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.

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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 Bextra, Geodon, Zyvox 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 admin0 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.

http://rt.prnewswire.com/rt.gif?NewsItemId=TO937&Transmission_Id=201310291636PR_NEWS_USPR_____TO937&DateId=20131029

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…

Posted on October 30, 2013 by admin

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.Pharmacy Development Corp. (“PDC”) was established in 2007 to expand the already existing chain of Mesa Pharmacy stores, further expand its pharmacy Compounding practice and continue the production and promotion of its private label whole food supplement line. PDC currently has two operating subsidiaries in Mesa Pharmacy, Inc. (“MPI”), a chain of pharmacies, and Life Genix, Inc (“LGI”), a whole food supplements company.

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. Read More… [ http://clicks.aweber.com/y/ct/l=DFs9Q&m=3iB0_pZAP.WJIAj&b=9fYSoyrlwm2ky4ZzFQ041Q ] Many physicians are concerned about prescribing oral controlled narcotic pain medication such as Oxycontin or Vicodin to their patients and are looking for an alternative delivery system. Using only FDA approved medications, MESA has developed a series of topical ointments, in different strengths, that provide the pain relief doctors seek.Compounding, where the pharmacist individually mixes the drugs, is a long established tradition in the pharmacy industry. 250 million compounding prescriptions are written each year in the U.S. and in 2009, in California alone, pharmacies were paid $340 million by insurance companies representing employers with injured workers.

What is compoundingCompounding is the mixing of drugs by a compounding pharmacist to fit the unique needs of a patient. Mesa Pharmacy provides customized compounds for pain management, bio-identical hormone replacement therapy and much, much more.

Mesa Pharmacy produces its custom compounds for pain management therapy and hormone replacement therapy at its Irvine retail pharmacy location. The Irvine facility has the capability of handling thousands of compounding prescriptions per month.

Compounding Benefits * Effective for neuropathic pain.

* Non-steroidal anti-inflammatory.

* Produces a heating sensation that interferes with neurotransmitter.

* Stimulates circulation and causes a cool and soothing effect.

* Gel based for maximized absorption.

Follow the CROWD and quickly put PAWS on your WATCH LIST! During the past three years, Mesa generated more than $25,000,000 in sales and is on track to exceed $10,000,000 in fiscal year 2013.

http://clicks.aweber.com/y/ct/l=DFs9Q&m=3iB0_pZAP.WJIAj&b=HdRR2UfkM2uJ4X2tFiiR_w Always do your own due diligence…

Happy Trading! Sincerely, PennyStockCrowd.com [

Read more: http://www2.thestockmarketwatch.com/newsletters/2013/10/30/new-crowd-favorite-paws-to-acquire-mesa-pharmacy-full-report-inside/#ixzz2jDX8rnYd

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:

• FDA announces voluntary recall of certain sterile products from Specialty Medicine Compounding Pharmacy (10/22/2013)
• FDA reminds health care providers not to use sterile products from NuVision Pharmacy (8/16/2013)
• FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding (8/11/2013)
• Federal judge enters consent decree with Med Prep Consulting (6/28/2013)
• FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee (5/24/2013)
• FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy (5/18/2013)
• FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop (5/8/2013)
• FDA announces voluntary nationwide recall by Balanced Solutions Compounding Pharmacy (4/21/2013)
• FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recall (4/15/2013)
• Summary: 2013 FDA Pharmacy Inspection Assignment (4/11/2013)
• FDA alerts health care providers and patients of the nationwide recall of all lots of sterile products distributed by Clinical Specialties Compounding Pharmacy (3/21/2013)
• FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey (3/18/2013)

CDER Statements:

• FDA Alerts Patients and Health Care Providers Not to Use Budesonide Solution from The Compounding Shop (9/27/2013)
• FDA Alerts Pharmacies to Concerns with Testing Conducted by Front Range Laboratories (8/21/2013)
• FDA Alerts Health Care Professionals about Sterile Products from Specialty Compounding (8/9/2013)
• Update on Main Street Family Pharmacy Products: Samples of injectable methylprednisolone acetate test positive for microbial contamination (6/6/2013; updated 6/13/2013)

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:

• Proactive Inspections Further Highlight Need for New Authorities for Pharmacy Compounding (4/11/2013)
• FDA Must Have New Authorities to Regulate Pharmacy Compounding (3/22/2013)

Recent Congressional Testimony:

• Reforming the Drug Compounding Regulatory Framework (7/16/2013)
• Examining Drug Compounding (5/23/2013)
• Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak (11/15/2012)
• The Fungal Meningitis Outbreak: Could It Have Been Prevented? (11/14/2012)

Public Meetings:

• Framework for Pharmacy Compounding: State and Federal Roles (12/19/2012)

Related Information:

• Multistate outbreak of meningitis and other infections (2012) 

Drug Safety and Availability--compounding issues at the FDA

Drug Safety and Availability

Criminal Investigations

Criminal Investigations

Counterfeit Medicine

Counterfeit Medicine

San Juan, Puerto Rico Updates Island Office Protects Consumers Near and Far

Consumer Updates Island Office Protects Consumers Near and Far

Consumer Updates FDA Helping to Advance Treatments Tailored to You

Consumer Updates FDA Helping to Advance Treatments Tailored to You

KUDOS to Alabama State Board of Pharmacy -Non-Resident Pharmacies:

APOTHECURE, INC., #113027

PERMANENTLY REVOKED, assessed monetary fine of $20,000.00

NEW ENGLAND COMPOUNDING CENTER, #112275/201114

REVOKED.

Alabama State Board of Pharmacy Disciplined BIRMINGHAM APOTHECARY, INC., #101560 Violated provisions of Alabama Pharmacy Practice Act; assessed monetary fine of $6,000.00.

Alabama State Board of Pharmacy: Disciplines Citizen Express Pharmacy and Delmous Vance, III

DELMOUS VANCE, III, #12502

PROBATION 2 years; assessed monetary fine of $10,000.00 (order states both Vance and Citizen’s fined $10,000.00).

Pharmacies:

CITIZEN EXPRESS PHARMACY, #102380

Assessed monetary fine of $10,000.00 (order states both Vance and Citizen’s fined $10,000.00).

source Alabama State Board of Pharmacy

UPDATED!! Alabama Board of Pharmacy: Fines and Discipline Imposed against Manufacturers--And You Thought The FDA Regulated Them....

Manufacturer/Wholesaler/Distributor:

K V PHARMACEUTICAL COMPANY, applicant for mfg/whse/dist

GRANTED upon payment of all required fees and subject to compliance; will not engage in the manufacturing any drugs; comply with terms and conditions of the Consent Decree of Permanent Injunction entered on March 6, 2009 – USA v KV Pharmaceutical Company, et al, in the US District Court for the Eastern District of Missouri, Case No.: 4:09cv-00334; submit to Board by July 15 and January 15 of each year verification of compliance.

NOVARTIS VACCINES & DIAGNOSTICS, INC., #191799

Assessed monetary fine of $500.00.

THER-RX CORPORATION, #192109

Comply with terms and conditions of the Consent Decree of Permanent Injunction entered on March 6, 2009 – USA v KV Pharmaceutical Company, et al, in the US District Court for the Eastern District of Missouri, Case No.: 4:09cv-00334; submit to Board by July 15 and January 15 of each year verification of compliance; assessed monetary fine of $5,000.00.

TRIGEN LABORATORIES, INC., #193875

Assessed monetary fine of $5,000.00; PROBATION 2 years.

UNITED DRUG SUPPLY, #194119

Assessed monetary fine of $500.00.

quoted from here

THE PROCTER AND GAMBLE DISTRIBUTING, LLC., #193786

Assessed monetary fine of $3,000.00.

HAEMONETICS CORPORATION, #193411

Assessed monetary fine of $500.00.

HAEMONETICS CORPORATION, #193412

Assessed monetary fine of $500.00.

NATIONS PHARMACEUTICALS, INC., #193629

Assessed monetary fine of $500.00.

SPECTRUM LABORATORY PRODUCTS, INC., #192564

Assessed monetary fine of $2,000.00; shall obtain pending proper Florida Permits; shall refrain from distribution of legend drugs into Florida until permits have been issued; shall provide copies of new approved Florida Permits to the Board.

COMMONWEALTH HOME HEALTHCARE, #900621

Assessed monetary fine of $2,500.00.

HEALTHCARE & DIAGNOSTIC SOLUTIONS, INC., Permit #193243

All drugs distributed e. g. domestically, importing or exporting, shall contain only pharmaceutical ingredients approved by the FDA, USP, USDA and/or HPUS; Assessed administrative fine of $10,000.00 to be paid within 30 days.