Wednesday, May 28, 2014
Second Question of the Day May 28, 2014 Where are the examples of people who have not been able to get legal compounded medications that they need? The compounding world is exploding with new pharmacies and sales representatives with promises of up to $500,000 a year for these sales representatives. Very few states have taken any action against bad compounders; the FDA has inspected and pointed out flaws in compounding pharmacies; yet the US Congress points a finger a the FDA for failing to meet with stakeholders. I have pointed this out before on this blog. You can't have it both ways--on one hand you blame the FDA for the NECC outbreak; on the other hand you don't give them the authority they need to do anything about it. Now Congress has given them authority, but it is critical of the FDA's implementing the very law Congress passed. What is the solution? Is Congress the ultimate one at fault in this situation?
FDA and Pan American Partners Work to Strengthen Regulatory Systems Posted on May 28, 2014 by FDA Voice By: Charles Preston, M.D., MPH
Regulatory systems are essential for good health care because they ensure safe, high quality and effective medicines. However, these systems must be strengthened in many parts of the world — a subject that is a core effort of the Pan American Network for Drug Regulatory Harmonization (PANDRH). - See more at: http://blogs.fda.gov/fdavoice/index.php/2014/05/fda-and-pan-american-partners-work-to-strengthen-regulatory-systems/?source=govdelivery&utm_medium=email&utm_source=govdelivery#sthash.KAPosK2K.dpuf
Wockhardt says FDA raises concern over U.S. unit
Reuters) - The U.S. Food and Drug Administration has expressed concerns over production processes at the U.S. unit of Wockhardt Ltd (WCKH.NS), a top executive said, possibly adding to a spate of regulatory troubles facing the Indian generic drugmaker.
The United States is Wockhardt's biggest market and the FDA has already banned the import of generic drugs from its two plants in India, citing quality lapses in the manufacturing process
continue to read here
The United States is Wockhardt's biggest market and the FDA has already banned the import of generic drugs from its two plants in India, citing quality lapses in the manufacturing process
continue to read here
Articles on Veterinary Transdermal Medication
Original Source: Veterinary Transdermal Medication: A to Z.
Abstract not available.Matching Channels
Pfizer is a global pharmaceutical company, the largest in world based on annual sales. In 2009, annual sales were worth $45,448m. Pfizer spend £550m on R&D in the UK alone, and have...
The 11th largest pharmaceutical company in the world, Abbott Laboratories generated sales of $16 billion in 2009 and has 90,000 employees. Within the medical device arm of the company, products of...
There are two known parathyroid hormone receptors in mammals termed PTH1R and PTH2R. These receptors bind parathyroid hormone and are members of the GPCR family of transmembrane proteins. * parathy...
Boehringer Ingelheim is a global pharmaceutical company with annual sales of over $16 billion, making it the 10th largest pharmaceutical company in the world based on sales. With bases in 47 c...
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Medicated adhesive patches have become a preferred method of delivery for everything from nicotine to hormones to motion sickness medication.
Drug delivery via transdermal patches will lead to US$6bn in new annual sales within the next 10 years
For the first approved generic Rivastigmine transdermal patch for dementia in Alzheimer\'s disease
Ireland-based Actavis has announced that its subsidiary received a complete response letter from the US Food and Drug Administration (FDA) raising issues regarding the company’s new drug application...
FDA says ANDA sponsors do not need to conduct real-world usability studies for generic transdermal patch drugs nor conduct adhesion studies in children.
Transdermal delivery of drugs is poised for a renaissance, with sales of patch-delivered drugs and vaccines jumping by up to $6 billion within the next 10 years.
VICTOR, N.Y., April 8, 2014 /PRNewswire/ -- FPR Specialty Pharmacy, developer of Focused Pain Relief—customized transdermal compounded medications for pain and inflammation—announced today...
NEW YORK, Feb 11 (Reuters) - National Veterinary Associates, one of the leading private owners of veterinary hospitals in the United States, is exploring a potential sale that could value the company...
Drug delivery via transdermal patches will lead to US$6bn in new annual sales within the next 10 years
For the first approved generic Rivastigmine transdermal patch for dementia in Alzheimer\'s disease
Ireland-based Actavis has announced that its subsidiary received a complete response letter from the US Food and Drug Administration (FDA) raising issues regarding the company’s new drug application...
FDA says ANDA sponsors do not need to conduct real-world usability studies for generic transdermal patch drugs nor conduct adhesion studies in children.
Transdermal delivery of drugs is poised for a renaissance, with sales of patch-delivered drugs and vaccines jumping by up to $6 billion within the next 10 years.
VICTOR, N.Y., April 8, 2014 /PRNewswire/ -- FPR Specialty Pharmacy, developer of Focused Pain Relief—customized transdermal compounded medications for pain and inflammation—announced today...
NEW YORK, Feb 11 (Reuters) - National Veterinary Associates, one of the leading private owners of veterinary hospitals in the United States, is exploring a potential sale that could value the company...
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Postoperative nausea and vomiting (PONV) is one of the most common and undesirable complaints recorded in as many as 70-80% of high-risk surgical patients. The current prophylactic therapy recommendat...
The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisatio...
The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisatio...
We believe a pharmacist's professional goal is simple to articulate but challenging to achieve - medication use that is safe and efficacious. Pharmacists do not operate alone in the medication use pro...
Abstract AIM: To determine the pharmacokinetics of a novel lipophilic formulation of transdermal methimazole compared to oral carbimazole.
The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisatio...
The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisatio...
We believe a pharmacist's professional goal is simple to articulate but challenging to achieve - medication use that is safe and efficacious. Pharmacists do not operate alone in the medication use pro...
Abstract AIM: To determine the pharmacokinetics of a novel lipophilic formulation of transdermal methimazole compared to oral carbimazole.
Imprimis Pharmaceuticals to Exhibit Go Dropless™ Cataract Surgery Formulations at 2014 Kiawah Eye Meeting
press release
continue to read here
May 28, 2014, 8:00 a.m. EDT
Imprimis Pharmaceuticals to Exhibit Go Dropless™ Cataract Surgery Formulations at 2014 Kiawah Eye Meeting
-- Imprimis' proprietary ophthalmic compounded formulations now available in 25 states and territories with a physician's prescription --
SAN DIEGO, May 28, 2014 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. /quotes/zigman/14072651/delayed/quotes/nls/immy IMMY +1.70% , a vertically-integrated specialty pharmaceutical company dedicated to delivering high quality, novel, and customizable medicines to physicians and patients at accessible prices, announced today its attendance at the upcoming 2014 Kiawah Eye Meeting ( http://www.healio.com/meeting/kiawaheye ) in Kiawah Island, SC, May 29-31, 2014.continue to read here
FDA directed to meet with stakeholders on compounding drug legislation
The Senate Appropriations Committee directed FDA officials on Friday to meet with doctors, patients and pharmacists regarding implementation of a bill that affects compounded human drugs, following a request from Sen. Lamar Alexander (R-Tenn.).
The Compounding Quality Act, which was signed into law in November, removed provisions of the Federal Food, Drug and Cosmetic Act (FDCA) that the U.S. Supreme Court ruled unconstitutional in 2002.
Compounded drugs refer to prescription medications that are personalized by pharmacists to meet the exact dosage and strength requirements of individual patients.
“The purpose of the compounding law is to end confusion and improve communication so we can help prevent another tragic meningitis outbreak,” Alexander, the ranking member of the Senate Health, Education, Labor and Pensions Committee, said. “If FDA isn’t sitting down with doctors, patients and pharmacists and communicating how it is implementing the law, then I will stay on FDA until it does.”
The Compounding Quality Act removed provisions of the FDCA related to compounded drugs that required compliance with current good manufacturing practices, labels that include adequate directions for use and FDA approval prior to marketing, according to the FDA.
Alexander led the call for the FDA to meet with stakeholders regarding implementation of the Compounding Quality Act after hearing concerns from doctors, patients and pharmacists.
The Senate Appropriations Committee said it was concerned that the FDA began to implement the Compounding Quality Act by issuing guidance and appointing members to the Pharmacy Compounding Advisory Committee without meeting with stakeholders first.
FDA was directed by the committee to meet with stakeholders to ensure ongoing access to safe compounded drugs.
continue to read here
The Compounding Quality Act, which was signed into law in November, removed provisions of the Federal Food, Drug and Cosmetic Act (FDCA) that the U.S. Supreme Court ruled unconstitutional in 2002.
Compounded drugs refer to prescription medications that are personalized by pharmacists to meet the exact dosage and strength requirements of individual patients.
“The purpose of the compounding law is to end confusion and improve communication so we can help prevent another tragic meningitis outbreak,” Alexander, the ranking member of the Senate Health, Education, Labor and Pensions Committee, said. “If FDA isn’t sitting down with doctors, patients and pharmacists and communicating how it is implementing the law, then I will stay on FDA until it does.”
The Compounding Quality Act removed provisions of the FDCA related to compounded drugs that required compliance with current good manufacturing practices, labels that include adequate directions for use and FDA approval prior to marketing, according to the FDA.
Alexander led the call for the FDA to meet with stakeholders regarding implementation of the Compounding Quality Act after hearing concerns from doctors, patients and pharmacists.
The Senate Appropriations Committee said it was concerned that the FDA began to implement the Compounding Quality Act by issuing guidance and appointing members to the Pharmacy Compounding Advisory Committee without meeting with stakeholders first.
FDA was directed by the committee to meet with stakeholders to ensure ongoing access to safe compounded drugs.
continue to read here
Must Read: Custom-drug makers to come under voluntary oversight; Regulators from Idaho, Minnesota, Nevada, Texas, Virginia and other states said they want to see their state lawmakers adopt similar definitions for outsourcing facilities and allow states to inspect the facilities along with federal regulators.
Michelle Ye Hee Lee, The Republic | azcentral.com
Jobs: Compounding Sales Representative (NY,Fl,PA,NJ) $250-$500,000 per year
SALES REP COMPOUNDED RX $250-$500,000.00 Per Year (NY)
Here is your chance to join a fast-growing business in the medical/pharma industry focusing on the dispensing of topical compounded RX medications for physicians and surgeons directly for a compounding pharmacy.
We are seeking qualified Reps/Account Executives whose duties are focused on opening new accounts and maintaining current accounts.
Compensation is 1099 commission based and we have reps making over $5000.00 per week
This position is an excellent opportunity to add additional income if you are currently a sales rep with a base of physicians. The best specialties include but are not limited to Orthopedics, Pain Management, Podiatry, Family Practice, ENT, Plastic Surgeons and Dental Surgeons.
Minimum 2 years experience in face to face medical sales with physician's in their offices.
Strong interpersonal skills
Closer mentality MUST BE COMFORTABLE MAKING IN EXCESS OF $150,000.00 Per Year
DO NOT RESPOND IF YOU ARE NOT CURRENTLY IN THE MEDICAL FIELD.
Immediate openings in the following territories:
FL,PA,NJ,NY
.
We are a PCAB Accredited Compounding Pharmacy, who uses PCCA bulk ingredients. We take compounding seriously.
Here is your chance to join a fast-growing business in the medical/pharma industry focusing on the dispensing of topical compounded RX medications for physicians and surgeons directly for a compounding pharmacy.
We are seeking qualified Reps/Account Executives whose duties are focused on opening new accounts and maintaining current accounts.
Compensation is 1099 commission based and we have reps making over $5000.00 per week
This position is an excellent opportunity to add additional income if you are currently a sales rep with a base of physicians. The best specialties include but are not limited to Orthopedics, Pain Management, Podiatry, Family Practice, ENT, Plastic Surgeons and Dental Surgeons.
Minimum 2 years experience in face to face medical sales with physician's in their offices.
Strong interpersonal skills
Closer mentality MUST BE COMFORTABLE MAKING IN EXCESS OF $150,000.00 Per Year
DO NOT RESPOND IF YOU ARE NOT CURRENTLY IN THE MEDICAL FIELD.
Immediate openings in the following territories:
FL,PA,NJ,NY
.
We are a PCAB Accredited Compounding Pharmacy, who uses PCCA bulk ingredients. We take compounding seriously.
- Principals only. Recruiters, please don't contact this job poster.
- do NOT contact us with unsolicited services or offers
post id: 4490846827
posted:
Tuesday, May 27, 2014
5/27/14 - Inovio Pharmaceuticals Subsidiary Sells Animal Health Assets
BLUE BELL, Pa., May 27, 2014 /PRNewswire/ Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) today announced that its 90%-owned subsidiary, VGX Animal Health, Inc. (VAH), has concluded an agreement for the sale of its animal health assets to Plumbline Life Sciences, Inc. (PLS) of Korea. The assets being transferred include an exclusive license with Inovio for animal applications of its growth hormone-releasing hormone (GHRH) technology and animal DNA vaccines plus a non-exclusive license to Inovio electroporation delivery systems. VGX Animal Health will receive $2 million in cash in multiple payments and 20% of the outstanding shares of PLS. VAH's 20% equity ownership position in PLS will be maintained without dilution up to $10 million of additional equity fundraising by PLS. Inovio Pharmaceuticals will receive milestone payments and royalties on product sales. Inovio retains the human applications of its GHRH technology.
Dr. J. Joseph Kim, President and CEO, said, "Inovio is sharply focused on its human immunotherapy products, consequently we own promising assets that are not being allocated appropriate resources. Our animal GHRH product candidates have notably improved cancer-related morbidity in dogs and increased herd productivity in livestock animals. We are pleased to monetize these assets with a deal that will result in a committed development of these products and market opportunities." About Plumbline Life Sciences, Inc. PLS is a venturecapital-backed animal health company based in Seoul,Korea, a strategic location in the fast-growing Asian market. The PLS management team includes experienced biotech managers from the US and Korea as well as aformer manager ofKorea Development Bank. More information about PLS can be found atwww.plumblinels.com. About Inovio Pharmaceuticals, Inc. Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon vaccines, in combination with its proprietary electroporation delivery, are generating best-in-class immune responses, with therapeutic T-cell responses exceeding other technologies in terms of magnitude, breadth, and response rate. Human data to date have shown a favorable safety profile. Inovio's lead vaccine, a therapeutic against HPV-caused pre-cancers and cancers, is in phase II. Other phase I and preclinical programs target prostate, breast, and lung cancers as well as HIV, influenza, malaria and hepatitis. Partners and collaborators include Roche, the University of Pennsylvania, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, US Dept. of Homeland Security, and University of Manitoba. More information is available at www.inovio.com. This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form10-K for the year ended December31, 2013, our Form 10-Q for the quarter ended March 31, 2014, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate. CONTACTS: Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com |
Texas: Brian Allen: Closed Formulary Closing the Door on Opioids
The door hinges creaked slightly as the young teenage boy opened the door to his mother’s bedroom and peered into the darkness. It wasn’t an unusual occurrence. His mom had been enduring the pain of a back surgery performed nearly two years earlier. Most mornings she needed some encouragement to wake up from a drug-induced sleep. But, on this morning, the room was eerily quiet as the boy entered. He touched her arm and, instead of the soft warmth he expected, he confronted the cold and lifeless body of his 42 year old mother. After battling addiction to opioids for more than 20 months, she surrendered to her pain by accidentally ingesting a toxic overdose of the medications that had been prescribed by her physician.
Sadly, this young man was confronted with nearly the same scenario two years later, as he found his father dead from a medical episode brought about by an over use of opioids. These tragedies are one of the fabrics weaving my family’s story—the teen’s mother was my younger sister. Tens of thousands of other families face the fear of this becoming their story every day as they witness loved ones struggle with addiction.
The use of opioid analgesics to treat pain is a significant issue in our country, to the point that, in 2011, the Centers for Disease Control (CDC) declared overdose deaths from prescription opioids a national epidemic. The latest figures from the CDC indicate that 16,500 people died from a narcotic painkiller overdose in 2010. In workers’ compensation, there has been a lot of talk about opioid analgesics and their accessibility, use, and impact when treating injured workers with chronic pain. Many states have taken steps to control the use of opioid analgesics in their workers’ compensation systems using a variety of methods ranging from treatment guidelines, drug testing, prescription drug monitoring programs, weaning programs, and pre-authorization requirements. A standout approach adopted by Texas in 2011, with others more recently following suit, is the closed formulary.
The Texas Closed Formulary
In 2005, when the Texas legislature was debating a significant overhaul of their workers’ compensation system, House Bill (HB) 7 was passed, requiring the newly created Division of Workers’ Compensation to develop a “closed formulary.” At the time, none of the stakeholders really knew what a closed formulary would look like or how it would be implemented, but there was a consensus that the use of opioid analgesics and other potentially addictive medications needed to be controlled. HB 7 contained a host of new provisions that required rulemaking and many of those provisions, including medical treatment guidelines, needed to be implemented before rules for a closed formulary could be adopted.
As early as 2008, the Division began having informal discussions with various individuals and groups about what a closed formulary might look like. More formal discussions and hearings followed. The natural fit, after much discussion, was to adopt a closed formulary based on the drug list contained in the previously mandated treatment guidelines from the Official Disability Guidelines (ODG) and to phase it in over time.
In January 2011, Texas formally adopted the closed formulary rule1, which included all drugs and over-the-counter medications that did not have an “N” designation in the ODG drug list. Medications indicated as “N” drugs, which include most opioid analgesics, could be prescribed but required the prescribing physician to engage in an involved prior authorization process. Additionally, the Division designed the rule such that it would be phased in over a two year period, making it effective for all new claims occurring on or after September 1, 2011, and then effective on September 1, 2103, for all “legacy claims,” claims that had occurred prior to September 1, 2011. The additional two year time frame was intentionally designed to allow payers and prescribing doctors to work together to determine if the currently prescribed “N” drug was appropriate or if another medication might be more beneficial to the injured worker.
continue to read here
Sadly, this young man was confronted with nearly the same scenario two years later, as he found his father dead from a medical episode brought about by an over use of opioids. These tragedies are one of the fabrics weaving my family’s story—the teen’s mother was my younger sister. Tens of thousands of other families face the fear of this becoming their story every day as they witness loved ones struggle with addiction.
The use of opioid analgesics to treat pain is a significant issue in our country, to the point that, in 2011, the Centers for Disease Control (CDC) declared overdose deaths from prescription opioids a national epidemic. The latest figures from the CDC indicate that 16,500 people died from a narcotic painkiller overdose in 2010. In workers’ compensation, there has been a lot of talk about opioid analgesics and their accessibility, use, and impact when treating injured workers with chronic pain. Many states have taken steps to control the use of opioid analgesics in their workers’ compensation systems using a variety of methods ranging from treatment guidelines, drug testing, prescription drug monitoring programs, weaning programs, and pre-authorization requirements. A standout approach adopted by Texas in 2011, with others more recently following suit, is the closed formulary.
The Texas Closed Formulary
In 2005, when the Texas legislature was debating a significant overhaul of their workers’ compensation system, House Bill (HB) 7 was passed, requiring the newly created Division of Workers’ Compensation to develop a “closed formulary.” At the time, none of the stakeholders really knew what a closed formulary would look like or how it would be implemented, but there was a consensus that the use of opioid analgesics and other potentially addictive medications needed to be controlled. HB 7 contained a host of new provisions that required rulemaking and many of those provisions, including medical treatment guidelines, needed to be implemented before rules for a closed formulary could be adopted.
As early as 2008, the Division began having informal discussions with various individuals and groups about what a closed formulary might look like. More formal discussions and hearings followed. The natural fit, after much discussion, was to adopt a closed formulary based on the drug list contained in the previously mandated treatment guidelines from the Official Disability Guidelines (ODG) and to phase it in over time.
In January 2011, Texas formally adopted the closed formulary rule1, which included all drugs and over-the-counter medications that did not have an “N” designation in the ODG drug list. Medications indicated as “N” drugs, which include most opioid analgesics, could be prescribed but required the prescribing physician to engage in an involved prior authorization process. Additionally, the Division designed the rule such that it would be phased in over a two year period, making it effective for all new claims occurring on or after September 1, 2011, and then effective on September 1, 2103, for all “legacy claims,” claims that had occurred prior to September 1, 2011. The additional two year time frame was intentionally designed to allow payers and prescribing doctors to work together to determine if the currently prescribed “N” drug was appropriate or if another medication might be more beneficial to the injured worker.
continue to read here
Congress Chastises FDA: “You’re Not Listening!”
“We found that FDA focused on perfecting their legal reasons for inaction,” a Senate committee wrote, “instead of protecting families.” Action Alert!
Last Friday, the Senate Appropriations Committee criticized the FDA for ignoring doctors, patients, and compounding pharmacists by issuing proposed new regulations on compounding pharmacies without sufficiently consulting the stakeholders.
The language scolding the FDA was inserted into a committee report at the request of Sen. Lamar Alexander (R-TN), who has committed himself to making sure stakeholders are heard: “If FDA isn’t sitting down with doctors, patients, and pharmacists and communicating how it is implementing the law, then I will stay on FDA until it does.”
While we applaud Sen. Alexander for his attention to this matter, it’s difficult not to say, “We told you so!” When the compounding legislation was passed in 2013, we warned legislators that the FDA would exploit the bill to expand and abuse its powers. Unfortunately, we were right. Nevertheless, we thank Sen. Alexander for his support, and encourage further oversight!
quoted from here
Last Friday, the Senate Appropriations Committee criticized the FDA for ignoring doctors, patients, and compounding pharmacists by issuing proposed new regulations on compounding pharmacies without sufficiently consulting the stakeholders.
The language scolding the FDA was inserted into a committee report at the request of Sen. Lamar Alexander (R-TN), who has committed himself to making sure stakeholders are heard: “If FDA isn’t sitting down with doctors, patients, and pharmacists and communicating how it is implementing the law, then I will stay on FDA until it does.”
While we applaud Sen. Alexander for his attention to this matter, it’s difficult not to say, “We told you so!” When the compounding legislation was passed in 2013, we warned legislators that the FDA would exploit the bill to expand and abuse its powers. Unfortunately, we were right. Nevertheless, we thank Sen. Alexander for his support, and encourage further oversight!
quoted from here
The Jobs in Compounding Pharmacy Sales Just Keep Coming....
- miami.craigslist.org › ... › all jobs › sales jobs
- 5 hours ago - Are you a seasoned pharmaceutical sales rep looking for more money? Do you have strong relationships with doctors, clinics and hospitals in your area?
- 7 hours ago - I am looking for a motivated individual who has previous experience within the compounding pharmacy field to join my team. I am looking for a special someone
...
Question of the Day May 27, 2014 So far every compounding pharmacy that has registered with the FDA as an outsourcing facility that the FDA has inspected has had a 483 issued showing problems with the compounding pharmacy. What does this tell the public? The compounding pharmacies all have room for improvement? The FDA is being too tough? None of the compounding pharmacies with outstanding compliance have registered or are willing to register? Will those inspected by the FDA bringing their "outsourcing facilities" in compliance with the DQSA? It just a question of knowing what is expected and then the outsourcers will fix what needs to be fixed?
view list of FDA registered outsourcing facilities and 483s here
FDA Warning Letter Nature's Pharmacy & Compounding Center Asheville, NC
May 9,
2014
VIA UPS
WARNING LETTER
(14-ATL-07)
William B. Cheek, Pharmacist and Co-owner
Nature’s Pharmacy & Compounding Center
752 Biltmore Ave
Asheville, NC 28803-2558
Dear Mr. Cheek:
From November 12, 2013 to November 22, 2013, a U.S. Food and Drug
Administration (FDA) investigator conducted an inspection of your facility,
Nature’s Pharmacy & Compounding Center, 752 Biltmore Ave, Asheville, NC
28803-2558. During the inspection, the investigator noted that you were not
receiving valid prescriptions for individually-identified patients for a portion
of the drug products you were producing. In addition, the investigator observed
serious deficiencies in your practices for producing drug products intended or
expected to be sterile, which put patients at risk. For example, your
compounding procedure for Lidocaine 4% solution/personal lubricant (1:1) Gel
used for urethral injection is to mix sterile lidocaine with non-sterile
lubricant in a non-sterile (b)(4) without any further
sterilization before it is filled into sterile bags and sealed. In addition,
your firm failed to demonstrate through appropriate studies that your
(b)(4) is able to provide adequate protection of the area in
which products intended or expected to be sterile are processed. Therefore, your
products may be produced in an environment that poses a significant
contamination risk. In addition, you do not use sterile disinfectants, including
a sporicidal agent, for disinfection of the area. FDA issued a Form FDA 483 to
your firm on November 22, 2013. Furthermore, a lack of sterility assurance
resulted in a voluntary recall of product on November 13, 2013.
Based on this inspection, it appears that you have produced drugs that
violate the Federal Food, Drug, and Cosmetic Act (FDCA).
A. Compounded Drugs Under the FDCA
At the time FDA inspected your facility, there were conflicting judicial
decisions regarding the applicability of section 503A of the FDCA [21 U.S.C.
§ 353a], which exempts compounded drugs from several key statutory requirements
if certain conditions are met. [1] Nevertheless, receipt of valid
prescriptions for individually-identified patients prior to distribution of
compounded drugs was relevant for both section 503A of the FDCA and the agency’s
Compliance Policy Guide 460.200 (CPG) (2002), which was then in effect
[2] During the
FDA inspection, the investigator observed that your firm does not receive valid
prescriptions for individually-identified patients for a portion of the drug
products you produce. Based on this factor alone, those drugs were not entitled
to the statutory exemptions for compounded drugs described in section 503A of
the FDCA and did not qualify for the agency’s exercise of enforcement discretion
set forth in the CPG. [3]
Since FDA inspected your facility, Congress enacted and the President
signed into law the Compounding Quality Act (CQA),[4] which amended FDCA section
503A by eliminating the advertising restrictions that had been the basis for
conflicting judicial decisions. The CQA otherwise left section 503A intact, and
so clarified that the remainder of section 503A, including the requirement of
valid prescriptions for individually-identified patients, is applicable in every
federal judicial circuit. Accordingly, the drugs you compound without valid
prescriptions for individually-identified patients are not entitled to the
exemptions in section 503A. [5]
In addition, we remind you that there are a number of other conditions that
must be satisfied to qualify for the exemptions in section 503A of the FDCA.
[6]
B. Violations of the FDCA
The drug products that you manufacture and distribute without valid
prescriptions for individually-identified patients are misbranded drugs in
violation of section 502(f)(1) [21 U.S.C. § 352(f)(1)] of the FDCA. In addition,
your drug products intended or expected to be sterile are prepared, packed, or
held under insanitary conditions whereby they may have been contaminated with
filth, or whereby they may have been rendered injurious to health. As such, all
drug products intended or expected to be sterile that you manufacture are
adulterated within the meaning of section 501(a)(2)(A) [21 U.S.C. §
351(a)(2)(A)] of the FDCA. Furthermore, because you manufacture and distribute
drugs without valid prescriptions for individually-identified patients, the
manufacture of those drugs are also subject to FDA’s Current Good Manufacturing
Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of
Federal Regulations (CFR), Parts 210 and 211. An FDA investigator observed
significant CGMP violations at your facility, causing such drug product(s) to be
adulterated within the meaning of section 501(a)(2)(B) of the FDCA [21 U.S.C. §
351(a)(2)(B)].
Misbranded Drug Products
Because the drug products for which you have not obtained valid
prescriptions for individually-identified patients are intended for conditions
that are not amenable to self-diagnosis and treatment by individuals who are not
medical practitioners, adequate directions cannot be written for them so that a
layman can use these drug products safely for their intended uses. Consequently,
their labeling fails to bear adequate directions for their intended uses,
causing them to be misbranded under section 502(f)(1) of the FDCA [21 U.S.C. §
352(f)(1)], and they are not exempt from the requirements of section 502(f)(1)
of the FDCA (see, e.g., 21 C.F.R. § 201.115). It is also a
prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any
act with respect to a drug, if such act is done while the drug is held for sale
after shipment in interstate commerce of the components used to make the drug
and results in the drug being misbranded.
Adulteration Charges
Additionally, an FDA investigator noted that drug products intended or
expected to be sterile were prepared, packed, or held under insanitary
conditions, whereby they may have become contaminated with filth or rendered
injurious to health, causing your drug products to be adulterated under section
501(a)(2)(A) of the FDCA [21 U.S.C. § 351(a)(2)(A)]. Examples of these
conditions include that your compounding procedure for Lidocaine 4%
solution/personal lubricant (1:1) Gel used for urethral injection is to mix
sterile lidocaine with non-sterile lubricant in a non-sterile (b)(4)
without any further sterilization process before it is filled into
sterile bags and sealed. In addition, your firm failed to demonstrate through
appropriate studies that your (b)(4) is able to provide
adequate protection of the area in which products intended or expected to be
sterile are processed. Therefore, your products may be produced in an
environment that poses a significant contamination risk. Furthermore, you do not
use sterile disinfectants, including a sporicidal agent, for disinfection of the
area.
An FDA investigator also noted CGMP violations at your facility, causing
the drug products for which you have not obtained valid prescriptions for
individually-identified patients to be adulterated under section 501(a)(2)(B) of
the FDCA [21 U.S.C. § 351(a)(2)(B)]. The violations include, for example:
1. Your firm failed to establish and follow
appropriate written procedures that are designed to prevent microbiological
contamination of drug products purporting to be sterile, and that include
validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
2. Your firm failed to establish an adequate
system for cleaning and disinfecting the room and equipment to produce aseptic
conditions (21 CFR 211.42(c)(10)(v)).
3. Your firm failed to establish an adequate
system for monitoring environmental conditions in aseptic processing areas (21
CFR 211.42(c)(10)(iv)).
4. Your firm did not have, for each batch of
drug product purporting to be sterile and/or pyrogen-free, appropriate
laboratory determination of satisfactory conformance to final specifications for
the drug product (21 CFR 211.167(a)).
5. Your firm failed to establish and follow
an adequate written testing program designed to assess the stability
characteristics of drug products and to use results of such stability testing to
determine appropriate storage conditions and expiration dates (21 CFR
211.166(a)).
6. Your firm failed to establish an adequate
air supply filtered through high-efficiency particulate air filters under
positive pressure in the aseptic processing areas (21 CFR
211.42(c)(10)(iii)).
7. Your firm failed to ensure that
manufacturing personnel wear clothing appropriate to protect drug product from
contamination (21 CFR 211.28(a)).
It is a prohibited act under section 301(k) of the FDCA [21 U.S.C. §
331(k)] to do any act with respect to a drug, if such act is done while the drug
is held for sale after shipment in interstate commerce of the components used to
make the drug and results in the drug being adulterated.
C. Corrective Actions
We acknowledge your action on November 13, 2013, to voluntarily recall all
sterile products within expiry, as well as your written response to the Form FDA
483 on November 26, 2013, notifying FDA that you have permanently ceased all
sterile compounding operations.
FDA strongly recommends that if you decide to resume production of sterile
drugs, your management immediately undertake a comprehensive assessment of your
operations, including facility design, procedures, personnel, processes,
materials, and systems. In particular, this review should assess your aseptic
processing operations and design. A third party consultant with relevant sterile
drug manufacturing expertise could be useful in conducting this comprehensive
evaluation.
As discussed above, your firm has manufactured and distributed drugs
without valid prescriptions for individually-identified patients, and the
manufacture of such drugs is subject to FDA’s drug CGMP regulations, 21 CFR
Parts 210 and 211. Before resuming such operations, you should fully implement
corrections that meet the minimum requirements of 21 CFR Part 211 in order to
provide assurance that the drug product(s) produced by your firm conform to the
basic quality standards that ensure safety, identity, strength, quality, and
purity.
You should also correct the violations of FDCA sections 501(a)(2)(A) and
502(f)(1) noted above.
D. Conclusion
The violations cited in this letter are not intended to be an all-inclusive
statement of violations at your facility. You are responsible for investigating
and determining the causes of the violations identified above and for preventing
their recurrence or the occurrence of other violations. It is your
responsibility to ensure that your firm complies with all requirements of
federal law and FDA regulations.
If you decide to resume sterile operations, you should take prompt action
to correct the violations cited in this letter. Failure to promptly correct
these violations may result in legal action without further notice, including,
without limitation, seizure and injunction. FDA may re-inspect to verify
corrective actions have been completed.
Within fifteen working days of receipt of this letter, please notify this
office in writing if you have taken any specific steps to correct violations, or
you may inform us that you do not intend to resume production of sterile
drugs. If you intend to resume production of sterile drugs in the future, please
include an explanation of each step being taken to prevent the recurrence of
violations, as well as copies of related documentation. If you do not believe
that the products discussed above are in violation of the FDCA, include your
reasoning and any supporting information for our consideration. In addition to
taking appropriate corrective actions, you should notify this office prior to
resuming production of any sterile drugs in the future. Your written
notification should be addressed to:
Marie Mathews, Compliance Officer
FDA Atlanta District Office
U.S. Food and Drug Administration
60 8th Street, N.E.
Atlanta, GA 30309
If you have questions regarding any issues in this letter, please contact
our office at 404-253-1161.
Sincerely,
/S/
Ingrid A. Zambrana
District Director
cc: Michael Rodgers, Pharmacist and Co-owner
Nature’s Pharmacy & Compounding Center
752 Biltmore Ave
Asheville, NC 28803-2558
[1] Compare
Western States Med. Ctr. v. Shalala, 238 F.3d 1090 (9th Cir. 2001)
with Medical Ctr. Pharm. v. Mukasey, 536 F.3d 383 (5th Cir.
2008).
[2] The CPG set forth
a non-exhaustive list of factors that FDA considered in determining whether to
take enforcement action when the scope and nature of a pharmacy's activities
raised concerns. This CPG has been withdrawn in light of new legislation. See
below.
[3] See 21
U.S.C. § 353a(a) (granting compounded drugs statutory exemptions if, among other
things, “the drug product is compounded for an identified individual patient
based on the . . . receipt of a valid prescription order or a notation, approved
by the prescribing practitioner, on the prescription order that a compounded
product is necessary for the identified patient . . . .”); CPG at 2 (“FDA
recognizes that pharmacists traditionally have extemporaneously compounded and
manipulated reasonable quantities of human drugs upon receipt of a valid
prescription for an individually-identified patient from a licensed
practitioner. This traditional activity is not the subject of this
guidance.”).
[4] Drug Quality and
Security Act, Public Law 113-54, 127 Stat. 587 (Nov. 27, 2013).
[5]The CQA contains a
number of other provisions, including new exemptions and requirements for
compounders seeking to operate as outsourcing facilities. A discussion of the
CQA and the agency’s plans to implement the new law may be found at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm1.
[6] For example,
section 503A also addresses anticipatory compounding, which includes compounding
(not distribution) before receipt of a valid prescription order for an
individual patient. We are not addressing anticipatory compounding
here.
quote from here
Independent pharmacies show people 'we really care'
May 26, 2014 | Updated: May 26, 2014 10:19pm
In 2008, when Milad and Maryana Attalla opened Katy Pharmacy, there were three other independent pharmacies nearby that compounded medicine, a specialized service prescribed by physicians whenever a manufacturer doesn't offer the desired medication in the right dose for their patients.Today, there are at least 13 independent compounding pharmacies in or near Katy, according to the Professional Compounding Centers of America. Milad Attalla said he thinks the key to that kind of growth is personal service.
John Norton, spokesman for the National Community Pharmacists Association, said the number of independent pharmacies in this country reached an all-time high of 40,000 in 1980.
"After the '80s you had big chains like Walgreens and CVS come along and start buying up independent pharmacies," Norton said. "Our numbers plummeted to 23,000, and it's remained stable there to this day."
Norton said independent pharmacies distinguish themselves by offering compounding and other services. For the Attallas, it's all about providing better customer service than his competitors.
"When my wife graduated from pharmacy school, she had people calling her to get her to work for them," Milad Attalla said. "It doesn't work like that anymore."
Maryana Attalla went to work for a large chain after earning a pharmacy degree from the University of Houston in 2006. But, she said, she wasn't prepared for the disconnect between what she learned in school and what her employer expected.
"One day my manager pulled me aside and told me that I was spending too much time talking to customers," she said. "I was told I only had time to fill prescriptions and answer the phone … that was all."
"And if she knew of a lower-priced alternative, she wasn't allowed to tell people about it," Milad Attalla said. "My wife's heart was broken."
Attalla, a native of Egypt, had immigrated to this country in 1991. After spending several years working for the Coptic Orthodox Church, he almost became a priest but opted to go into business instead.
He was liquidating three furniture stores he owned in 2008 when his wife proposed they open a pharmacy.
"I knew it would cost between $500,000 and $750,000 to do that, because you have to stock so many medicines," Milad Attalla said. "In the end we spent closer to $1 million."
The couple opened their first store in August 2008. In addition to compounding medicine, they offered traditionally manufactured medicines, which came to account for about 70 percent of their business.
Then came the break-ins. Six times thieves struck Katy Pharmacy in search of narcotics. Milad Attalla said one heist in 2010 cost them $270,000, of which insurance covered only $50,000.
So the couple moved the store to its current location on a more visible street corner in Katy. They also installed multiple security lights, alarms and video cameras.
Today, Katy Pharmacy employs two other pharmacists in addition to Maryana Attalla and seven technicians. It has had the same employees since 2009.
"I come here because of Maryana," said customer Judy Foland, 72. "She always has time to talk to me, no matter what time I call or when I come in."
Milad Attalla estimates the pharmacy's gross revenue is $2 million annually. But he says money was never the reason for launching the business.
"One elderly man came in who was taking 24 different medicines," Milad Attalla said. "Twenty-four! My wife talked to his physicians and got that down to seven. That's why we do this."
A longtime member and volunteer with Saint Mary & Archangel Michael Coptic Orthodox Church in Houston, Milad credits the couple's faith for their business success. "It's all been a gift," he said.
quoted from here
Monday, May 26, 2014
Strawbridge: Racing in denial about image problems--he noted that American Thoroughbred racing has become associated with “a sinister substances mixed in a black bag” and called for reform.
George Strawbridge, Jr., has been deeply involved in Thoroughbred racing for most of his life, and his green and white Augustin Stable silks are familiar on both sides of the Atlantic. Among the top flat runners Strawbridge has raced alone or in partnership are Selkirk, a European star who went on to success as a sire; homebred Moonlight Cloud, a six-time G1 winner in France; American champions Informed Decision, Forever Together, and Waya; and such major stakes-winners as With Anticipation, Tikkanen, Collier Hill, Turgeon, and Silver Fling, who competed at the highest levels in Europe and the United States. A onetime amateur steeplechase rider, Strawbridge also is the National Steeplechase Association’s all-time leading owner by purse earnings, and his jump-racing notables include Hall of Fame ’chaser Cafe Prince and the winners of four Carolina Cups between 1982 and 2008 (Quiet Bay, Gogong, Invest West, and Imagina).
Today, his American string consists of about 20 horses in training, divided between his longtime trainer Jonathan Sheppard and Graham Motion. He also has 24 horses in Europe with trainers Ian Balding, Jonathan Pease, Freddie Head, and John Gosden.
Strawbridge, 77, has been an outspoken opponent of horse slaughter and race-day medications and is a member of the Water Hay Oats Alliance (WHOA), which advocates federal legislation to ban performance-enhancing drugs on race day under the oversight of the non-governmental United States Anti-Doping Agency (USADA). In 2011, as the Thoroughbred Club of America’s Honor Guest, he noted that American Thoroughbred racing has become associated with “a sinister substances mixed in a black bag” and called for reform.
continue to read here
WPS Medicare- Iowa, Kansas, Missouri and Nebraska-Billing for Compounded Drugs
Billing for Compounded Drug Refills Used in Implantable Epidural/Subarachnoid Pain Pumps
The use of infusion pumps is covered by a National Coverage Decision (NCD) (Publication 100-03, Chapter 1, Section 280.14).
Implantable epidural/subarachnoid pain pumps need to be refilled approximately every 30 days. The capacity of these pumps is small (~18 milliliters); therefore, a highly concentrated, sterile, preservative-free solution is needed for these pump refills. A compounding pharmacy usually compounds these solutions from a powdered drug or a highly concentrated solution based on each patient's prescription, then delivers the compounded drug to the physician for pump refilling in the office/clinic setting. Some hospitals and medical centers also have the necessary equipment and sterilization facilities to prepare these solutions.
There has been some confusion regarding the billing and reimbursement for the medications used for these pain pump refills. WPS Medicare will use the guidelines listed below to reimburse providers for compounded drugs and the associated services.
Guidelines
- When drugs are compounded for these refills, they will be paid using the method described below: baclofen (Lioresal), bupivacaine (Marcaine, Sensorcaine), clonidine (Duraclon), fentanyl (Sublimaze), hydromorphone (Dilaudid), morphine (Astramorph, Duramorph, Infumorph), sufetanil (Sufenta), and ziconotide (Prialt). Note that this is not an all inclusive list of such medications.
- Use HCPCS code J3490 (Unclassified drugs) with one unit of service and with the KD modifier ("Drug or biological infused through DME [durable medical equipment]") for the entire compounded drug refill. Each subsequent ingredient of the compound would have one (1) unit of service and zero charges. A description for all J3490 NOC must be included in the SV101-7 data element. NDC code reporting is not required by Medicare; however, may be reported in the 2410/LIN03.
- Drug-specific "J" codes should not be billed for these compounded drug mixtures used in epidural/subarachnoid pain pump refills. These true codes do not specifically describe the actual formulations of the drugs used in this compounding process.
- An invoice is required for each claim. Electronic submitters should indicate that they have an invoice available upon request by putting "Documentation Available Upon Request" in the electronic equivalent of Item 19 of the CMS 1500 claim form. WPS Medicare will send an ADS (development) letter requesting the invoice, which is needed to make the payment determination. If you do not indicate the availability of the invoice, or if it you do not return it in a timely fashion, the claim may be denied as unprocessable.
- In addition to indicating the availability of an invoice in Item 19 of the
CMS 1500 form (or its electronic equivalent), include:
- Name of the drug;
- Exact total dosage (number of milligrams or micrograms) for that patient;
- Route of administration (i.e., "internal pump") or the brand name of the pump.
FiercePharma Manufacturing Has An Number of Stories About API, Inspections Overseas, etc.
SeQuent continues to build Indian API assets with Arvee acquisition
Over the past 18 months, India's SeQuent Scientific has won FDA approval of its API plant, sold its specialty chemicals business and acquired a stake in Shasun Pharma. The Bangalore-based business is maintaining the pace and further bolstering its API production business by agreeing to buy Arvee Synthesis.
Report: FDA to inspect more Sun plants in the next few weeks
When the FDA issued an import alert against Sun Pharma's plant in Gujarat in March, the drugmaker reassured investors the facility accounted for just 1% of U.S. sales. But with the allegations of failings at the plant becoming more and more damning, the FDA is reportedly following its now-familiar strategy of going after other facilities in the network.
Power morcellator fallout continues after FDA advisory warning
In the fallout of an FDA advisory that warned of risks tied to a surgical procedure to remove uterine growths, patients and providers remain torn over the safety and efficacy of related devices.
Logistics company RXTPL rails at FDA for identifying it in drug seizure report
The FDA this week sent U.S. Marshals into an Ohio warehouse to seize more than $11 million worth of drugs marketed by Ascend Pharmaceuticals which it claims are unapproved. But a mention in the FDA press release that the drugs were warehoused by Masters Pharmaceutical has brought a world of pain down on the third-party logistics company.
India to double its drug inspection staff
In the face of FDA actions against some of India's biggest drugmakers and a barrage of criticism of its regulators, the Indian government and industry have already responded with a PR campaign, and now India says it will spend more than $500 million to double its inspection staff and upgrade capabilities.
FDA officials say they're 'serious' about pharma's free speech
FDA officials are having a rethink on free speech--and that could end with an about-face on off-label marketing.
FDA weighs the free-speech case for off-label marketing
What with key court decisions apparently backing First Amendment protections for drug promotions, the FDA has moved off-label communications to the top of its to-do list--and off-label marketing is a hot-button issue, what with the series of multibillion-dollar settlements with the U.S. Justice Department.
Should FDA allow drug ads to include price comparisons? A planned study aims to find out
The agency's concern is that consumers could be more swayed by lower prices than by safety and effectiveness--so it's aiming to find out whether that's the case.
FDA balks at accepting all EU plant inspections
The FDA talks a lot about how working with other countries, sharing information and insights, can allow it to stay on top of of the ever-expanding global supply chain while working within a finite budget. But even with Europe, whose geography includes countries as different as the U.K. and Romania, it can be harder to walk the walk than to talk the talk.
Read more: FDA - FiercePharma http://www.fiercepharma.com/tags/fda#ixzz32sWPxne0
Subscribe at FiercePharma
5/26/14 - Research and Markets: Global and Chinese Veterinary Drug Industry Report 2014
| DUBLIN(BUSINESS WIRE) Research and Markets (http://www.researchandmarkets.com/research/sr3xsj/global-and) has announced the addition of the "Global and Chinese Veterinary Drug Industry Report 2014" report to their offering. The report provides a basic overview of the industry including definitions, classifications, applications and industry chain structure. Veterinary drug market analysis is provided for both the international and Chinese domestic situations including development trends, competitive landscape analysis, key regions development status and a comparison analysis between the international and Chinese markets. Development policies and plans are also discussed and manufacturing processes and cost structures analyzed. Veterinary drug industry import/export consumption, supply and demand figures and cost price and production value gross margins are also provided. The report focuses on 20 industry players providing information such as company profiles, product picture and specification, capacity production, price, cost, production value and contact information. Upstream raw materials and equipment and downstream demand analysis is also carried out. Veterinary drug industry development proposals and marketing channels are analyzed. Finally the feasibility of new investment projects are assessed and overall research conclusions offered. Key Topics Covered:
 Research and Markets Laura Wood, Senior Manager. press@researchandmarkets.com U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Sector: Pharmaceuticals, Animal Healthcare/Veterinary Source: Research and Markets |
Saturday, May 24, 2014
Job Opening at Medisca for Outside Sales Representative
Employee Type: Full-Time
Location: Lansing, MI
Job Type: Sales, Business Development, Pharmaceutical
Experience: At least 1 year(s)
Date Posted: 5/23/2014
Job Description
Outside Sales Representative
The main purpose of the Outside Sales Representative position is to build and strengthen customer relationships, increase sales within the assigned territory, provide excellent service to customers and prospect new accounts. This position focuses equally on both prospecting new business and maintaining & servicing existing customers.
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 millions of people.
For more information please visit our website at: www.medisca.com
Join our Talent Network: http://www.jobs.net/jobs/medisca/en-us/join
JOB DUTIES:
- Client Maintenance & Satisfaction Assurance
- Daily visits to clients to remain updated on their compounding needs
- Probe customers to find out about possible business expansion
- Gather information on compounding needs, close sales & forecast future requirements
- New Business Development & Sales Reports
- Search for potential clients, visit medical complexes and obtain referrals
- Ask customers for the opportunity to quote on competitor’s chemicals or devices
- Describe sales visits made and tack expenses weekly
- Work collaboratively with Inside Sales Representatives (ISR)
- Discuss existing accounts with ISR and strategize on how to increase business
- Advise ISR of visits planned to coordinate contact
- Provide leads and referrals to ISR
TRAVEL: Daily travel in local area, occasional further distance road trips (within the state)
Job Requirements
QUALIFICATIONS & REQUIREMENTS:- College or University Diploma, preferably in a Science field
- One (1) to four (4) years of sales experience
- Experience as a pharmacy technician and knowledge of compounding an asset
- Fluent English required (spoken & written)
- Ideal candidate would be memorable, dynamic & animated
- Proven abilities in finding and closing sales
- Effective organizational, time management and interpersonal skills
- Knowledge of Microsoft Office (Excel, Word, Outlook). Knowledge of Syspro and/or Vintara computer programs is considered an asset
If you feel that you have the skills required for this Outside Sales Representative position, apply now by sending your resume to:
Compounding Sales Representative Job Opening in Dallas/Ft Worth
Specialty Pharmaceutical Sales Representative - Compounding
Royse City Pharmacy - Dallas/Fort Worth Area
Posted 3 days ago
- ExperienceMid-Senior level
- Job functionSales
- Employment typeFull-time
- IndustryPharmaceuticals
- Job ID14047895
About this job
Job description
As a representative for Royse City Pharmacy you will operate under a common set of standard operating procedures and educate physicians in the surrounding area of Royse City / Dallas about compounding and how it can benefit their practice. Training will be provided as needed to strengthen any weak areas of knowledge you may have about varying medications or generalized topics. Salary plus bonuses can reach into the low-mid six figures for motivated sales representatives.
Desired Skills and Experience
- You must have a minimum of 1 years experience in speaking with physicians and have extensive physician lists to call on.
- Be self motivated and have a hunger for success
- Must possess excellent interpersonal skills
- You must have a vehicle in good working order with a valid drivers license and insurance
- Be able to develop an overall marketing/sales plan and execute it autonomously
- Must have stable job history
Friday, May 23, 2014
AVMA Provides Valuable Regarding Which States Require a veterinarian to provide their clients with a written prescription
Client request for prescriptions
Last updated May 2014
The following is a list of states that AVMA research has found
with specific statutes, rules or agency policy statements addressing whether or
not a veterinarian is required to provide a written prescription at the request
of his or her client. Twenty-one states have adopted laws, regulations or policy
statements that specifically or implicitly require veterinarians to provide
their clients with a written prescription upon request in some circumstances. An
additional ten states incorporate into their discipline standards for
veterinarians the AVMA’s Principles of Veterinary Medical Ethics, which state
that veterinarians should honor a client’s request for a prescription in lieu of
dispensing. (Section III-C). Most recently in May 2014, the Montana Board of
Veterinary Medicine adopted a regulatory provision stating that if a
veterinarian, based upon his or her medical opinion, is willing to dispense
medication, then the veterinarian must also provide a prescription in place of
said medication should the owner request a prescription.
Arizona requires a dispensing veterinarian to notify an animal
owner that some prescription-only drugs and controlled substances may be
available at a pharmacy. The dispensing veterinarian may provide a written
prescription to the animal owner if so requested.
California law requires a prescribing veterinarian to offer to give a written prescription to a client that the client may elect to have filled by the prescriber or by a pharmacy.
California law requires a prescribing veterinarian to offer to give a written prescription to a client that the client may elect to have filled by the prescriber or by a pharmacy.
It’s important to note that even in states not listed below,
state boards of veterinary medicine could find in acting on a complaint that
failure to honor a client’s request for a prescription constitutes
unprofessional conduct, leading to discipline against a veterinarian.
Unprofessional conduct generally refers to a departure from or failure to
conform to the standards of acceptable and prevailing practice of a veterinary
medicine.
more information and a state chart available here
Reminder for ISHP that in Idaho all compounded drug products must be pursuant to a patient specific prescription order. Drug items compounded for "office use" and not patient specific are considered to be manufacturing by both Federal and State law. Only registered outsourcing facilities may compound for office use
Legal and Public Affairs Update
John Sullivan
As we move through spring and enjoy the change in the weather there are a few items I wanted inform and/or remind our members about. The first item is to remind us all that compounded drug products must be pursuant to a patient specific prescription order. Drug items compounded for "office use" and not patient specific are considered to be manufacturing by both Federal and State law. Only registered outsourcing facilities may compound for office use. A list of registered pharmacies can be found at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm.
The board of pharmacy is enforcing this for all sterile compounded products, so ensure that your practices are following current law.
Another item related to compounding is the proposed USP General Chapter 800 related to compounding of Hazardous Drugs. There is an open comment period available through July 31, 2014. You can view the proposed chapter by following the link: http://www.usp.org/usp-nf/notices/compounding-notice. This chapter applies to all personnel who are involved in handling hazardous drugs including those not in your pharmacy departments. I encourage all of you that handle hazardous drugs to review the chapter and follow the instructions listed on the website should you have any comments.
quoted from ISHP May 2014 Newsletter
John Sullivan
As we move through spring and enjoy the change in the weather there are a few items I wanted inform and/or remind our members about. The first item is to remind us all that compounded drug products must be pursuant to a patient specific prescription order. Drug items compounded for "office use" and not patient specific are considered to be manufacturing by both Federal and State law. Only registered outsourcing facilities may compound for office use. A list of registered pharmacies can be found at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm.
The board of pharmacy is enforcing this for all sterile compounded products, so ensure that your practices are following current law.
Another item related to compounding is the proposed USP General Chapter 800 related to compounding of Hazardous Drugs. There is an open comment period available through July 31, 2014. You can view the proposed chapter by following the link: http://www.usp.org/usp-nf/notices/compounding-notice. This chapter applies to all personnel who are involved in handling hazardous drugs including those not in your pharmacy departments. I encourage all of you that handle hazardous drugs to review the chapter and follow the instructions listed on the website should you have any comments.
quoted from ISHP May 2014 Newsletter
Sun Valley CE on Oregon Law and Sterile Compounding September 26, 27, and 28th, 2014
Sun Valley
September 26, 27 and 28th, 2014
What’s in the works?
13 hours of CE - Including covering the new Board of Pharmacy requirements for a Sterile Compounding, the highly demanded Pharmacy Law and the Oregon requirements for continuing education on Pain
Two outstanding speakers sponsored by ASHP Advantage
The ever-popular Casino Night
A weekend away from work
Time to renew acquaintances and meet new friends
Technician program
Poster and awards sessions
Annual Fall Business meeting (can’t wait for that!)
Fun for all!
quoted from here
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