1-11 to mean that a prescriber may not write multiple prescriptions on the same date with instructions to fill some of those prescriptions at a later date. This applies to Schedule II prescriptions as well as all other CDS prescriptions, including Hydrocodone.
- There is no legal limitation on the days’ supply for any CDS prescription.
- quoted from here
Friday, November 29, 2013
Alabama State Board of Pharmacy--Opening for Secretary on board
Alabama State Board of Pharmacy
Open PositionSecretary
PO Box 381988
Birmingham, AL, 35238
Office: 205/981-2280
Fax: 205/981-2330
Website: http://www.albop.com
Key Points: Compounding Quality Act 11/29/2013byMelissa Gilmore | Polsinell
The Compounding Quality Act (CQA) amends the U.S. Food, Drug & Cosmetic Act (Act) to create a new, voluntary category of compounders called "outsourcing facilities" (OF). Compounded drugs are those mixed by a pharmacist that differ from commercially available drugs according to individual needs. If a pharmacy chooses to register as an OF, it will be exempt from the new drug application, labeling, and track and trace requirements imposed on pharmaceutical manufacturers. In addition, the OF will be permitted to dispense drugs without an individual patient prescription.
In order to register as an OF, the facility must do the following:
- Compound by or under the direct supervision of a licensed pharmacist;
- Pay a $15,000 annual fee (small business fee TBD);
- Register annually with FDA;
- Report to FDA every June and December:
- what drugs have been compounded in the facility in the prior 6 months
- adverse events;
- Allow FDA inspections
- on a risk-based frequency schedule, depending on prior safety performance
- additional fees to be assessed if reinspection is necessary.
OFs are prohibited from:
- Compounding from any bulk substance that does not appear on a list of APIs deemed permissible by FDA;
- Compounding any drugs that appear on a list of drugs deemed by FDA to be demonstrably difficult to compound;
- Reselling a compounded drug;
- Intentionally falsifying a prescription for a compounded drug.
continue to read here
Thursday, November 28, 2013
Changes to USEF, FEI Medication Rules for 2014
November 27, 2013
Here's what you need to know about changes to the USEF and FEI drug and medication rules. ... Read More
BHA Tightens Rules on Prohibited Substances The Horse
November 28, 2013
Trainers can be charged if their horses receive some prohibited substances, even without a positive sample. ... Read More
DRUG MIXERS TO RECEIVE MORE SCRUTINY President signs bill into law bolstering federal oversight of compounding pharmacies By Associated press 12:01 A.M.NOV. 28, 2013
WASHINGTON — Compounding pharmacies that custom-mix medications in bulk are expected to come under more federal oversight under a bill signed into law Wednesday by President Barack Obama.
Last year a meningitis outbreak from contaminated steroid pain injections killed 64 people and sickened more than 750 across the country.
continue to read here
Is this True? VPI states Roadrunner is the "largest national compounding pharmacy with over 10,000 veterinary clinic customers." VIP members gets a percent discount.
RoadRunner Compounding Pharmacy – Located in Phoenix, AZ, RoadRunner is the largest national compounding pharmacy with over 10,000 veterinary clinic customers. They deliver new prescriptions overnight and renewal prescriptions, 2nd day. VPI members get a 2% volume discount quarterly.
quoted here
quoted here
If these were the stats in 2009 for veterinary prescriptions, what are they now in 2013--2009 estimated to be a $125 million dollar industry and it was a NEW and Emerging Market then!!
Eaton fills 800 to 900 prescriptions a day and ships them around the country. The company will use the growth capital to expand its sales team and develop of its own assortment of in-house drugs that will undergo tests through clinical trials, Bubnack said. Eaton, founded in 1999, sells to over 9,000 veterinary clinics nationwide.
The market for pet medication compounding is a bit tough to measure as many vets still handle the process themselves, instead of outsourcing, but Huntington estimates it to be approaching $125 million and growing. Bubnack says vets are finding it increasingly difficult and costly to carry large inventories of drugs. “They’re there to treat the animal, not build a business around prescriptions,” Bubnack said.
read more here
Is this True? Do Veterinary Compounding Pharmacy Make This Much a Year?
ROADRUNNER PHARMACY, INC.
ROADRUNNER PHARMACY, INC. was founded 18 years ago in 1995 and generated a total revenue of over $8m.
This company is listed in Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers.
This company is listed in Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers.
source found here
Who Knew This Type of Information Was Available on the Internet--Eaton/Roadrunner
Eaton Veterinary Lab/Roadrunner 401(K) PlanEaton Veterinary Lab Roadrunner Pharmacy
- Type of Plan: Single-Employer
- Plan Year: 2011/01/01-2011/12/31
- Plan Effective Date: + Add the plan effective date for this 401k plan
Health Care Compliance Association 18th Annual Compliance Institute
Attend the most comprehensive healthcare compliance event
Hello Doletta,
The Compliance Institute, the flagship education and networking conference for healthcarecompliance professionals, is scheduled for March 30-April 2, in San Diego, California. Register by Jan. 7th to save $575 off registration.
HCCA’s 18th annual Compliance Institute is unparalleled in opportunities to learn the latest techniques and best practices for building and managing effective healthcare compliance programs.
The Compliance Institute offers:
- More than 140 sessions to choose from on a variety of topics from beginner to advanced.
- Nine learning tracks to help make course selection easier. Follow one track all the way through, or hop around. Tracks include: General Compliance/Hot Topics, Long-Term Care, Privacy & Security, Physician Compliance, Compliance Lawyer, Auditing & Monitoring, How to Succeed as a Compliance Professional, Quality of Care, and Advanced Discussion Groups.
- More than 230 speakers who are industry and government leaders in healthcare compliance.
- 20+ networking opportunities throughout the conference to connect with compliance and ethics peers, including: SpeedNetworking, SpeedMentoring, Tweetup, a volunteer event, receptions, lunches, and breaks.
- 24+ CEUs toward a Compliance Certification Board designation, and many others.
- CCB exams at the conclusion of the event. Sit for an exam to become certified in Healthcare Compliance (CHC)®, Healthcare Research Compliance (CHRC) ® or Healthcare Privacy Compliance (CHPC) ®.
View the conference brochure or the conference website for more information about the program. See you in sunny San Diego.
Register now!Wednesday, November 27, 2013
Sports book of year 2013: Jamie Reid wins with horse racing story Doped • 'A rollicking tale of crooked bookies and nobbled nags' • Author 'thrilled and delighted' by surprise outcome Sean Ingle The Guardian, Wednesday 27 November 2013 16.13 EST
Doped: The Real Life Story of the 1960s Racehorse Doping Gang by Jamie Reid, a rollicking tale of crooked bookies and nobbled nags – with a sprinkle of sex and royalty for good measure – is the surprise winner of the William Hill Sports Book of the Year for 2013.
Reid's story, only the second racing book after Seabiscuit: The True Story of Three Men and a Racehorse in 2001 to win the award, beat the favourites Seven Deadly Sins: My Pursuit of Lance Armstrong by David Walsh and I Am Zlatan Ibrahimovic by Ibrahimovic and his ghostwriter David Lagercrantz.
Reid – a racing punter and columnist at the Financial Times – receives a £25,000 cheque, £2,500 William Hill bet and a day at the races. Appropriately he promised to place his bet on "a nice each-way horse that is talked up by those in the know".
Doped tells the true story of Bill Roper, a bookmaker and gambler who attempted to finance his extravagant lifestyle by doping horses – and how he was brought down after he attempted to nobble a royal horse. It is written like a thriller and it came as little surprise that Reid confirmed that he had already received several approaches for the film rights.
"After tonight we'll have to tell them that they will cost a bit more now," he joked.
continue to read here
Obama Signs Drug Compounding, Tracking Bill Into Law Reuters | Posted: 11/27/2013 4:46 pm EST
Nov 27 (Reuters) - President Barack Obama signed a bill into law on Wednesday that gives U.S. health regulators greater oversight of bulk pharmaceutical compounding and strengthens their ability to track drugs through the distribution pipeline.
The Drug Quality and Security Act clarifies the authority of the Food and Drug Administration over compounded medications and creates a new class of compounding manufacturer known as an "outsourcing" facility, which will be able to sell to hospitals in bulk.
The law was prompted by quality control problems that led to a deadly outbreak of fungal meningitis in 2012 traced to a tainted pharmaceutical mixed by a Massachusetts compounding pharmacy. The product has been linked with more than 50 deaths.
The law also creates a national set of standards to track pharmaceuticals through the distribution chain to help thwart the introduction of fake medications into the drug supply.
Last year, fake vials of Roche Holding AG's cancer drug Avastin appeared in the United States from Britain, where they were purchased from a Turkish wholesaler
continue to read here
The Drug Quality and Security Act clarifies the authority of the Food and Drug Administration over compounded medications and creates a new class of compounding manufacturer known as an "outsourcing" facility, which will be able to sell to hospitals in bulk.
The law was prompted by quality control problems that led to a deadly outbreak of fungal meningitis in 2012 traced to a tainted pharmaceutical mixed by a Massachusetts compounding pharmacy. The product has been linked with more than 50 deaths.
The law also creates a national set of standards to track pharmaceuticals through the distribution chain to help thwart the introduction of fake medications into the drug supply.
Last year, fake vials of Roche Holding AG's cancer drug Avastin appeared in the United States from Britain, where they were purchased from a Turkish wholesaler
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Obama signs bill regulating compounding pharmacies The Associated PressStaff 57 minutes ago
WASHINGTON — Compounding pharmacies that custom mix medications in bulk could come under more federal oversight under a bill that's been signed into law by President Barack Obama.
Last year a meningitis outbreak from contaminated steroid pain injections killed 64 people and sickened more than 750 across the country.
The sickness was traced to a now-closed pharmacy in Framingham, Mass., the New England Compounding Center, where inspectors found unsterile conditions. The company had shipped more than 17,600 doses of the implicated injection to 23 states.
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INTERESTING READ! Lessons from the Field: How I investigated the Hormone Hoax by Cathryn Jakobson Ramin
In an investigation for More magazine, journalist and author Cathryn Jakobson Ramin found that women who use "custom" hormones created by compounding pharmacies have no idea what they're getting and are taking a huge risk.
She shares details with ReportingonHealth.org
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