Wednesday, June 26, 2013

Has policy change in insurance coverage for compounded medications a subtle shift?


Harvard Pilgrim Compounding Policy Change Could Reflect Subtle Shift

A New England insurer's new policy restricting coverage for compounded medications has not been replicated by other companies regionally and nationwide, sources said, as Harvard Pilgrim faces pushback over the change.
source insider

Imprimis Pharmaceuticals Begins Enacting Long-Term Business Strategy to obtain IP from PCCA By Staff and Wire Reports Wednesday, 26 June 2013 07:13

mprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) has taken the first steps in implementing its long-term drug development strategy. 
On June 17, 2013, Imprimis announced it has acquired rights to certain intellectual property (IP) related to certain innovations from the compounding pharmacy operations of Buderer Drug Company.  Imprimis is a specialty pharmaceutical company uniquely focused on the commercial development of compounded drug formulations, which are initially designed by compounding pharmacies.  Imprimis has one drug candidate, Impracor, a topical NSAID, for the treatment of pain from sprains, strains and joint pain.  Impracor is expected to begin Phase III trials in the 3rd quarter of 2013. 

In 2012 Imprimis entered a relationship with Professional Compounding Centers of America, Inc. (PCCA).  This relationship provides Imprimis with exclusive access to PCCA’s library of approximately 10,000 compounded drug formulations and PCCA’s database of corresponding patient and prescriber clinical experience information collected by PCCA’s service center.  Imprimis has put together a system to mine the library for potential large market drugs.  The library contains compound formulations developed by both PCCA and compound pharmacies that are part of PCCA’s over 3,900 members.  Buderer Drug Company is one of PCCA’s members. 

continue reading here

KUDOS to DOJ and FDA for Complaint Filed in United States District Court in New Jersey Against A Compounding Pharmacy With Multiple Violations! Balls Now in the Compounding Groups Court

June 26, 2013
By Sue Tuck Richmond

It could take years for this case to reach a final result in the federal court system.  But we will see if groups like IACP try to fight this DOJ/FDA attempt.  What such groups advocate in this case will be very telling about their true position on a lot of issues currently being discussed. .  Also this case will help show whether the judicial system believes the FDA has enforcement authority in this cases or not.

Stayed Tuned. This will get very interesting

MUST READ! FDA Complaint Filed Against MED PREP CONSULTING, INC, and GERALD R. TIGHE,

read complaint here

FDA BLOG- FDA Attempts To Shutter A Compounding Pharmacy For Good Posted Wed, 06/26/2013 - 7:47am by Ed Silverman


n the latest ‘get tough’ move by the FDA against wayward compounding pharmacies, the agency has filed a lawsuit seeking a permanent injunction against a New Jersey pharmacy called Med Prep Consulting for a host of violations associated with distributing contaminated medications.
The move comes three months after Med Prep recalled all of its nearly 100 products after a Connecticut hospital noticed "visible particulate contaminants" that turned out to be mold in 50 millimeter bags of an intravenous solution (back story). New Jersey officials then took legal action to revoke its permit and license (see this).
continue reading here

SAVE THE DATE NOVEMBER 14-17, 2013 ASPL Developments in Pharmacy Law Seminar XXIV cl

more information here

“Lost in the Gray: Navigating the Problems of Pharmaceuticals in the Gray Market,” by Brittany Mahugh


January 28, 2013

Brittany Mahugh wins ABA health law writing competition

The American Bar Association (ABA) has recently named University of Oregon School of Law 3L student Brittany Mahugh first-place winner of its Health Law Student Writing Competition. As winner, Mahugh will receive a $500 honorarium, and her paper, “Lost in the Gray: Navigating the Problems of Pharmaceuticals in the Gray Market,” will be published in the Health Lawyer journal, the ABA’s bi-monthly magazine for the health law field. In addition, Mahugh will fly to Miami this February to attend the Emerging Issues in Health Law Conference, the ABA’s 13th annual conference exploring emerging issues in healthcare law.

Membership in the American Bar Association Health Care Section Required here

Supreme Court Rules in Bartlett Generic Drug Preemption Case; Says State-Law Design-Defect Claims That Turn on a Drug Warning’s Adequacy are Preempted


Tuesday, June 25, 2013

Source: FDA Law Blog

Posted: 24 Jun 2013 06:56 PM PDT

By Kurt R. Karst –

Shortly after 10:00 AM this morning (6/24), the generic drug industry let out a collective sigh of relief. It was at that time the U.S. Supreme Court issued its highly anticipated ruling in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-0142). In a big win for the generic drug industry, the Court, in a 5-4 decision penned by Justice Alito (and joined in by Chief Justice Roberts and Justices Scalia, Kennedy, and Thomas), held that state-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by the FDC Act and under the Court’s 2011 decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011). Jutice Breyer filed a dissenting opinion joined in by Justice Kagan. Justice Sotomayor filed a separate dissenting opinion joined in by Justice Ginsburg. The composition of Justices in the 5-4 Bartlett decision mirrors that of the 5-4 decision in PLIVA.

As we previously reported, the question presented to the Court was whether the U.S. Court of Appeals for the First Circuit erred when it ruled that federal law does not preempt state-law design defect claims concerning generic drug products because any conflict between federal and state law can be avoided if the the generic drug manufacturer stops selling its products.

continue to read here

Tuesday, June 25, 2013

In the Matter of: Exchange Rx, LLC 9816 Gilespie St, STE 120 Las Vegas, NV 89183 ORDER TO CEASE AND DESIST


BEFORE THE STATE BOARD OF PHARMACY OF SOUTH CAROLINA

In the Matter of:
Exchange Rx, LLC
9816 Gilespie St, STE 120
Las Vegas, NV  89183
ORDER TO CEASE AND DESIST
DIE #:  2013-15  Respondent
TO THE ABOVE NAMED RESPONDENT:
WHEREAS, the Board is charged with promoting, preserving and protecting the health, safety and welfare
of the  public  by  and  through  the  effective  control  and  regulation  of the  practice  of pharmacy,  the  licensure,
pennitting, control and regulation of all sites or persons, in or out of this State, that distribute, manufacture, possess
or sell drugs or devices within this State, and
WHEREAS,  it  has  been  brought  to  the  attention  of the  South  Carolina  Board  of Pharmacy
(hereinafter "the Board") that Respondent has facilitated the distribution or shipping of legend drugs into
South Carolina.  Therefore Respondent is  in  violation of S.C.  Code  Ann.  § 40-43-30(14), 40-43-84(A)
(Supp.2003) and Reg.99-43; and
WHEREAS, it is unlawful to  engage in the sale, purchase, distribute or trade of a drug, or offer
to sell, purchase, or trade a drug, or the dispensing of a drug unless permitted in this State; and
WHEREAS, you are not currently authorized by the Board to have charge of, engage in, or carry
on, for yourself or another, the sale or distribution ofprescription orders drugs anywhere within this State
pursuant S. C. Code Ann. §40-43-83 or 40-43-90; and
WHEREAS, this Order is  authorized by § S.c. Code Ann.  §§  40-43-60; 40-43~150(B), 40­
43-140,40-1-100, and 40-1-120 (Supp. 2003).
THEREFORE,  YOU  ARE  HEREBY  NOTIFIED  AND  EXPRESSLY  ORDERED  to
immediately cease and desist from facilitating the shipping, distributing, selling, or trading prescription
drugs  into  the  State  of South  Carolina  until  as  required  by  S.C.  Code  Ann.  §  40-43-83  and  other
applicable law as recited above, and until such time,  if ever, as you may be properly authorized by the
Board in accordance with law.
VIOLATIONS MAY BE PUNISHED BY THE IMPOSITION OF CIVIL PENALTIES IN
AMOUNTS  UP TO TEN THOUSAND DOLALRS ($10,000.00)  FOR EACH VIOLATION AND
CRIMINAL  PENALTIES  WmCH  MAY  INCLUDE  FINES  OR  IMPRISONMENT,  AS
PROVIDED BY LAW.
SOUTH CAROLINA BOARD OF PHARMACY
May 01, 2013  BY:
Lee
&(},~ Ann Bundrick, R.Ph.
Board Administrator

BEFORE THE STATE BOARD OF PHARMACY OF SOUTH CAROLINA In the Matter of: BOOTHWYN PHARMACY INC Cease and Desist Order


BEFORE THE STATE BOARD OF PHARMACY OF SOUTH Ct\ROLINA
In the Matter of:
BOOTHWYN PHARMACY INC
2341 CHICHESTER AVE
BOOTHWYNt
PA  19061  ORDER TO CEASE AW':O~ESIST
Respondent.
TO THE ABOVE NAMED RESPONDENT:
WHEREAS, the Board  is  charged with  promoting,  preserving and  protecting the  health, safety
and welfare of the public by and through the effective control and regulation of the practice of pharmacy,
the  licensure,  permitting,  control  and  regulation  of all  sites  or  persons,  in  or  out  of this  State,  that
distribute, manufacture, possess or sell drugs or devices within this State, and
WHEREAS,  it  has  been  brought  to  the  attention  of the  South  Carolina  Board  of Pharmacy
(hereinafter "the Board")  that  Boothwyn  Pharmacy,  a  non-resident  pharmacy,  has  distributed  drugs  to
patients by shipping medications  into South Carolina and  therefore  is  in  violation of  S.C. Code Ann.  §
.,
40-43-30(14), 40-43-84(A) (Supp.2003) and Reg.99-43 and
WHEREAS, it  is  unlawful  to  engage  in  the sale,  purchase, or trade of a  drug,  or offer to sell,
purchase, or trade a drug, or the dispensing of a drug unless permitted in this State and
WHEREAS, you are not currently auth6rized by the Board to  have charge of, engage in, or carry
on,  for  yourself or another,  the sale of prescription  drug orders  anywhere within  this  State  pursuant to
S.C. Code Ann. § 40-43-83 or 40-43-80; and
WHEREAS, this Order is  authorized  by  § S.C.  Code Ann.  §§  40-43-60;  40-43-150(B),  40-43­
140,40-1-100, and 40-1-120 (Supp. 2003).
THEREFORE,  YOU  ARE  HEREBY  NOTIFIED  AND  EXPRESSLY  ORDERED  to
immediately  cease and  desist  from  shipping drugs  into  the  State  of South Carolina until  as  required  by
S.C.  Code Ann.  § 40-43-83  and such  time,  if ever,  as  you  may  be  properly  authorized  by  the  Board  in
accordance with law.
VIOLATIONS MAYBE PUNISHED BY THE IMPOSITION OF CIVIL PENALTIES IN
AMOUNTS UP TO TEN THOUSAND DOLALRS ($10,000.00)  FOR EACH VIOLATION AND
CRIMINAL  PENALTIES  WHICH  MAY  INCLUDE  FINES  OR  IMPRISONMENT,  AS
PROVIDED BY LAW.
SOUTH CAROLINA BOARD OF PHARMACY
May 3, 2013  8y:~~,~'L P'ikeAnD Bundrick, R.Ph.
Board Administrator

IN THE MATTER OF: BARNEY'S COMPOUNDING CENTER, ORDER from South Carolina Board of Pharmacy


SOUTH CAROLINA DEPARTMENT OF LABOR, LICENSING & .REGULATION

BEFORE THE STATE BOARD OF PHARMACY

IN THE MATTER OF:

BARNEY'S COMPOUNDING CENTER,
 ORDER
Applicant.
This matter is before the Board pursuant to the application, dated November 27,2012, of
Barney's Compounding  Center  (Applicant),  for  a  permit  as  a  non-resident  phaimacy  in  this
State.  At its meeting on January 16,2013, the Board considered this application with a quorum
present.  Applicant  appeared  and  offered  testimony  to  supplement its  application  for  a  non­
resident pharmacy license.  .
After delibe"ration,  the  Board  voted  to DENY Applicant's request for  licensure  for  the
reasons stated in this Order.  .
FINDINGS OF FACT
1. Applicant applied for a non-resident pharmacy permit on N ~vember 27, 2012.
2. Ashley Riggs is the Pharmacy Resident.  Ms. Riggs is a licensed Pharmacist.
3. Applicant  was  issued  an  Order to  Cease  and  Desist  because  the  Augusta,  Georgia
location  (LTC)  was  shipping  medicine  to  South  Carolina  without  the  appropriate
permit.
4. Applicant applied for licensure after Order to Cease and Desist was issued.
CONCLUSIONS OF LAW
In  an  application  hearing,  "(t)he  applicant shall  demonstrate  to  the satisfaction  of the
board that the applicant meets all requirements for the issuance of a license." S.C. Code Ann.  §
40-1-130  (1976,  as  amended).  Thus,  the  burden  of proof in an  application  for  licensure  or
certification is on the Applicant to proVide full, complete, and accurate responses to all questions
on the application and to demonstrate that he or she is qualified for the license sought.
In this  case,  Applicant  violated  South Carolina Law  by  shipping  drugs  into  this  state
without a non-resident permit. Ms. Riggs could not answer many of the Board's questions as to
why the drugs were shipped to South Carolina without a non-resident permit. THEREFORE; IT  IS  ORDERED  that  Applicant's  application' for  a  non-resident
phannacy permit in this State is DENIED.
AND IT IS SO ORDERED.
SOUTH CAROLINA DEPARTME

In the Matter of: Dakota Precision Rx, Inc Compounding Labs 705 E. Main Street Ste 200 Bismark, ND 58501 ORDER TO CEASE AND DESIST


BEFORE THE STATE BOARD OF PHARMACY OF SOUTH CAROLINA

In the Matter of:
Dakota Precision Rx, Inc
Compounding Labs
705 E. Main Street Ste 200
Bismark, ND  58501  ORDER TO CEASE AND DESIST
OIE #:  2013-58  Respondent
TO THE ABOVE NAMED RESPONDENT:
WHEREAS, the Board is  charged with promoting, preserving and protecting the health, safety and welfare
of the  public  by  and  through  the  effective  control  and  regulation  of the  practice  of pharmacy,  the  licensure,
permitting, control and regulation of all sites or persons, in or out of this State, that distribute, manufacture, possess
or sell drugs or devices within this State, and
WHEREAS,  it  has  been  brought  to  the  attention  of the  South  Carolina  Board  of Pharmacy
(hereinafter  "the Board")  that  Respondent  has  distributed  legend drugs  by shipping medications  into
South Carolina.  Therefore Respondent is in violation of S.C.  Code Ann.  § 40-43-30(14), 40-43-84(A)
(Supp.2003) and Reg.99-43; and
WHEREAS, it is unlawful to engage in the sale, purchase, distribute or trade of a drug, or offer
to sell, purchase, or trade a drug, or the dispensing of a drug unless permitted in this State; and
WHEREAS, you are not currently authorized by the Board to have charge of, engage in, or carry
on, for yourself or another, the sale or distribution of prescription orders drugs anywhere within this State
pursuant S. C. Code Ann. §40-43-83 or 40-43-90; and
WHEREAS, this Order is authorized by § S.C. Code Ann.  §§  40-43-60; 40-43-1S0(B), 40­
43-140,40-1-100, and 40-1-120 (Supp. 2003).
THEREFORE,  YOU  ARE  HEREBY  NOTIFIED  AND  EXPRESSLY  ORDERED  to
immediately cease  and desist from shipping, distributing, selling, or trading prescription drugs  into the
State  of South Carolina  until  as  required  by S.C.  Code  Ann.  §  40-43-83  and  other  applicable  law as
recited above, and until such time, if ever, as you may be properly authorized by the Board in accordance
with law.
VIOLATIONS MAY BE PUNISHED BY THE IMPOSITION OF CIVIL PENALTIES IN
AMOllNTS UP TO TEN THOUSAND DOLALRS ($10,000.00)  FOR EACH VIOLATION AND
CRIMINAL  PENALTIES  WIDCH  MAY  INCLUDE  FINES  OR  IMPRISONMENT,  AS
PROVIDED BY LAW.
SOUTH CAROLINA BOARD OF PHARMACY
May 07, 2013  BY:  e~~~  Lee Ann Bundrick, R.P

In the Matter of: Clinical Specialties Compounding Pharmacy 318 Baston Road, Suite 103 Augusta, GA 30907 ORDER TO CEASE AND DESIST


BEFORE THE STATE BOARD OF PHARMACY OF SOUTH CAROLINA

In the Matter of:
Clinical Specialties Compounding Pharmacy
318 Baston Road, Suite 103
Augusta, GA  30907  ORDER TO CEASE AND DESIST
Respondent.
TO THE ABOVE NAMED RESPONDENT:
WHEREAS, the Board is  charged with  promoting, preserving and  protecting the health, safety
and welfare of the public by and through the effective control and regulation of the practice of pharmacy,
the  licensure,  permitting,  control  and  regulation  of all  sites  or  persons,  in  or  out  of this  State,  that
distribute, manufacture, possess or sell drugs or devices within this State, and
WHEREAS,  it  has  been  brought  to  the  attention  of the  South  Carolina  Board  of Pharmacy
(hereinafter "the Board") that Clinical Specialties Compounding Pharmacy, a non-resident pharmacy, has
distributed drugs by shipping medications into South Carolina and therefore is in violation of  S.c. Code
Ann. § 40-43-30(14), 40-43-90 and Reg.99-43  and
WHEREAS, it is  unlawful to engage in the sale, purchase, distribute or trade of a drug, or offer
to sell, purchase, or trade a drug, or the dispensing of a drug unless permitted in this State and
WHEREAS, you are not currently authorized by the Board to have charge of, engage in, or carry
on, for yourself or another, the sale or distribution of prescription drug orders anywhere within this State
pursuant to S.C. Code Ann. § 40-43-83 or 40-43-90; and
WHEREAS, this  Order is  authorized  by  § S.C. Code Ann.  §§  40-43-60;  40-43-150(B),  40-43­
140,40-1-100, and 40-1-120 (Supp. 2003).
THEREFORE,  YOU  ARE HEREBY  NOTIFIED  AND  EXPRESSLY  ORDERED  to
immediately  cease  and  desist from  shipping,  distributing, selling or trading  prescription  drugs  into the
State  of South  Carolina  until  as  required  by  S.C.  Code  Ann.  § 40-43-83  and  other  applicable  law  as
recited  above,  until such time,  if ever,  as  you may  be  properly  authorized  by  the Board  in  accordance
with law.
VIOLATIONS MAY BE PUNISHED BY THE IMPOSITION OF CIVIL PENALTIES IN
AMOUNTS  UP  TO  TEN  THOUSAND  DOLLARS  ($10,000)  FOR  EACH  VIOLATION  AND
CRIMINAL  PENALTIES  WHICH  MAY  INCLUDE  FINES  OR  IMPRISONMENT,  AS
PROVIDED BY LAW.
SOUTH CAROLINA BOARD OF PHARMACY
March 15,2013  BY:
Board Administrator

South Dakota Board of Pharmacy Meeting July 12, 2013 – Pierre | regular meeting and rules hearing - proposed rules


Diamond Jubilee: The Federal Food, Drug, and Cosmetic Act Turns 75! By Kurt R. Karst –

t was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, enacted by President Theodore Roosevelt less than 32 years before on June 30, 1906.  Clocking in at just under 20 pages of text, the Public Law version of the 1938 FDC Act, 52 Stat. 1049, is a far cry from the 700-plus page behemoth statute of today.  (The June 11, 1938 Conference Report on S. 5, which became the FDC Act, was also quite short – just 24 pages in length.  See our previous post on the expansion of the FDC Act and FDA regulations.)  And the statute will continue to expand with likely changes to the law concerning drug compounding and drug supply chain (i.e., track and trace) currently being debated by Congress. 
continue reading here

Question of the Day June 25, 2013 In the State of Texas Pharmacists Fill Out forms Indicating Whether they do Compounding and What Specific Kinds of Compounding Such Nuclear or Sterile.

What is the penalty or consequence when a compounding pharmacists or pharmacy fails to answer those questions or falsely answers those questions on the form?  I assume by intentionally failing to state one does compounding the pharmacy is lessening the chance of being inspected more frequently or being inspected at all.  What should be the penalty or consequence in the future?  How does the state avoid the arguments that it was merely an oversight and not intentional.  In the federal government similar offenses are prosecuted under 18 U.S.C. 1001 for providing a false statements.  Does Texas have a similar criminal offense and does the state prosecute for it?  What about other states?  How do they handle this or plan to handle it?

Hospitals Opting to Do Own Drug Compounding


Although state and federal policies haven’t changed regarding drug compounding, some hospitals plan to take matters into their own hands after last year’s deadly fungalmeningitis outbreak, the Fort Myers News-Press reports. Lee Memorial Health System is among the increasing number of hospitals that have decided to do drugcompounding within their own facilities instead of sending the medication elsewhere. Not only is it safer, according to Lee Memorial officials, but it’s also cheaper. 
source found here and Fort Myers News-Press

CPS Expands Compounding Pharmacy Inspections Comprehensive Pharmacy Services (CPS) expands it's compounding pharmacy inspection services.


Memphis, TN (PRWEB) June 25, 2013
Memphis, TN –Comprehensive Pharmacy Services (CPS), the nation’s largest pharmacy services provider, recently completed two Compounding Pharmacy inspections. CPS began receiving inquiries for compounding pharmacy audit services after being chosen by the Massachusetts State Board of Pharmacy to assist with the inspections of the commonwealth’s compounding pharmacies in the wake of the New England Compounding Center (NECC) meningitis outbreak.
U.S. Pharmacopeia (USP) compounding standards have far-reaching impact on a wide range of pharmacy policies and procedures to mitigate patient safety risks. They are designed both to reduce infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals. The CPS team conducted an audit for mediStat Pharmacy in Foley, Alabama, a national leader in compounding pharmacy services with over 5,000 prescribers and 25,000 patients. “We were looking for qualified experts to come in, assess our operations, and provide recommendations for safety procedure improvements”, said Jason Rogers, mediStat President.
CPS was also chosen by Vanderbilt University Medical Center in Nashville, Tennessee, to assist in the evaluation of potential compounding pharmacy outsourced vendors. “In light of the recent negative events affecting compounding pharmacies, VUMC wanted assurances that their patients would not be harmed through utilization of compounded pharmaceutical products. Prior to entering into any relationship with a compounding pharmacy, the medical center wanted a comprehensive inspection of the facilities and compounding practices from a company with actual experience inspecting third party compounding pharmacies for compliance,” said Sherry Umhoefer, R.Ph., DVP of Compliance and Regulatory Services for CPS.
“Companies like mediStat and Vanderbilt should be recognized for the proactive decisions they are making to improve patient care,” said Edward Choy, Pharm. D., Divisional Vice President for CPS. Choy also said he is thankful CPS had the expertise and resources available to provide compounding inspection services when the crisis occurred and hopes they can partner with other facilities to help prevent costly mistakes in the future.
About Comprehensive Pharmacy Services: CPS is the nation’s largest pharmacy services provider, partnering with more than 350 hospitals and health care facilities in 48 states (including D.C., Puerto Rico and the USVI) and employing over 1,800 pharmacy professionals. For more information, visit http://www.cpspharm.com.

Press release

Monday, June 24, 2013

Dr. Allen Explains the Difference Between Compounding and Unapproved Drugs

To read his article click
here

ASHP Comments on Draft Version of House Compounding Bill


6/24/2013


Clear lines need to be defined between traditional compounding and compounding outsourcers, ASHP told the author of a draft compounding bill set to be considered by the House of Representatives.

In a letter last week to Rep. Morgan Griffith (R-Va.), the Society noted that pharmacists who practice in hospital and health-system settings need to be assured that entities compound large scale, non-patient specific preparations are properly supervised to enable patients to receive safe medications.

The draft legislation keeps traditional pharmacy compounding, including compounding within a hospital or health system, under the authority of state boards of pharmacy. Rep. Griffith is a member of the House Committee on Energy and Commerce’s Health Subcommittee. He is expected to formally introduce the bill by the end of the month. Look for more updates on the legislation in the coming days.

Quoted from here

Arizona Board of Pharmacy Compounding Task Force Meeting June 28, 2013 Agenda

View here

Arizona Board of Pharmacy June 27, 2013 Agenda

view here

Question 2 of the Day June 24, 2013 What Changes Will Be Made to the HELP Senate Committee Version of the Compounding Legislation Before It Hits the Senate Floor? Are the rumors true is the Senate Version Gaining Support?


Justice Department sues La. pharmaceutical company; the U.S. Food and Drug Administration said it found evidence the company has been making and selling prescription painkillers and over-the-counter cold remedies and wound cleansers without obtaining FDA approval.

article found here

DOJ Press Release

Compounding Center's Safety and Cost Benefits With i.v.STATION Robot


BOZEN, Sud-Tirol, Italy, June 24, 2013 /PRNewswire/ --
Gannett's News Press yesterday released a news article including a video of how Health Robotics' i.v.STATION Robot customer LeeSar Compounding Services in Fort Myers, improved patient safety and reliability and reduced costs with the i.v.STATION Robot for seven Florida hospitals, after it started to use it in 2011: http://www.health-robotics.com/en/testimonials/
"Though safety is a big stated reason for in-house compounding at LeeSar and Lee Memorial's health centers, simple cost and supply demands also are driving much of the move here. LeeSar estimates the robotic devices produce compounded products at 20 percent lower than the cost of buying the medication elsewhere, or a difference of about $180,000 a year per machine. This is why we did it: Reliability - we could rely on these things to do it and do it right; Cost: we're saving a substantial amount of money; And safety," said Simpson, the CEO of LeeSar."
The News Press continued: "Lee Memorial Health System, which had spent about $1 million a year to buy pre-mixed products, now only spends about $50,000, said John Armistead, who oversees the organization's pharmacy services. And LeeSar, which started mixing less than two years ago, on Friday ordered its third robotic compounding device, each retailing for about $400,000."
"To help with its own quality control, LeeSar recently recruited a safety expert from Bristol-Myers Squibb and has put its robot devices in environmentally controlled rooms that exceed the devices' safety protocols, said Kenneth Greco, executive director of LeeSar's pharmaceutical services. All robotically compounded products are stored for two weeks, while samples of each batch are shipped off of lab testing to make sure no contaminated products are released, Greco said. So far, none have, he said. Aside from equipment cleaning and handling, human error is largely removed from the equation, he said. The checks and balances are really good, said Greco, and you don't have to rely on the variances of person to person."
The News Press continued: "Contaminated batches of injectible steroids prepared at the Massachusetts-based New England Compounding Center were linked to about 700 cases of fungal infections, including meningitis, in 20 states. More than 50 associated deaths were reported, including five in Florida. Instead of outsourcing all this drug mixing, health systems are opting more and more to just do it themselves. A report in April by the U.S. Department of Health and Human Services found that 56 percent of sampled U.S. hospitals are planning to change pharmacy practices and drug purchasing as a result of the NECC scandal. Here at LeeSar, a Fort Myers-based medical supplier that Lee Memorial Health System partially owns, devices like i.v.STATION produce about 600 suchcompounded IV solutions and injectables a day for patients at seven Florida hospitals."
In 2013, at least 50 Pharmacy FDA inspections have taken place after the fatal meningitis events, closures and recalls at compounding pharmacies, including the recent inspections of four compounding facilities operated by the largest provider (PharMedium), with troubling results made available by the FDA on its website.
About Health Robotics:
Founded in 2006 and now reaching 80% total IV Robots market share in the world [including over 90% the Oncology Robots global market], Health Robotics is the undisputed leading supplier of life-critical intravenous medication robots, providing mere than 400 hospital installations in 5 continents with the only fully-integrated Robotics-based technology, IV Workflow, and manual compounding software automation solutions. Health Robotics' second generation products [i.v.STATION, i.v.SOFT, and i.v.STATION ONCO] have been found [through scientific and peer-reviewed studies([) (1) (]) (,) ([) (2) (]) ] to greatly contribute to ease hospitals' growing pressures to improve patient safety([1]) , increase throughput, and contain costs([) (1) (]) . Through the effective and efficient production of sterile, accurate, tamper-evident and ready-to-administer IVs, Health Robotics' medical devices and integrated workflow solutions help hospitals eliminate life-threatening drug([) (1) (]) and diluent([) (1) (]) exchange errors, improve drug potency([2]) , decrease other medical mistakes and sterility risks, work more efficiently([) (1) (]) , reduce waste and controlled substances' diversion, and diminish the gap between rising patient volume/acuity and scarce nursing, and pharmacy staff. For more information, please visit: http://www.health-robotics.com
For additional information, please contact: Luisa Celeghin, celeghin@health-robotics.com, +39-0403-498-468
--------------------------------------------------
1. Impact of Robotic Antineoplastic Preparation on Safety, Workflow, Costs. Seger, Churchill, Keohane, Belisle, Wong, Sylvester, Chesnick, Burdick, Wien, Cotugno, Bates, and Rothschild. Brigham & Women's Hospital, Massachusetts College of Pharmacy, and Harvard Medical School. Journal of Oncology Practice, Nov. 2012, Volume 8, number 6.
2. Validation of an automated method for compounding monoclonal antibody patient doses: case studies of Avastin(R), Remicade(R), and Herceptin(R). Peters, Capelle, Arvinte, van de Garde. St. Antonius Hospital. mAbs January 2013, Volume 5, Issue 1.
SOURCE Health Robotics

Update on the Status of the Law of Compounding Medications and Drugs Blog


Pageviews by Countries

Graph of most popular countries among blog viewers
EntryPageviews
United States
2852
China
528
Poland
180
Ukraine
152
United Kingdom
116
France
97
Germany
89
Japan
35
Russia
33
Netherlands
31

In a little over a year, the Law of Compounding Medications and Drugs Blog has been more successful than I ever imagined.  Over 150,000 views, about 100 countries viewing it, and well over 4000 posts.  My initial reason for doing the blog disappeared rather quickly after starting the blog and a bigger and better reason--educating and working for reform and safety in this area--came along.

At times I struggled as to whether to continue or just let it go and move on as I have written about before. The blog has taken more of my time than I had ever expected or planned.  My family who initially encouraged me and supported me on the blog are now starting to beg me to not spend so much time on it or stop all together.  And just when I decide I am going to stop, one of you sends me a note or we talk, and your encouragement and kind words of how resourceful the blog is to you keep me going--even when you say I don't agree with you about a particular issue.  I have made so many wonderful friends across the United States who are far greater experts about compounding.  I have learned so much from you.  You each have added a piece to the puzzle of the law of compounding.  Thank you for all that you have taught me.

Tennessee Board of Pharmacy May 2013 Discipline Report

found here

Vermont Board of Pharmacy Disciplinary Action from 2002 to present



Abel Jr., Richard RX07-0705 January 26, 2007
Aetna Specialty Pharmacy LLC 2011-598 December 7, 2011
Aimi, William RX11-0806 January 24, 2008
Alter, Howard RX01-0103 April 13, 2004
Armstrong, David 2009-457 July 25, 2012
Atwood, Christy RX47-0605 September 29, 2005
Aubut, Katelynne 2009-88 October 29, 2009
Bandana Trading, Inc. 2011-595 January 25, 2012
Bandana Trading, Inc. RX15-0807 March 27, 2008
Bardshar, Patricia RX15-0906 December 10, 2007
Barker, Richard RX16-0601 April 27, 2006
Barton Pharmacy RX23-1208 February 1, 2010
BET Pharmacy RX05-0807 January 24, 2008
Brauer, Joann RX16-1104 June 22, 2005
Breen Jr., Willis RX12-0104 December 2, 2004
Bressel, Cody RX09-0806 January 26, 2007
Brooks Pharmacy #368 RX15-1105 May 22, 2006
Brooks Pharmacy #413 RX26-0205 December 8, 2005
Brooks Pharmacy #807 RX27-0604 December 2, 2004
Brooks Pharmacy #834 RX14-0906 December 10, 2007
Bryan, Hugh RX15-0303 December 4, 2008
Bushee, Jason M2010-86 September 1, 2010
Bushee, Jason APP-RX03-0705 September 29, 2005
Carlin, Benjamin 2012-290 August 22, 2012
Carpenter, Kenneth F. RX31-0306 August 17, 2007
Carpenter, Kenneth F. RX10-0202 June 26, 2002
Champine, Kayce RX47-1206 September 20, 2007
Clinkscale, Robert RX14-0203 March 30, 2006
Cohen, Jeffrey 2011-516 October 24, 2012
College Pharmacy, Inc. 2011-367 September 28, 2011
Comeau, Stephen 2009-332 March 23, 2011
Comeau, Stephen RX60-0107 March 27, 2008
Comeau, Stephen RX48-0605 April 27, 2006
Corey, Emery 2010-55 September 23, 2010
Corner Drug Co., Inc. RX16-0906 January 24, 2008
Crease, Albert 2011-349 September 28, 2011
Crease, Albert M2012-9 January 23, 2013
Crystal, Robert M2010-36 December 8, 2011
Crystal, Robert APP-RX22-0205 September 29, 2005
DeFranco, Thomas RX13-0203 March 25, 2004
DeFranco, Thomas 2009-198 September 23, 2009
DeFranco, Thomas M2010-13 December 2, 2010
Deno, Carol ULP-RX30-0306 May 18, 2006
Derry Pharmacy RX12-1004 February 24, 2005
Dimick, Tara* RX30-0109 October 29, 2009
Doltz, Frederick* 2009-408 April 27, 2011
Drumm, Deborah RX16-0303 May 28, 2003
Dufort, Michael RX06-0902 September 25, 2002
Dunham, Robyn 2009-142 June 25, 2010
Durham, James RX08-1201 January 24, 2002
Ebelt, Patty RX45-1106 April 26, 2007
Edson, Robert RX46-1106 May 17, 2007
Enosburg Pharmacy RX61-0107 March 27, 2008
Enosburg Pharmacy RX49-0605 April 27, 2006
Fausel, Edward RX11-0905 February 24, 2006
Fisher, Janet 2011-854 July 25, 2012
Fletcher Allen Health Care Pharmacy 2011-492 May 30, 2012
Forkey, Jeffrey RX43-0506 December 6, 2006
Forkey, Jeffrey RX73-0507 December 10, 2007
Fortier, Thomas 2013-11 May 15, 2013
Frank, Seth RX48-1206 July 25, 2007
Frontier Pharmacy ULP-RX19-1205 May 18, 2006
Govendo, Jacie RX06-1003 August 9, 2004
Greater Falls Pharmacy RX10-0805 May 23, 2006
Haggett, Amy 2010-94 October 27, 2010
Hannaford Food & Drug #303 RX51-0308 July 23, 2009
Hannaford Food & Drug #355 RX52-0308 June 25, 2009
Hannaford Food & Drug #355 M2010-43 May 30, 2012
Hanson, Jeannette ULP-RX29-0306 May 18, 2006
Hanson, John ULP-RX28-0306 May 18, 2006
Henderson, Rhonda J. RX04-1001 May 17, 2002
Harbor Pharmacy RX06-0705 January 26, 2007
Harry's Discount Pharmacy RX15-0204 November 1, 2004
Harry's Discount Pharmacy RX04-0704 June 22, 2005
Harvie, Richard RX21-0304 November 22, 2004
Hightower, Travis 2009-573 April 29, 2010
Hochberg, Steven RX10-1202 January 28, 2004
Hoeppner, Philip 2011-1 May 18, 2011
Hollister, Steven RX53-0308 February 2, 2009
Huntress, Jeff M2009-117 July 27, 2011
Huntress, Jeff RX42-0108 February 2, 2009
Illingworth, Gary RX34-0306 May 17, 2007
Immediate Pharmaceutical ULP-RX14-0104 June 1, 2004
Kelly, Michael RX06-0904 March 14, 2005
Kelley, Heather RX12-1005 December 6, 2006
Kendall, Lisa RX35-0306 August 23, 2006
Kinney Drugs, Inc. #11 2010-132 February 23, 2011
Kinney Drugs, Inc. #69 RX18-0204 September 24, 2004
Kinney Drugs, Inc. #93 RX72-0608 February 1, 2010
Knightes, David M2011-132 October 21, 2011
Knightes, David* 2011-122 August 24, 2011
Koch, Cynthia M2009-83 January 25, 2012
Koch, Cynthia* RX06-0807 March 26, 2009
Lakeridge Pharmacy ULP-RX16-0204 June 28, 2004
Lakeside Pharmacy Inc. RX42-0505 November 3, 2009
Lakeside Pharmacy Inc.* 2009-455 November 7, 2011
Lakeside Pharmacy Inc.* M2010-12 November 14, 2012
Lemire, Erica 2011-443 December 7, 2011
Lincare Pharmacy Inc. APP-RX07-0904 February 17, 2005
Little, David RX08-1002 November 7, 2003
Mackin, Benjamin 2009-143 February 1, 2010
Mango, Lawrence RX66-0408 March 26, 2009
Marble Works Pharmacy 2011-337 January 25, 2012
Marchelewicz, John RX06-1299 October 10, 2001
Marchelewicz, John* RX11-1203 September 20, 2007

Vermont Board of Pharmacy May 15, 2013 Unapproved Minutes--Default Hearing for Royal Palm Compounding Pharmacy Continued


BOARD OF PHARMACY – Unapproved Minutes
Secretary of State, Office of Professional Regulation
23 College Street, Schulmaier Hall, Montpelier, VT 05602
May 15, 2013 at 9:00 A.M.
1. The meeting was called to order at 9:01 a.m.
Members Present: Ms. Julie A. Eaton, RPh, Vice-Chair; Mr. Steven M. Vincent, RPh; Mr. Larry
Labor RPh; Mr. King Milne, RPh; and Mr. James Arisman, Esq., Public Member.
Members Absent: Mr. Jeffrey P. Firlik, RPh, Chair and Ms. Judith Wernecke, Public Member,
Secretary
OPR Personnel Present: Mr. Larry S. Novins, Board Counsel; Mr. Colin Benjamin, Board
Counsel; Mr. Ed Adrian, Prosecuting Attorney; Mr. Dan Vincent, Inspector; Mr. Ronald Klein
RPh, Executive Officer; and Ms. Aprille Morrison, Licensing Board Specialist.
Others Present: Mr. Theo Kennedy, Esq. and Mr. Mike Fish
2. The Vice-Chair called for approval of the Minutes of the April 24, 2013 meeting as presented.
Mr. Labor made a motion to accept the minutes with corrections. The motion was seconded by
Ms. Eaton. Motion passed.
3. Hearings/Stipulations et al:
9:15 am – Stipulation and Consent Order Re.: Thomas Fortier, Docket # 2013-11. Mr. Labor
made a motion to accept the Order as presented. The motion was seconded by Ms. Eaton. Mr.
Vincent did not participate in the hearing as he was the Investigative Team member. The motion
passed.
9:15 am – Summary Suspension Re.: Kelly Conn, Docket # 2013-212. Ms. Conn participated in
the hearing by telephone. Prosecuting Attorney for the State, Ed Adrian, informed the Board that
he had spoken with Ms. Conn the previous day and that she would like to voluntarily surrender
her pharmacist license. Mr. Adrian requested the Board accept Ms. Conn’s request. Mr.
Arisman made a motion to accept Ms. Conn’s request for voluntary surrender of her Pharmacist
license. Mr. Vincent seconded the motion. Motion passed. Mr. Adrian dismissed the Summary
Suspension Order. The Board requested Ms. Conn return her paper copy of her license to the
Board within the next seven (7) days.
Mr. Adrian informed the Board that the Default hearing that was on the agenda for Royal Palm
Compounding Pharmacy, docket # 2010-391, was continued. The hearing will be set for a later
Pharmacy Board meeting.
4. Report of Concluded Investigation:
Report of Concluded Investigation for 2010-682. Ms. Eaton made a motion to reject the report.
The motion was seconded by Mr. Arisman. Mr. Vincent did not participate in the vote as he was
the Investigative Team member. Motion passed. The Board did not feel it was appropriate to
close the case as the pharmacist manager in this case did not follow proper reporting
procedures regarding drug losses.

Vermont Board of Pharmacy June 26, 2013 Agenda

view here

2013 IACP State Legislative Tracker--Note this Tracks More than Just Changes to State Laws Relating to Compounding

to view click here

The Law of Compounding Medications And Drugs: Question of the Day: June 24, 2013 Shouldn't the...

The Law of Compounding Medications And Drugs: Question of the Day: June 24, 2013 Shouldn't the...

Question of the Day: June 24, 2013 Shouldn't the Pharmacists Responsible for a Compounding Pharmacy Being Disciplined Also Always Be Disciplined By the State Board of Pharmacy? Shouldn't the Owner of the Pharmacy if a Pharmacists Also Always Be Disciplined? What is the Point of Disciplining the Pharmacy when Compounding Pharmacists Can Simple Move to Another Pharmacy Such as Has Been Done in Apothecure and Franck's?


Question of the Day June 23, 2013 Does the Law of Supply and Demand Dictate That There Are Too Many Compounding Pharmacies Nationwide To Compete For the Market And Thus Legislation or Regulations Are Needed to Reduce the Number of Compounding Pharmacies?

AVMA July 2013 Issue Addresses Stability of Three Commonly Compounded Extemporaneous Enrofloxacin Suspensions


Stability of three commonly compounded
extemporaneous enrofloxacin suspensions
for oral administration to exotic animals
Enrofloxacin has been used in many exotic animal species, but
no oral suspensions of enrofloxacin are currently commercially
available. Thus, compounded formulations are often used. In
a study of the stability of 3 extemporaneous oral suspensions
of enrofloxacin mixed with readily available flavoring vehicles
and stored at room temperature in amber vials, the enrofloxacin
concentration in all 3 formulations was retained within acceptable limits (ie, 90% to 110% of the nominal concentration) for
up to 56 days. Subjectively, cherry syrup flavoring was better at
masking the smell and taste of enrofloxacin than was corn syrup
or liquid sweetener. See PAGE 85

quoted from here

Fungal Outbreak May Still Threaten NJ Patients, Nine Months Later Uncertainty reveals shortcomings, frustrations associated with state healthcare system

By Andrew KitchenmanJune 24, 2013 in Healthcare 

Nine months after more than four dozen New Jerseyans got sick from the largest healthcare-associated fungal outbreak in U.S. history, state officials still aren’t sure if there will be more cases.
That is one of several open issues that continue to be monitored concerning the incident, which led to a range of illnesses including fungal meningitis and strokes.
“Patients are still at risk, even though it’s many months after the incident,” said Dr. Barbara Montana, the medical director for the state Department of Health communicable disease service.
The outbreak, which began last September due to contaminated steroid products from Massachusettscompounding pharmacy New England Compounding Center (NECC), led to 51 New Jersey residents becoming ill, including some who have suffered long-term damage.
Montana discussed the response to the outbreak at an event focused on reducing healthcare-associated infections hosted by the Healthcare Quality Professionals of New Jersey at the New Jersey Hospital Association office in West Windsor.
The steroid products were used in injections in six New Jersey facilities. The infections were concentrated at two Cumberland County centers.
The longest time thus far recorded between a New Jersey patient receiving an infected shot and becoming sick is 228 days, according to state officials. This extended period has made it a challenge to keep track of all of the patients who received the shots.

Sunday, June 23, 2013

More drug-mixing done in Southwest Florida, thanks to scare

June 22, 2013 Written by Frank Gluck
The device vaguely resembles a high-tech vending machine, though the robotic arm and syringes behind its display glass are clear giveaways that it doesn’t dispense soft drinks.
Most commonly, it’s actually producing mixed pharmaceuticals and intravenous solutions like magnesium sulfate, a drug used for hospital patients needing to replenish their electrolytes or those needing an anti-convulsant.
Here at LeeSar, a Fort Myers-based medical supplier that Lee Memorial Health System partially owns, devices like this produce about 600 such mixed, or “compounded” IV solutions and injectables a day for patients at seven Florida hospitals. And, given drug shortages and recent deadly contamination scandals at drug mixing facilities elsewhere, business here is expected to grow.

continue to read here