Wednesday, October 30, 2013

[C’s Discount Pharmacy, Inc. et al. v. Louisiana CVS Pharmacy, LLC, No. 13-2989 Section “C”(3), E.D. La., 2013 U.S. Dist. LEXIS 140939]--

Here are the facts:  Plaintiffs in Louisiana sold two pharmacies to CVS. Part of the  agreement purchase and sales agreement included a non-competition clause prohibiting sellers from competing within 10 miles for a period of 5 years.  CVS paid a stated $1.1 million for the benefits of the non-competition agreement. The agree also included a provision for a $1 million “holdback” to assure payment of the seller’s indemnification obligations. The holdback was to be paid on March 30, 2013. CVS refused, however, to pay the holdback, claiming that plaintiffs had, contrary to the non-competition agreement, competed by directing former customers of theirs to pharmacies other than CVS. Plaintiff sued to demolish the agreement.

Be sure and read this case or the summary if you are a member of ASPL and receive their e-news.

American Society for Pharmacy Law (ASPL) is accepting nominations for the Joseph L. Fink, III, Founders Award.


Joseph L. Fink III Founders Award


The American Society for Pharmacy Law (ASPL) is accepting nominations for the Joseph L. Fink, III, Founders Award. The Founders Award was established in 2004 to recognize sustained and outstanding service and contributions to the professions of pharmacy and law. The award is named for Joseph L. Fink, III, who founded ASPL in 1974 and served as the Society’s first president.
Any ASPL member may nominate a person for the Award. The nominee need not be a current ASPL member. The Award may be awarded annually, but if no person nominated meets the criteria, the award will not be given.
The award consists of a perpetual plaque kept in the ASPL office with the names of each of the past recipients, as well as an individual award for the recipient.
The award will be presented at the ASPL Annual Meeting held in conjunction with the American Pharmacists Association (APhA) Annual Meeting & Exposition to be held March 28 - 31, 2014 in Orlando, FL.

To nominate an individual for the award, please submit a nomination form and all supporting documentation to ASPL by January 17, 2014. A nomination form may be downloaded from the ASPL website here. Nomination Form (PDF)
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F.D.A. Moves To Rein In Pain Killers The F.D.A. moves to rein in America’s huge usage of powerful painkillers. We’ll look at where they’re drawing the line.

read here

Some Important FACT! re: pharma marketing settlements

The recent slew of pharma marketing settlements with the Department of Justice goes to show that there's room for improvement when it comes to curbing dishonest advertising. Over the past decade, drugmakers have agreed to pay close to $14 billion in penance for off-label and safety-related claims. But for some companies, those settlements haven't deterred repeat misbehavior. Pfizer ($PFE), for one, has wrapped two marketing settlements for north of $400 million: one in 2004 totaling $430 million for promotions of seizure drug Neurotonin, and another in 2009 worth $2.3 billion--including a record-setting $1.3 billion in criminal penalties--over BextraGeodonZyvox and Lyrica.

Read more: UPDATED: FDA aims to train docs to spot misleading drug ads--and report them - FiercePharma http://www.fiercepharma.com/story/fda-aims-train-docs-spot-misleading-drug-ads-and-report-them/2013-10-29#ixzz2jDkkAhOu
Subscribe at FiercePharma

UPDATED: FDA aims to train docs to spot misleading drug ads--and report them October 29, 2013 | By Carly Helfand Read more: UPDATED: FDA aims to train docs to spot misleading drug ads--and report them - FiercePharma http://www.fiercepharma.com/story/fda-aims-train-docs-spot-misleading-drug-ads-and-report-them/2013-10-29#ixzz2jDk0EkQ0 Subscribe at FiercePharma


Third Question of the Day October 30, 2013 If you are traditional compounding pharmacy that does not wish or are financially able to become an outsourcing facility should you be looking to cut bait and SELL to a larger group like Mesa is selling to PAWS? Do you think the window of opportunity for selling will probably be a small one after federal compounding legislation passed?


Second Question of Day October 30, 2013 How many veterinary colleges and ce covers education of veterinarians on violations of federal and state criminal laws relating to compounding, prescriptions, health care, HIPPA etc? How many associations that represent vets make sure the members are educated in this area?


Don't Think I Can Post This Important Message from New Mexico Board of Veterinary Medicine Too Many Times--Not only does it violate the state's regs--it may also violate federal criminal laws!!



IMPORTANT MESSAGE FROM THE BOARD:

The Board continues to be notified of the solicitations to veterinarians for the purchase of drugs for re-sale to companies offering an incentive of paying a percentage of the sales of the drugs to the veterinarian ordering the drugs.  Be advised, this type of dispensing of prescription drugs is in violation of the Board's Rules and Regulations, specifically:

16.25.9.17 A. No legend or controlled drug shall be prescribed, dispensed, or administered without the establishment of a veterinary-client-patient relationship.

COMPOUNDING VETERINARIAN PRODUCTS:
The Board of Pharmacy has provided clarification concerning the compounding of veterinarian products.  Please click on the link to view the Board of Pharmacy's Regulation concerning this topic.
Controlled Substances Dispensed by Veterinarians
The Board of Pharmacy has provided a helpful link to the PMP Dispensing Practitioner Manual to assist licensees in the controlled substances reporting to the Board of Pharmacy. Click here to access the instruction sheet.
quoted from here

Did I just read this right--PDC gets a royalty on collection for each prescription filed by MESA? Really?

PDC will be paid a royalty on collection for each prescription filled by MESA as well as receiving 500,000 shares of PAWS Series D Convertible Preferred Stock. The parties will begin the process of transferring MESA’s license from PDC to PAWS as soon as possible and the transaction is intended to close upon the issuance of a new California pharmacy license or sooner. PDC has the right to appoint three members to the Board of Directors as soon as the new license is issued and the audit of MESA’s operations is completed.


MUST READ--Look at these numbers on orders and sales--Here is actual Press Release that Explains Paws will now purchase Mesa: The PAWS Pet Company, Inc. Executes Agreement to Acquire MESA Pharmacy, Inc. 29 October 2013 The PAWS Pet Company, Inc. Executes Agreement to Acquire MESA Pharmacy, Inc. Orders expected to exceed $25 Million in 2014


  • The PAWS Pet Company, Inc. Executes Agreement to Acquire MESA Pharmacy, Inc.

  • 29 October 2013 by 0 Comments
The PAWS Pet Company, Inc. Executes Agreement to Acquire MESA Pharmacy, Inc. Orders expected to exceed $25 Million in 2014

PALO ALTO, CA, Oct. 29, 2013 /PRNewswire via COMTEX/ — The PAWS Pet Company, Inc. (OTCQB:PAWS), announced it has executed an agreement to acquire MESA Pharmacy, Inc. as part of its new strategy to become a dominant player in the delivery of compounded pharmaceutical products to consumers.
The PAWS Pet Company, Inc. (OTCQB:PAWS) has executed an agreement to acquire MESA Pharmacy, Inc. (MESA) from its parent, Pharmacy Development Corp. in exchange for preferred stock. PAWS will be filing a report on Form 8-K within the next few days. Previously, the Company had announced that it and PDC had determined to enter into a joint venture, however progress on PDC/MESA’s audit has been much better than anticipated and the parties have determined that purchasing MESA would be better for all of the parties and their respective shareholders.
MESA focuses on providing custom compounded non-narcotic, transdermal topical pain medications that are marketed to industrial health physicians and clinics. MESA has developed a series of topical ointments, in different strengths, that provide the pain relief doctors seek.
During the current month, according to MESA, it has received more than $3,400,000 in orders and filled more than $1,500,000 in actual prescriptions. MESA believes that it is on track to exceed $25,000,000 in revenues during fiscal year 2014 with much greater revenues a very real possibility.
PDC will be paid a royalty on collection for each prescription filled by MESA as well as receiving 500,000 shares of PAWS Series D Convertible Preferred Stock. The parties will begin the process of transferring MESA’s license from PDC to PAWS as soon as possible and the transaction is intended to close upon the issuance of a new California pharmacy license or sooner. PDC has the right to appoint three members to the Board of Directors as soon as the new license is issued and the audit of MESA’s operations is completed.
Furthermore, the holders of a majority of the Company’s Series B Convertible Preferred Stock shares have agreed to vote to reduce the maximum conversion rate in order to offset the new Series D stock, on a fully diluted basis.
Additionally, PAWS intends to spin off its remaining airline related properties, freeing the Company of much of its debt and further intends to settle most of its remaining debt in the very near future.
“We are excited about these developments, for our company and our shareholders, and we believe with MESA’s great team, a great foundation for future growth is set”, said Dan Wiesel CEO of The PAWS Pet Company. He continued, “With the execution of this agreement, the way forward for PAWS is clear and we will now focus on completing the licensing process, domesticating the Company in Nevada and changing our name to Praxsyn Corporation.”
About The PAWS Pet Company, Inc.
The PAWS Pet Company, Inc. is undergoing a transition from the pet space to the pharmaceutical space. This exciting transition strategy has been developed to take advantage of the changes underway in traditional medical services. PAWS believes that great opportunities exist in pharmaceuticals and how they are delivered to the public.
For more information on The PAWS Pet Company go to www.thepawspetcompany.com For more information on Pharmacy Development Inc. go to www.pharmacydevelopment.com Company Contact: ir@thepawspetcompany.com
Forward-Looking Statements
Certain statements made in this press release are forward-looking in nature (within the meaning of the PrivateSecurities Litigation Reform Act of 1995) and, accordingly, are subject to risks and uncertainties. The actual results may differ materially from those described or contemplated and consequently, you should not rely on these forward-looking statements as predictions of future events. Certain of these risks and uncertainties are discussed in the reports we filed with the SEC.
SOURCE The PAWS Pet Company, Inc.



Update on Previous Posted: But another reminder of what is happening in the compounding pharmacy world with buying and expanding...Mesa had sales in excess of $25,000,000 in sales and is on track to exceed $10,000,000; 250 million compounding prescriptions are written each year in the U.Sin fiscal year 2013.


New Crowd Favorite *PAWS* to Acquire Mesa Pharmacy! Full Report Inside…

KUDOS! Alabama State Board of Pharmacy Takes on Non-Resident Compounding Pharmacies Also.


Non-Resident Pharmacies:

APOTHECURE, INC., #113027
PERMANENTLY REVOKED, assessed monetary fine of $20,000.00

INSTITUTIONAL PHARMACY SOLUTIONS, #113800/201931
Assessed monetary fine of $1,000.00. 

CHRONISCRIPT, A WALGREENS PHARMACY #113819/201945
SUSPENDED 24 months; assessed monetary fine; shall revert to PROBATION after fine paid and compliant with PDMP.

KG PHARMACY, #113058/201607
Assessed monetary fine of $1,000.00.

SUMMIT PHARMACY, INC., #113820/201946
Assessed monetary fine of $1,000.00.

CORAM ALTERNATE SITE SERVICES, Permit #113198/201672
Assessed administrative fine of $1,000.00 to be paid within 10 days.



Question of the Day October 30, 2013 What Should Congress Do Given two choices about Veterinary Compounding: Include or Exclude in the federal legislation? Make your best agreements. This is something hotly debated.


It Shows that FDA is working Hard to Make its Website more user friendly, it is adding more and more information and keeping the Website Up to Date. For example, see the compounding page


News and Updates

For recent compliance actions, safety alerts, and related news releases, see Pharmacy Compounding: FDA Actions.
FDA Press/News Releases:
CDER Statements:
Firm Press Releases:
  • Firm Press Release:  Specialty Medicine Compounding Pharmacy Issues Voluntary Recall of Certain Unexpired Compounded Sterile Products (10/19/2013)
  • Firm Press Release: Leiter’s Compounding Pharmacy Issues Voluntary Nationwide Recall of Three Product Lots Due to Lack of Assurance of Sterility Concerns Related to its Independent Testing Vendor (9/10/2013)
  • Firm Press Release: Park Compounding: Sterile Medication Recall – Concerns of Sterility Assurance at Testing Vendor (9/10/2013)
  • Firm Press Release: Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of Two Medications Due to Concerns of Sterility Assurance at Testing Vendor (9/9/2013)
  • Firm Press Release: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (8/9/2013)
  • Firm Press Release: University Compounding Pharmacy Initiates a Nationwide Voluntary Recall of Certain Pharmacy Products due to Lack of Assurance of Sterility Concerns (9/6/2013)
  • Firm Press Release: Medaus Pharmacy Initiates a Nationwide Recall of Certain Pharmacy Products due to Questions Surrounding an Independent Third Party’s Sterility Testing (9/4/2013)
  • Firm Press Release: Wellness Pharmacy, Inc. Issues Voluntary Recall of Six Medications Due to Concerns of Sterility Assurance at Testing Vendor (8/26/2013)
  • Firm Press Release: JCB Laboratories Issues Voluntary Recall of Six Drug Product Lots Due to Concerns of Sterility Assurance at Testing Vendor (8/26/2013)
  • Firm Press Release: Park Pharmacy & Compounding Center is Issuing a Voluntary Recall of Two Compounded Sterile Preparations. The Recall is Due to a Lack of Sterility Assurance (8/23/2013)
  • Firm Press Release: FDA reminds health care providers not to use sterile products from NuVision Pharmacy (8/16/2013)
  • Firm Press Release: Clarification to News Release Issued on August 9th Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (8/15/2013)
  • Firm Press Release: FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding (8/14/2013)
  • Firm Press Release: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (8/09/2013)
  • Firm Press Release: Beacon Hill Pharmacy d/b/a Rxtra Solutions Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance (7/31/2013)
  • Firm Press Release: Lowlite Investments, Inc. d/b/a Olympia Pharmacy Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Compounded Between December 17, 2012, and March 27, 2013, Due to Concerns About Sterility Assurance (5/29/2013) 
  • Firm Press Release: Main Street Family Pharmacy, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products (5/28/2013)
  • Firm Press Release: Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients (5/15/2013)
  • Firm Press Release: In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area (5/6/2013)
  • Firm Press Release: Nora Apothecary & Alternative Therapies Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (4/22/2013)
  • Firm News Release: Balanced Solutions Compounding Pharmacy, LLC. Announces a Voluntary Nationwide Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (4/17/2013)
    Firm Press Release: ApothéCure, Inc. Recalls All Lots of All Sterile Products Compounded, Repackaged, and Distributed by ApothéCure, Inc. Due to Sterility Assurance Concerns (4/15/2013)
  • Firm Press Release: NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility Assurance Concerns (4/15/2013)
  • Firm Press Release: Green Valley Drugs Announces Voluntary Nationwide Recall of All Lots of All Sterile Products Compounded, Repackaged, and Distributed by Green Valley Drugs Due to Quality Control Concerns (4/5/2013)
  • Firm Press Release: Pallimed Solutions, Inc. Announces Voluntary Nationwide Recall of All Sterile Compounded Products Dispensed Since January 1, 2013 Due to Possible Filament Contamination (3/25/2013)
  • Firm News Release: Clinical Specialties Compounding Pharmacy Recalls All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance (3/20/2013)
  • Firm News Release: Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (3/20/2013) 
  • Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (3/17/2013)
  • Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of Magnesium Sulfate 2gm In Dextrose 5% In Water, 50ml For Injection Due To Mold Contamination (3/16/2013)  
FDA Voice Blogs:
Recent Congressional Testimony:
Public Meetings:
Related Information: