Wednesday, April 16, 2014

Brief of Amicus Curiae Alliance of Independent Pharmacists – Texas, International Academy of Independent Pharmacists, Unique Pharmaceuticals, Inc. and Professional Compounding Centers of America filed in

No. 13-1014
In the
On Petition for Review from the Second Court of Appeals, Fort Worth, Texas

4 02/12/2014 ...many patients whose health care needs cannot be met by manufactured medications. Unique Pharmaceuticals, Inc., (UPI) is an industry-leading, FDA-registered compounding pharmacy outsourcing facility providing safe, trusted, high-quality, sterile compounded preparations. UPI provides preparations to hospitals, clinics, surgery centers and physician offices ...Other 13-1014

Attix Pharmaceutical USA, LLC has been sued before and settled case for Telephone Consumer Protection Act Violations of sending unsolicated faxes--See Complaint and Exhibit

For The First Time Ever Caught on Camera: Horse Racing Exposed – Drugs, Deception and Death

Testing, Testing: How Strong Are Racing’s Drug Testing Programs? | Paulick Report – Thoroughbred Horse Racing News

Testing, Testing: How Strong Are Racing’s Drug Testing Programs? | Paulick Report – Thoroughbred Horse Racing News

West Virginia to Tackle Latest Round of Model Drug Rules

West Virginia to Tackle Latest Round of Model Drug Rules

AVMA plans to develop a proposal for federal legislation for compounding legislation

 Task force to develop proposal for compounding legislation

​Posted April 16, 2014
Posted April 16, 2014
A new AVMA task force will develop a proposal for federal legislation to address issues related to veterinary compounding, pursuant to the Association’s policies on compounding. The AVMA Executive Board approved the task force during a Feb. 21 conference call.
Issues related to veterinary compounding the task force will likely address include the legality of compounding from bulk substances, anticipatory compounding, maintaining office stocks of compounded products, and dispensing compounded products from office stocks.
In June 2013, the board updated AVMA policy regarding compounding to help the Association advocate for inclusion of veterinary compounding in federal legislation then under consideration. In late 2013, however, Congress passed and the president signed the Drug Quality and Security Act without provisions addressing veterinary compounding.
Nevertheless, the Food and Drug Administration is seeking to refine the agency’s approach to veterinary compounding. The Association submitted comments to the FDA encouraging the agency to refer to AVMA policies as the agency moves forward. In 2014, the FDA plans to revise the existing compliance policy guide on “Compounding of Drugs for Use in Animals,” last updated in 2003.
On the legislative front, Rep. Lee Terry of Nebraska spoke during a November 2013 congressional hearing about his desire for legislation to address veterinary compounding issues. In January, Congress asked that the Government Accountability Office prepare a report on the compounding of drugs for use in animals.
The AVMA Legislative Advisory Committee recommended formation of the AVMA task force to lead a dialogue among veterinarians, pharmacists, drug manufacturers, and the FDA about how to address veterinary compounding in federal legislation and regulations. The International Academy of Compounding Pharmacists also has requested a formal discussion with the Association on the subject.
The Task Force on Veterinary Compounding Legislation is a team of seven AVMA members knowledgeable in the compounding needs of practitioners along with invited participants from other organizations.
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Recently Updated Advisory Committee Materials-FDA provides contact information for Compounding Advisory Committee

Recently Updated Advisory Committee Materials

Pharmacy Compounding Advisory Committee Pharmacy Compounding Advisory Committee Roster

Pharmacy Compounding Advisory Committee Pharmacy Compounding Advisory Committee Roster

Question of the Day April 16,, 2014 What is or will be the FDA's position regarding providing samples of compounding preparations under the DQSA? Does it matter if the samples are being provided under 503A or 503b? Are samples allowed if a compounding pharmacy is an outsourcing facility? How can samples be provided if compounded preparations are suppose to be patient specific under 503A? Should compounding pharmacies receive warning letters from the FDA if they hand out samples or should states regulate this area?

Another job opending: Compounding Pharmacy Marketing Rep (Northern California) --Commissions range from $300 to $1200 per Script and all of its refills (20%); Has over 5,000+ doctors writing and have treated 100,000+ patients; We have in-office samples for Physicians, FREE

Compounding Pharmacy Marketing Rep (Northern California)
Compounding Pharmacy
Why would you want to become a Compounding Sales Representative with our client?
Commissions range from $300 to $1200 per Script and all of its refills (20%).
Real time tracking of prescriptions being written and commissions paid. You know what you are getting paid before you receive your pay.
Currently there are reps obtaining 100, 150, 200+ prescriptions a month (please do the math).
You receive an efax each time a prescription is written by one of your doctors.
You receive detailed financial reports each week.
You do not have to wait for insurances companies to pay us before we pay you. For example if you get a script written, filled and billed on September 30th you will receive your commission for that script Oct 15th.
NO surprises, completely transparent!
Every patient receives their medication, even if not approved. Should a patient's script be declined, we send them a 40 gram emergency supply, overnight, and free!!!
We have in-office samples for Physicians, FREE.
Although, these positions are 100% commissions (1099), we supply you with all your marketing materials, business cards, script pads, access to Rep Portal and more at no cost to you.
All medications are shipped FedEX Overnight to each patient at not cost.

Our Client is a group of Compounding Pharmacies that specializes in customizing medications to meet the needs and preferences of each individual patient. They can work with physicians, veterinarians, or other health practitioners to come up with medication that is right for each and every patient. They are dedicated to caring for all patients as individuals.
Considering that a patient's health care must be as unique as the individual him/herself, the best medical solutions often arise from compounding.

Our Client has and is:
Combined compounding experience over 40 years
Licensed in every state
Dedicated to caring for patients as individuals
Specializes in the formulation of drugs that are not commercially available
Pharmacists use state-of-the-art technology with approved ingredients so the finished medication meets the doctor's exact specifications
Has over 5,000+ doctors writing and have treated 100,000+ patients
Has worked with every major insurance company
Has worked with Medicare and Medicaid

What is Compounding?
Compounding combines an ageless art with the latest medical knowledge and state-of-the-art technology, allowing specially trained professionals to prepare customized medications to meet each patient's specific needs. Compounding is fundamental to the profession of pharmacy and was a standard means of providing prescription medications before drugs began to be produced in mass quantities by pharmaceutical manufacturers. The demand for professional compounding has increased as healthcare professionals and patients realize that the limited number of strengths and dosage forms that are commercially available do not meet the needs of many patients, and that these patients often have a better response to a customized dosage form that is "just what the doctor ordered".
Our compounding professionals can prepare
unique dosage forms containing the best dose of medication for each individual.
medications in dosage forms that are not commercially available, such as transdermal gels, troches, "chewies", and lollipops.
medications free of problem-causing excipients such as dyes, sugar, lactose, or alcohol.
combinations of various compatible medications into a single dosage form for easier administration and improved compliance.
medications that are not commercially available.
Quality Compounding Maximizes Therapeutic Outcomes
The efficacy of any formulation is directly related to its preparation, which is why THE SELECTION OF YOUR COMPOUNDING PHARMACY IS CRITICAL. Ongoing training for compounding pharmacists and technicians, state-of-the-art equipment, and high quality chemicals are essential. Experience and ingenuity are important factors as well. When tweaking a formula or developing a unique preparation, the compounding pharmacist must consider physical and chemical properties of both the active ingredient and excipients, solubility, tonicity, viscosity, and the most appropriate dosage form or device for administering the needed medication. Standard Operating Procedures should be in place, stability studies should be considered when compounding, and appropriate potency and sterility testing should be performed.
Our compounding professionals can formulate suitable medications as sublingual drops, oral and nasal sprays, lollipops, rectal solutions and suppositories, and other customized dosage forms. Please contact us to discuss your patients' needs.
  • Principals only. Recruiters, please don't contact this job poster.
  • do NOT contact us with unsolicited services or offers
  • quoted from here