What is characterized as "greed" here is a good first step, but, it refers to only a stratum of greed layered on top of the baseline enrichment--what are already very high profit margins that can be obtained from mixing drugs from scratch from chemicals that may have no warranties on their certificates' stated attributes--a reality that probably has not been disclosed to parties involved in compounded drug transactions, including payers. It may not be characterized as "greed" if you only mark-up for the pharmacy--but is it is okay to expose patients to untested drugs if you keep the margins under the radar? Does it become greed only when you mark-up in a manner that trips the payer alarms, after building in added profits for the pharmacy, the doctors, the business partners, etc? Then the non-FDA approved drugs stand out like neon on a black and white photocopy. The recent case highlighting creams sold for thousands revealed that the pharmacy was charging less than 100.00. If on Finally a Compounder Says It: Greed Is Not Good!!
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Anonymous
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at 5:00 PM
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If you look across the industry over decades, you will notice the “would-be” NDA/ANDA/BLA holders’ organized market entry campaigns that pop-up simultaneously across the nation—bioidentical hormones, chelation therapy, nicotine lollipops, topical pain creams take I (local anesthetics) and topical pain creams take II (centrally acting agents). These national “launches” have taken on new meaning after the Supreme Court decision, with pharmacies nudged by the “would-be” NDA/ANDA/BLA and patent holders to hire individual or shared sales forces to “detail” specific products to any willing doctor, or medical practice, or hospital, or alternative care setting. It is a truly brilliant model for escaping and/or circumventing public health oversight—spread the manufacturing across 10,000 pharmacies, and, separated into so many pieces it has very little chance of raising regulatory scrutiny, by FDA, states, or other. And if people are being harmed in small numbers here and there from on Compounding Group Taps Former Express Scripts Official
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Anonymous
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at 11:36 AM
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The sooner payers (and pharmacists and doctors) recognize that they are the "pass throughs" in a vastly decentralized, sub-standard drug industry, the better. The "would be" NDA/ANDA holders are the entities filing patents, selling chemicals and formulas, and marketing and promotional materials, without warranty, escaping layers and layers of legal and regulatory scrutiny under the imprimatur of the practice of medicine and pharmacy. File a patent, write a recipe, source the chemicals, call in the marketers, drop it into 10,000 pharmacies or doctors' offices nationwide and "game-on." on Compounding Group Taps Former Express Scripts Official
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Anonymous
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at 10:28 AM
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I could not access the entire article, but, if you look at historical warning letters over time, you will see the FDA has used the same enforcement options prior to 1997 FDAMA, and under Section 503A, and under Section 503A in regions where it held with advertising restrictions severed after the SC ruling, and where 503A was not in force post SC ruling, under prior guidance. The new law resolves ambiguity--nothing new with respect to enforcement options? on FDA Releases Slew of Warnings to Compounding Pharmacies
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Sunday, August 31, 2014
More Very Imformative Comments from Readers!
Finally a Compounder Says It: Greed Is Not Good!!
The Compounder Forum: Greed Is Not Good Read It here
Saturday, August 30, 2014
Compounding Group Taps Former Express Scripts Official
The United Compounding Network, which was launched last month to negotiate with payers and pharmacy benefit
managers on reimbursement for compounded drugs, named its key leaders, including a former high-level manager from
Express Scripts, a PBM which has drawn the ire of compounders for recently restricting its coverage of such products.
UCN Wednesday (Aug. 27) named David Ott as president and Diana Baumohl as vice president of business development.
Ott held executive positions with Anthem/ WellPoint Health Networks and worked most recently as founder and
principal consultant of Innova Health Solutions, UCN said. Baumohl has worked more than 20 years in the healthcare
industry, including “a variety of executive management positions at Express Scripts, Inc. (ESI),” UCN said in a press
release. “As VP of Business Development, her understanding of the market from both sides will guide UCN’s efforts in
working with compounding pharmacies and payors.”
The network will include state-regulated compounding pharmacies that, based on accreditation and quality standards,
meet a higher bar. The network plans to negotiate reimbursement levels and provide other services, such as standardized
claims billing.
In July Express Scripts started blocking compounding coverage of more than 1,000 bulk ingredients because of increased
prices. It is among other PBMs and payers making recent coverage changes for compounded drugs. The separate Patients and
Physicians for Rx Access — which includes participation from the International Academy of Compounding Pharmacists,
physicians and patients — also recently formed to fight the coverage restrictions. — Alaina Busch McBournie
quoted from here
Wow!! Here are some of the Reasons Prescribers and Patients Should Beware of Compounded Medications including Compounded Pain and Scar Creams!!
There are numerous theoretical basic science, animal and clinical science safety signals related to any proposed multi-ingredient transdermal formulation intended for the far reaching indications for which the compounded creams are marketed-- from scar removal to the treatment of cardiovascular circulatory problems. There are also very serious safety signals related to prior compounded cream deaths.
The pervasively marketed, patent-holding compounded pain creams simply have not been investigated and vetted prior to marketing--they are experimental. But you would not know that from their promotion.
More Great Comments From Readers!! Must Read!!
at 6:23 PM
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"...GMP requirements" above should read "...GMP requirement exemptions" on The New Federal Compounding Law by Mike Corrado
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Anonymous
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at 5:56 PM
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Under 503A, compounded drugs that meet stipulated conditions are exempt from 3 provisions of the FFDCA, and, they may still be held to other provisions for which they are not exempt. Guidance available here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377052.pdf If you read most recent FDA warning letters, making drugs under unsanitary conditions can result in adulteration charges, wether or not conditions are being met for new drug, labeling, and GMP requirements. Bird feathers fungus and filth should not make their way into FDA-approved or compounded pharmaceuticals, regardless of whether or not they are intended for sterile administration. on The New Federal Compounding Law by Mike Corrado
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Anonymous
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at 5:54 PM
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Non-sterile compounds are covered under the original 503A, which was substantially weakened by the Supreme Court ruling but which may have been corrected under DQSA, with clarifications regarding false and misleading claims. But I agree--non-sterile compounds can be just as dangerous, and are currently heavily marketed through sophisticated programs. Check out this patent for "compounded transdermal pain management," including 30-40% by weight of ketamine, intended for mixture with other potent and potentially toxic substances, including clonidine, and local anesthetics implicated in previous compounded drug deaths and for which FDA has taken prior enforcement actions: https://www.google.com/patents/US20130085171?dq=ininventor:%22Charles+D.+HODGE%22&hl=en&sa=X&ei=SkkCVKXEA43BggSp7IHACw&ved=0CFAQ6AEwBw on Second Question of the Day August 30, 2014 Did Congress make a huge mistake by not including nonsterile compounded medications in the DQSA because they may pose just as big a risk as sterile compounded medications?
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U.S. congress debates doping in horse racing
August 30, 2014
Leaders from the horse racing industry spoke before the United States congress to discuss whether the sport needs federal oversight to ban doping. Legislation in the U.S. could be followed by similar bills passed in Europe.
Congress considered legislation regulating horse racing in the 1980’s. Last month, federal authorities arrested members of a Mexican cartel using racehorses bred and trained in the United States for laundering drug money.
Sen. of has proposed legislation to ban race-day medication in horse racing. Udall's bill would ban substances such as , a diuretic that is considered a performance-enhancing drug.
continue to read here
Congress considered legislation regulating horse racing in the 1980’s. Last month, federal authorities arrested members of a Mexican cartel using racehorses bred and trained in the United States for laundering drug money.
Sen. of has proposed legislation to ban race-day medication in horse racing. Udall's bill would ban substances such as , a diuretic that is considered a performance-enhancing drug.
continue to read here
Job Opening Marketing Coordinator (south River Compounding Pharmacy)
Aug. 29, 2014
Marketing Coordinator (south River Compounding Pharmacy)
ConfidentialRichmond, Virginia
Marketing Coordinator Job Description:
Develop an effective marketing program that reaches out to individuals, health
practitioners, local businesses, and organizations. Combine traditional and
non-traditional marketing tools to grow the business with an end result of
life long relationships with our customers. Planning, implementing and
executing a marketing program that shows constant and consistent growth with a
strong ROI.
Creatively contribute to and maintain social media & networking to build/
enhance our brand. Maintain and grow Web-site(s) and E-Commerce store(s).
Perform support tasks for Outside Sales/Marketing Reps
Skills Required:
Minimum 2 year AA degree in marketing with a 4 year BA desired
Minimum 2 years of experience in a marketing position with skills transferable
to job description above, specific to South River Compounding Pharmacy
Experience with and full working knowledge of and Volusion
Previous experience in outside B2B sales desired
Available and willingness to work times and days dictated by the needs of the
business
Project manager level of experience and understanding of event planning and
execution
Excellent record keeping and organizational ability required
Experience in health care field desired
Job Responsibilities:
A. Advertising -- Buys/Placement/Layout
B. Monthly Patient Newsletter -- Create content/Layout/Delivery
C. Monthly Practitioner Newsletter -- Create content/Layout/Delivery
D. Seminars/Events -- Research, Plan, Market, Execute, Analyze
E. Community Outreach
F. Social Media -- Note: Hands on proof of competency and full understanding
will be required by any candidate for the position.
1. Facebook, Twitter, Linkedin, 4square, Google+, Pintrest -- All SM outlets
are used
2. Create overall SM marketing plan
3. Coordinate with staff
4. Post
5. Optimize
6. Update
G. Website(s)/Online Store(s) -- Note: Hands on proof of competency and full
understanding will be required by any candidate for the position.
1. Update as needed with content
2. Coordinate content with staff
3.
4. Overhaul when needed
H. Outside Marketing/Sales Reps
1. Participate in sales calls
2. Coordinate events for Reps
3. Analyze and record post event information/results
4. Manage doctor lists and reports
quoted from here
Develop an effective marketing program that reaches out to individuals, health
practitioners, local businesses, and organizations. Combine traditional and
non-traditional marketing tools to grow the business with an end result of
life long relationships with our customers. Planning, implementing and
executing a marketing program that shows constant and consistent growth with a
strong ROI.
Creatively contribute to and maintain social media & networking to build/
enhance our brand. Maintain and grow Web-site(s) and E-Commerce store(s).
Perform support tasks for Outside Sales/Marketing Reps
Skills Required:
Minimum 2 year AA degree in marketing with a 4 year BA desired
Minimum 2 years of experience in a marketing position with skills transferable
to job description above, specific to South River Compounding Pharmacy
Experience with and full working knowledge of and Volusion
Previous experience in outside B2B sales desired
Available and willingness to work times and days dictated by the needs of the
business
Project manager level of experience and understanding of event planning and
execution
Excellent record keeping and organizational ability required
Experience in health care field desired
Job Responsibilities:
A. Advertising -- Buys/Placement/Layout
B. Monthly Patient Newsletter -- Create content/Layout/Delivery
C. Monthly Practitioner Newsletter -- Create content/Layout/Delivery
D. Seminars/Events -- Research, Plan, Market, Execute, Analyze
E. Community Outreach
F. Social Media -- Note: Hands on proof of competency and full understanding
will be required by any candidate for the position.
1. Facebook, Twitter, Linkedin, 4square, Google+, Pintrest -- All SM outlets
are used
2. Create overall SM marketing plan
3. Coordinate with staff
4. Post
5. Optimize
6. Update
G. Website(s)/Online Store(s) -- Note: Hands on proof of competency and full
understanding will be required by any candidate for the position.
1. Update as needed with content
2. Coordinate content with staff
3.
4. Overhaul when needed
H. Outside Marketing/Sales Reps
1. Participate in sales calls
2. Coordinate events for Reps
3. Analyze and record post event information/results
4. Manage doctor lists and reports
quoted from here
The New Federal Compounding Law by Mike Corrado
The New Federal Compounding Law | NDNR
ndnr.com/practice-building/the-new-federal-compounding-law/
21 hours ago - Compounding Problems for Your Practice and Patients? Mike Corrado. This past November, Congress passed – and the president signed into law – the Drug ...CafePharma Message Board Continues to Light Up About Compounded Pain Creams and Insurance Issues
One note of Caution Regarding the Claims of what the Law is or isn't on this Board are not always correct as I am sure some of the rumors etc or not all true.
CafePharma Message Board found here
CafePharma Message Board found here
Friday, August 29, 2014
Another Comment: More References to FDA-Approved Ingredients when they are not; they are made from untested formulas provided without warranty, with chemicals accompanied by COAs with Disclaimers regarding Test Results. How has this gone unquestioned for so long?
comment:
- said...
- Here's another presentation that makes reference to FDA-approved ingredients, in the payer space. Accreditation can and has occurred in this area without considering the stark limitations from which these drug products arise: made according to untested formulas provided without warranty, with chemicals accompanied by certificates of analysis with disclaimers regarding test results. I'm not sure how this unsettling foundation has gone unquestioned by professionals and academics who have observed the rapid expansion of this industry in deafening silence.
- http://c.ymcdn.com/sites/www.iacprx.org/resource/resmgr/CCH_2014/Session_6_Third_Party_Networ.pdf
- August 29, 2014 at 7:34 PM
A nonpharmacist should be capable of leading Ohio's Pharmacy Board: editorial
The General Assembly recently changed Ohio law so that the executive director of Board of Pharmacy no longer need be a licensed pharmacist.
Executive directors of some of Ohio's 20-plus occupational boards must be licensed members of the profession his or her board regulates. But that's not required of all executive directors. For example, Ohio doesn't require Medical Board's executive director to be a physician.
It's clear Gov. 's administration wanted Ohio law changed so a nonpharmacist could lead the Pharmacy Board's staff, something first proposed when the administration drafted the mid-biennium budget bill, House Bill 483.
For whatever reason, that didn't stay in HB 483. But the House inserted the proposal in another measure, Amended Substitute Senate Bill 230, and passed the amended bill 88-6. The Senate concurred, and signed the bill June 17.
The Ohio Pharmacists Association believes the state should have kept requiring the Pharmacy Board's executive director to be a pharmacist, given the complex rules the panel enforces. That's a fair point. But considering that the Medical Board staff is led by nondoctors, it's hard to see why similar management would imperil the Pharmacy Board.
continue to read here
Executive directors of some of Ohio's 20-plus occupational boards must be licensed members of the profession his or her board regulates. But that's not required of all executive directors. For example, Ohio doesn't require Medical Board's executive director to be a physician.
It's clear Gov. 's administration wanted Ohio law changed so a nonpharmacist could lead the Pharmacy Board's staff, something first proposed when the administration drafted the mid-biennium budget bill, House Bill 483.
For whatever reason, that didn't stay in HB 483. But the House inserted the proposal in another measure, Amended Substitute Senate Bill 230, and passed the amended bill 88-6. The Senate concurred, and signed the bill June 17.
The Ohio Pharmacists Association believes the state should have kept requiring the Pharmacy Board's executive director to be a pharmacist, given the complex rules the panel enforces. That's a fair point. But considering that the Medical Board staff is led by nondoctors, it's hard to see why similar management would imperil the Pharmacy Board.
continue to read here
Houston and East Texas Area has a Number of Job Openings for Compounding Pharmacy Techs--Still Not Much Sign of Compounding Industry Growth Slowing Down
Job Description
Company
Location
Posted
Pharmacy Technician Supervisor
A Specialty Compounding Pharmacy has an immediate opening for a strong Pharmacy Technician for its Pharmacy Technician Supervisor role. This person...
Pharmacy Technician
A Specialty Pharmacy has an immediate opening for a strong Compounding Pharmacy Technician possessing Sterile or Non-Sterile Compounding Pharmacy...
Pharmacy Technician
A Specialty Pharmacy has an immediate opening for a strong Compounding Pharmacy Technician possessing Sterile or Non-Sterile Compounding Pharmacy...
Must Read!!! Kentucky to Tackle Drug Compounder Concerns for Horses
By Frank Angst
In a 12-month period that has seen drug compounders linked to horse deaths at a training center and integrity issues at the track, the Kentucky Commission is researching ways it could add regulatory oversight of drug compounders.
Reform-minded KHRC rules committee chairman Ned Bonnie on Aug. 27 called on fellow members of the committee to research the problems horse racing has encountered with drug compounders and come up with ideas to tackle the issue. The rules committee can make recommendations to the full commission.
"It's a serious matter in Kentucky and elsewhere," said Bonnie, who presented each of the committee members with research on compounders and other issues he hopes the committee will soon address.
Mary Scollay, Kentucky Equine Medical Director for the KHRC, said compounders operate under little federal oversight when compared to pharmaceutical companies that manufacture drugs. She said in recent months compounded medications have been linked to horse deaths and failed drug tests.
"There is risk. People should basically assume they are administering an unknown when they use a compounded substance," Scollay said. "They should be used with extreme caution. We have concerns with the health and safety of the horse and integrity of the sport. It is potentially a very dangerous situation."
Read more on BloodHorse.com: http://www.bloodhorse.com/horse-racing/articles/87063/kentucky-to-tackle-drug-compounder-concerns#ixzz3BnxcGF8H
In a 12-month period that has seen drug compounders linked to horse deaths at a training center and integrity issues at the track, the Kentucky Commission is researching ways it could add regulatory oversight of drug compounders.
Reform-minded KHRC rules committee chairman Ned Bonnie on Aug. 27 called on fellow members of the committee to research the problems horse racing has encountered with drug compounders and come up with ideas to tackle the issue. The rules committee can make recommendations to the full commission.
"It's a serious matter in Kentucky and elsewhere," said Bonnie, who presented each of the committee members with research on compounders and other issues he hopes the committee will soon address.
Mary Scollay, Kentucky Equine Medical Director for the KHRC, said compounders operate under little federal oversight when compared to pharmaceutical companies that manufacture drugs. She said in recent months compounded medications have been linked to horse deaths and failed drug tests.
"There is risk. People should basically assume they are administering an unknown when they use a compounded substance," Scollay said. "They should be used with extreme caution. We have concerns with the health and safety of the horse and integrity of the sport. It is potentially a very dangerous situation."
Read more on BloodHorse.com: http://www.bloodhorse.com/horse-racing/articles/87063/kentucky-to-tackle-drug-compounder-concerns#ixzz3BnxcGF8H
Second Question of the Day August 29, 2014 Does attending a Veterinary Symposium from PCCA or a similiar source qualify a pharmacist to do veterinary compounding? Lee Sisby Compounding is advertising its pharmacist just came back from a Veterinary Symposium with a lot of insights into vet compounds and they can now help your pet. Do you agree?
Our pharmacist Alan just came back from a Veterinary Symposium with a lot of insights into vet compounds. Give us a call to see how we can help your pets as well!
quoted from here
quoted from here
Key Comments Regarding OmniPlus Lawsuit: compounding pharmacy business models almost exclusively use non-FDA approved chemicals as starting materials rather than mixing one or more FDA-approved ingredients
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Well and there it is, just like
the saleswoman said, in #18--maybe the lawyers believed the marketing claim
too. "Compounded done by OmniPlus consists of mixing one or more
FDA-approved ingredients at the direction of the physician to meet the
individual patient's specific needs" on More information on Dan Milosvic
Remove content | Delete | Spam
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I note that #16 in the complaint
reads "Compounding pharmacies have the ability to mix multiple
FDA-approved drugs or active ingredients to create a medication specifically
tailored to a patient's needs." The language is misleading. Compounding
pharmacy business models almost exclusively use non-FDA approved chemicals as
starting materials, with the entire industry supported and facilitated by
suppliers to the U.S. market, pharmacies do this to reap exceptionally large
profit margins by dropping the bottom out of acquisition costs. This may be
where some of the payer confusion arises from. At a medical meeting several
years ago, a compounded drug saleswoman stated that although the drug she was
promoting was not FDA approved, the individual ingredients contained in the
drug were approved by FDA. That statement is false--FDA only approves product
s in their finished dosage forms, with packaging and labeling for safe use.
Maybe payers were marketed to also, and believed the on More information on Dan Milosvic
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Very Important Must Read Comment!! Texas Board of Pharmacy is Zeroing in on primary concern regarding the foundation of the industry-thousands of untested recipes/formulas that may be unsafe, ineffective, or missing important warnings/precautions for safe use
The People’s Pharmacy order by the
Board is an important one that will be difficult to meet at a level of rigor
that will protect patients—the order requires that policies be developed to
detect (implicating surveillance methods) and prevent errors in the dispensing
of compounded preparations (pharmacies little or no control over condition of
chemicals on receipt—ie moisture content, microbial bioburden). But even more
challenging, the order requires policies be developed to ensure the accuracy of
formulas used. The Board is zeroing in on a primary concern regarding the
foundation of the industry—thousands of untested recipes/formulas that may be
unsafe, ineffective, or missing important warnings/precautions for safe use. on
Texas Board of Pharmacy Disciplinary
Action for September 2013 -February 2014
Another Great Comment and Reminder From Reader Regarding Pre-printed Prescriptions
Pre-printed prescriptions were at
issue with respiratory (nubulizer) compounding decades ago, leading to
questionable reimbursements under Medicare Part B (the unapproved drugs may not
have been intended by prescribers, and, at the very least, the preprinted forms
did not include material facts about the products--seems they have resurfaced
here, particularly with respect to pain cream concoctions. Claims are made on
the benefit side, with little or no risk disclosure. on Question of the Day August 29, 2014
Should PBMs recoup claims and immediately terminate Network Proviider for all
claims relating to compounding pharmacies who have been using form/check the
box that were in violation of the Provider Manual? How much total money could
be recouped from this violation alone?
Check out this tip from a reader regarding prior matter involving precursors (butanediol) linked to Houston, Texas
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Check out this prior matter
involving precursors (butanediol) with links to Houston, TX Genapharm:
http://www.fda.gov/downloads/ICECI/.../UCM091464.pdf on Texas man gets 20 years in synthetic
drug deaths - FOX 26 News | MyFoxHouston
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Anonymous
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at
11:56 AM
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PBM Audit Lawyers: DEA’s Rescheduling of Compounds Containing Hydroco...
PBM Audit Lawyers: DEA’s Rescheduling of Compounds Containing Hydroco...: By Jonathan E. Levitt, Esq. and Benjamin J. Hochberg, Esq. On August 22, 2014, the United States Drug Enforcement Administratio...
2 From Calif. Accused In $105M Fraud Case
| By Anthony Clark Carpio, Huntington Beach Independent, Calif. | |
| McClatchy-Tribune Information Services |
continue to read here
Question of the Day August 29, 2014 Should PBMs recoup claims and immediately terminate Network Proviider for all claims relating to compounding pharmacies who have been using form/check the box that were in violation of the Provider Manual? How much total money could be recouped from this violation alone?
Very Important!! Georgia Pharmacy Association Audit Alert Regarding Pre-Printed Prescriptions and Express Scripts' Provider Manual
Audit alert: Pre-printed presciptions
20Aug
By Andrew Kantor
We have received information about a recent audit recoupment of a pre-printed, compounded prescription. Please be aware that language in the ’ Provider Manual regarding pre-printed prescriptions is in Section 2.10 and reads as follows:
Network Providers may not produce, distribute, or accept pre-printed or pre-populated prescriptions for Covered Medications that include a controlled substance. This prohibition includes “check the box” order forms. Network Provider acknowledges and agrees that using, accepting,and/or distributing pre-printed or pre-populated prescription forms that include controlled substances constitutes a violation of law, including but not limited to, the Controlled Substances Act and its implementing regulations. PBM may, in its sole discretion, recoup claims and immediately terminate Network Provider for violating this section of the Provider Manual.
OIG Releases Special Fraud Alert: Laboratory Payments to Referring Physicians
Many physicians and other healthcare providers refer a high volume of patient specimens to third party clinical laboratories every day. The (OIG) for the U.S. Department of and Human Services recently issued a Special Fraud Alert that addresses these relationship between labs and physicians.
The OIG’s Alert focuses on laboratories that may be violating the Federal Anti-Kickback Statute (AKS) in an effort to win business from referring physicians. OIG’s chief concern is that physicians will do business with the lab that pays the most, rather than the best lab, and that physicians will order tests that are not medically necessary, particularly if the payment arrangement is tied to the number of referred tests.
The OIG focused on two types of arrangements that they fear pose a substantial risk of fraud and abuse, including (1) specimen collection and processing, and (2) registry arrangements.
- See more at: http://www.policymed.com/#sthash.cn520PJ4.dpuf
The OIG’s Alert focuses on laboratories that may be violating the Federal Anti-Kickback Statute (AKS) in an effort to win business from referring physicians. OIG’s chief concern is that physicians will do business with the lab that pays the most, rather than the best lab, and that physicians will order tests that are not medically necessary, particularly if the payment arrangement is tied to the number of referred tests.
The OIG focused on two types of arrangements that they fear pose a substantial risk of fraud and abuse, including (1) specimen collection and processing, and (2) registry arrangements.
- See more at: http://www.policymed.com/#sthash.cn520PJ4.dpuf
In race for bigger margins, drug makers willing to lose the India "advantage"
By Zeba Siddiqui
MUMBAI (Reuters) - Indian drugmakers are fleeing a regulatory morass at home and moving some research and development to and the United States as try to boost margins by producing high-value drugs.India's $15 billion a year pharma industry, the world's largest source of cheap generics, is already reeling from a string of drug recalls and quality control issues which have called into question the regulator's oversight.
Now, companies like Piramal Enterprises Ltd, and are investing millions of dollars and placing their future growth in foreign regulators' hands, as they seek to add more complex drugs to their product lines.
"We have lost what is called the India advantage," said , vice-chair of Mumbai-based Piramal Enterprises which last year moved some clinical trials for new drugs abroad.
"The India advantage was saying we can research molecules...and finish the clinical trials and the cost would be one-tenth of the West," she said.
"Now, we have to acquire small groups of highly specialised people who can work on a particular type of product and know exactly how to do it. That's the new alternative - to really invest in R&D abroad," she added.
Indian drugmakers rely on cheap generics for the bulk of their revenue, but like their global peers, they are focusing more on niche markets such as ophthalmology and oral contraceptives, and difficult-to-make products such as inhalers and injectables in a bid to achieve higher profit margins.
continue to read here
Review; Comment Request; Guidance for Industry on Fees for Human Drug Compounding. Outsourcing Facilities
Docket No. FDA-2014-D-0329 - The Office of the Federal ...
www.ofr.gov/(S(4mu01etsd4epjrevv0iippia))/.../2014-20719_PI.pdf
27 mins ago - Review; Comment Request; Guidance for Industry on Fees for Human Drug Compounding. Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic ...Thursday, August 28, 2014
More information on Dan Milosvic
Overview of Dan Milosevic in Houston, TX
Dan Milosevic is the Office Manager of Pain & Health Management Center Inc and inactive roles in one additional company .
Dan Milosevic is connected to other officers through these corporate roles. One of the top connections is Charmaine Kray .
Dan's past corporate interests include the Manager of Texas Pain Consultants .
view chart here
Dan Milosevic is connected to other officers through these corporate roles. One of the top connections is Charmaine Kray .
Dan's past corporate interests include the Manager of Texas Pain Consultants .
view chart here
Records Similar to Dan Milosevic
 | Dan Milosevic | Administration at Applied Pain Associates, Pllc | |
| | Dan Milosevic Houston, Texas | Principal at Medical Billing and Consulting Services, Ltd | |
| | Dan Milosevic | Administration at Spine and Joint Pain Center |
Question of the Day August 28, 2014 Is the Dan Milosevic who is the President of Alternative Medicine and Pharmacy Inc. d/b/a/ OmniPlus Pharmacy and who verified the complaint against Express Scripts the same person who started Medical Billing and Consulting Services in Houston, Texas?
Dan Milosevic started Medical Billing and Consulting Services in Houston, TX, after working as a consultant in billing and practice management for a solo practitioner. Dan was so effective—he doubled his client’s monthly revenue—that his client began talking about him to other practitioners. That was when he decided to establish Medical Billing and Consulting Services. “I felt I could offer the same level of service and efficiency to other providers,” he states. That was in 2007and five years later, his company is growing stronger each year.
We specialize in pain management,” Dan declares. “Because of our experience in billing for this specialty, we are able to bring in 30 - 40 percent more revenue than other companies that handle multiple specialties.” Dan has four employees working on behalf of his four clients and they bill $1.2 million in charges per month with a net collection ratio around 95%. He plans to leverage his expertise in pain management billing for attracting new clients within the specialty of anesthesia.
“When I opened my company, the most important decision we had to make was picking the right medical billing software,” Dan notes. He knew what he wanted in a software solution and looked at numerous systems before selecting Kareo. “It met all our criteria then and it continues to meet our expectations,” he says. “It is an online system, so you can access it from anywhere in the world as long as you have an Internet connection. It’s very easy to set up, learn and run. It offers electronic eligibility, electronic claims submission to almost all payors, very advanced reporting capabilities and a scheduling system.” Dan says Kareo’s outstanding support sets it apart from other systems. “Many times, you can resolve any issues you may have using Kareo’s free online tools, like the support library with numerous solutions for different problems, and the FAQs. I have been on Kareo for five years and in all that time, I have never had to call their technical support team!”
Dan appreciates the fact that Kareo is very user friendly on many levels. “You can set new clients up on Kareo in just minutes. I’ve used a lot of other system and Kareo is by far the simplest to use. Our clients love Kareo and the fact that all they need is a computer and internet access. Basically, once they are set up on Kareo, they can start scheduling patients right away.” The outstanding support is as big a plus for clients as it is for Dan and his employees. “Kareo offers useful videos so if you have a problem, you just find the appropriate video and your problem is solved!” That is a real timesaver when clients have an issue they want to resolve right away, Dan says, since they have no qualms about using Kareo’s easy-to-access tools to find the answer they need.
Another useful feature, according to Dan, is electronic eligibility. He says it saves his staff time and increases their productivity. “With other systems, you need to visit multiple websites to check a patient’s insurance eligibility and verify their benefits,” he notes. “With Kareo you can do that with the click of a button, right from within the software! In five or ten seconds, you know all about a patient’s benefits. That saves at least five minutes and if you are working on billing for 20 patients, that means you’re saving over an hour and a half!”
Dan says Kareo’s scalability will easily allow him to double his client base, as he plans to do in 2012. “Kareo helped us to increase our productivity and profitability, while at the same time decreased our costs by more than 30 percent. Overall, I would say that selecting Kareo is one of our best business decisions.”
quoted from here
We specialize in pain management,” Dan declares. “Because of our experience in billing for this specialty, we are able to bring in 30 - 40 percent more revenue than other companies that handle multiple specialties.” Dan has four employees working on behalf of his four clients and they bill $1.2 million in charges per month with a net collection ratio around 95%. He plans to leverage his expertise in pain management billing for attracting new clients within the specialty of anesthesia.
“When I opened my company, the most important decision we had to make was picking the right medical billing software,” Dan notes. He knew what he wanted in a software solution and looked at numerous systems before selecting Kareo. “It met all our criteria then and it continues to meet our expectations,” he says. “It is an online system, so you can access it from anywhere in the world as long as you have an Internet connection. It’s very easy to set up, learn and run. It offers electronic eligibility, electronic claims submission to almost all payors, very advanced reporting capabilities and a scheduling system.” Dan says Kareo’s outstanding support sets it apart from other systems. “Many times, you can resolve any issues you may have using Kareo’s free online tools, like the support library with numerous solutions for different problems, and the FAQs. I have been on Kareo for five years and in all that time, I have never had to call their technical support team!”
Dan appreciates the fact that Kareo is very user friendly on many levels. “You can set new clients up on Kareo in just minutes. I’ve used a lot of other system and Kareo is by far the simplest to use. Our clients love Kareo and the fact that all they need is a computer and internet access. Basically, once they are set up on Kareo, they can start scheduling patients right away.” The outstanding support is as big a plus for clients as it is for Dan and his employees. “Kareo offers useful videos so if you have a problem, you just find the appropriate video and your problem is solved!” That is a real timesaver when clients have an issue they want to resolve right away, Dan says, since they have no qualms about using Kareo’s easy-to-access tools to find the answer they need.
Another useful feature, according to Dan, is electronic eligibility. He says it saves his staff time and increases their productivity. “With other systems, you need to visit multiple websites to check a patient’s insurance eligibility and verify their benefits,” he notes. “With Kareo you can do that with the click of a button, right from within the software! In five or ten seconds, you know all about a patient’s benefits. That saves at least five minutes and if you are working on billing for 20 patients, that means you’re saving over an hour and a half!”
Dan says Kareo’s scalability will easily allow him to double his client base, as he plans to do in 2012. “Kareo helped us to increase our productivity and profitability, while at the same time decreased our costs by more than 30 percent. Overall, I would say that selecting Kareo is one of our best business decisions.”
quoted from here
Original Source: Stability of compounded thioguanine oral suspensions.
Purpose Updated information on the stability of compounded thioguanine oral suspensions prepared with currently available ingredients, as well as results of testing to determine if the addition of an antioxidant could extend shelf life by inhibiting formation of guanine, are presented. Methods Using triturated thioguanine tablets, three compounded suspensions were prepared: (1) a reference formulation containing methylcellulose and simple syrup, (2) an equivalent formulation using Ora-Plus and Ora-Sweet, an...
continue to read hereInteresting and Important Comments from Readers Being Posted
"Breaking News: Concierge Compounding Pharmaceuticals Inc. v. Express Scripts Inc.: A Lawsuit seeking to Stop Express Script from Terminating a Compounding Pharmacy from its Network-hearing set for tomorrow August 29, 2014"
3 Comments - Show Original Post Collapse comments
Anonymous said...- Is this the pharmacy with registration hurdle in Idaho due to felony charge? See: http://bop.idaho.gov/board_meeting/2013-08-13and14_Minutes_Final_01-09-2014.pdf
- Anonymous said...
- Very very interesting case developing here. If chemical ingredients for mixing up largely experimental compounded drugs hold separate NDCs and are covered under tier II, separate co-pays should be required for each ingredient? Otherwise, pharmacies could compound multiple active ingredients in one dosage form for the sole purpose of avoiding co-pays, particularly if the AWPs for the ingredients are sufficiently inflated?
Hard to believe I just used the acronym AWP and chemical ingredient the same sentence--in the grand American tradition, this is compounding "super-sized."
- Anonymous said...
- The co-pay issue is in the self interest of the payer, i.e., controlling over utilization, but, there are other more troubling patient safety and supply chain security concerns related to paying for ingredients, versus finished pharmaceuticals.
Thinking in high-level marketing sound bites, it all sounds really good--the doctor orders a customized drug when a patient cannot use an FDA-approved product, partly the result of industry failing to invest in small market needs.
But if you scratch below the surface, there is a lot of missing information--does the doctor or insurer consider that the formulas haven't been evaluated for safety and efficacy? Even more troubling may be the chemical ingredients themselves--these white powders in jars, having traveled through global supply channels, may come with "certificates of analysis," that, at the high level marketing sound bite, sound really good too. But, displayed results may exclude criteria relevant to the dosage form made (residual solvents, microbial content), and for the criteria that are listed, the stated results may not be guaranteed by the seller. How does this white powder in a jar become a tier ii level Rx product?
You can't distill this level of necessary problem-solving, albeit for a sometimes necessary pharmacy practice, into a soundbite.
More Breaking News: Another Lawsuit OmniPlus Pharmacy from Texas suing Express Scripts--Here is the docket/Documents are available on Pacer
| Date Filed | # | Docket Text |
|---|---|---|
| 08/25/2014 | 1 | COMPLAINT against defendant All Defendants with receipt number 0865-4464876, in the amount of $400 Jury Demand,, filed by Alternative Medicine and Pharmacy, Inc. . (Attachments: # 1 , # 2 Exhibit B, # 3 , # 4 Exhibit D, # 5 Exhibit E, # 6 Civil Cover Sheet, # 7 Summons, # 8 Summons, # 9 Original Filing Form)(King, Douglas) (Entered: 08/25/2014) |
| 08/25/2014 | 2 | NOTICE OF PROCESS SERVER by Plaintiff Alternative Medicine and Pharmacy, Inc. Process Server: Amy R. Post (BAK) (Entered: 08/25/2014) |
| 08/25/2014 | 3 | DISCLOSURE OF CORPORATION INTERESTS CERTIFICATE by Plaintiff Alternative Medicine and Pharmacy, Inc.. Parent companies: None, Subsidiaries: None, Publicly held company: None,. (BAK) (Entered: 08/25/2014) |
| 08/25/2014 | 4 | MOTION for Temporary Restraining Order by Plaintiff Alternative Medicine and Pharmacy, Inc.. (King, Douglas) (Entered: 08/25/2014) |
| 08/25/2014 | 5 | MEMORANDUM in Support of Motion re 4 MOTION for Temporary Restraining Order filed by Plaintiff Alternative Medicine and Pharmacy, Inc.. (King, Douglas) (Entered: 08/25/2014) |
| 08/25/2014 | Case Opening Notification: 2 Summons(es) issued. The summons were emailed to attorney Douglas W. King. Judge Assigned: Charles A. Shaw. (BAK) (Entered: 08/25/2014) | |
| 08/25/2014 | 6 | MOTION to Expedite Discovery by Plaintiff Alternative Medicine and Pharmacy, Inc.. (Attachments: # 1 Exhibit First Interrogatories, # 2 Exhibit First Document Requests, # 3 Exhibit First Requests for Admissions)(King, Douglas) (Entered: 08/25/2014) |
| 08/25/2014 | ***REMARK - Judge Shaw was assigned to case before Motion for Temorary Restraining Order was filed. New judge will be assigned and new summons issued. (BAK) (Entered: 08/25/2014) | |
| 08/25/2014 | Case Opening Notification: 2 Summons(es) re-issued. The summons were emailed to attorney Douglas W. King. All corporate parties must file Disclosure of Corporate Interest form. The form can be found on the court website. Judge Assigned: . Attorney contacted by both Lori Miller-Young and Beth Kirkland regarding filing of memorandum stating when hearing for TRO is to be held. (BAK) (Entered: 08/25/2014) | |
| 08/26/2014 | 7 | ORDER: IT IS HEREBY ORDERED that the plaintiff's motions for a temporary restraining order [# 4 ] and to expedite discovery [# 6 ] are set for a hearing on Thursday, August 28, 2014 at 10:30 a.m. in Courtroom 14-South. (Motion Hearing set for 8/28/2014 10:30 AM in Courtroom 14S before District Judge Catherine D. Perry.) Signed by District Judge Catherine D. Perry on August 26, 2014. () (Entered: 08/26/2014) |
| 08/27/2014 | 8 | ENTRY of Appearance by Sarah C. Hellmann for Defendants Express Scripts, Inc., Medco , Inc.. (Hellmann, Sarah) (Entered: 08/27/2014) |
| 08/27/2014 | 9 | ENTRY of Appearance by Kyle P. Seelbach for Defendants Express Scripts, Inc., Medco Health Services, Inc.. (Seelbach, Kyle) (Entered: 08/27/2014) |
| 08/27/2014 | 10 | DISCLOSURE OF CORPORATION INTERESTS CERTIFICATE by Defendant Express Scripts, Inc... (Seelbach, Kyle) (Entered: 08/27/2014) |
| 08/27/2014 | 11 | DISCLOSURE OF CORPORATION INTERESTS CERTIFICATE by Defendant Medco Health Services, Inc... (Seelbach, Kyle) (Entered: 08/27/2014) |
| 08/27/2014 | 12 | MOTION to Continue Hearing on Plaintiff's Motion for Temporary Restraining Order and Expedited Discovery by Defendants Express Scripts, Inc., Medco Health Services, Inc.. (Seelbach, Kyle) (Entered: 08/27/2014) |
| 08/27/2014 | 13 | RESPONSE in Opposition re 12 MOTION to Continue Hearing on Plaintiff's Motion for Temporary Restraining Order and Expedited Discovery filed by Plaintiff Alternative Medicine and Pharmacy, Inc.. (King, Douglas) (Entered: 08/27/2014) |
| 08/27/2014 | 14 | Docket Text ORDER: Re: 12 MOTION to Continue Hearing ; ORDERED DENIED, hearing will go forward as previously scheduled unless parties jointly notify the court that they have agreed to a different schedule. Signed by District Judge Catherine D. Perry on 8/27/14. (CDP) (Entered: 08/27/2014) |
| 08/27/2014 | ***REMARK: Exhibits A, B, and C were placed under seal by the clerk at the request of plaintiff's counsel. Plaintiff's counsel advised the defendants have already been served with the documents. () (Entered: 08/28/2014) | |
| 08/28/2014 | 15 | Minute Entry for proceedings held before District Judge Catherine D. Perry: Motion Hearing held on 8/28/2014 re 4 MOTION for Temporary Restraining Order filed by Alternative Medicine and Pharmacy, Inc.. Counsel inform the Court that they have reached an agreement. The Court and counsel discussed deadlines regarding Preliminary Injunction. Order to follow. (Court Reporter:G. Madden.) (FTR : No.) (MCB) (Entered: 08/28/2014) |
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