Friday, June 27, 2014

Absolute Must Read as I have Suggested Before--Cafepharma-- a lot of the legal and practice issues are discussed--for example here is discussion regarding how much 1099 sales reps get paid and a disagreement as to whether 1099 commissions violate the law

1099 Compounding Commissions?


What is the norm commission rate for these companies? I will be 1099 and this will be an addition to my 1099 medical device position. Pharmacy looks to be very reputable. They have a realtime RX tracking software that shows all reimbursements. Lots of transparency and shows the billing pathways for pt. tracking.

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  #2  
Old 05-28-2013, 07:17 PM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Commission ranges from 15%-20% with some companies offering money for entertaining and travel. The money can be quite lucrative with refills etc...do your research on the pharmacy. There are plenty of pharmacies but only a handful are doing it right. Who is the pharmacy you are considering?
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  #3  
Old 05-30-2013, 12:49 AM
Anonymous
 
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Default Re: 1099 Compounding Commissions?

Im not the OP but had a similar question. I am looking at Focused Pain Solutions out of NY. Their comission seems to be quite a bit higher - $90 for any script over $225
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  #4  
Old 05-30-2013, 08:27 AM
Anonymous
 
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Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
Im not the OP but had a similar question. I am looking at Focused Pain Solutions out of NY. Their comission seems to be quite a bit higher - $90 for any script over $225
OP here, pretty sure 20% is higher than $90. I don't want to give name just yet, but they are in the Carolinas and seem to be very legit.
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  #5  
Old 05-30-2013, 08:58 AM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

$90 per script isn't bad if the creams were billing out at $225 but they typically bill between $500 and $2500 per script. I believe the $90 is a flat commission. Do the math and you can do considerably higher.
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  #6  
Old 05-30-2013, 11:47 PM
Anonymous
 
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Exclamation Re: 1099 Compounding Commissions?

Dude this is fad not long term. Insurances are figuring out overpriced pain creams are a rip off. I give it a year!
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  #7  
Old 05-31-2013, 06:09 AM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
Dude this is fad not long term. Insurances are figuring out overpriced pain creams are a rip off. I give it a year!
Okay by me, I love something easy in my bag that is highly profitable. Make hay.
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  #8  
Old 06-01-2013, 05:15 PM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
Dude this is fad not long term. Insurances are figuring out overpriced pain creams are a rip off. I give it a year!
You sound like the guy that said cars were just a fad and that people would get tired of them breaking down and running out of fuel and would come back to horses.

The creams are cheap compared to the pain pills that physically and mentally impair the patients in addition to getting them addicted. The opioids cause such common problems as low testosterone and constipation just to name a few. How many people die every day from drug overdose that got their start from legal pain pills. What's the cost in human lives? What's the cost for all the accidents caused by people who are driving impaired that end up crippled all their lives or in the hospital for months or even just a few weeks? Have the reimbursement rates dropped for the opioid medications except when a generic has come out? No? Then why would the insurance companies want to discourage physicians from prescribing the pain creams that in the long run are much cheaper to the bottom line?
The pain creams have been going on for years and years so why now? No answer? No, I didn't think so.
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  #9  
Old 06-01-2013, 05:30 PM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
Im not the OP but had a similar question. I am looking at Focused Pain Solutions out of NY. Their comission seems to be quite a bit higher - $90 for any script over $225
You can take that $90 offer if you want or earn 20% to 24% from Supreme Medical Solutions. Since most scripts go for $1,000 or more We represent a PCAB accredited pharmacy that is licensed in all 50 states, has a pharmacist available 24/7 and unlike all the competition we offer you some additional product lines that are a perfect fit and compliment each other and they also pay you a residual income. There are only about 132 PCAB accredited pharmacies in the US out of about 7,000 compounding pharmacies and a ton of those are only licensed in their own state or don't take insurance or don't sell pain creams.
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  #10  
Old 06-05-2013, 12:31 PM
Anonymous
 
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Default Re: 1099 Compounding Commissions?

I have some snake oil that cures all ailments too and will only charge you 2k
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  #11  
Old 06-06-2013, 07:52 AM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
I have some snake oil that cures all ailments too and will only charge you 2k
OP here, I don't care if it is snake oil or not. Have you ever tried a compounded cream? I have several years ago and it worked well for my shoulder pain. I'm not asking providers who don't already write these scripts. I am just having my providers write them with me.
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  #12  
Old 06-06-2013, 02:27 PM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
I have some snake oil that cures all ailments too and will only charge you 2k
Tell us how you would defend big pharma when they came out with Voltaren Gel when all it is really consists of is a NSAID in a transdermal cream and yet they charged big bucks. They took a generic product and put it in a transdermal cream and yet they have charged the medical field a ton of money. At least the compounding pharmacies put additional ingredients in their medication to further reduce pain. There is a ton more to producing a transdermal medication with 5-6 active ingredients than mass producing a ton of Voltaren Gel that the Novartis & Endo reps are selling. If your loved one was suffering in pain which of these two products would you want to help make the pain go away?
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  #13  
Old 07-02-2013, 12:44 AM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
You can take that $90 offer if you want or earn 20% to 24% from Supreme Medical Solutions. Since most scripts go for $1,000 or more We represent a PCAB accredited pharmacy that is licensed in all 50 states, has a pharmacist available 24/7 and unlike all the competition we offer you some additional product lines that are a perfect fit and compliment each other and they also pay you a residual income. There are only about 132 PCAB accredited pharmacies in the US out of about 7,000 compounding pharmacies and a ton of those are only licensed in their own state or don't take insurance or don't sell pain creams.



Uh.... Didn't Supreme Medical Just run into issues with waiving of copays and sever ties to the compounding pharmacy they represented?
It won't be long until insurance companies figure out they are being billed huge sums of money for these creams and the compounding companies are pocketing a ton of money. Let's be real, how long until insurance companies put amstopmto this high priced practice?
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  #14  
Old 07-17-2013, 09:22 PM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
Uh.... Didn't Supreme Medical Just run into issues with waiving of copays and sever ties to the compounding pharmacy they represented?
It won't be long until insurance companies figure out they are being billed huge sums of money for these creams and the compounding companies are pocketing a ton of money. Let's be real, how long until insurance companies put amstopmto this high priced practice?
They will just pay less. The payments are based on known generic quantities and concentrations. The higher the concentration and volume, the higher the price. Many insurance companies such as BCBS still reimburse, but instead of 120g and more at a time, they will only approve 30g or a weeks supply. There is nothing magical about the compounds or underhanded about the pharmacies (if they are billing appropriately). Happy hunting.
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  #15  
Old 11-14-2013, 12:51 PM
Anonymous
 
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Default Re: 1099 Compounding Commissions?

Just to set the story straight, Florida Board of Pharmacy requires or recommends strongly that all sales people are employees because of pharmacy compliance issues. Most legit companies are contracting their employee sales team. Commissions ranges are factored as salary not a per transaction basis. Figure up to 20-25%
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  #16  
Old 03-21-2014, 11:41 PM
Anonymous
 
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Default Re: 1099 Compounding Commissions?

Medimix only paying 15%. Suxs
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  #17  
Old 03-24-2014, 06:26 PM
Anonymous
 
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Default Re: 1099 Compounding Commissions?

I pay 25% for all pain, scar, wound care, and sinus formulations. Awesome pharmacy, ships nationally in 48 hours. I'm looking for seriously motivated reps.
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  #18  
Old 03-24-2014, 10:58 PM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
I pay 25% for all pain, scar, wound care, and sinus formulations. Awesome pharmacy, ships nationally in 48 hours. I'm looking for seriously motivated reps.
I'm sure you won't tell the name of the company, but what state are you in?
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  #19  
Old 03-26-2014, 08:34 AM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
Medimix only paying 15%. Suxs
Yes, but MediMix is here to stay. Many have gotten tempted with smaller pharmacies but want to come back. At least there is transparency and great customer service.
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  #20  
Old 04-16-2014, 02:45 PM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
I'm sure you won't tell the name of the company, but what state are you in?
In Texas with 3 pharmacies.
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  #21  
Old 04-28-2014, 01:41 PM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Any well paying and reputable companies in NJ?
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  #22  
Old 04-29-2014, 09:27 AM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
I pay 25% for all pain, scar, wound care, and sinus formulations. Awesome pharmacy, ships nationally in 48 hours. I'm looking for seriously motivated reps.
How do I get in touch with you????
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  #23  
Old 05-02-2014, 12:49 AM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Commissions aren't everything, but 15-20% is pretty standard. Service, efficacy, quality, are all very important for sustained business. These docs don't want to get patient complaints about anything. Sometimes the companies try to lure away reps with higher %, but you'll make less when you lose credibility with the product. Find a leader, a good % and quality product, and you'll make money. Some companies like to bonus reps over and above their performance when deserved. Lots of ways to incentivize sales performance.
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  #24  
Old 05-02-2014, 07:31 AM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
Commissions aren't everything, but 15-20% is pretty standard. Service, efficacy, quality, are all very important for sustained business. These docs don't want to get patient complaints about anything. Sometimes the companies try to lure away reps with higher %, but you'll make less when you lose credibility with the product. Find a leader, a good % and quality product, and you'll make money. Some companies like to bonus reps over and above their performance when deserved. Lots of ways to incentivize sales performance.
Agree with this comment 100%..spot on. Look for good pharmacy and good support with sales transparency. The fly by night start up pharmacies trying to throw out high commissions to lure reps away would be a very bad move. Do your homework, ask to speak to several reps.
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  #25  
Old 05-02-2014, 11:42 AM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
Commissions aren't everything, but 15-20% is pretty standard. Service, efficacy, quality, are all very important for sustained business. These docs don't want to get patient complaints about anything. Sometimes the companies try to lure away reps with higher %, but you'll make less when you lose credibility with the product. Find a leader, a good % and quality product, and you'll make money. Some companies like to bonus reps over and above their performance when deserved. Lots of ways to incentivize sales performance.
Right on. Stay away from the small pharmacies who will most likely be out of the compound biz, soon. Make sure you have a good lead manager who provides accurate information and a pharmacy who has a data system portal. Also look for those who have credentials and are licensed in most states.

All you need are a few prescribers who believe in the product and who prescribe often. This has been a great opportunity for many in adding great, additional income.
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  #26  
Old 05-19-2014, 02:47 PM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

any pharmacy or rep working on a 1099 commission only basis is violating federal and state anti-kickback laws. If your doing get ready for a major legal issue. large fines and possible jail
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  #27  
Old 05-19-2014, 07:43 PM
Anonymous
 
Posts: n/a
Default Re: 1099 Compounding Commissions?

Quote:
Originally Posted by Anonymous View Post
any pharmacy or rep working on a 1099 commission only basis is violating federal and state anti-kickback laws. If your doing get ready for a major legal issue. large fines and possible jail
So all distributors who sell Ortho products as 1099 are violating anti-kickback laws as well according to your logic. The law you are referring to that you think compounders are violating would apply to every medical rep selling 1099. You are wrong.
 

Second of the Day June 27, 2014 Is it legal for pharmacies or pharmacists to belong to a group that obtains huge savings from compounding suppliers in return for all the member compounders purchasing from those suppliers?

 

Kudos to Dr Loyd Allen Again for his Editorial in Compounding this Week: Editorial: What is Compounding Pharmacy, Part VII: Education and Training of a Compounding Pharmacist

read here

Upcoming Veterinary Conferences

6/29/2014 - 7/2/2014 MVMA Summer Conference
6/29/2014 - 7/1/2014 Montana VMA
7/10/2014 - 7/13/2014 NCVMA Summer Conference
7/10/2014 - 7/12/2014 UVMA (Utah)
7/17/2014 - 7/20/2014 Mississippi VMA

List of 2014 FDA Inspection Report Documents Released to Public Continues to Grow--Frank's Lab dba Trinity Care Solutions is back on the list!!

2014 Te Velde Holsteins, LLC 6/17/14

2014 Te Velde Holsteins, LLC 6/17/14

2014 Bee-Line Farm 6/16/14

2014 Bee-Line Farm 6/16/14

2014 Terry Pominville 6/16/14

2014 Terry Pominville 6/16/14

2014 Edwin Brasil Dairy 6/12/14

2014 Edwin Brasil Dairy 6/12/14

2014 Nutrishop 6/5/14

2014 Nutrishop 6/5/14

2014 Rod McNeal Dairy 6/5/14

2014 Rod McNeal Dairy 6/5/14

Drug Safety Podcasts FDA Drug Safety Podcast: FDA adding general warning to testosterone products about potential for venous blood clots

Drug Safety Podcasts FDA Drug Safety Podcast: FDA adding general warning to testosterone products about potential for venous blood clots

About the Center for Drug Evaluation and Research Drug Safety Oversight Board Meeting, May 15, 2014

About the Center for Drug Evaluation and Research Drug Safety Oversight Board Meeting, May 15, 2014

Thursday, June 26, 2014

Question of the Day June 27, 2014 How much does illegal compounding drive up the cost of manufactured drugs?


Report: Specialty drug costs will skyrocket in next two years

Report: Specialty drug costs will skyrocket in next two years

More comments from Texas Board of Pharmacy 2003-04 task force on compounding and disagreement over rules

Read here

Texas Board of Pharmacy 2003 Minutes discussing task force on compounding very telling--the task force also recognized that the repeated incidents of improperly prepared and contaminated sterile preparations that have injured and killed patients in other states have pointed to a potential problem that could happen in Texas. PCCA award winning compounder opposed 5 percent rule


Task Force on Compounding

President Anderson introduced Larry Trissel, R.Ph., Chair of the Task Force on Pharmacy Compounding. President Anderson explained that Mr. Trissel would present the task force report, and the Board would vote on whether to accept the report, but no action would be taken until a later date.
Mr. Trissel directed the Board's attention to the final report of the task force, which included a list of the task force members. (See Attachment #33.) Mr. Trissel recognized task force members Ben Fry, R.Ph., and Pat Downing, R.Ph., who were also present. Mr. Trissel reported that the task force held two meetings, on September 5, 2002, and January 17, 2003. The task force was charged with:
reviewing current federal and state requirements for pharmacy compounding;
reviewing current standards of practice for pharmacy compounding; and
making recommendations to the Board regarding standards for pharmacy compounding in Texas that provide necessary compounded medications while protecting the health, safety, and welfare of the public.
Mr. Trissel directed the Board's attention to the written task force report (See Attachment #33). He then made a brief presentation to the Board that included the following comments:
The task force recognized . . . there could be no doubt that the need for compounding of patient-specific preparations is essential to the proper conduct of modern therapies.
. . . the task force also recognized and agreed that the current Texas pharmacy rules regarding pharmacy compounding have already included some important and necessary safeguards that may not be in place in some other states.
. . . the task force also recognized that the repeated incidents of improperly prepared and contaminated sterile preparations that have injured and killed patients in other states have pointed to a potential problem that could happen in Texas.
Although the task force believed additional quality assurance functions are necessary, there also was recognition that the United States Pharmacopeia (USP), the official drug standards setting body for the United States, is in the process of issuing a comprehensive delineation of the necessary requirements for sterile compounding. . . . specifically designated to set appropriate and necessary quality assurance standards for pharmacy compounding that can be enforced by the state boards of pharmacy.
It was the consensus of the task force that the best approach the Texas State Board of Pharmacy could take for the citizens of Texas is to adopt these USP requirements and enforce them for all categories of pharmacies located in Texas and for Class E pharmacies that send compounded preparations into Texas.
The task force also reached consensus on the need to enhance pharmacists' training and education with regard to compounding and pharmaceutical calculations. To this end, additional continuing education requirements specific to compounding have been recommended. In addition, the task force has suggested that the Texas State Board of Pharmacy formally recommend to appropriate educational associations and institutions that education and training in compounding and pharmaceutical calculations receive greater emphasis (or be reintroduced in some cases) in pharmacy school curriculums providing strengthened and more thorough understanding of the complexities involved.
. . . the task force agreed that the principal distinction of compounded preparations compared to manufactured drug products is the patient-pharmacist-physician relationship that exists in compounding that does not exist in manufacturing. . . . The task force agreed unanimously that any preparation compounded by a pharmacist for a specific patient in response to a valid prescription or medication order was clearly compounding and not manufacturing. . . . there was less agreement on what proportion of a compounding pharmacy's business needs to be patient-specific to qualify as a pharmacy and not be a manufacturer. . . . A suggestion was made by Mr. Peacock to equate obtaining and recording the identities of patients who received pharmacy-compounded preparations administered by practitioners in their practices after the actual administration with conventional patient-specific prescriptions and medication orders for purposes of this determination . . . the majority of the task force members (but not all) agreed to recommend to the Board that a maximum of 5% of all prescription medications dispensed in the previous 12 months be permitted to be non-patient-specific compounded dosage units for an establishment to be considered a pharmacy and not a manufacturer, if the patients' identities could be obtained after the fact of drug administration.

(See Attachment #33 for the complete text of Mr. Trissel's comments.)

President Anderson recognized Karen Tannert, R.Ph., a member of the task force, who was also in the audience.
The Board discussed the recommendations of the task force. Mr. Trissel answered questions posed by the Board. Mr. Downing advised the Board that he did not agree with the 5% restriction. The Board felt that Mr. Peacock's suggestion to obtain patient-specific information was innovative. Ms. Dodson pointed out that any rules the Board passes will have to match federal regulations.
Ms. Tannert advised the Board that the 5% recommendation fell within the limits established by the Food, Drug, and Cosmetic Act.
Following additional discussion, the motion was made by Mr. Caldwell to thank the task force for their efforts and accept the report, as presented. The motion was seconded by Mr. Brimberry and passed unanimously.
The Board directed staff to:
draft rules, based on the recommendations of the task force;
submit the draft of the rules to the task force for review and comments; and
present the suggested rules to the Board at the May 2003 Board Meeting.
Mr. Brimberry advised the Board that he had copies of materials from an NABP meeting in Chicago that compare USP guidelines and FDA rules concerning compounding, if anyone would like to have a copy. Ms. Dodson advised the Board that currently TSBP's rules concerning compounding are more stringent than NABP's recommendations.

Third Question of Day June 26, 2014 If traditional Compounders are only compounding patient specific compounds and following all the rules such as no commercially available that works and outsourcing facilities compounded larger quantities then how much money would traditional compounders make? Is this why traditional Compounders fight so hard to be able to compound for office use? Greed and money? The needs will be met by outsources who are regulated by the FDA so Compounders cannot argue consumers will have to do without the drugs.


Huge list of veterinary and compounded drugs--Enforcement Report - Week of June 25, 2014

Enforcement Report - Week of June 25, 2014

FDA Warns GSK plant

Flulaval is the company’s older flu drug, which has been to some extent superceded by Relenza – but FDA inspectors noted “deviations from current good manufacturing practice (CGMP) requirements” in its production at GSK’s plant in Quebec. 
Continue to read here

Numbing medications can harm teething babies, FDA warns Published: June 26, 2014 6:24 PM

Read here

Stability of hydroxyprogesterone caproate alone and in a compounded pharmaceutical product Yang Zhao⇑, Joseph Bettinger, Steve Caritis and Raman Venkataramanan

340B contract pharmacy arrangements

340B contract pharmacy arrangements

Pharmacy Service Company Settles Whistleblower Suits

Pharmacy Service Company Settles Whistleblower Suits

Omnicare agreed to pay $124 million to settle two whistle-blower lawsuits that claimed the company engaged in a kickback scheme with skilled-nursing facilities across the country.
Continue to read here

Drugs in racing: BHA plans zero tolerance policy on steroid use

The British Horseracing Authority (BHA) has announced a new zero tolerance approach to the use of steroids in the sport.
Under the new rules, horses cannot be injected with steroids at any time.
Lengthier bans have also been introduced for horses breaking the rules, from six to 14 months.
Continue to read here

Accused killer wants jury to hear execution details

An accused killer, battling the possibility of death by lethal injection, believes the jury asked to condemn her should be told exactly how she will die; and that the drugs injected into her veins might cause her to writhe and gasp like two men executed earlier this year.

Continue to read here

Buyers Should Be Wary of Sites Claiming to be Legitimate Internet Pharmacies from Other Countries, Consumer Reports Advises

Buying medications online from other countries is dangerous since many websites claiming to be an Internet pharmacy from a particular country are not located in that country and are in fact operating illegally, as reflected in an article from Consumer Reports. “Most Internet pharmacies claiming to be Canadian are not,” Carmen A. Catizone, MS, RPh, DPh, executive director/secretary of NABP toldConsumer Reports. “Frequently, they are fake storefronts selling cheap generics from third world countries.” The article also indicates that even drugs that do come into the US from Canada fall into a “regulatory no-man’s land” that may leave consumers with little recourse if there is a problem with a medication. Instead of purchasing medication through potentially illegal online drug sellers, Consumer Reports suggests patients ask their health care providers about ways to receive discounts on both generic and brand-name medications.

Continue to read here

Stephen Dank suspected of forgery by pharmacist, doctor in Essendon supplements scandal 7.30 By Louise Milligan

Stephen Dank, the sports scientist at the centre of the Essendon supplements saga, has been suspected of forgery by both a pharmacist and a doctor who worked closely with him.
Continue to read here

21 Oklahoma death row inmates sue state over execution protocol Nearly two dozen inmates are suing the state Corrections Department and several of its employees, asking the court to allow them a say in whether or not they can be lethally injected with the same mixture of drugs used in a botched execution in April.

Nearly two dozen inmates are suing the state Corrections Department and several of its employees, asking the court to allow them a say in whether or not they can be lethally injected with the same mixture of drugs used in a botched execution in April.

Continue to read here

Oklahoma death row inmates sue to halt execution

Two months after a botched execution in Oklahoma, 21 death row inmates in the southern US state filed suit against prison authorities on procedures to put convicts to death.

Continue to read here

The standardization of nonsterile compounding: a study in quality control and assessment for hormone compounding.

The standardization of nonsterile compounding: a study in quality control and assessment for hormone compounding.
Int J Pharm Compd. 2014 Mar-Apr;18(2):162-8
Authors: Wiley TS, Odegard RD, Raden J, Haraldsen JT
Abstract
Sterile and nonsterile compounding of medication has attracted much attention over the last few years due to the onset of various infections and negative compounding practices. This paper reports on the standardization of compounded hormones utilizing the Wiley Protocol, which provides nonsynthetic bioidentical estradiol, progesterone, dehydroepiandrosterone, and testosterone in a transdermal topical cream base for women and men in a standardized dosing regimen. Here, we present data from 2008 through 2012, which details the process of standardization and quality testing of the hormones through submission of random compounded samples for quality control and assessment. Pharmacies delivering the Wiley Protocol were required to follow the same compounding formulation, as well as submit random samples for quarterly testing. Sample concentrations were tested using high-performance liquid chromatography. We found that pharmacies that submitted samples had a 91% passing rating with a percent of target of 98.6% +/- 8.4%. It was also determined that pharmacies that prepared more compounded cream had a higher passing rating than those that prepared limited quantities. We found that standardization across multiple pharmacies could be achieved through quarterly testing of submitted samples by a third-party laboratory when following necessary procedures as defined by the Wiley Protocol. It was also determined that experience and training were a critical factor in the mixing of compounded prescriptions, with high consistency and accuracy providing patient safety.




PMID: 24881121 [PubMed - indexed for MEDLINE]


More...

Second Question of Day June 26, 2014. Is Congress going to support the task it gave the FDA to do and provide it with the necessary funding to try to get the runaway, out-of-control compounding pharmacies and pharmacists who care nothing about safety and only about money and who continue to invoke fear in the public claiming they will not have access to the drugs they "want?"


Kentucky oncology practice and its manager plead guilty to purchasing and selling unapproved chemotherapy drugs

Hematology and Oncology Center (HOC) PLLC of Somerset, Kentucky has pleaded guilty to federal charges that the firm purchased and sold unapproved and improperly labeled chemotherapy drugs. HOC’s former office manager, Natarajan Murugesan, also pleaded guilty to assisting with these activities, which are violations of the Federal Food, Drug, and Cosmetic Act. The charges were brought by the U.S. Attorney’s Office for the Eastern District of Kentucky.
Agents from the FDA’s Office of Criminal Investigations led this investigation with assistance from the U.S. Department of Health and Human Services’ Office of Inspector General.
“The FDA commends the U.S. Attorney’s Office, Eastern District of Kentucky, for pursuing these allegations and for helping protect U.S. consumers from potentially receiving counterfeit, ineffective, or contaminated medicines,” said Philip Walsky, acting director of the FDA’s Office of Criminal Investigations. “The FDA is committed to ensuring that consumers have access to high-quality drugs that are safe and effective."
The criminal charges relate to a civil settlement agreed to in January 2014 by HOC, Murugesan, and N Mullai, M.D.  Dr. Mullai was not charged criminally. Under the earlier civil settlement, HOC, Murugesan, and Mullai agreed to pay $2,000,000, plus interest, to resolve charges that they violated the False Claims Act. These charges included submitting false claims to the Medicare program for misbranded, unapproved chemotherapy drugs administered through HOC’s Somerset, Kentucky, clinic.
HOC obtained substantial amounts of chemotherapy drugs and other cancer treatment drugs from a foreign drug distributor in Canada operating under the name Quality Specialty Products (QSP). These drugs were obtained from Turkey, India, the European Union, and other international locations. 
Often, the drugs arrived at HOC with labels and dosage instructions in foreign languages. In 2012, the FDA sent letters to medical practices, including HOC alerting them that the cancer medicines they purchased from QSP were unapproved and potentially counterfeit.
Quoted from here

Finding the Cause of Thrombosis in Some Immunoglobulin Treatments

Finding the Cause of Thrombosis in Some Immunoglobulin Treatments

More incidents of bad compounding in the past

Pseudomonas Bloodstream Infections Associated with a Heparin/Saline Flush --- Missouri, New York, Texas, and Michigan, 2004--2005

Weekly

March 25, 2005 / 54(11);269-272
On January 26, 2005, CDC was notified of four cases of Pseudomonas fluorescens bloodstream infection among patients at an oncology clinic in Missouri. All patients had received a heparin/saline flush to prevent clotting of indwelling, central venous catheters. The flushes were preloaded in syringes by IV Flush and distributed by Pinnacle Medical Supply (Rowlett, Texas). On January 31, a nationwide alert against use of all heparin or saline flushes preloaded in syringes by IV Flush was issued by the Food and Drug Administration; the company recalled these products. As of February 15, state and local health departments and CDC had identified a total of 36 Psuedomonas species infections in patients in four states who were administered the heparin/saline flushes from multiple lots. This report describes the ongoing investigation and provides recommendations for investigation and management of potential cases.
Continue to read here