Tuesday, January 7, 2014

Compounding paediatric medicines from adult preparations may result in poor content uniformity

More standardised methods are needed for the extemporaneous preparation of paediatric medicines,according to a doctoral dissertation examined at the University of Eastern Finland. Hospital pharmacies modify adult medicines for children when there are no suitable paediatric medicines available. Medicines intended for adults can be modified for children into oral suspensions, oral powders or capsules the contents of which are emptied for use. However, the study showed that the quantity of the active ingredient per dosage can vary widely in these preparations, depending on the dosage form and handling of the product.

continue to read here

Compounding pharmacy bill negotiators haven't met

Conference committee named 2 months ago

By Andy Metzger

Updated: Monday, January 6, 2014, 7:45 PM EST
STATE HOUSE, BOSTON - Appointed in early November, the conference committee charged with finalizing a bill to tune up the state’s regulation of compounding pharmacies will meet for the first time this week.

“We’re meeting soon,” said Rep. Jeffrey Sanchez, a Jamaica Plain Democrat and House chairman of the Committee on Public Health who drafted the House bill.

The House passed its compounding pharmacy bill Oct. 2, 2013 on a vote of 157-0. On Oct. 30, 2013 the Senate voted 38-0 for its bill. The negotiating team was named Nov. 7, or about two months ago.

Four major bills, including the pharmacy regulation legislation, passed the House and Senate in differing forms last year but have failed to emerge from six-member conference committees.
continue to read herehttp://www.wwlp.com/news/politics/state-politics/compounding-pharmacy-bill-negotiators-havent-met

Monday, January 6, 2014

TherapeuticsMD provides an update regarding REPLENISH--will it be superior to current market of compounded hormone medications?

TherapeuticsMD provides an update regarding REPLENISHLast but not least, TherapeuticsMD, a women's health care company, provided an update regarding its phase 3 trial for TX 12-001HR, an experimental treatment for menopause symptoms.
TherapeuticsMD has now completed its 50th site enrollment for the double-blind, placebo-controlled trial, known as REPLENISH. REPLENISH will measure the reduction in the frequency and severity of hot flashes over a 90-day period while checking endometrial protection for a year.
TX 12-001HR is one of the company's four main hormone therapies. According to a study commissioned by the company, the current market for hormone therapies is estimated to be worth over $3.7 billion per year.
TX 12-001HR stands out from other hormone therapies because it is the first and only bioidentical low-dose HRT (hormone replacement therapy) combo. This means it contains two equal low doses of the hormones 17ß-estradiol and progesterone, which is considered a superior option to the current market of "compounded" (customized) menopausal drugs.
If approved by 2016, analysts believe TX 12-001 could generate peak sales of $300 million -- hardly a blockbuster, but not a bad boost for a company that only reported $3.8 million in revenue in fiscal 2012.

quoted from here

Aratana acquires Okapi Sciens and Vet Therapeutics--will we see more pet medications soon and less of need to compound animal medications

Aratana acquires Okapi SciencesMeanwhile, Aratana Therapeutics, a company focused on pet medications, today announced its acquisition of Okapi Sciences, which has a proprietary pet antiviral platform and five clinical and development stage candidates in its pipeline. Two of Okapi's most promising antiviral products include its feline herpes and feline immunodeficiency virus franchises.
The acquisition was made for approximately $14 million in cash, a promissory note for $15 million with a maturity date of Dec. 31, 2014, and a possible additional payment of $16 million in cash or shares of common stock.
Aratana, which I identified in a previous article as one of the top-performing biotech IPOs of 2013, has no marketed products. However, it announced that it had met all of its 2013 milestone developments in late December -- a clinical study for its osteoarthritis drug for dogs showed promising results, it initiated a study with 150 dogs for its appetite-stimulating drug, and outlined plans for a field study for its drug for postoperative pain in dogs.
Aratana also acquired Vet Therapeutics in October to add veterinary biologics to its pipeline. The combined acquisitions of Vet and Okapi could significantly accelerate the speed at which Aratana's products reach the market, so investors should stay tuned to the company's progress.

quoted from here

Published in the January 2014 issue of the American Journal of Obstetrics & Gynecology is a study finding that 17-hydroxyprogesterone caproate (“17P”), an injectable medication that is used to prevent prematurity, obtained from 15 compounding pharmacies throughout the United States “did not raise safety concerns when assessed for potency, sterility, pyrogen status, or impurities.”

4. Published in the January 2014 issue of the American Journal of Obstetrics & Gynecology is a study finding that 17-hydroxyprogesterone caproate (“17P”), an injectable medication that is used to prevent prematurity, obtained from 15 compounding pharmacies throughout the United States “did not raise safety concerns when assessed for potency, sterility, pyrogen status, or impurities.” (17P is an unusual, possibly unique, case, in that it is a medicine that is FDA-approved–sold under the brand-name Makena–but also available in compounded form. For background, see here.) In an editorial accompanying the AJOG study, Arnold Parry and Samuel Cohen write that “it is critical for obstetrical providers to understand that the cost of compounded 17P is much lower than that of the FDA-approved product, and many patients will have limited access to the FDA-approved product based on their insurance coverage.”

quoted from here

Did compounded medications and healthcare reform affect your 2013 prescription drug plan results?

Posted by Chris Hanson-Ehlinger on Mon, Jan 06, 2014 @ 09:30 AM
In January many prescription drug plan sponsors look back at 2013 to examine cost trends, assess the impact of clinical programs and plan designs and begin planning for 2015. Most plans rely on standard management reports to help them measure performance. You’ll gain more insight into your plan if you request topic-specific custom reports from your PBM. For example, this year you may want to delve deeper into plan performance related to compounded medications and health care reform implications.
Compounded medications
For most plans, compounded prescriptions represent a relatively small portion of total claims submitted by pharmacies. For other plans, though, the trend for these prescriptions can be as high as 150 percent. Because compounded prescriptions can contain multiple medications, they do not fall neatly into any therapeutic category and are not typically captured in standard PBM management reports.
continue to read here

Question of the Day January 6, 2014: IACP Claims It has Set the Record Straight with David Miller Editorial in Ocala Star-Banner. Did it?

IACP Sets the Record Straight with Ocala Star-Banner ...

iacpdconnection.wordpress.com/.../iacp-sets-the-record-straight-with-oca...

3 hours ago - IACP is continuing to work to set the record straight about pharmacy compounding, and its necessity for patients. Click here http://bit.ly/1dJvTUC to read the ...

Enforcement Report - Week of January 1, 2014

Legislator: Expect FDA Regulation to Stay Under the Microscope in 2014

Diluted chemo scandal led to changes, but are they enough?

Extemporaneously Compounded Sterile Medications, Journal of Pain and Palliative Care Pharmacotherapy, Informa Healthcare

Sunday, January 5, 2014

Pharmacy Compounding Provisions of Drug Quality and Security Act Are Focus of New FDLI Food and Drug Law Policy Forum

“The Need for Clarity: Where Should FDA Focus Its Resources When Implementing the Compounding Provisions of the Drug Quality and Security Act?” is the topic addressed by Karla L. Palmer, Director, Hyman, Phelps & McNamara, P.C. in the latest issue of FDLI’s Food and Drug Policy Forum (Volume 3, Issue 23, December 18, 2013).
In this Policy Forum, Palmer discusses policy questions raised by the “Compounding Quality Act” or Title I of the recently enacted Drug Quality and Security Act (DQSA). Specifically, Palmer states that “the law raises significant concerns about oversight and enforcement, and the ability of pharmacies and ‘outsourcing facilities’—a compounding category created by the DQSA—to meet the recognized need for compounded medications.” The author provides an overview of the Act’s revisions to sections 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) and the addition of the new section 503B.
Palmer asserts that while DQSA Title I provides some clarity, FDA and state boards of pharmacy must quickly come to terms on the enforcement authority and priorities under Section 503A. Palmer also recommends that FDA promulgate a list of “permissible” substances because the Act requires outsourcing facilities compounding from bulk substances to articulate a “clinical need.” Palmer further explains that the limited number of outsourcing facilities FDA anticipates will register initially will not be able to meet the demand for compounded drugs listed on FDA’s drug shortage list, which will negatively affect the availability of medications in short supply.

Download document here

Ilisa Bernstein, Deputy Director, Office of Compliance, CDER | Slides

Ilisa Bernstein, Deputy Director, Office of Compliance, CDER | Slides

CDC & FDA: Collaboration & Challenges — FSMA, Food Outbreaks, Pharmacy Compounding & Emerging Health Issues | January 29 | Atlanta, GA

CDC & FDA: Collaboration & Challenges — FSMA, Food Outbreaks, Pharmacy Compounding & Emerging Health Issues | January 29 | Atlanta, GA

a session on compounding

3:30-5:00 p.m.

Roundtable Discussion – Identifying and

Responding to Medical-Product Associated

Illness Outbreaks (Focus on Pharmacy

Compounding)

Panelists will lead an interactive discussion on

recent developments in pharmacy compounding,

including how CDC and FDA have worked together

to respond to contaminated product. Panelists will

also discuss the future of pharmacy compounding

and agency roles in finding and responding to

product quality problems and their collaboration on

investigating outbreaks of illness connected to

medical products.

Joseph F. Perz, DrPH, Ambulatory and Long Term

Care, Prevention and Response Branch, Division of

Healthcare Quality Promotion, CDC

William Kitchens, Partner, Arnall Golden Gregory,

LLP

T.C. Spencer Pryor, Partner, Alston & Bird, LLP

Polly J. Price, Professor of Law, Emory University

School of Law

GCP and GMP - FDA Concerns on Contamination Control and Compounding Pharmacies-webinar

Thursday, January 23, 2014 2:00 PM - 3:00 PM EST

- Webinar Registration here

My Horse Daily: The Horseracing Integrity and Safety Act Would Put an End to Doping in Horse Racing

The Horseracing Integrity and Safety Act, which is sponsored by Sen. Tom Udall (D-N.M.) and Reps. Ed Whitfield (R-Ken.) and Joe Pitts (R-Penn.), would put an end to doping in horse racing by providing the USADA with the authority to clean up the sport and enforce strict anti-doping standards.
Under the Horseracing Integrity and Safety Act, the USADA would develop rules for permitted and prohibited substances and create anti-doping education, research, testing, and adjudication programs for horse racing.
continue to read here

Second Question of Day January 5, 2013 Wonder how many compounded medications are being used? Restraining order against horse slaughter plant extended for 10 days

Restraining order against horse slaughter plant extended for 10 days

The Truth About Compounding Pharmacies | Stable Management-A Veterinarian's View

The Truth About Compounding Pharmacies | Stable Management

Question of the Day January 6, 2013 How many insurance companies require this for compounded prescriptions? How many compounding pharmacies fill it out? How many fill it out correctly

COMPOUND PRESCRIPTIONS

The pharmacy or dispensing facility must complete the remaining portion of

this form and return it to the member/patient or provide the member/patient

with a Universal Claim Form for a Compounded Medication.*

• Provide an 11 digit NDC number for each of the ingredient(s) in the medication

• Indicate the drug ingredient(s) and quantity.

• Indicate the metric quantity dispensed in number of tablets, grams or milliliters for liquids,

creams, ointments or injectables.

• Indicate the amount paid for the prescription by the patient.

The original pharmacy prescription label or cash receipt should accompany this claim form or the

Universal Claim Form for a compounded medication. Prescription labels and receipts will not be

returned; you may wish to make copies for your records.

C O M P O U N D P R E S C R I P T I O N S

For pharmacy use only*

NDC# Drug/Ingredient Quantity Charge

Total Charge: $

Note: If the medication/drug was purchased in a foreign country,

the currency must be converted into US dollars.

see actual form here

And the job openings for compounding pharmacists continue to be announced....

Compounding Pharmacist / Compounding Lab Manager (Bronx, NY)

Are you a self-directed, detailed, energetic, high-achieving, reliable and ethical pharmacist with impeccable customer service, strong communication and people management skills? Are you looking to RUN and GROW pharmaceutical compounding practice? Then we want you!

We recognize that our success as an organization depends on our employees; therefore, we strive to build a team of excellence in order to reach our greatest potential. If you are an enthusiastic, ambitious and determined individual, we want YOU to join our growing company! We offer a great benefit package along with competitive wages and unlimited growth opportunity. We welcome you to be a part of our winning team, to excel in an enriching career and make a difference in the lives of people.

JOB SUMMARY: Pharmacist will be responsible for supervising technicians and other auxillary personnel and overseeing all pharmacy practice activity at our state of the art compounding facility. The incumbent will be interfacing with staff on technical and formulation queries, as well as providing, advice to prescribers.

WHAT YOU WILL BE DOING:

• Supervise and lead all aspects of the pharmaceutical compounding practice
• Work closely with Chief Operating Officer and Pharmacist Owner
• Ensure the facility is current on all regulatory issues and standards of practice for pharmaceutical compounding
• Assist/Develop appropriate SOPs and Policies & Procedures
• Participate in continuous quality improvement
• Accurately verify medication orders and when necessary, enter them onto electronic system.
• Review prescriber orders for proper dosage, allergies, drug interactions.
• Supervise Pharmacy Technicians. Verify and approve technician-prepared medications.
• Prepare compounded preparations.
• Provide drug information to patients and medical professionals
• Assist in development of educational materials and presentations for staff and medical professionals.

WHAT WE ARE LOOKING FOR:
• Minimum five (5) years' experience working as an RPh
• Experience in Non-Sterile and Sterile Compounding is preferred.
• Familiar with USP 795/797, State and Federal Regulatory bodies
• Excellent communication skills required; fluent English (oral & written)
• Proven abilities to apply judgement, ethical practice and decision making skills
• Knowledge of Microsoft Office (Word, PowerPoint, Excel) required
• Strong leadership skills.
• NYS Pharmacist License
• PharmD or BS in Pharmacy

Location: Bronx, NY
Compensation: Competitive Salary
Principals only. Recruiters, please don't contact this job poster.
do NOT contact us with unsolicited services or offers
quoted from here

And the compounding pain management sales jobs continue to grow

Job Title:	Specialty Sales Rep - Product Launch - Miami, FL
Employer:	RxSalesPros
City:	Miami, FL

Company Description RxSalesPros is a National Pharmaceutical and Biotechnology recruiting firm that specializes in expansions, startups and placing top Sales and Sales Leadership talent. Job Description Our client is small, unique Pain Management and CNS organization specializing in niche therapeutic products in the therapeutic areas of Neurology and Pain Management. Currently selling a unique CNS compound, OUR CLIENT RECENTLY HAD A VERY NOVEL AGENT APPROVED BY THE FDA FOR CHRONIC PAIN. IT IS THE FIRST PRODUCT OF ITS KIND AND CARRIES SOME VERY UNIQUE BENEFITS TO IT. As part of our Clients efforts to expand their specialty sales force, they are looking for the best of the best talent. If you want to be part of this exciting opportunity to launch and brand and build a business, and are a qualified experienced specialty sales rep (Pain Management experience is preferred but NOT mandatory) please apply here. We are looking for current, high performing, high science, highly specialized Sales Representatives that have experience in account management, to join a market leading organization. As a Specialty Representative, you would be responsible for driving sales and strengthening relationships with key customer channels. You would also be responsible for: Developing strong business relationships with health care partners and customers Building territory plans to launch a new brand into the territory Developing strategies to approach potential customers and increase sales Distributing appropriate information to health care professionals as needed Clinical resource for customers Organizing and executing sales presentations Organizing group events and conferences for health care professionals Expert with clinical data in pain and neurology markets Keeping current with the competition's products, service offerings and activity Establishing and maintaining effective working relationships with all company support departments Being fully compliant with all safe use initiatives and company policies and procedures. Effectively deliver products safe use education to appropriate customers Planning and implementing an effective call plan Abiding by company policies and procedure Excellent 401K, industry leading health benefits, and excellent career growth opportunities. Proven sales success 3 or more years of experience as a successful pharma sales professional Successful sales experience in B2B or “buy and bill” is a plus National level annual sales award in 2 of last 5 years Specialty sales experience in pain/neurology preferred Demonstrates strong competencies Judgment and decision making Planning and organizing skills Problem-analysis and problem solving skills Presentation skills Resilience Adaptability Displays high level of integrity and takes ethical actions w/ physicians, patients, employees Entrepreneurial spirit Driven with ability to “figure it out” Passion and proven ‘inner drive’ – hates to lose Excellent communicator (listening and speaking) Seeks first to understand Strong negotiation skills Must be a closer and highly competitive Challenger…willing to challenge customers and colleagues Exemplifies Company Values 4 year Degree required quoted from here

Compounding series shows good, bad of industry

By David G. Miller
Special to the Star-Banner

Published: Sunday, January 5, 2014 at 6:30 a.m.

Last Modified: Friday, January 3, 2014 at 6:09 p.m.

The Ocala Star-Banner deserves credit for devoting the resources and space to the subject of pharmacy compounding. It is a topic very much on the minds of local readers due to the tragic deaths of several residents from the meningitis outbreak relating to the New England Compounding Center (NECC) as well as earlier adverse events involving a local compounding pharmacy.

We are grateful that the paper called our organization and our board members for comment and perspective. We offer the following comments in response to the series and the related editorial.

continue to read here

Saturday, January 4, 2014

Shaking Off Prior Criticism, FDA Forges Ahead with Additional Social Media Monitoring Plans

Posted: 3 January 2014
By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) recently issued a notice indicating that it is seeking the services of a company to help it monitor online sentiment, keep abreast of social media conversations and even determine "influencers" to better target its outreach.
The FDA "Sources Sought" notice was posted on 23 December 2013 to the government's Federal Business Opportunities (FBO) website.

Existing Plans

It is similar in many respects to an earlier contract awarded to help the agency monitor social media traffic. That contract was subject to a considerable amount of scrutiny by some legislators, including Republican Tom Coburn (R-OK), who included the project in his influential yearly "Wastebook" (#87) of allegedly superfluous taxpayer-funded projects.
"Being liked is important, but maybe federal agencies should take some time away from figuring out what people think about them and spend more time just doing their job," Coburn's report quipped.
That contract called for awardee IB5k to assist FDA's office of External Affairs in three areas:

helping it to refine its future social media strategies by gauging the success and impact of current ones
monitoring "overall conversations to see what the public is discussing about our work," as well as answering questions and developing content to serve consumer needs
formulating an "at-a-glance" presentation of what FDA is working on for public audiences
continue to read here

Sixth Question of the Day January 4, 2014 If Congress is going to watch over and hold the FDA accountable to make sure another compounding disaster doesn't happen in the future, who is going to step up to the plate and hold the states accountable?

Updated List of Countries Viewing Blog

Added-Georgia and Montenegro

Algeria
Antigua and Barbuda

Argentina

Australia

Austria

Azerbaijan

Bahamas
Bangladen

Bangladesh

Barbados

Belgium

Benin

Bosina & Herzegovina

Brazil

Bulgaria

Cayman Islands

Canada

Chile

China

Columbia
Congo (Republic)

Costa couRica

Cote d'lvoire

Croatia

Cyprus

Czech Republic

Denmark
Dominica

The Devastation of Horse Racing Drugs

Professional horse racing is a high-stakes, high-pressure world of fierce competition, with trainers and owners who go to extremes to gain a competitive advantage. In the United States, the use of drugs to obtain that advantage is quite common. If you consider the amount of money involved, it's easy to understand why. PETA, for instance, estimates that care for a single horse can cost as much as $50,000 annually. David Wells, once among the sport's premier trainers, had won $1.5 million in an 11-month period when he was indicted as part of a ring of unscrupulous trainers and other horse racing insiders. More, it's not uncommon for owners to pay $1 million or more for a top-tier thoroughbred.
Integrity Crisis
As confidence in the integrity of North American horse racing has eroded, the sport has seen profits decrease. Between 2007 and 2013, the total amount of money wagered on North American horse racing decreased by more than $4 billion. A poll conducted by The Jockey Club once found that 80 percent of bettors consider the likelihood of drug-use when handicapping races and when deciding which horses upon which to wager. US legislators have taken note of the sport's drug-fueled issues and have made efforts to curtail them; but illegal drug use is difficult – if not impossible – to eradicate. It's a problem that reaches beyond banned substances, too, as some drugs made illegal in most of the world are legal in the United States. The use of certain drugs might sometimes be in the horse's best interest, but more often, horse racing drugs are administered in the service of winning and making money, with a callous disregard for the animal's health and wellbeing. The following list includes types of performance-enhancing substances used in US horse racing and descriptions for each.
Stimulants
As with human beings, stimulants are used to provide a temporary energy boost, which in theory, can give a horse the extra oomph necessary to win a race or improve a workout time. Caffeine is one banned stimulant that's been commonly used in horse racing. Trainers and owners have grown more careful about using it, though, as it's easily detected. Etorphine, commonly known as elephant juice, is a tranquilizer in larger animals but can be used as a stimulant in horses at proper doses.
Pain-relief compounds
This class of horse racing drugs alleviates or masks a horse's pain from disease or injury, allowing the animal to effectively ignore the injury. The problem with these drugs is that running on an injury has great potential to exacerbate the damage – many times gravely. Phenylbutazone, commonly referred to as "bute" is one type of pain-relief compound used to lessen pain in racehorses. Bute is classified as a "nonsteroidal anti-inflammatory drug" (a commonly used drug-class in humans). In high doses, it can be used to help injured horses perform better, leading to greater, sometimes irreversible injury in the long run. More exotic types of substances have also been used for pain relief in horse racing to allow the animals to ignore pre-existing injuries. These include cobra venom and dermorphin (frog juice), a powerful opiate extracted from the skin of the South American waxy tree frog. In the US horse racing, these substances are rarely administered in the best interests of the animals.
Anabolic Steroids
As with human athletes, steroids are used in horses to increase strength, stamina and to enhance healing and decrease healing times. In the United States, steroids are routinely used in the training process. As long as a horse doesn't test positive for steroids on race day, the animal is cleared for competition.
Beta Blockers and Erythropoietin
Beta blockers are a class of drugs that reduce the impact of stress hormones, which can be especially beneficial in racehorses, as these animals are under high amounts of stress. These compounds slow the heart rate and promote a sense of calm. Erythropoietin is a hormone that regulates the production of red blood cells. This compound is used to increase oxygen delivery to muscles, which can be critical during exertion. These compounds have also proven popular among human athletes.
Sodium bicarbonate
Sodium bicarbonate isn't a drug at all, but rather a common, inexpensive household item. Commonly known as baking soda, sodium bicarbonate can be used to enhance endurance, recovery and to mask the presence of illegal substances in a horse's system. Baking soda isn't as beneficial to horses running shorter distances, but can be advantageous in training, as it neutralizes the effects of lactic acid, a byproduct produced by the muscles during exercise. This neutralizing effect provides sodium bicarbonate's benefits in recovery and endurance.
Lasix
Lasix might well be the most controversial substance in US horse racing. This substance is a powerful diuretic that's banned in almost every other horse racing country. It provides a couple of benefits. First, the amount of urine excreted because of the drug is so great that horses have been known to lose 20 pounds or more after taking it. The obvious benefit is that the horse has much less weight to carry during the race; the obvious danger is that the animal can suffer dehydration and even kidney damage from running on this drug. Lasix has a legitimate medical use, too, in that it effectively controls exercise-induced pulmonary hemorrhage EIPH in horses. EIPH is a condition wherein physical exertion causes the horse to bleed from the lungs. The primary symptom is bleeding from the nose during and/or after a race. EIPH can pose a serious threat to a horse's life and animals are commonly forced into retirement if they exhibit the condition a certain number of times. One study found that, in a single year, 95 percent of all race horses in the United States were injected with Lasix on race day.
Although legislators and US horse racing professionals have made efforts to curb the use of performance-enhancing substances, there's still a long way to go. Generally, if a horse tests clean for banned substances on race day, it's cleared to race, meaning many such substances are used in training. Exacerbating the problem is the fact that hundreds of new substances are developed each year, making it extremely difficult, if not impossible, to detect them all. Regulators clearly have their work cut out for them. These poor animals spend most of their lives isolated from other horses, and rarely develop meaningful relationships with human handlers. The final and greatest injustice many of them face, however, comes at the end of their racing careers. When these animals can no longer race, many of them are slaughtered; even Derby-winning horses have ended up in slaughterhouses.

Written by Sharon Rogers

quoted from here

Racing symposium: Out-of-competition testing faces hurdles

TUCSON, Ariz. – Out-of-competition testing will likely become more prevalent in U.S. horse racing jurisdictions as the next frontier in combating illegal drug use, but efforts to implement the programs continue to be haunted by issues involving privacy, jurisdiction, and the breadth of drugs that can be considered a positive, racing officials said Wednesday during the second day of the University of Arizona Symposium on Racing and Gaming.
Out-of-competition testing programs have been implemented in at least seven racing states over the past five years, including California, New York, and Kentucky, and regulators have generally been satisfied with the results of the programs. Although approximately 10,000 out-of-competition tests have failed to yield a single positive test in a Thoroughbred horse under the programs, supporters of the programs have said that they act as a deterrent to horsemen attempting to use illegal medications that can have effects long after they have cleared a horse’s system.
However, the programs also have faced pushback from some horsemen’s groups, most notably in New York. The groups have said that they support out-of-competition testing programs, but they have raised issues with the scope of the some of the existing regulations allowing for the testing, including complaints that some statutes have granted regulators powers that are so broad that they violate state constitutional protections on privacy and warrantless searches.
continue to read here

Insurance Company will no longer cover compounded hormones effecctive November 1, 2013

read here

FDA Published 483s for Compounding Pharmaciea and Testing Labs as January 4, 2014

Abrams Royal Pharmacy, Dallas, TX, 483 Issued 12/20/2013 (PDF - 5.3MB)¹

Americare Compounding, LLC., Garden City South, NY, 483 Issued 6/19/2013 (PDF - 754KB)²

Anazaohealth Corporation, Tampa, FL, 483 Issued 2/22/2013 (PDF - 1.5MB)³

Apothecure, Inc., Dallas, TX, 483 Issued 4/17/2013 (PDF - 3.9MB)⁴

ARL Biopharma, Inc. dba Analytical Research Laboratories, Oklahoma City, OK, 483 Issued 11/8/2012 (PDF - 382KB)⁵

Avella of Deer Valley, Inc, Phoenix, AZ, 483 Issued 2/25/2013 (PDF - 1.2MB)⁶

Axium Healthcare Pharmacy (dba Balanced Solutions Compounding), Lake Mary, FL, 483 Issued 3/15/2013 (PDF - 638KB)⁷

Beacon Hill Medical Pharmacy, P.C., Southfield, MI, 483 Issued 7/19/2013 (PDF - 2.7MB)⁸

Blue Ridge Pharmacy and Compounding Center, Raleigh, NC, 483 Issued 10/23/2013 (PDF - 1.3MB)⁹

Boston Analytical, Inc., Salem, NH, 483 Issued 11/9/2012 (PDF - 490KB)¹⁰

Brookfield Prescription Center dba MD Custom Rx, Brookfield, WI, 483 Issued 12/13/2013 (PDF - 5MB)¹¹

Cantrell Drug Company, Little Rock, AR, Amended 483 Issued 11/4/2013 (PDF - 6.5MB)¹²

Central Admixture Pharmacy Services, Inc., (CAPS), Chicago, IL, 483 Issued 2/22/2013 (PDF - 545KB)¹³

Central Admixture Pharmacy Services, Inc. (CAPS), Homewood, AL, 483 Issued 3/7/2013 (PDF - 600KB)¹⁴

Central Admixture Pharmacy Services, Inc., (CAPS), Kansas City, MO, 483 Issued 2/28/2013 (PDF - 1.1MB)¹⁵

Central Admixture Pharmacy Services, Inc., (CAPS), Livonia, MI, 483 Issued 2/22/2013 (PDF - 1.5MB)¹⁶

Central Admixture Pharmacy Services, Inc., (CAPS), Livonia, MI, 483 Issued 2/28/2013 (PDF - 1.5MB)¹⁷

Central Admixture Pharmacy Services, Inc. (CAPS), Wallingford, CT, 483 Issued 2/19/2013 (PDF - 3.2MB)¹⁸

Central Admixture Pharmacy Services, Inc. (CAPS), Woburn, MA, 483 Issued 1/29/2013 (PDF - 3MB)¹⁹

Clinical Apothecaries, Medina, OH, 483 Issued 11/20/2013 (PDF - 660KB)²⁰

Clinical Specialties Compounding Pharmacy, Augusta, GA, 483 Issued 4/2/2013 (PDF - 1.6MB)²¹

College Pharmacy Incorporated, Colorado Springs, CO, 483 Issued 3/15/2013 (PDF - 1.9MB)²²

The Compounding Shop, Inc., St. Petersburg, FL, 483 Issued 9/3/2013 (PDF - 105KB)²³

The Compounding Shop St. Petersburg, FL, 483 Issued 3/22/2013 (PDF - 1.3MB)²⁴

The Compounding Shop St. Petersburg, FL, Amended 483 Issued 3/25/2013 (PDF - 10MB)²⁵

Custom Compounding Center, Los Alamitos, CA, 483 Issued 12/13/2012 (PDF - 1.2MB)²⁶

Delta Pharma, Inc., Ripley, MS, 483 Issued 10/2/2013 (PDF - 1.4MB)²⁷

Drugs are Us, Inc. (dba Hopewell Pharmacy), Hopewell, NJ, 483 Issued 3/21/2013 (PDF - 532KB)²⁸

Dyna Labs, LLC, St. Louis, MO, 483 Issued 11/13/2012 (PDF - 961KB)²⁹

Eagle Analytical Services, Houston, TX, 483 Issued 6/17/2013 (PDF - 1.4MB)³⁰

Foundation Care LLC, Earth City, MO, 483 Issued 3/19/2013 (PDF - 1.4MB)³¹

Foundation Care LLC, Earth City, MO, 483 Response Dated 4/9/2013 (PDF - 1.1MB)³²

Front Range Laboratories, Incorporated, Loveland, CO, 483 Issued 8/30/2013 (PDF - 3.5MB)³³

FVS Holdings, Inc. (dba Green Valley Drugs), Henderson, NV, 483 Issued 3/15/2013 (PDF - 1.4MB)³⁴

Grandpa's Compounding Pharmacy, Inc., Placerville, CA, 483 Issued 9/10/2013 (PDF - 4.1MB)³⁵

Home Infusions Solutions, Inc., Horsham, PA, 483 Issued 5/21/2013 (PDF - 1.3MB)³⁶

Home Intensive Care Pharmacy, Inc., San Antonio, TX, 483 Issued 3/1/2013 (PDF - 443KB)³⁷

IV Solutions of Lubbock, Lubbock, TX, 483 Issued 3/20/2013 (PDF - 798KB)³⁸

IV Solutions of Lubbock, Lubbock, TX, 483 Response Dated 4/2/2013 (PDF - 929KB)³⁹

JCB Labs, LLC, Wichita, KS, 483 Issued 2/27/2013 (PDF - 483KB)⁴⁰

Lee and Company dba Lee Pharmacy, Inc., Fort Smith, AR, 483 Issued 2/21/2013 (PDF - 619KB)⁴¹

Leiter's Cambrian Park Drugs, Inc., dba Leiter's Pharmacy, San Jose, CA, 483 Issued 11/5/2013 (PDF - 3.8MB)⁴²

Leiter's Compounding Pharmacy, San Jose, CA, 483 Response Dated 11/25/2013 (PDF - 5MB)⁴³

Lowlite Investments, Inc. (dba Olympia Pharmacy), Orlando, FL, 483 Issued 3/21/2013 (PDF - 1.6MB)⁴⁴

Lowlyn Pharmacies, Inc., Blanchard, OK, 483 Issued 3/8/2013 (PDF - 732KB)⁴⁵

Main Street Family Pharmacy, LLC, Newbern, TN, 483 Issued 6/11/2013 (PDF - 1.9MB)⁴⁶

Medaus, Inc., Birmingham, AL, 483 Issued 3/22/2013 (PDF - 712KB)⁴⁷

Medi-fare Drug and Home Health Center, Blacksburg, SC, 483 Issued 6/21/2013 (PDF - 2.4MB)⁴⁸

Medi-Fare Drug & Home Health Center, Inc., Blacksburg, SC, 483 Issued 1/18/2013 (PDF - 1.1MB)⁴⁹

MedPREP Consulting Inc., Tinton Falls, NJ, 483 Issued 4/3/2013 (PDF - 942KB)⁵⁰

Nature's Pharmacy & Compounding Center, Asheville, NC, 483 Issued 11/22/2013 (PDF - 1MB)⁵¹

Nora Apothecary and Alternative Therapies, Inc., Indianapolis, IN, 483 Issued 3/21/2013 (PDF - 623KB)⁵²

NuVision Pharmacy, Inc., Dallas, TX, FDA Requested Recall Letter Issued 7/26/2013 (PDF - 797KB)⁵³

NuVision Pharmacy, Inc., Dallas, TX, 483 Issued 4/17/2013 (PDF - 2.8MB)⁵⁴

Oakdell Pharmacy, Inc., San Antonio, TX, 483 Issued 3/1/2013 (PDF - 817KB)⁵⁵

Pallimed Solutions, Inc., Woburn, MA, Amended 483 and Cover Letter Issued 4/9/2013 and 483 Issued 3/29/2013 (PDF - 3.3MB)⁵⁶

Pentec Health, Inc., Boothwyn, PA, 483 Issued 4/1/2013 (PDF - 2MB)⁵⁷

PharMEDium Services, LLC, Cleveland, MS, 483 Issued 2/22/2013 (PDF - 796KB)⁵⁸

PharMEDium Services LLC, Edison, NJ, 483 Issued 2/28/2013 (PDF - 541KB)⁵⁹

PharMEDium Services LLC, Memphis, TN, 483 Issued 3/22/2013 (PDF - 1.3MB)⁶⁰

PharMEDium Service, Inc., Sugarland, TX, 483 Issued 2/27/2013 (PDF - 1.7MB)⁶¹

Pharmacy Creations, LLC, Randolph, NJ, 483 Response Issued 9/3/2013 (PDF - 39KB)⁶²

Pharmacy Creations, Randolph, NJ, 483 Issued 8/19/2013 (PDF - 368KB)⁶³

Pharmagen Laboratories, Inc, Stamford, CT, Amended 483 Issued 08/26/2013 (PDF - 2.6MB)⁶⁴

Pharmagen Laboratories, Inc, Stamford, CT, 483 Issued 08/23/2013 (PDF - 2.5MB)⁶⁵

Pine Pharmacy and Home Care Products Center, Inc., Williamsville, NY, 483 Issued 12/16/2013 (PDF - 5.3MB)⁶⁶

Pine Pharmacy and Home Care Products Center, Inc., Williamsville, NY, 483 Issued 7/19/2013 (PDF - 1.4MB)⁶⁷

Portage Pharmacy, Inc., Portage, MI, 483 Issued 3/6/2013 (PDF - 1.5MB)⁶⁸

RC Compounding Services, LLC, Poland, OH, 483 Issued 2/7/2013 (PDF - 209KB)⁶⁹

RxSouth, LLC (dba RX3 Pharmacy), Chester, VA, Referral Letter to VA Board of Pharmacy Issued 8/13/2013 (PDF - 2.6MB)⁷⁰

RxSouth, LLC (dba RX3 Pharmacy), Chester, VA, 483 Issued 12/14/2012 (PDF - 1.7MB)⁷¹

Specialty Compounding, LLC, Cedar Park, TX, 483 Issued 9/13/2013 (PDF - 3.4MB)⁷²

Specialty Compounding Pharmacy, Cedar Park, TX, 483 Issued 3/22/2013 (PDF - 744KB)⁷³

Specialty Medicine Compounding Pharmacy, P.C., South Lyon, MI, 483 Issued 11/5/2013 (PDF - 3.2MB)⁷⁴

Stewart Compounding Pharmacy, Fayetteville, NC, 483 Issued 3/25/2013 (PDF - 1.7MB)⁷⁵

Total Pharmacy Services, Inc., Houma, LA, 483 Issued 5/22/2013 (PDF - 713KB)⁷⁶

Triangle Compounding, Cary, NC, 483 Issued 3/1/2013 (PDF - 880KB)⁷⁷

University Pharmacy, Inc., Salt Lake City, UT, 483 Issued 2/26/2013 (PDF - 1.4MB)⁷⁸

Village Fertility Pharmacy, Inc., Waltham, MA, 483 Issued 3/13/2013 (PDF - 553KB)⁷⁹

Wedgewood Village Pharmacy, Inc. Swedesboro, NJ, 483 Issued 2/11/2013 (PDF - 3.4MB)⁸⁰

Wells Pharmacy Network LLC, Ocala, FL, 483 Issued 07/26/2013 (PDF - 1.1MB)⁸¹

Wiley Chemists, Inc., Santa Fe, NM, 483 Issued 10/2/2013 (PDF - 535KB)⁸²

FDA 483 Pine Pharmacy and Home Care Products Center, Inc., Williamsville, NY

Pine Pharmacy and Home Care Products Center, Inc., Williamsville, NY

483 Issued 12/16/2013⁹¹ (PDF – 5.3MB)
483 Issued 7/19/2013⁹² (PDF – 1.4MB)

Recalls, Market Withdrawals, & Safety Alerts Baxter Initiates Nationwide Voluntary recall Of Select Lots of Premix Parenteral Nutrition

Recalls, Market Withdrawals, & Safety Alerts Baxter Initiates Worldwide Voluntary Recall Of Select Lots Of 5 percent Dextrose Injection, USP And 0.9 percent Sodium Chloride Injection, USP Intravenous (IV) Solutions

Recalls, Market Withdrawals, & Safety Alerts Baxter Initiates Worldwide Voluntary Recall Of Select Lots Of 5 percent Dextrose Injection, USP And 0.9 percent Sodium Chloride Injection, USP Intravenous (IV) Solutions

New England Compounding Pharmacy Bankruptcy Proof of Claims Due: 1/15/2014

Abbott Settlement With DOJ Highlights Feds’ Anti-Fraud Efforts / Abbott will pay $5.47 million to resolve allegations that it paid physicians for teaching assignments, speaking engagements and conferences with the expectation that they would in return facilitate product purchases at their hospitals. / “The Gray Sheet” December 30 2013 5:25 PM

FDA Closes 2013 With Flurry Of Citations For Misleading Rx Promotions

By Brenda Sandburg / Email the Author / View Full Issue
Word Count: 788 / Article # 14131230003 / Posted: January 2 2014 4:10 PM

Executive Summary

Office of Prescription Drug Promotion issues 23 letters in 2013, five less than the previous year.

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Friday, January 3, 2014

Gallup Poll Shows Consumers Continue to Rank Pharmacists As the Second Most Trusted Profession

view here Gallup Web site.

Texas Board of Pharmacy Job Opening for Investigator III or Enforcement Specialist

JOB VACANCY NOTICE

Investigator III (1352)

Salary Group B16

Listing No. TBP14-013 Opening Date: December 30, 2013

Functional Title: Enforcement Specialist Closing Date: Until Filled

Type: Full-Time

Beginning Salary: $2,853/month

Refer To: Carol Fisher

JOB DESCRIPTION:

The Texas State Board of Pharmacy (TSBP) is seeking an enthusiastic and highly motivated professional to perform moderately complex investigative work. The ideal applicant should: (1) have highly developed interpersonal skills and ability to deal with the public in a tactful and professional manner; (2) be able to communicate clearly and effectively verbally and in writing; (3) demonstrate organizational skills in order to manage multiple priorities concurrently; (4) operate in a responsible manner, especially when handling sensitive/confidential materials and issues; and (5) exhibit a strong work ethic and commitment to customer service. Primary responsibilities include: (1) investigating complaints alleging violations of the laws and rules governing the practice of pharmacy, which includes interviewing complainants and subjects of complaints and preparing reports on findings; (2) processing complaints according to established procedures, including data entry duties; (3) providing information, interpretation & explanations of laws and rules governing the practice of pharmacy to Board customers; and (4) providing technical assistance to Division Director.

MINIMUM QUALIFICATIONS (License, Education, Experience):

High school education or equivalent is required. Graduation from an accredited four-year college or university is preferred. Three years experience of job-related experience is required. Job-related experience includes investigative work; work as a legal secretary or assistant; work involving regulatory programs or law enforcement; or work involving handling/investigating customer complaints. Previous experience at the Texas State Board of Pharmacy (TSBP) or in a pharmacy licensed by TSBP is desirable. Must have demonstrated ability of office equipment and personal computer, including word processing and data entry. Must have knowledge of Microsoft Word and Excel. Must be able to demonstrate knowledge of business English, including terminology, spelling, and grammar. Conditions of employment are: (1) must be able to complete and pass required online class regarding security of criminal records; and (2) must pass state and national fingerprint identification checks.

REMARKS

Application must be submitted with a cover letter that focuses on the applicant's unique qualifications for the position. Applicant must complete State of Texas Application for Employment. Resumes will not be accepted in lieu of State Application. Application must be completed with all requested information. Incomplete & unsigned applications will not be considered. Applicants who are selected for interviews will be required to complete basic skills tests in the Austin office. Applicant must be eligible and authorized to work in the United States. Job description and State of Texas application may be downloaded from the TSBP website: http://www.tsbp.state.tx.us.

Mail or fax completed applications to: Texas State Board of Pharmacy, 333 Guadalupe St, Ste 3-600, Austin Texas 78701, FAX 512/305-8009.

TSBP JOB OPENINGS

Investigator III

A State of Texas Application can be obtained from TSBP (call the TSBP receptionist at 512-305-8001) or:

found here

Fifth Question of the Day January 3, 2014 Why are more good compounding pharmacists not willing to report and speak out against the bad compounding pharmacists?

Fourth Question of the Day January 3, 2014 Should the DEA being doing more to shut down illegal compounding pain medications pharmacies?

Third Question of the Day January 3, 2014 Should more consumers be suing compounding pharmacies for the false advertising promises that are being made?

Second Question of the Day January 3, 2014 What can organizations like IACP, NABP etc. do to discourage and prevent false advertising claims related to compounded preparations?

Question of the Day January 3, 2014 Should state boards of pharmacy and state attorney generals be doing more to shut down or prevent compounding pharmacies from making false claims in advertising?

Another Must Watch: TVG Racing Roundtable - Medication In Horse Racing

watch here

MUST WATCH: Racing for their Lives: An In-Depth Look at Doping in the U.S. Horse

In this special edition of Americas Now, investigative correspondent Mike Kirsh opens the gates on the U.S. horse racing industry. He explores the staggering amount of illegal performance enhancing

watch here

Lamar Alexander 01/03/2014 | Press release Alexander: Congress Must Hold FDA Accountable in 2014 to Help Prevent Another Nightmare Like Meningitis Outbreak -

Says he'll push for oversight hearing, monitor progress to ensure proper implementation of legislation Congress passed in November
***
"Tennesseans deserve to know that the FDA and other regulators are properly implementing this new law, which makes clear who is on the flagpole to prevent another nightmare like the deadly meningitis outbreak of 2012." - Lamar Alexander
MARYVILLE, Jan. 3 - U.S. Senator Lamar Alexander (R-Tenn.), the lead Republican on the Senate health committee, today said that he'll push in 2014 for an oversight hearing of the Food and Drug Administration and monitor its activities to ensure proper implementation of his legislation to help prevent another meningitis outbreak in Tennessee, which became law on Nov. 27.
"We worked for a year to create legislation that would help prevent another meningitis outbreak like the one that killed 16 Tennesseans and made so many others sick," Alexander said. "Tennesseans deserve to know that the FDA and other regulators are properly implementing this new law, which makes clear who is on the flagpole to prevent another nightmare like the deadly meningitis outbreak of 2012."
The Drug Quality and Security Act distinguishes between compounders engaged in the traditional pharmacy practice of making customized drugs for specific patient needs from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register with the FDA as "outsourcing facilities" and become subject to federal oversight like traditional drug manufacturers. Those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy.
The legislation is based on a proposal Alexander introduced in the U.S. Senate, as well as an agreement he helped reach with the U.S. House of Representatives. It also includes provisions to track and trace the more than 4 billion prescriptions that are written every year to help ensure their safety, and provides patients with better information on compounded drugs.
In November of 2012, when the Senate Health, Education, Labor and Pensions (HELP) Committee held its first hearing on the deadly meningitis outbreak, Alexander called for a new model of oversight of sterile compounding pharmacies. Alexander and HELP Committee Chairman Tom Harkin (D-Iowa), House Energy and Commerce Chairman Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.) announced a legislative agreement and the bill was passed by the House on Sept. 28. The Drug Quality and Security Act cleared by both houses of Congress on Nov. 18, and the president signed it Nov. 27.
- See more at: http://www.noodls.com/view/A10A6333F95112AA6117DF79A93EE34638193DB2?rh=#sthash.pW72S30g.dpuf

Time to Fix Glitch in Pharmacy Law?

By Carol Gentry

After a long delay, the Florida Department of Health wants to fix a gap in the law that made it powerless over out-of-state compounding pharmacies.

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5:03

Hear Health News Florida’s audio story on the outbreak and its aftermath.

continue to read here

PharMedium Provides a virtual tour (remember it registered as outsourcing facility with FDA)

A look inside PharMEDium

Enjoy a virtual tour of PharMEDium

Alexander plans to keep tabs on FDA work with compounding pharmacies Jan 3, 2014

U.S. Sen. Lamar Alexander wants to monitor how well the U.S. Food and Drug Administration is using a new law passed by Congress to prevent another fungal meningitis outbreak.
He said today that he will push for an oversight hearing on the agency’s regulation of compounding pharmacies. FDA Commissioner Margaret Hamburg has said the law does not give her agency all the powers it would have liked, but that it was a step forward in defining regulatory authority. Members of Congress criticized her agency for failing to do its job when a contaminated steroid made by Massachusetts-based New England Compounding Center caused an outbreak that sicked 751 people with 64 deaths.
Tennessee has been one of the hardest hit states.
“We worked for a year to create legislation that would help prevent another meningitis outbreak like the one that killed 16 Tennesseans and made so many others sick,” Alexander said. “Tennesseans deserve to know that the FDA and other regulators are properly implementing this new law, which makes clear who is on the flagpole to prevent another nightmare like the deadly meningitis outbreak of 2012.”
continue to read here

Where Have All the (Critical) Pharma Bloggers Gone, Long Time Passing?

Effective December 31, 2013, UBM Canon will cease producing the MedAdNews, Pharmalive, Pharmalot, eKnowledgeBase and R&D Directions brands (read the announcement here). Everyone in the Pharma Blogosphere was surprised and saddened by this announcement. I think Richard Meyer of World of DTC Marketing Blog expressed it best:

"This is a loss for the industry that is very much at a crossroads of marketing to patient, consumers and health care professionals. Ed Silverman, the author of Pharmalot, will especially be missed as his voice and stories added insight to the complex and changing world of healthcare marketing. We need people like Ed, John Mack and others to be the [conscience] of our industry and remind everyone that developing good products is good medicine which in turn means good business. I shall miss the publication very much."

Back in 2007 I surveyed readers and asked them: How Readable, Credible & Useful are Pharma Blogs? Pharmalot was in the number one or two position in all these categories (see chart above left and read more about the survey here).
continue to read here