Tuesday, December 2, 2014

2014 My Lady's Manor Farm, Inc. 11/24/14

2014 My Lady's Manor Farm, Inc. 11/24/14

2014 Hirsch's Dairy Farm 11/20/14

2014 Hirsch's Dairy Farm 11/20/14

2014 Long Island Pharmaceuticals LLC 11/20/14

2014 Long Island Pharmaceuticals LLC 11/20/14

2014 Urban Moonshine, Inc. 11/20/14

2014 Urban Moonshine, Inc. 11/20/14

And more Expansion: ScripsAmerica, Inc acquistion of Main Avenue Pharmacy

Some Information on Imprimis Agreement to Acquire South Coast Specialty Compounding dba Park Compounding

News Breaks
December 2, 2014
08:06 EDTIMMYImprimis signs agreement to acquire South Coast Specialty Compounding
Imprimis announced that it has entered into a stock purchase agreement to acquire South Coast Specialty Compounding, DBA Park Compounding. The acquisition of Park is expected to close on or about January 1, 2015, subject to the satisfaction of certain customary closing conditions. As part of the transaction, Imprimis also entered into a non-exclusive license agreement with Park. The license agreement allows Park to immediately begin making and dispensing Imprimis' proprietary ophthalmology and urology formulations in the 13 states in which it is currently licensed, including California, Nevada, Oregon, and Hawaii. Following the close of the transaction, Imprimis expects Park to continue its current profitable sales model, while building upon the Park formulation portfolio with the addition of Imprimis' patent-pending Dropless and other proprietary formulations. Imprimis anticipates that Park will recognize revenues of nearly $4 million in 2014. In addition, with this acquisition, Imprimis will gain access to the significant expertise of innovative pharmacists and an experienced staff, immediate prescription dispensing redundancy, and new licenses in key states. The Park transaction represents the second pharmacy acquisition by Imprimis. On April 1, 2014, Imprimis acquired Pharmacy Creations, LLC, a New-Jersey based compounding pharmacy. With Park and Pharmacy Creations, both PCAB-accredited facilities, Imprimis can now distribute its formulations into 37 states, representing approximately 75% of the U.S. population. Imprimis is dedicated to adding additional state pharmacy licenses in the near term with the goal of reaching nationwide distribution capability. Imprimis may also build or otherwise access a 503B FDA-registered outsourcing facility to further its nationwide distribution channels.

quoted from here

Question of the Day December 2, 2014 Will Praxsyn (previously Paws Pet Company)/ Mesa Pharmacy Inc.,continue to take over the market of transdermal medications?


PRAXSYN CORPORATION ANNOUNCES CHANGE OF DOMICILE FROM ILLINOIS TO NEVADA

IRVINE, Calif., November 5, 2014 – Praxsyn Corporation (OTCQB: PXYN) announced today that the majority of its shareholders have voted to change domiciles from the state of Illinois to Nevada. Praxsyn Corporation shareholders entitled to vote authorized the change of domicile via their majority written consent due to: a) Nevada’s favorable corporate laws; b) lower corporate income taxes; and c) easily accessible corporate filings through the Nevada Secretary of State’s web portal.

And the Game is On: Imprimis Acquires second Pharmacy: South Coast Specialty

Douglas W. House, SA News Ed...
  • In a all-stock transaction, Imprimis Pharmaceuticals (IMMYacquires South Coast Specialty Compounding. As part of the transaction, Park signs a license agreement allowing it to immediately begin making and dispensing Imprimis' ophthalmology and urology formulations in the 13 states where it is currently licensed, including CA, NV, OR and HI.
  • Park will generate almost $4M in top line revenue in 2014.
  • Imprimis acquired its first pharmacy, Pharmacy Creations, LLC, in April 2014.
Read comments
IMMY price at time of publication: $8.40. Check IMMY price now »

Monday, December 1, 2014

AVMA Seeks Feedback on Compounding 12/1/2014

impact how veterinarians are able to compound in the future, which is important because we … one could take metronidazole pills and compoundthem into a flavored liquid.  What …
Date: 12/1/2014
https://www.avma.org/Members/Community/Discussions/Pages/AVMA-NOAH-Discussion-Boards.aspx?action=ViewPosts&fid=2&tid=211

AVMA November Board of Directors Wrap-Up

November Board of Directors Wrap-Up

Alabama Board of Pharmacy Non-Resident Pharmacies Forms


NON-RESIDENT PHARMACIES
NEW Non-Resident Pharmacy Registration Application    Printable PDF FilePDF  Please also complete a Non-Resident Pharmacy Verification Form Printable PDF File PDF
If requesting a change of address, name change or ownership notification print  BLANK Non-Resident Renewal Application  Printable PDF File PDF  
Non-Resident Renewal Statement Printable PDF File PDF
Inspection Report for 797 Sterile Compounding   Printable PDF File  PDF    
Non-Resident Pharmacies that compound Sterile products will need to complete and file this report along with their application.
Inspection Report for 795 Non-Sterile Compounding   Printable PDF File  PDF    
Non-Resident Pharmacies that compound Non-Sterile products will need to complete and file this report along with their application.

All Pharmacies Who Do Business in Georgia Should Review All These Rules

Georgia Board of Pharmacy New Rules Nonresident Pharmacy Rules!! Make Sure You Are Ready to Comply

Oklahoma Board of Pharmacies Sample Compounding Inspection Form

Look at the New Oklahoma Board of Pharmacy Licence Application and the Questions that Must be Answered and Beginning January 1, 2015, all new and renewal non-resident pharmacy license applications that require a parenteral permit (i.e. pharmacies compounding sterile drug products) will also be required to have an Oklahoma licensed pharmacy manager or pharmacist-in-charge (535:15-9-7).


Case Reported Before But Probably One of the Biggest of the Year in Pharmacy Law: HIPPA

  • Walgreen Case Opens Door For State Law HIPAA Claims

    Walgreen Co. recently suffered a major blow when the Indiana Court of Appeals affirmed a 2012 jury verdict for $1.4 million arising from a trial that uncovered sordid details of a pharmacist breaching a customer’s prescription information. The decision provides an avenue for plaintiffs to skirt the Health Insurance Portability and Accountability Act prohibition of a private right of action to go after the deep pockets of employers,... (continued)

December 1, 2014 Companies Can't Turn Blind Eye To Whistleblowers

  • December 1, 2014

    Companies Can't Turn Blind Eye To Whistleblowers

    National and multinational companies across the globe aren’t doing enough to respond to would-be whistleblowers' concerns, which, left unaddressed, could mushroom into larger problems for those companies down the road, according to a report released Monday by Freshfields Bruckhaus Deringer LLP.

California Supreme Court to Review whether states $250,000 malpractice cap violates the law

  • November 26, 2014

    Calif. High Court To Review Malpractice Cap Law

    California’s high court will review the constitutionality of the state’s $250,000 cap on damages in medical malpractice suits, less than a month after voters summarily rejected a measure that would have raised the cap to $1 million, according to a consumer advocacy group on Wednesday.

Make Sure your PIC has an active Kentucky pharmacist license if you are an out-of-state pharmacy providing medications to Kentucky

Non-Resident Pharmacy Permit Information

Pursuant to KRS 315.0351, a non-resident pharmacy permit is required to provide prescription medications to citizens of the Commonwealth. Pharmacy permits expire annually on June 30th. Renewal postcards will be mailed at the end of April. Online renewals will be available beginning in May.

Requirements for a non-resident Pharmacy Permit

Pharmacist in Charge must have an active Kentucky pharmacist license. Senate Bill 88 amends KRS 315.0351 to require out-of-state pharmacies that are providing prescription medications to citizens of the Commonwealth to have a pharmacist-in-charge who holds a Kentucky pharmacist license. This Kentucky licensed pharmacist may be any employee pharmacist of the pharmacy
  • Complete the Application For Non-Resident Pharmacy Permit and indicate that you are a "New Pharmacy".
  • A payment of $100, by check, made out to the "Kentucky State Treasurer".
  • Required documentation found on page 4 of the application.
  • Mail the completed application, check and required documents to
    State Office Building Annex, Suite 300
    125 Holmes Street
    Frankfort, KY 40601

FDA November 26, 2014 Enforcement Report Includes Findings on Abrams Royal Pharmacy








Product TypeProduct DescriptionCode InfoClassificationReason for RecallRecalling FirmDrugs Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231. Lot #: 05152013@4 (also written as 051513-4), Exp 11/11/13 Class I Non-Sterility: The firm's contract testing laboratory found sterility failures. Abrams Royal Pharmacy
Drugs Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX Lot# 041013-13 (also been written as "041013@13") Exp: 06/09/2013 Class I Non-Sterility Abrams Royal Pharmacy
Drugs Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX Lot number 04302013@21 (also written as 043013-21), exp 10/27/2013 Class I Non-Sterility; contract laboratory identified Staphylococcus warneri in the product Abrams Royal Pharmacy

Another animal health biotech plots an IPO FierceBiotech | May 19, 2014 Another drug developer for the animal health field is going public. Parnell Pharmaceuticals outlined plans to raise $57.5 million in an IPO designed to fuel its work on new therapies for family pets as well as production animals.

http://www.fiercebiotech.com/story/another-animal-health-biotech-plots-ipo/2014-05-19

Lawsuit Filed Against the FDA for Newly Approved Animal Drugs

United States Files False Claims Act Lawsuit Against Las Vegas Hospice and Related Entities for Billing Medicare and Medicaid for Ineligible Patients

Texas OIG is now considering a $90 million contract with an Austin company to detect fraud, even though the company has little experience after suffering a blow in court

2014 November/December NABP Newsletter

19 of the 188 VPP Pharmacies do Sterile Compounding; 188 do non-sterile compounding; 61 do both

read more details in the November/December 2014 NABP Newsleter

Board Compliance Staff Attend Two-Day Compounding Training Session to Expand Knowledge, Skills for Future Inspectionsrre

Second Question of the Day December 1, 2014 Is inviting veterinarians into your compounding pharmacy for a tour as this pharmacy did a great way to increase business? Why or why not?

Roadrunner Express Summer 2013 - Roadrunner Pharmacy  

https://www.roadrunnerpharmacy.com/.../NewsletterFinalSummer2013.p...
compounding pharmacy sends a life-saving medication .... practice with array of DEAapproved compounded controlled use items for in-clinic usage. Verify your  ...

Another Flashback: Compounding pharmacy should face deeper DEA investigation, says Rep. Markey


Meningitis outbreak
The company that made the pain relieving steroid at the center of a growing fungal meningitis outbreak should face a deeper investigation into its activities with federally-controlled drugs, said a U.S. lawmaker.
Rep. Edward Markey (D-MA) on Oct. 16 urged the Department of Justice to begin a wider investigation into the Framingham, MA-based New England Compounding Center (NECC), to see it the firm violated laws and regulations for controlled prescription drugs. Markey said the company may have been improperly distributed nearly 1,000 controlled substances, including cocaine, morphine and ketamine that come under the purview of the Drug Enforcement Administration.


Another Flashback: Pharmacies Ill-Prepared For Potential DEA Crackdown

By Rachel Slajda

Law360, New York (September 18, 2012, 8:38 PM ET) -- Many pharmacies' day-to-day operations appear to violate the U.S. Drug Enforcement Administration's policies on controlled substances, and the pharmacies are risking their DEA registrations if the agency cracks down — a not-implausible scenario as the DEA battles widespread prescription drug abuse. 
At issue is whether retail and compounding pharmacies can give controlled substances to doctors, rather than directly to patients. A prime example, pointed to by the industry and supportive lawmakers, is intrathecal pain medications that must be injected directly into a patient's spinal fluid.
http://www.law360.com/articles/379346/pharmacies-ill-prepared-for-potential-dea-crackdown

Flashback: Pharmacy Law: Compounding Controlled Substance Medications for Equine Patients Joseph L. Fink III, BSPharm, JD Published Online: Thursday, January 1, 2009

A pharmacy specializing in veterinary pharmaceuticals had its registration revoked by the US Drug Enforcement Administration (DEA), because, in the view of the agency, it was engaged in "manufacturing" and "distributing" controlled substances, rather than "compounding" and "dispensing" them. The pharmacy challenged the interpretation at the level of an agency hearing as well as a request for reconsideration and, after the subsequent revocation of its DEA registration, sought judicial review of the action of the administrative agency. - See more at: http://www.pharmacytimes.com/publications/issue/2009/2009-01/2009-01-9982#sthash.y9h7BK3C.dpuf

Express Scripts May Have the Most to Gain and Compounding Pharmacies May have the Most to Lose from the Pending Lawsuits

Sue Tuck Richmond
December 1, 2014

Earlier this year Express Scripts said the average cost for compounded prescription had risen from about $90 to $1,100 and that in a number of cases less expensive alternatives than compounded prescriptions existed.  Express Scripts then took a bold move.  It then announced it would deny coverage for approximately 1,000 active ingredients  (API) used to make a variety of compounded medicines.  Three compounding pharmacies filed a federal lawsuit, claiming Express Scripts is violating federal law.

As I have mentioned before on the blog, I think there is a potential issue of whether these compounding pharmacies have standing to bring this lawsuit.  At this point, I will leave that issue to the lawyers in the case and the court to determine.

Assuming this case moves forward on the merits with no one being dismissed for lack of standing, the final results will be ground breaking to say the least.  What is also going to be very interesting is the discovery phrase.  The underlying documents that these compounding pharmacies may have to produce in discovery could end up being very telling about the industry.  In some ways, one might hope that standing isn't an issue just so documents can be produced, interrogatories can be asked and answered, and depositions can be taken.  A wealth of information about the compounding industry could be invaluable.  There has been some chatting on the internet about this becoming a class action. Wow. Wouldn't that be a "discovery" dream for some to learn all the in's and out's of the compounding industry.

If Express Scripts loses the lawsuit filed against them by three compounding pharmacies, what have they lost?  Sure compounding pharmacies will claim victory and tout how they fought for patient's rights. Sure Express Scripts will have lost legal fees involved in the litigation, but the bottom line is they will just go back to covering API that is used to make compounded medications as they did prior to their announcement to exclude coverage.

The bigger issue is what will the compounding industry lose if they three compounding pharmacies lose this case.  There will be binding precedent on that books that allows PBMs to exclude coverage for API used to make compounded medications.  Other PBMs and insurance companies could then follow Express Scripts lead to not just restrict coverage but also to eliminate coverage causing compounding pharmacies to lose a bigger piece of the pie than they have already lost.   In my opinion the stakes are very high for compounding pharmacies in this lawsuit.  In my opinion, it is essential that they win the cases they have filed; otherwise, their decision to sue may have a much larger impact than compounding pharmacies, pharmacists and consumers of compounded drugs have bargained for.

This is definitely a case to keep a close watch on.  It will most likely have a huge impact no matter who wins the case.

ASADA seeks subpoenas to compel Shane Charter and Nima Alavi to give evidence in Essendon case

  1. ASADA seeks subpoenas to compel Shane Charter and ...

    www.foxsports.com.au/.../story-e6frf3e3-1227140988775
    Fox Sports
    13 hours ago - ... the banned peptide Thymosin beta-4 to former Bombers sports scientist Stephen Dank in 2012 and Alavi the pharmacist who allegedly compoundedthe drug.

Pharmacy Benefit Manager Faces Lawsuit by Compounding Pharmacies

Between state crackdowns, drug formularies, and stricter inspections compounding pharmacies are feeling the pressure....read Ben Miller's article at Worker's Comp central

FierceAnimal Top Stories

The Asia-Pacific Amino-acids, Peptides & Proteins Market is Expected to Reach $716.6 million by 2018

The amino-acids, peptides, & proteins market in Asia-Pacific is estimated to grow from around $491.4 million in 2012 to $716.6 million by 2018, at a CAGR of ...

ASADA faces collapse of peptide case against Bombers

  1. ASADA faces collapse of peptide case against Bombers ...  

    www.theaustralian.com.au/.../story-fnca0u4y-12271411051...
    The Australian
    7 hours ago - Mr Alavi told ASADA that a batch of Thymosin peptide sourced by Mr Charter from China was delivered to his pharmacy. He compounded the peptide and ...

Question of the Day December 1, 2014 Just as the ASADA is having trouble producing witnesses, isn' this a problem in the United States regarding illegal compounding pharmacies and pharmacist who make illegal compounds? No one in the industry (especially the good compounders) wants to do what is right and report or give evidence against the bad compounders, and this in turn tarnishes the good compounders because they stand by silently as if aiding and abetting the bad, illegal compounders to stay in business, allowing all compounders not just the ones who deserve the negative, bad image to receive it. What long-term effect will this have on the good compounders? Will they eventually be the ones forced out of business by the corruption and illegal compounding?


ASADA reportedly struggling to produce key witnesses in case against 34 past and present Essendon players : Alavi told the anti-doping agency a batch of Thymosin from China was delivered to his pharmacy and he compounded the peptide and gave it to controversial sports scientist Stephen Dank.

ASADA reportedly struggling to produce key witnesses in ...

www.abc.net.au/.../5931420?...
Australian Broadcasting Corporation
6 hours ago - Alavi told the anti-doping agency a batch of Thymosin from China was delivered to his pharmacy and he compounded the peptide and gave it to controversial

Prime Therapeutics Pharmacy Audit Recovery Guidelines

Pharmacy Audit Recovery Guidelines - Prime Therapeutics  

www.primetherapeutics.com/.../RecoveryGuidelinesE...
Prime Therapeutics
20 hours ago - original documentation supporting drug was compounded. CNE. Incorrect. NDC(s) billed on compound claim. Incorrect NDC submitted for XYZ drug- Pharmacy.