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Sunday, June 30, 2013

The Law of Compounding Medications And Drugs: Compounders Still Disappointed at Latest Senate Ve...

The Law of Compounding Medications And Drugs: Compounders Still Disappointed at Latest Senate Ve...: Senate Health Committee Updates Compounding Bill, But Concerns Persist Drug compounders -- expressing disappointment in the latest vers...

Compounders Still Disappointed at Latest Senate Version of Compounding Bill


Senate Health Committee Updates Compounding Bill, But Concerns Persist

Drug compounders -- expressing disappointment in the latest version of the Senate compounding bill -- said the legislation further bolsters FDA's authority and favors the drug industry.
source found here

Links to Pending Legislation in Congress Relating to Compounding

strengthen regulation of compounding drugs by pharmacies (see S. 959), S3531 [15MY] (see H.R. 2186), H2954 [23MY]

source Thomas

Push Back on Harvard Pilgrim Compounding Policy Change


(Daily News - 06-25-2013)
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.
quoted from here

ALABAMA STATE BOARD OF PHARMACY Next Board Meeting Wednesday July 17, 2013


IACP Comments on House Draft ComIpounding Bill


Last week, IACP was asked to submit comments on a House draft bill being put forth by U.S. Representative Morgan Griffith (R-VA)Please click here to read IACP's comments.

IACP's Latest (June 27, 2013) Summary on the Senate HELP Committee Version of the Compounding Bill--and Copy of Latest Draft


Senate Releases Revised Compounding Bill, Today

The Senate has just released its revised version of the Compounding Bill. Please click here to review. The IACP Legislative Team currently is reviewing this Bill line-by-line, and will provide a comprehensive report as soon as completed. Please see IACP's initial comments below:
Initial Summary
The language in S. 959 released on Thursday, 27 June 2013 includes the following:
  • A definition that all compounded drugs are "new drugs" as defined within the FDCA (page 57)
  • Defines the repackaging and distribution in interstate commerce of sterile drugs without individual patient prescriptions as the activities of a "compounding manufacturer." (page 59)
  • Provides for anticipatory compounding only in instances where the historical volume is directly associated with an individual patient prescription (page 64)
  • Hospitals and health-systems with wholly owned inpatient and outpatient facilities are exempted from being considered compounding manufacturers even if they ship interstate (page 66)
  • Traditional compounding is exempted from the "new drug" requirements of an NDA/ANDA and the AERS if the pharmacy is in full compliance with this section of the law as well as state law. (page 66)
  • The FDA may develop a "do not compound" list based upon "demonstrably difficult" criteria (which is undefined).  (pages 68/69)
  • The FDA may develop a "do not compound" list for drugs which are currently under a REMS when produced by manufacturers (page 69)
  • Compounding of "commercially available" products are restricted to "documented clinical differences" for an individual identified patient or, if in drug shortage, subject to a 3 day notification to the FDA requirement (page 72-74)
  • Compounding manufacturers who are preparing drugs that are in shortage must notify the FDA 14 days in advance before preparing any compounds.  (page 73)
  • The repackaging of a currently marketed drug into a format/dosage form that is also currently marketed (e.g., Avastin and Lucentis) is prohibited.  (page 74)
  • Prior to compounding a medication under REMS may only be done so with prior advance proof and submission to the FDA that the pharmacy is capable of meeting the REMS requirements (page 77)
  • API-based compounding must still be upon the existence of a monograph or when using a drug product that appears on a list to be established by the FDA.  No mention is made of other nationally recognized compendia (e.g., homeopathic medicines).  (Page 77)
  • The FDA is empowered to prohibit the compounding of a preparation with an API-based ingredient even if there is a monograph published in the FDA (Page 80)
  • The GAO will prepare an analysis and report on veterinary compounding. (page 106)
  • False and misleading advertisements of a compounded preparation by either a traditional compounder or manufacturer has defined penalties (107)
References to compliance with USP standards that appeared in an earlier draft have been removed.  No language provided by IACP to preserve the ability of prescribers to order "office-use" medications was included.
quoted from here

IACP P2PC Offering Free Postcard Download to Members to Send to Patients-wants to increase advocacy group from 164,000 to 200,000 this year


IACP P2PC Has the following downloads available:
Pharmacy Compounding - General
Compounding for Bio-identical Hormone Patients
Compounding for Veterinary Patients
Compounding for Pediatric Patients
Compounding for Geriatric Patients

Go to IACP website to download

Is The DEA Targeting Anyone And Everyone… http://www.jimplagakis.com/?p=6359


Pharmacy Practice News - Some MDs Blame GPOs for Chronic Drug Shortages

Pharmacy Practice News - Some MDs Blame GPOs for Chronic Drug Shortages

TN pharmacy board sets July meeting Jun. 29, 2013 |


he Tennessee Board of Pharmacy will take disciplinary actions and consider requests for reinstatement of licenses when it meets July 9 and 10.
The meeting occurs as new rules are coming into effect allowing the state to take quicker action against a compounder’s license when a serious safety issue arises. The board has had to deal with two outbreaks in the past year stemming from contaminated medicines made by compounding labs.
July’s meeting begins at 9 a.m. July 9 in the Iris Room at 227 French Landing. The second day begins at 8 a.m. July 10 at the same location.
Other new rules recently instituted by the board create a separate licensing category for medicine manufacturers, require proof that a manufacturer is registered with the U.S. Food and Drug Administration and require special registration whenever any pharmacy — whether retailer, manufacturer or wholesaler — performs sterile compounding.
The board began looking at its rules following the fungal meningitis outbreak that began last summer. A more recent outbreak underscored the need for better regulations.
While the fungal meningitis outbreak, which was first discovered in Tennessee, was traced to a steroid made by Massachusetts-based New England Compounding Center, another outbreak of what have thus far been less serious illnesses involving the same medicine has been linked to a Tennessee-based operation, Main Street Family Pharmacy in Newbern.
Contact Tom Wilemon at twilemon@tennessean.com or 615-726-5961.
quoted from here

Medication shortages: 'Truly a public health crisis'


Marie McCullough, Inquirer Staff Writer POSTED: Sunday, June 30, 2013, 6:32 AM Rationing medical care is denounced as immoral in the United States, yet it goes on daily in hospitals, clinics, nursing homes, ambulances, and pharmacies. Since 2006, this country has had worsening shortages of sterile generic injectables - drugs given by shots or intravenously. Currently, more than 300 medicines crucial to treating cancer, infections, cardiac arrest, premature infants, pain, and more are in short supply.
Read more at http://www.philly.com/philly/health/20130630_Medication_shortages___Truly_a_public_health_crisis_.html#idTHsRwivo5euUCv.99

Characterization 101: Spinning Like the Tornados in Oklahoma, the Media Sure Knows How to Put the Worse Spin on News Relating to the FDA When It Comes to Compounders, Compounding Pharmacists and Compounding Pharmacies: Be Careful What You Believe the Truth to Be

June 30, 2013
by  Sue Tuck Richmond

The day was like any other except by the time I had reach my daughter's school parking lot I received a text from her saying the school was in lock down. The meteorologists had been warning us for days that Oklahoma might have an outbreak of tornadoes that day.  I had survived the 1999 tornado while barely pregnant with my daughter, with the tornado coming right over my house. The destruction then to houses in our area was unreal.  The only question today was whether the meteorologists were going to be right.

Parents in the parking lot started running.  I ran to the school gym.  A grandmother and I decided we would rather be in the school with the kids so we headed for the main building, and just as I made it to the office the city sirens went off, and school officials said get in a class room and under a desk NOW!  Under the desk, I prayed first, then learned my daughter was across the hall under a mattress.  It was hit or miss as to when she could get my text or I could get hers.  Calls to her failed. I was told that the tornado was headed straight for my son's school, and then it was to  hit my daughter's school.

It seem like I was under that desk forever, but it was probably less than an hour.  The tornado missed my daughter's school, and we were allowed to leave.  I left not knowing if the tornado had hit my son's school or my house.  I only knew it had taken out two elementary schools.  By luck at this point, I was able to get to my son's school in a short amount of time even though poles were down, lights were out, chaos was everywhere, and debris was flying. I was so happy to see my son standing outside with his principal and teacher at his school waiting on me.  We had no power at home, but we had a home.  Some of our friends were not so lucky.
 
Media from all over came to Oklahoma to cover the story.  There was no spin put on the destruction, the media told the truth, but at the same time, it was very hard to characterize.  The pictures show some of the destruction, but until you actually drive through the neighborhoods and see it for yourself, you really cannot comprehend the devastation that this tornado caused that day.  And even at that you would have had had to know what it looked like before...where those schools, homes, businesses and trees stood; otherwise, you still would not believe the damage done that one afternoon.  There is still much of the mess left to clean up.

I have written  Misleading 101: Don't Leave It to Speculation-Set The Record Straight and Tell the Truth before on the blog.  I have not addressed the spin the media is putting on these compounding issues.  One of the latest headlines indicated that the FDA wants to shut down Med Prep Consulting for good. Another said that the FDA was making an example of one compounder in taking legal action.  During and after the NECC meningitis outbreak, the media criticized the FDA for not doing something.  Now they are being criticized because they are doing something to prevent future harm to the public.  As I have suggested before to the compounding organizations, media and public you cannot have it both ways: on one hand criticizing the FDA for not taking action and then also criticizing the FDA when they do take action.  You either want and believe the FDA should take action in specific situations similar to the NECC meningitis outbreak or you don't.  And media when you spin up the stories about compounding like an Oklahoma tornado and mischaracterize what is actually being done, you cause destruction like was done in May in Oklahoma--and it takes along time to clean up the mess. Please read and understand the action the FDA took recently.  Specifically note the compounding pharmacy admitted the conduct and entered into a consent decree with the FDA and there are things the compounding pharmacy can do to come into compliance.  Readers please be careful and read media reports with a questioning mind as to whether or not a reporter is putting a spin on a story and not really telling you the truth or at least the entire truth.

.

Friday, June 28, 2013

Drug Integrity and Supply Chain Security Letters to Doctors about Suspect Prescription Drugs Distributed by Medical Device King

Drug Integrity and Supply Chain Security Letters to Doctors about Suspect Prescription Drugs Distributed by Medical Device King

SCOTUS Bartlett Decision Highlights Instability Of Federal Pre-emption Law



The Supreme Court's decision Monday (June 24) that federal law pre-empts state law in the case of a generic design defect claim highlights the instability of this area of the law and could prompt Congress to re-examine the issue, attorneys said.

quoted from here

United States Senate HELP Committee Updates Compounding Bill--Compounders Still Not Happy


Senate Health Committee Updates Compounding Bill, But Concerns Persist

Drug compounders -- expressing disappointment in the latest version of the Senate compounding bill -- said the legislation further bolsters FDA's authority and favors the drug industry.

source found here

NCPDP WG10 Specialty and Compound Pharmacy Task Group


NCPDP WG10 Specialty and Compound Pharmacy Task Group
7/1/2013 - 7/1/2013   
10:30am Pacific, 11:30 am Mountain, 12:30 pm Central, 1:30 pm Eastern
more information here

Tricare to stop covering some compounded prescription drugs-changed effects 44000 Tricare beneficiaries; Tricare received roughly 500,000 compound claims from beneficiaries in 2012, worth $330 million.


Starting July 24, Tricare will no longer cover compounded prescriptions drugs that contain ingredients not approved by the Food and Drug Administration.
Tricare pharmacy benefit manager Express Scripts sent letters this month to 44,000 Tricare affected beneficiaries notifying them of the change.
The beneficiaries will have to speak with their doctors about alternatives, or to their pharmacist to determine whether their formula can be altered to comply with the new requirement.
Compounded medications are tailored for individuals by pharmacists, combining a conventional medication with other ingredients to tweak a dosage, change delivery (from a pill to a liquid or liquid to a patch, for example) or eliminate an allergen.
Many compounded prescriptions use inert ingredients such as bulk chemicals and powders that are not subject to FDA approval, and by law, Tricare is barred from providing prescription drug coverage for compounds with unapproved ingredients, Tricare spokesman Austin Camacho said.
The move also protects the beneficiary, he added: “Most bulk chemicals and bulk powders are not subjected to FDA approval, therefore their safety and effectiveness is not established.”
Tricare decided to stop reimbursing claims for these medications because recent changes to federal standards for pharmacy claim submissions have led to an increase in oversight of all pharmacy claims, including those in government and commercial plans.
The new standards “have increased the visibility of what is contained in a compounded prescription” and Tricare now has the ability to identify compound prescription claims that contain a non-approved ingredient, Camacho said.
Tricare received roughly 500,000 compound claims from beneficiaries in 2012, worth $330 million.
Camacho stressed that Tricare is not halting all reimbursements for compounded prescriptions, just those with unapproved ingredients or not subject to FDA approval, such as vitamins and dietary supplements.
“This is a vital service that helps many people, including those who need medications that are not available commercially and others who are allergic to inactive ingredients in FDA-approved medicines,” Camacho said.
quoted from here

Compounding Animal Drugs from Bulk Ingredients: Not Prohibited by Federal Food Drug and Cosmetic Act, Affirmed as Recently as 2011 June 28, 2013 - See more at: http://www.mcguirewoods.com/Client-Resources/Alerts/2013/6/Compounding-Animal-Drugs-Bulk-Ingredients.aspx#sthash.ztsQGwz4.dpuf


Compounding Animal Drugs from Bulk Ingredients: Not Prohibited by Federal Food Drug and Cosmetic Act, Affirmed as Recently as 2011

June 28, 2013
The Federal Food Drug & Cosmetic Act (FD&CA) gives FDA broad, wide and far-reaching regulatory powers. Prohibiting the compounding of medicines from bulk ingredients, however, is not one of them. The position that the FD&CA prohibits pharmacists from compounding animal drugs from bulk ingredients is simply incorrect.
A federal district court, the only court to review the issue, explicitly rejected the position that the FD&CA prohibits pharmacists from compounding animal drugs from bulk ingredients:
The undisputed evidence … shows that allowing the FDA to enjoin a pharmacist’s traditional, state-authorized practice of bulk compounding of animal drugs could destabilize the pharmacy profession and leave many animal patients without necessary medication. Such a result would be especially troublesome because the FDA’s longstanding policy has been to permit, and even promote, pharmacists’ compounding from bulk ingredients. The FDA cannot simply upset the expectations it helped to create through decades of inaction without explanation, especially where it asserted expansion of authority impacts the federal-state balance and potentially subjects many individuals and companies to criminal liability.
United States v. Franck’s Lab, Inc., et al. (816 F. Supp. 2d 1209 (M.D. Fl. 2011) (emphasis added)).
The FDA’s Historical Regulation and Enforcement of Compounding with Bulk Substances Further Questions the Implied FD&CA Prohibition
1938For approximately the first 50 years after the enactment of the FD&CA in 1938, the FDA generally left regulation of compounding to the states.
1988United States v. 9/1 Kg. Containers (854 F.2d 173 (7th Cir. 1988)) held that bulk ingredients suppliers could not sell to veterinarians except for specific circumstances. The case did not mention selling to pharmacists and courts have distinguished 9/1 Kg. Containers as being inapplicable to pharmacists.
1989United States v. Algon Chemical, Inc., (879 F.2d 1154 (3rd Cir. 1989)) held that bulk ingredients suppliers could not sell to veterinarians except for specific circumstances. The case did not mention selling to pharmacists and courts have distinguished Algon Chemical, Inc. as being inapplicable to pharmacists.
1992The 1992 Compliance Policy Guide listed nine noninclusive activities that the FDA believed improperly crossed the line between “pharmacist” and “manufacturer.” Compounding drugs from bulk substances was not among the nine prohibited practices.
1994Animal Medicinal Drug Use Clarification Act (AMDUCA) – The FDA regulations promulgated to implement AMDUCA. The regulations did not purport to regulate the practice of compounding and instead point to the FDA’s nonbinding guidance documents regarding compounding. Further, the regulations distinguish between nonfood-producing animals and food-producing animals. With regard to nonfood-producing animals, the regulations state: “[b]ecause extralabel use of animal and human drugs in nonfood-producing animals … does not ordinarily pose a threat to the public health, extralabel use of animal and human drugs is permitted in nonfood-producing animal practice except when the public health is threatened.”
1996The 1996 Compliance Policy Guide listed 13 situations that would likely indicate compounding subject to regulatory action. Compounding from bulk drug substances for use in nonfood animals was expressly identified as a “compounding situation [which] would not ordinarily be considered a regulatory action.” Compounding from bulk drugs for use in food animals, however, was one of the listed scenarios. The FDA noted in the Guide that there was “occasionally a need to utilize … bulk drug substances for compounding into an appropriate dosage form.” The FDA would thus condone compounding animal drugs from bulk where (1) a legitimate medical need was identified; (2) there was “a need for an appropriate dosage regimen” for the patient’s species; and (3) there was “no marketed approved animal drug” that “may treat the condition diagnosed in the available dosage form.” The FDA asserted in the Guide that “two Federal Appeals Court decisions, Algon and 9/1 kg. Containers, affirmed the FDA position that the FD&CA does not permit veterinarians to compound unapproved finished drug products from bulk drugs unless the finished drug is not a new animal drug. The principle established by the court applies equally to compounding by pharmacists.” Notably, the FDA similarly asserted in the Guide that compounding a new animal drug from “an approved … human or animal drug” would result in a violation of the FD&CA, but acknowledged that this would no longer be the case when the AMDUCA became effective.
1997The Food and Drug Modernization Act of 1997 (FDAMA) authorized pharmacists to compound drug products “using bulk drug substances” so long as the bulk drugs comply with the applicable USP monograph or if no monograph exists, the bulk drugs are components of drugs approved by the FDA.
2000In FDA v. Brown & Williamson (529 U.S. 120 (2000)), the Supreme Court found that in certain circumstances, a literal reading of a broadly drawn public health statute (specifically, the FD&CA) should be rejected when it encompasses conduct that exceeds the original congressional intent. The Court declared that “Congress could not have intended to delegate a decision of such economic and political significance to an agency in so cryptic a fashion” and the Court found that the FDA’s claim to jurisdiction contravened the clear intent of Congress.
2002In Thompson v. Western States (535 U.S. 357 (2002)), the Supreme Court noted the importance of compounding and agreed with the government’s position that because obtaining FDA approval for a new drug is a costly process, it would as a practical matter “eliminate the practice of compounding and thereby eliminate availability of compounded drugs for those patients who have no alternative treatment.” Although the Supreme Court invalidated the advertising provisions of the FDAMA, the Court found that “it would not make sense to require compounded drugs created to meet the unique needs of individual patients to undergo the testing required for the new drug approval process.” Furthermore, the Supreme Court expressly acknowledged the historical importance of traditional pharmacy compounding and openly questioned whether Congress could have intended to subject compounded drugs to the FD&CA’s new drug approval process.
2002The 2002 Compliance Policy Guide addresses human drugs, but allows use of compounding from bulk for human drugs so long as the bulk ingredients are FDA-approved.
2003The 2003 Compliance Policy Guide addresses animal drugs. FDA did not publish the Guide in Federal Register or invite public comment. More than 70 members of Congress wrote separately to the FDA reiterating policy concerns of the 2003 Guide regarding compounding from bulk substances. While the 2002 Guide permits compounding of human drugs from bulk substances under certain circumstances, the practice was entirely prohibited for animals, except for nine listed exceptions, by the 2003 Guide. Further, while the 1996 Guide acknowledges the occasional utility of compounding from bulk, this was absent in the 2003 Guide. Note the disparate treatment of human and animal compounding: Under the 2002 and 2003 Guides, “a pharmacist who compounds medication from bulk for ingestion by a horse is … subject to an FDA enforcement action, while the same pharmacist compounding medication from bulk for ingestion by the human rider of that horse is not.”
2004FDA issued notice of revising the 2003 Guide but has never taken action to revise it. In 2005, 26 senators and 72 congressmen reiterated their displeasure over the agency’s failure to revise the 2003 Guide and subject it to notice and comment procedures.
2006In Medical Center v. Gonzales (451 F.Supp.2d 854 (W.D. Tex. 2006)), the court, citing Algon and 9/1 Kg. Containers as additional support, held that compounded drugs are new animal drugs under the FD&CA, and unless the compounded drugs are exempt under the FD&CA’s AMDUCA provisions, compounded drugs are subject to FD&CA’s unsafe, adulteration and misbranding requirements. As with human drugs, the FD&CA contains no blanket “implicit exemption” for animal drugs produced by compounding.
2007A FDA Center for Veterinary Medicine (CVM) update from May 2007 regarding concerns about supplies of pergolide for horses noted CVM’s efforts included trying to make the approved product available through veterinary distribution channels and exercising enforcement discretion as appropriate over the pharmacy compounding of pergolide. Bulk substance used for pharmacy compounding should be labeled for “animal use only.” All pharmacy compounding must be done under a “valid veterinary prescription.”
2011The court in Franck’s Lab distinguished Algon and 9/1 Kg. Containers. The court noted that neither case mentioned pharmacists or the practice of pharmacy. Algon and 9/1 Kg. Containers also predated a number of important legal developments relating to both the FDA’s regulation of compounding and the Chevron doctrine. The court held that in enacting the FD&CA in 1938, Congress did not intend to give the FDA per se authority to enjoin the longstanding, widespread, state-regulated practice of pharmacists’ filling a veterinarian’s prescription for a nonfood-producing animal by compounding from bulk substances.

- See more at: http://www.mcguirewoods.com/Client-Resources/Alerts/2013/6/Compounding-Animal-Drugs-Bulk-Ingredients.aspx#sthash.ztsQGwz4.dpuf

Tinton Falls drug compounding business admits to health violations and will remain closed


Alexi Friedman/The Star-Ledger

on June 28, 2013 at 2:40 PM, updated June 28, 2013 at 2:41 PM

Read here

The Med Prep decree "shows that the FDA will take aggressive enforcement actions to ensure the safety of its drugs," FDA acting associate commissioner for regulatory affairs Melinda Plaisier said in a statement.


Judge orders injunction against New Jersey compounding pharmacy



NEW YORK (Reuters) - A federal judge has entered a consent decree and permanent injunction against a New Jersey compounding pharmacy after it was discovered that some of its products might be contaminated, the Food and Drug Administration said Friday.

Med Line Prep Consulting Inc compounded and distributed drugs for hospital and healthcare facilities. It ceased operations in March following a voluntary recall of products compounded at its facility in New Jersey.

The recall was prompted by the discovery of mold contaminating sterile bags of intravenous solution at a hospital in Connecticut.

The regulation of so-called compounding pharmacies, which combine, mix or alter medical ingredients, has been in the spotlight since a deadly meningitis outbreak last year linked to steroid injections ma,de by the New England Compound Center in Massachusetts.

Continue here


Question of the Day :June 28, 2013 If Pharmacy is Pharmacy, then why aren't physicians and veterinarians working together toward best solution for state and federal compounding legislation?

And if pharmacy and pharmacy why is Congress considering the veterinary or animal side separate from the human side?  Is the fact Congress is considering them separate the first indication that pharmacy is not pharmacy always--or that animal and human compounding pharmacy are different or should be treated different?  If Congress treats animal and human compounding differently but the state boards of pharmacy treat them the same, won't this cause more confusion than there is now about compounding and also won't it make the laws hard to apply and comply with?

Job Openings for Compounding Pharmacist in Florida

Compounding Pharmacist

Healthcare & Medical - Bonita Springs, FL 34135
A newly acquired Pharmacy Compounding company in south west Florida has an opening for a pharmacist with experience compounding medications. This client company compounds customized pain medication according to the doctors specific requirements and ships within 24 hours, providing exceptional service rarely found in the marketplace. 

Job Opening for Compounding Sales Rep in Atlanta


Pharmaceutical Sales Representative-Atlanta

Healthcare & Medical - Atlanta, GA 30005
A newly acquired Phamacy Compunding company has an opening for a sales pro with experience selling to doctors in the "pain management" marketplace which would include neuro-muscular, rheumatoid and ortho physcians as well as other doctors that consistently have to manage pain. This client company compounds customized pain medication according to the doctors specific requirements and ships the n...
Tags for this job: Pharmaceutical sales, pain management, 1099 sales,compounding

Thursday, June 27, 2013

Reminder About Texas Pharmacy Association 2013 Conference and Expo--Compounding topic on pain management presented by Chris Simmons


3:00 p.m. – 5:00 p.m.  CONCURRENT EDUCATION SESSIONS
HIPAA, HITECH and the New Texas Privacy Law (HB 300): What You Need To Know Now
Presented by Amanda Ellis, Attorney at Law
4:15 p.m. – 5:15 p.m.  CONCURRENT EDUCATION SESSIONS
Pain Management Compounding Opportunities
Presented by Chris Simmons, R.Ph.

more information found here

The Government’s Use of Civil Forfeiture to Combat Health Care Fraud and Pill Mills in Florida Posted on June 25, 2013

By Christopher E. Brown, J.D., The Health Law Firm, and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Recently we have seen government prosecutors and agencies, including the Medicaid Fraud Control Unit (MFCU), the U.S. Attorney General’s (AG) Office, and local sheriff and police departments use the Florida Contraband Forfeiture Act against health professionals and health facilities in health-related cases.

continue reading here


Article : ASHP Comments on Draft Version of House Compounding Bill

Article : ASHP Comments on Draft Version of House Compounding Bill

Update on Michigan State Legislation Dealing With Compounding

The state of Michigan has not yet moved on compounding legislation; however, it’s expected that a bill will be introduced in the fall when legislators return from summer recess. 

read more here

KUDOS to IACP!! It is Publishing a Wonderful Fax Facts For Its Member Each Week With Updates On Compounding Issues

to read this weeks updates (June 26, 2013) from IACP click here

Pharmacies Sending Sterile Compounds into Florida Need to Stay On Top of Law Changes


Special Sterile Compounding Permit Application Information
The Florida Board of Pharmacy is developing a new application which will be required for certain
pharmacies who will engage in the preparation of compounding sterile products.  The application is not
yet available.  You are not required to apply until Rule 64B16-28.100, Florida Administrative Code, is
finalized and adopted to include the new form DH-MQA 1270.
All permitees, with the exception of stand alone Special Parenteral/Enteral and Special
Parenteral/Enteral Extended Scope, that are currently compounding sterile products are required to
submit this application and will be issued a new Special Sterile Compounding permit number (in
addition to your usual pharmacy permit).
This website will be updated with information and instructions on how and when to submit your
application.  
Those applying for this permit will be required to submit information from current policies and
procedures which will be reviewed before an inspection is requested

source found here

CMS Wants To Let Medicare Plans Restrict Potential Drug Abusers To Single Pharmacy



Key CMS and officials from the HHS Office of Inspector General on Monday (June 24) recommended that Congress let plans restrict high-risk Medicare beneficiaries from using multiple pharmacies to curb "doctor shopping" and reduce prescription drug abuse, a policy that some Medicaid programs and commercial plans use for beneficiaries with "drug-seeking behavior."
quoted from here

Pharmacy Practice News: "In Operating Room, a Switch To Prefilled Syringes Pays Off" in Puerto Rico


June 27, 2013

San Juan, Puerto Rico—Incorporating standardized, ready-to-use anesthesia medications in the operating rooms helped one hospital in St. Louis significantly increase proper labeling of medicines and reduce medication waste. Click here

DR. MOHLER: A true story of greed, feisty pregnant women and the FDA doing the right thing | PostIndependent.com

DR. MOHLER: A true story of greed, feisty pregnant women and the FDA doing the right thing | PostIndependent.com

Pharmacy Practice News - Canadian Chemo Dilutions Hint at U.S. Vulnerabilities

Some patients not yet notified of possibly tainted shots -including people in Louisiana, Texas and Arkansas Jun. 27, 2013 6:27 PM


A month after a nationwide recall by a Tennessee drug compounder, 19 health facilities in three states have not yet notified all patients who were injected with a steroid that may have been contaminated with bacteria, fungus or both.
In a report issued Thursday, officials with the U.S. Centers for Disease Control and Prevention said the 19 facilities received methylprednisolone acetate from the Main Street Family Pharmacy in Newbern since Dec. 1, 2012.
Though the facilities lagging behind in notification were not identified, the CDC said that 10 are in Louisiana, eight in Texas and one in Arkansas, and that they either haven’t begun notifying patients or haven’t neared completion.
continue reading here

Copy of Proposed Consent Decree for Permanent Injunctive Relief in FDA v. Med Prep Consulting Regarding Permanent Injunction--showing agreement between FDA and Med Prep

can be viewed here.  It appears that Med Prep and the FDA have agreed to the terms and conditions stated in the proposed consent decree.  The court will most likely sign the order as is, but it is free to reject it or parts of it in some circumstances.  As can be seen from reading this proposed consent decree for permanent injunctive relief, there are various requirements for Med Prep to do as corrective action.  Thus, showing the reports of the FDA permanently putting Med Prep out of business are exaggerated.  As noted in paragraphs 13-15 the requirement of who Med Prep must provide a copy of the decree to, including subsequently people associated with or people who buy Med Prep.

Other Actions for Junk Faxes Filed by Dr. Mark W. Sturdy


In previous post found here, the case against Lowlite Investments Inc d/b/a Olympia Pharmacy was highlighted.  It appears the other actions previously filed by Dr. Mark W. Sturdy resulted in dismissals.

Mark W Sturdy is a party in 3 cases.

3:11-cv-03430-RM-BGCDr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic v. WM Healthcare Solutions, Inc. et alfiled 12/01/11   closed 01/15/13
3:11-cv-03452-RM-BGCDr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic v. ALLACCEM, Inc. et alfiled 12/30/11   closed 04/18/12
3:13-cv-03126-RM-BGC

Dr Mark W Sturdy v. Lowlite Investments Incfiled 04/30/13


Update on Status of Dr. Mark W. Sturdy v. Lowlite Investments d/b/a/ Olympia Pharmacy--junck faxes from compounding pharmacies

Defendant
John Does 1-10

Date Filed#Docket Text
04/30/20131 COMPLAINT against John Does 1-10, Lowlite Investments, Inc., d/b/a Olympia Pharmacy ( Filing fee $ 350 receipt number 0753-1579273.), filed by Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. (Attachments: # 1 Exhibit A, # 2 Civil Cover Sheet, # 3 Summons)(Edelman, Daniel) (Entered: 04/30/2013)
04/30/20132 NOTICE of Appearance of Attorney by Daniel A Edelman on behalf of Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic (Edelman, Daniel) (Entered: 04/30/2013)
04/30/20133 NOTICE of Appearance of Attorney by Dulijaza Julie Clark on behalf of Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic (Clark, Dulijaza) (Entered: 04/30/2013)
04/30/20134 MOTION to Certify Class by Plaintiff Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. Responses due by 5/17/2013 (Edelman, Daniel) (Entered: 04/30/2013)
04/30/20135 MEMORANDUM in Support re 4 MOTION to Certify Class filed by Plaintiff Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. (Attachments: # 1 Exhibit A, # 2 Exhibit B)(Edelman, Daniel) (Entered: 04/30/2013)
04/30/20136 NOTICE of Appearance of Attorney by Michelle R Teggelaar on behalf of Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic (Teggelaar, Michelle) (Entered: 04/30/2013)
04/30/20137 MOTION to Continue and enter Plaintiff's Motion for Class Certification by Plaintiff Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. Responses due by 5/17/2013 (Clark, Dulijaza) (Entered: 04/30/2013)
05/02/2013  TEXT ORDER by Magistrate Judge Byron Cudmore: Plaintiff's Motion to Enter and Continue Plaintiff's Motion for Class Certification 7 ALLOWED in that Plaintiff's Motion for Class Certification 4 will remain of record and taken under advisement until the parties are at issue. The ECF response date from Motion 4 is stricken. Plaintiff to take steps to serve Defendants. (LB, ilcd) (Entered: 05/02/2013)
05/15/20138 Summons Issued as to Lowlite Investments Inc.. Original returned to attorney for service. (MJ, ilcd) (Entered: 05/15/2013)
06/07/20139 SUMMONS Returned Executed by Mark W Sturdy. Lowlite Investments Inc served on 5/30/2013, answer due 6/20/2013. (Clark, Dulijaza) (Entered: 06/07/2013)
06/19/201310 MOTION For Leave to Participate in Case While Application For Admission is Pending by Defendant Lowlite Investments Inc. Responses due by 7/8/2013 (Tingley, Amy) (Entered: 06/19/2013)
06/19/201311 Consent MOTION for Extension of Time to File Response/Reply to Class Action Complaint by Defendant Lowlite Investments Inc. Responses due by 7/8/2013 (Tingley, Amy) (Entered: 06/19/2013)
06/21/201312 ORDER by U.S. Magistrate Judge Byron Cudmore: Motion for Leave to Participate in Case While Application for Admission is Pending 10 ALLOWED in part. See written order. (LB, ilcd) (Entered: 06/21/2013)
06/21/2013  TEXT ORDER by Magistrate Judge Byron Cudmore: Motion for Extension of Time to File Answer or Other Response to Class Action Complaint 11 ALLOWED without objection. Extension granted to 7/5/2013. (LB, ilcd) (Entered: 06/21/2013)

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