Sunday, September 28, 2014

Petition for Review under Tex. R. App. P. 53.1 Style: RANDOLL MILL PHARMACY, KVG ENTERPRISES, INC., GARY G. DALEY, JOHN WAYNE BAILEY, JAMES ROBERT FORSYTHE, KEVIN LYNN HEIDE, JULIE KNOWLTON LUBBERT AND CARA MORRELL v.: STACEY MILLER AND RANDY MILLER --Reply brief on the Merits filed on behalf of Randoll Mill Pharmacy, et. al and Brief on Mertis filed on behalf of Stacey and Randy Miller; How many state court cases with compounding medication issues are on-going?

09/19/2014Reply brief filedPetitioner Reply brief on the Merits filed on behalf of Randoll Mill Pharmacy, et al.  
 [ PDF/55 KB ]
09/05/2014Brief filedRespondent Brief on the Merits filed on behalf of Stacey and Randy Miller. 
 [ PDF/207 KB ]

The Pharmacy Sage: Sacred Cows

 The Pharmacy Sage said...
Hello and thank you for this post.

In the pharmacy industry, outright denial is commonplace. I hear a lot of anger online about what has been going on, and not a lot of solutions. Your blog continues to be a guiding light for many.

A problem I see again and again is the problem of "Sacred Cows". I explain what this means in my latest blog post. I hope you'll read it and respond with your thoughts.

Here is a link:http://thepharmacysage.com/pharmacy-problems/

Saturday, September 27, 2014

Second Question of the Day September 27, 2014 There has yet to be any real and meaningful acknowledgment from pharmacists and the major groups that represent them that the compounding pharmacy world is in crisis, has serious dangers and concerns, and that the industry needs to change even if it means less money in their pockets. Instead the focus continues to be on fighting or pushing back, denying the problems are more than a few isolated incidents despite evidence to the contrary. Isn't the first thing the compounding pharmacists and industry needs to do to improve their image and restore faith in them is to acknowledge the problems and take responsiblity for them?


FDA Warning Letter to Young Living

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm416023.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm416023.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm416023.htm

FDA Allowed to Continue to collect Drug Compounding Fees

FDA will be able to collect new drug compounding user fees authorized by the Drug Quality and Security Act (DQSA) under the continuing resolution that cleared Congress and was signed by President Barack Obama last week.

Question of the Day September 27, 2014 Is anyone else scared by the amount of questions and comments on the Internet regarding compounding that state something like I would like to expand my pharmacy to include compounding but I don't have a clue what to do or I have a doctor who wants me to compound wound care creme but I have never done that can anybody tell me how to do it? I don't know about the readers, but personally I wouldn't want a compounded medication from someone who is asking on the Internet how to make it or having to call another pharmacist to "consult" on the basics of compounding. This to me just points out a huge flaw in the system and process and the grave dangers of a number of compounded medications.


Friday, September 26, 2014

Dr. Kiss, the finding "casts doubt on the trustworthiness of the bevacizumab currently being compounded for intraocular use by mostly unregulated pharmacies nationwide."

http://www.consultant360.com/story/protein-content-compounded-bevacizumab-varies-considerably

Marigold Pharmacy shut down

http://www.comoxvalleyrecord.com/news/277287521.html

Ruidoso: All American Futurity the Last Straw for a Crackdown? | Paulick Report – Thoroughbred Horse Racing News (Don't forget to read all the very interest comments below this article)

Australia's TGA Launches Web-based ADR Reporting

Australia’s TGA Launches Web-based ADR Reporting
Australia’s Therapeutic Goods Administration (TGA) has launched a web-based medicines and vaccine related adverse event (adverse drug reaction, or ADR) reporting system for the use of consumers.
- See more at: http://www.raps.org/focus-online/news.aspx#sthash.qB1qSUlD.dpuf

History of sterile compounding in u.s. hospitals

Nurses Compounding Medications | Baby Information PDF

inbabyproducts.com/tag/nurses-compounding-medications
12 hours ago - History of sterile compounding in u.s. hospitals: learning Description: Ture ee ... 6 section a – prescribing, dispensing and compounding drugs part 1 

College of Pharmacists of BC shuts down Marigold Compounding and Natural Pharmacy in Courtenay over public safety concerns

College of Pharmacists of BC shuts down Marigold Compounding and Natural Pharmacy in Courtenay over public safety concerns

Doctors and Lawyers: Why Can't We All Just Get Along

NEW CLE PROGRAM
Register for the latest CLE from the American Bar Association Health Law Section.
Doctors vs. Lawyers: Why Can't We All Just Get Along
Tuesday, October 14, 2014
12:00 PM - 1:30 PM Eastern
1.5 CLE Requested
Webinar
Our expert panelists will discuss:
  • The current state of relations between physicians and attorneys in the context of the legal and regulatory environment within the healthcare delivery system
  • How current and future regulatory and compliance mandates affect physicians, attorneys and healthcare delivery models
  • An overview of legislative and policy proposals to "reform" the tort system, including the possible reintroduction of the proposed legislation known as HR 5, and the potential impact of such proposals
  • Tort reform and medical malpractice litigation: How should doctors and lawyers prepare for continued changes in the legislative arena, while maintaining high professional standards of advocacy and patient care?
2 easy ways to learn more and registe

TN Drug Compounder Forged Prescriptions!!!

meningitis-etc: TN Drug Compounder Forged Prescriptions ...

meningitis-etc.blogspot.com/.../tn-drug-compounder-forged-prescription...
16 hours ago - By Walter F. Roche Jr. The owner of a Cleveland, Tenn. drug compounding pharmacy repeatedly forged prescriptions for a diet drug in her son's name, the state ...

AVMA Pharmacy Issues Page Updated

Pharmacy Issues

Enforcement Reports September 24, 2014

Enforcement Reports September 24, 2014

Unique Pharmaceuticals, Inc. Lack of Assurance of Sterility--Mold Like Substance

Drugs NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502 Lot # 00083844 Exp. 07/13 Class II Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.

FDA Law Blog Points Out that Under the Current Definition of Dispensing a pharmacy's dispensing Controlled Substances (including compounded pain medications used via intrathecal pump, testosterone pellets etc.) to ANYONE other thanthe ultimate user patient or research subject is illegal!!! How many compounding pharmacists are guilty? Even if the Ensuring Safe Access to Prescription Medication Act of 2014 introduced by John Cornyn, a senator from the Compounding Capital of the World-Texas and Sherrod Brown, its passage would not protect those who have violated the law in the past from prosecution

And while I normally agree with the FDA Law Blog authors on this one, I think what is being overlooked is the compounding pharmacists role in this and how it would interplay with the DQSA and office use that is prohibited.  A detailed analysis needs to be done of The Ensuring Safe Access to Prescription Medication Act of 2014 before it is passed especially in light of all the current issues with compounding and compounded pain medications.

Legislation Would End “Constructive Transfer” and Change CSA Definition of “Dispense” to Permit Pharmacy Delivery of Controlled Substances to Physicians for In-Office Administration
 

Check Out Marla Ahlgrimm and her Photographs on Pinterest

Marla Ahlgrimm on Pinterest

Check Out Marla Ahlgrimm and her Photographs on Pinterest

Marla Ahlgrimm on Pinterest

Check Out Marla Ahlgrimm and her Photographs on Pinterest

Marla Ahlgrimm on Pinterest

U.S. Marshals Seize Botanical Substance Kratom from Southern California Facility - Drugs.com MedNews

U.S. Marshals Seize Botanical Substance Kratom from Southern California Facility - Drugs.com MedNews

Compounding Pharmacies Criticized by Health Report--Australian Compounding Pharmacies called out on counterfeit drugs


Compounding pharmacies criticized by Health Report : 29/04/2013 :
In last week's episode of ABC Radio National's The Health Report, which focused on counterfeit drugs, host Norman swan took a swipe at Australian compounding pharmacies, saying they are subject to little regulatory control and that there is no guarantee that consumers will actually get what is prescribed for them.

" ... we haven't even broached the subject of substandard medications, in particular those made in some Australian compounding pharmacies at the request of prescribing doctors. There is virtually no regulatory control of either the prescribing doctors in this respect or the pharmacies, and you haven't a clue what you're getting."
premium You need to log in to read the rest of this article. Click here for details

Question of the Day September 26, 2014 How many compounding pharmacies or pharmacists are involved in fake or counterfeit drug operations? How many technically make counterfeit commerically available drugs under the guise of "compounding"?


FDA Working Hard to Warn Doctors to Beware of Fake or Counterfeit Drugs

http://tbo.com/health/fda-warns-doctors-to-beware-fake-drug-distributors-20140923/

Partnership for Safe Medicines Provides Shocking Statistics!! Counterfeit drug incidents around the world have caused an estimated 700,000 deaths from malaria and tuberculosis alone, reports the International Policy Network.

Read the Partnership for Safe Medicines 5 Kinds of Poisons in Counterfeit Medications

FDA Information for Healthcare Professionals (Drugs) Know Your Source: Protecting Patients from Unsafe Drugs: Remember if it sounds to good to be true then it probably is

Information for Healthcare Professionals (Drugs) Know Your Source: Protecting Patients from Unsafe Drugs

FDA and DOJ have steadily increased prosecutions of Illegal and Unapproved Drugs since 2012

Drug Supply Chain Integrity News and Events

                                          
-

Thursday, September 25, 2014

Pharmaceutical startup creates prefabricated drug dosages to support patient-centric compounded medicine

http://medicalxpress.com/news/2014-09-pharmaceutical-startup-prefabricated-drug-dosages.html

Pew Foundation: Summary of PCAST's Report on Combating Antibiotic Resistance

Summary of PCAST's Report on Combating Antibiotic Resistance

The President’s Council of Advisors on Science and Technology (PCAST) released a report to the president Sept. 18 recommending steps the federal government can take to combat antibiotic resistance.Read More

Pew Foundation: Summary of the National Strategy for Combating Anticebiotic Resistan

Summary of the National Strategy for Combating Anticebiotic Resistance

On Sept. 18, 2014, the Obama administration took unprecedented action to curb one of the world’s most pressing health care crises: the emergence of antibiotic-resistant bacteria. Read More

Check out the web page for Cyclin Pharmaceuticals, Inc. and what they supply in the compounding world

http://apliahrt.com/

Copy of Indictment Recently Unsealed against Marla Ahlgrimm and Balbar Bhogal--Look at the entities the indictment alleges the defendants were tied to:

Indictment alleges Ahlgrimm tied to:
Women't Health America Foundation, Inc. (WHA)
Madison Pharmacy Association, LLC (MPA)
Cyclin Pharmaceuticals
Madison Biodiagnostics (MBD)
Restore
CP International LLC. (CPI)

Indictment alleges Bhogal tied to:
Nutragen

Indictment here

Press Release from DOJ Regarding Marla Ahlgrimm and Balbir Bhogal

Department of Justice
Office of Public Affairs

FOR IMMEDIATE RELEASE
Friday, September 12, 2014
Wisconsin Pharmacist and Nevada Pharmacologist Charged with Smuggling Counterfeit Pharmaceuticals Using a Costa Rican Internet Pharmacy
A Wisconsin pharmacist and a Nevada pharmacologist were arraigned on an indictment today in Federal Court in Central Islip, New York, before United States Magistrate Judge Gary Brown. The defendants are charged with conspiring to supply at least four million misbranded and counterfeit pharmaceuticals to an illegal Internet pharmacy based in Costa Rica that catered to U.S. customers.
Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division; United States Attorney Loretta E. Lynch of the Eastern District of New York; Assistant Director in Charge George C. Venizelos of the FBI’s New York Field Office; Acting Special Agent in Charge James Royal of the U.S. Food and Drug Administration (FDA), Office of Criminal Investigations’ New York Field Office and Special Agent in Charge James T. Hayes Jr. of Homeland Security Investigations’ (HSI) New York Field Office made the announcement.
The 10-count indictment charges Marla Ahlgrimm, 59, of Madison, Wisconsin, and Balbir Bhogal, 67, of Las Vegas, Nevada, with importing and distributing controlled substances and misbranded drugs, trafficking in counterfeit drugs, mail and wire fraud, smuggling and money laundering.
According to the indictment and information presented at the arraignment, from June 2007 through May 2010, Ahlgrimm and Bhogal, who is a dual U.S. and Indian citizen, allegedly arranged for the manufacture in India of millions of tablets of controlled substances, including alprazolam and phentermine, and prescription drugs, including carisoprodol and counterfeit Viagra. Although they did not hold an importer’s license from the Drug Enforcement Administration, the defendants allegedly arranged for the importation of the same drugs into the United States. Neither the incoming packages nor the tablets themselves were labeled or identified as controlled substances or prescription drugs.    
The drugs were allegedly intended to supply an Internet pharmacy based in Costa Rica that catered to customers within the United States, including Brooklyn and Queens, New York. The Internet pharmacy used call centers and websites based outside the United States, but filled the orders from inside the United States using individuals who were not licensed pharmacists to bottle, label and drop-ship the drugs. To facilitate the operation, the defendants allegedly wired money from Costa Rica to the United States and then to India.
An indictment is merely an accusation, and the defendants are presumed innocent unless and until proven guilty.  
The case was jointly investigated by the FBI, FDA’s Office of Criminal Investigations, and HSI. The case is being prosecuted by Senior Counsel Evan C. Williams of the Criminal Division’s Computer Crime and Intellectual Property Section and Assistant U.S. Attorney William P. Campos of the Eastern District of New York.

NABP: Illegal Sales of Prescription Drugs Present Challenge for eBay, ABC News Reports


 Topics: Counterfeit Drugs and Buying Medicine Online
Although eBay, the online shopping and selling platform, has policies banning the listing and sale of any substance requiring a prescription, an ABC News report alleges that the such drugs continue to be sold on the site, and are often relisted after complaints are filed.
Read More →

Sterile Compounding Pharmacy Network SurgicalMeds Partners With Pharmacy Benefit Manager RxPreferred Benefits - KUSI News - San Diego, CA

Sterile Compounding Pharmacy Network SurgicalMeds Partners With Pharmacy Benefit Manager RxPreferred Benefits - KUSI News - San Diego, CA

Question of the Day September 25, 2014 With recent arrests and indictments of compounding pharmacists tied to specific universities touting and turning out compounding pharmacists should accrediation bodies for these colleges and unversities take a closer at these programs?


Reminder of Topical Bases for Compounding Recently Recalled for fungal contamination (Previously found in FDA August 6, 2014 Enforcement Report)

Powerpoint has been posted before but is an essential read: Secundum Artum According to the Art: Findings and Observations of Pharmacy Compounding by Florida Department of Health

Updated! Compounding Registered Outsourcing Facilities 9/19/2014

FDA and FTC Warning Letter!! 2014 Natural Solutions Foundation 9/23/14

2014 Natural Solutions Foundation 9/23/14

2014 dōTERRA International, LLC 9/22/14

2014 dōTERRA International, LLC 9/22/14

Just Who is Marla Ahligrimm

Ahlgrimm is co-founder of Madison Pharmacy Associates, the first pharmacy in the United States devoted to women’s health, and is the former owner of Women’s Health America. - See more at: http://drugtopics.modernmedicine.com/drug-topics/news/pharmacist-accused-internet-fake-pill-scheme?page=full#sthash.EuE7KRO9.dpuf

  1. Marla Ahlgrimm - Wikipedia, the free encyclopedia

    en.wikipedia.org/wiki/Marla_Ahlgrimm
    Wikipedia
    Marla Ahlgrimm is an American entrepreneur, author, philanthropist, pharmacist and ... Ahlgrimm is the co-founder of Madison Pharmacy Associates, the first ...
  2. http://marlaahlgrimm.com/
  3. http://marlaahlgrimm.com/marla-ahlgrimm-cv/

Wednesday, September 24, 2014

Marla Ahlgrimm a prominent Compounding Pharmacist Has Been Charged with Counterfeit Drug Importation--Indicted for conspiring to supply at least 4 million misbranded and counterfeit pharmaceuticals to American Customers of a Costa Rica-based pharmaceutical company!!!

  • How Drug Cartels Counterfeit Pills | Motherboard

    motherboard.vice.com/en_ca/.../how-drug-cartels-counterfeit-pills
    Vice
    5 days ago - The pair, named Marla Ahlgrimm and Balbir Bhogal, were a pharmacist and a pharmacologist, indicted for “conspiring to supply at least four million misbranded ...
  • Pharmacist accused in Internet, fake-pill scheme | Drug Topics

    drugtopics.modernmedicine.com/.../pharmacist-accused-internet-fake-pil...
    5 days ago - Marla Ahlgrimm, 59, of Madison, Wisconsin was charged in federal court in New York with allegedly importing and distributing controlled substances and  ...
  • When Counterfeit and Contaminated Drugs Are Deadly ...

    www.psmag.com/.../counterfeit-contaminated-drugs-dea...
    Pacific Standard
    6 days ago - Marla Ahlgrimm and Balbir Bhogal have been accused of masterminding a scheme to manufacture imitation versions of drugs like Xanax and Viagra in India,  ...
    You visited this page on 9/17/14.
    1. DOJ reopens counterfeit drug charges against Madison ...

      host.madison.com/.../article_6c54f1ff-0584-5bbf-9a3...
      The Daily Cardinal
      Sep 14, 2014 - Marla Ahlgrimm of Madison, seen here in 2010, was charged in a New York federal court last week with counterfeit drug importation. An earlier case in 2010 was  ...
    2. 2 charged with smuggling counterfeit pharmaceuticals

      www.ice.gov/.../140915new...
      U.S. Immigration and Customs Enforcement
      Sep 15, 2014 - The 10-count indictment charges Marla Ahlgrimm, 59, of Madison, Wisconsin, ... at the arraignment, from June 2007 through May 2010, Ahlgrimm and Bhogal,  ...
    3. A pharmacist and pharmacologist are charged with ...

      www.iprcenter.gov › Newsroom › ICE
      Operation In Our Sites
      Sep 12, 2014 - The 10-count indictment charges Marla Ahlgrimm, 59, of Madison, Wisconsin, and Balbir Bhogal, 67, of Las Vegas, Nevada, with importing and distributing ...
  • host.madison.com/marla-ahlgrimm.../image_1064649...
    The Daily Cardinal
    Sep 13, 2014 - Marla Ahlgrimm of Madison, seen here in 2010, was charged in a New York federal court last week with counterfeit drug importation. An earlier case in 2010 was ...
  • Women's Health is Unique, Says Marla Ahlgrimm - CNN ...

    ireport.cnn.com/docs/DOC-1132296
    iReport
    May 14, 2014 - Marla Ahlgrimm, a pharmacist with three decades of prescription compounding experience, says that women's health needs are unique and often require