UPS pays $40M to end online pharmacies probe By PAUL ELIAS - Associated Press Friday, Mar. 29, 2013 | 10:44 AM Read more here: http://www.fresnobee.com/2013/03/29/3235552/ups-pays-40m-to-end-online-pharmacies.html#storylink=cpy

SAN FRANCISCO -- Shipping company UPS has agreed to pay $40 million to end a federal criminal probe connected to its work for online pharmacies.

The U.S. Department of Justice announced Friday that the Atlanta-based company would also "take steps" to block illicit online drug dealers from using their delivery service.

The DOJ says the fine amount is the money UPS collected from suspect online pharmacies.

UPS won't be charged with any crimes. Its biggest rival, FedEx Corp., has also been a target of the federal investigation.

The investigation of the two companies stems from a global campaign to shutter illicit online pharmacies launched in 2005. Since then, dozens of arrests have been made and thousands of websites closed worldwide as investigators continue to broaden the probe beyond the operators.

Read more here: http://www.fresnobee.com/2013/03/29/3235552/ups-pays-40m-to-end-online-pharmacies.html#storylink=cpy

The FDA BLog has a must read--Disclosures in a Small Space: The FTC’s Revisions to .Com Disclosure

 Katie Bond –

s

Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures.  The FTC released the original guide 13 years ago, when mobile phones had not yet met the internet and social media barely existed.  In the new version of the guide, updated recommendations and new examples focus on how to craft disclosures given the smaller screen sizes of smartphones as compared to computers and the character and space limitations of most social media (e.g., the 140-character limit for Twitter tweets).

Clear & Conspicuous Requirement.  Under the FTC Act, if a disclosure is necessary to prevent a claim from being deceptive, then the disclosure must be “clear and conspicuous.”  The revised guide, like the 2000 version, continues to emphasize that advertisers should consider the following factors in determining whether an online disclosure is clear and conspicuous:

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FDA cites contamination issues in Delta compounding phamacy Mississippi State strengthening safety requirements

In the wake of contaminated steroid shots at New England Compounding Center linked to a deadly meningitis outbreak, the Food and Drug Administration has discovered problems at a Mississippi Delta compounding pharmacy.

Mississippi is now strengthening safety requirements. “We’re beefing up our compounding rules,” said Frank Gammill, executive director for the state Board of Pharmacy.

The FDA has accelerated inspections of compounding facilities across a dozen states. Last month, it visited the Cleveland facility run by the Illinois-based PharMEDium and reported that procedures designed to prevent contamination of drug products failed to include adequate validation of the sterilization process.

PharMEDium officials say patient safety is their highest priority and that none of the company’s products has been linked to a patient’s death. The New England center’s contamination is linked to 50 deaths.

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RI Compounding Issues Involved:: HEALTH Director Fine Denies License Restoration for Pharmacist Leo Blais' pharmacist license was reinstated just two days earlier, with restrictions. By Lauren CostaEmail the authorMarch 28, 2013

  

The RI Dept. of Health announced Monday the restoration of former state Sen. Leo Blais' pharmacist license, but with stipulations. Just two days later, HEALTH Director Michael D. Fine denied the restoration.

Last March, Director Fine suspended Blais' license indefinitely after a "dispensing error" at his East Greenwich pharmacy, Apothecare Compounding Solutions, resulted in a 2-year-old and an 11-month-old receiving multiple unintended doses of morphine.

The Dept. of Health also cited Blais for removing drugs from his pharmacy, to an unlicensed and unauthorized location during the RI flood event of 2010, as well as compounding prescription drugs in an environment not meeting standards; both allegations that he disputes. 

It was the third time he had disciplinary action taken against him; once in 1999 and again in 2007. 

Last Friday, Blais accepted a court-ordered two-year suspension retroactive to March 23, 2012, with the second year of suspension stayed. His license was on probation during the second year and he was also forbidden from serving as a Pharmacist-in-Charge or an instructor during that period of time. Blais was also required to undergo 40 hours of training; 20 in the areas of law and ethics and 20 in the area of compounding.

In a letter sent to Administrative Hearing Officer Catherine Warren on Wednesday afternoon, Fine said he "disapproved of the Consent Order ratified by the Rhode Island Board of Pharmacy" that allowed Blais his license back.

According to the Health Dept., Fine took this action under the authority of Rhode Island General Law Chapter 5, Section 19.1-5, which requires all board actions to be approved by the director.

“After reviewing the Consent Order ratified by the Board of Pharmacy, I consider the agreement between the parties outlined in the order to be insufficient, given the facts leading to the Summary Suspension of Leo Blais,” Director Fine said. 

Click here to learn about a Barrington couple outraged at the license reinstatement order after Blais administered mislabeled morphine to their 11-month-old daughter.

Source found here

NABP Reports 2012 Year-End Clearinghouse Totals: 4,223 Disciplinary Actions Reported by State Boards of Pharmacy

NABP’s 2012 year-end
data results show a total of
4,223 disciplinary actions
reported by the state boards
of pharmacy to the NABP
Clearinghouse. Of the
4,223 actions reported, 61%
were actions taken against
pharmacists and 39% were
actions taken against pharmacy
technicians.

Continue to read here

NABP 2013 Newsletter Points Out Difficult Legal and Practicual Challenges for Boards of Pharmacy Created by Interstate and International Business

Subpoena Knows No Borders
By Dale J. Atkinson, JD
Advancements in technology increase
the likelihood of licensees practicing
across state and international lines.
As has been emphasized in previous
Newsletter articles, and in a feature
article in this issue, physical presence
is not necessarily a prerequisite to
practice. That is, practitioners can use
technology to render services within
the scope of practice as defined without
stepping foot within the jurisdiction
where the patient is located. Practice
without physical presence creates
difficult legal and practical challenges
for boards of pharmacy. The courts are
currently, and will continue to grapple
with jurisdictional issues involving what
board and/or court has the authority
to adjudicate administrative disputes.
Further, the investigative processes will
also be challenged regarding the gathering
of relevant information to pursue
administrative prosecution. Consider the
following.
A physician (Licensee)
is licensed in both Kansas
and Missouri. In 2009, the
Kansas State Board of Healing
Arts (Board) opened an
investigation of the Licensee
based upon information
that a patient filed a lawsuit
alleging medical negligence,
fraud, and misrepresentation.
The lawsuit was filed
in Missouri based upon the
fact that the medical services
were rendered in Missouri.
The Board issued a subpoena
to the Licensee requesting
documents related to the
medical treatment of the
patient. The Board took
the position that it had the
authority to investigate the
Licensee’s practice and issue
the subpoena because the Licensee
holds a Kansas license
and the allegations in the
Missouri lawsuit constituted
grounds for discipline under
the Kansas Healing Arts Act.
The Licensee filed a petition
in district court seeking
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NOTE:  That each states law is different as to these types of issues and that one state's law is not binding on another state, but is merely persuasive authority.

The April 2013 NABP Newsletter is Jam Packed With Compounding News

To read click here

NABP TO OFFER--Compounding Pharmacy Information Sharing Network Available to Boards Soon Data on Preparation of Patient-Specific Drugs and Non-Patient- Specific Drugs to Be Included

For more information click here

Question of the Day: Are Compounding Pharmacists Being Unfairly Treated in the Press?

Lobbyists weigh in on pharmacy oversight

4 hours ago by editor 0

By Kimberly Kindy and Lena H. Sun

Drug companies are ramping up efforts on Capitol Hill to block specialty pharmacies from mass producing drugs in lightly regulated conditions, urging lawmakers to require that these enterprises return to their traditional roles or face stricter standards.

Commercial drug makers are also pressing a lobbying campaign aimed at stopping these specialty pharmacies, known as compounders, from making “knockoff” drugs for people and their pets that the companies say are costing them millions of dollars in annual profits, records and interviews show.

This rapidly escalating struggle reaches far beyond congressional efforts to rein in reckless compounding pharmacies that began in October after tainted steroids from the Massachusetts-based New England Compounding Center (NECC) were linked to a meningitis outbreak that has killed 48 people.

Amid a public outcry, lawmakers began considering draft legislation to address public safety concerns. With a bill in the works, a range of companies, business associations and health organizations have begun pressing their own interests along a wide front.

Veterinary groups, for instance, have launched their own lobbying campaign opposing the drugmakers. These groups warn that any legislation that required patient-specific prescriptions would deprive them of vital drug stockpiles and that pets would die at their clinics.

Hospitals want to ensure that any new oversight of compounders by the Food and Drug Administration does not cripple the firms’ operations, which could worsen drug shortages.

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Brief History: Passed House: 3/11/13, 97-0. Committee Activity: Health Care: 3/27/13.

SENATE BILL REPORT

HB 1800

This analysis was prepared by non-partisan legislative staff for the use of legislative members in their deliberations. This analysis is not a part of the legislation nor does it constitute a statement of legislative intent.

As of March 26, 2013

Title: An act relating to compounding of medications.

Brief Description: Concerning the compounding of medications for physician offices or ambulatory surgical centers or facilities to be used by a physician for ophthalmic purposes for nonspecific patients.

Sponsors: Representatives Cody, Morrell and Schmick.

Brief History: Passed House: 3/11/13, 97-0.

Committee Activity: Health Care: 3/27/13.

SENATE COMMITTEE ON HEALTH CARE

Staff: Mich'l Needham (786-7442)

Background: Compounding is a practice in which a pharmacist prepares a prescription by combining two or more ingredients. Compounding is authorized in specific situations and in limited quantities. The compounding of an inordinate amount of drugs, relative to the practice site in anticipation of receiving prescriptions without any historical basis, is considered manufacturing. Manufacturers must obtain a license and meet additional state and federal regulatory requirements.

The Board of Pharmacy allows pharmacists to conduct compounding in limited situations. Pharmacists may compound drugs for individual patients when there is a pharmacist/patient/prescriber relationship and the patient presents a prescription. Pharmacists may also compound drug products that are commercially available for individual patients when it is in anticipation of orders based upon routine, regularly observed prescribing patterns. In addition, pharmacists may compound drugs in very limited quantities prior to receiving a prescription based upon a history of receiving prescriptions from a certain pharmacist/patient/prescriber relationship.

Pharmacists are prohibited from offering compounded drug products to others for resale, except to a practitioner to administer to an individual patient.

Summary of Bill: The Board of Pharmacy must adopt rules to authorize the compounding of ophthalmic medications for use by a physician for nonspecific patients in physician offices, ambulatory surgical centers, and ambulatory surgical facilities. The rules must establish limits on the quantities that may be made available and requirements to record the dispensing of the compounded medication, including the identity of the patients and the amounts dispensed.

The term manufacture, as it relates to legend drugs, excludes the compounding of ophthalmic medications for use by a physician for nonspecific patients in physician offices, ambulatory surgical centers, and ambulatory surgical facilities.

Appropriation: None.

Fiscal Note: Available.

Committee/Commission/Task Force Created: No.

Effective Date: The bill contains an emergency clause and takes effect immediately.

Drug plan targets a need, not greed

Imagine a newborn baby in an intensive care unit who needs a specific, customized drug. Imagine further that there is another baby in the unit who needs the same drug. Now imagine there is only enough of the drug on hand for one of them, and you have to decide who receives it.

This and similar situations are playing out in hospitals, ambulances and specialized clinics throughout the nation — the result of a serious and widespread drug shortage that’s growing more critical every day.

Legislation amending existing state law being considered by the General Assembly would allow Tennessee pharmacists to help alleviate this problem. It does not compromise patient safety and will help compounding pharmacies safely make specialized medicine for vulnerable patients whose lives depend on its availability.

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PCCA Suggested Guidelines for Choosing a Compounding Pharmacy A Has some Excellent Suggestions For Choosing a Compounding Pharmacy

Suggested Guidelines for Choosing a Compounding Pharmacy

When you initially contact a compounding pharmacy, you may want to ask them for the following information:

1. Does the pharmacy use PCCA-tested Formulas and Pharmaceutical Ingredients?
2. What initial training is required for the pharmacy staff members when they begin working there?
3. What ongoing education do staff members receive? Do they participate in formal continuing compounding education programs?
4. Does the pharmacy have a quality assurance and continuous quality improvement program? Does the pharmacy have its compounded preparations tested for potency to ensure you are getting the right amount of medication? Do they test their sterile preparations to ensure sterility? Ask for details.
5. How are patients educated on the appropriate use of their compounded prescriptions? Does the pharmacy conduct a review of all the patients' current medications along with any compounded preparations?
6. If the pharmacy is in a different state than the one you reside in, and you are considering having them ship a compounded prescription to you, first verify that they are appropriately licensed to dispense prescriptions in your state as well.

Question quoted from here

NABP States Take Action to Ensure Safety of Compounded Drugs March 27, 2013 3:00 pm

Through board of pharmacy inspections of compounding pharmacies and proposed laws to tighten requirements for compounding, states are taking action to help ensure the safety of compounded drugs, reports The Washington Post. The article highlights the ongoing Iowa nonresident compounding pharmacy inspection program, a program initiated in partnership with NABP. Any disciplinary actions resulting from inspections would have to be addressed by other boards of pharmacy, Lloyd Jessen, JD, RPh, executive director, drug control program administrator, Iowa Board of Pharmacy, and NABP Executive Committee member told The Washington Post. The report also notes that the United States Food and Drug Administration (FDA) is in support of legislation that would authorize the agency to regulate entities that operate like manufacturers, though they are registered as compounding pharmacies. “Rather than wait for the decision on whether it’s going to be FDA or the states,” boards of pharmacy are going to make sure they do their best to protect patients, noted Carmen Catizone, MS, RPh, DPh, NABP executive director/secretary. 

More information about the Iowa compounding pharmacy inspection program and other issues related to the regulation of compounding are included in the April 2013 NABP Newsletter article “Compounding Pharmacy Information Sharing Network Available to Boards Soon” (PDF).

Quoted from here

2013 Annual Meeting State Boards of Pharmacy and NABP—Gateway to Shared Responsibility and Success May 18-21, 2013 St Louis, MO

For more information click here

Veterinary Pharmacy Issues: Identifying Illegal Practices and Distinguishing Supply Chain Variations ACPE #205-000-13-004-L03-P

Monday, May 20, 2013

8:15 - 10:15 AMJoint CPE

Veterinary Pharmacy Issues: Identifying Illegal Practices and Distinguishing Supply Chain Variations

ACPE #205-000-13-004-L03-P
(0.2 CEUs – 2 contact hours)

Target Audience: Pharmacists
Activity Type: Application-based

Learning ObjectivesAt the conclusion of this session participants will be able to:

1. Illustrate why pharmacists who dispense veterinary medicines should possess particular skills.
2. Describe the additional training necessary for pharmacists to practice veterinary pharmacy.
3. Explain the legal differences between the human and veterinary drug supply chain.

DescriptionMany pet owners think that Fido is part of the family, but who should prescribe and dispense veterinary medicines? This session’s discussion will center around what knowledge is necessary regarding drug therapy and pharmacokinetics in veterinary medicine and why a lack of such knowledge may place our animal counterparts at risk. Additionally, attendees will learn the differences between the two drug supply chains – the how and the why the veterinary drug supply chain is legally allowed to be separate and vary from the human drug supply chain.

For more information click here

The Compounding/Manufacturing Debate: When Is a Duck Not a Duck? ACPE #205-000-13-001-L03-P

Saturday, May 18, 2013

2 - 4 PM

Pre-Meeting CPE

The Compounding/Manufacturing Debate: When Is a Duck Not a Duck?

ACPE #205-000-13-001-L03-P
(0.2 CEUs – 2 contact hours)

Target Audience: Pharmacists
Activity Type: Application-based

Learning ObjectivesAt the conclusion of this session participants will be able to:

1. Explain how a compounding pharmacy might be registered as a manufacturer by Food and Drug Administration (FDA).
2. Describe how states can enforce their regulations when it comes to the activities of compounding pharmacies acting as manufacturers.
3. Describe how compounding pharmacies that are acting as manufacturers may be regulated in the future.

DescriptionThe New England Compounding Center tragedy resulted in regulators conducting in-depth investigations of compounding pharmacies. This has brought to light the realization that these types of entities may be operating in a gray area of law. During this special pre-meeting continuing pharmacy education (CPE) panel session, federal and state regulators and compounding experts will discuss the perplexities surrounding the issue of compounding pharmacies acting as manufacturers and the resultant and ongoing regulatory challenges facing the boards of pharmacy.

For more information click here

AVMA Now: Toolkits, Fly-Ins, and Compounding

AVMA Now: Toolkits, Fly-Ins, and Compounding

Safety Alerts for Human Medical Products Palimed Solutions, Inc. Sterile Compound Products: Recall - Visible Particulates Observed

Safety Alerts for Human Medical Products Palimed Solutions, Inc. Sterile Compound Products: Recall - Visible Particulates Observed

Radford v. New England Compounding Pharmacy, Inc. et al

Radford v. New England Compounding Pharmacy, Inc. et al

Boggs v. New England Compounding Pharmacy, Inc. et al

Boggs v. New England Compounding Pharmacy, Inc. et al

Another Compounding Pharmacy Recalls All Products After Contaminant Found In Several Drug Compounds Posted: March 27, 2013 Author: Jennifer Walker-Journey

Once again, the Food and Drug Administration (FDA) is ordering therecall of all sterile products manufactured by a compounding pharmacy, this time because visible particles were seen floating in several different compounds. The FDA says the potential health risksare unknown at this point because the contaminant is as yet unidentified. However, particulate matter has the potential to damage or obstruct blood vessels, which could induce emboli, cause systemic allergic reaction, or cause tissue responses to the foreign material.

The recall was ordered on all sterile products made by Pallimed Solutions, Inc., based in Woodburn, Mass., which does business as Pallimed Pharmacy. The products are used for a wide range of therapeutic uses including for treatment of erectile dysfunction, testosterone replacement therapy, vitamin injections, and ophthalmic preparations.

All products are packaged in glass vials and were distributed to patients and/or physicians’ offices through Friday, March 22, 2013. Patients and doctors who received these products are in the following states: California, Connecticut, Florida, Georgia, Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan, Nevada, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia and Wisconsin.

The recall of all sterile products from Pallimed follows within weeks or days of two similar recalls from compounding pharmacies that distribute products across state lines.

continue reading here

New England Compounding Center had history of problems before contamination -settled case in 2004 involving death caused by bacterial meningitis March 27, 2013

The New England Compounding Center touted cleanliness in its Quality Assurance Report Card sent to customers, despite internal testing that showed "widespread contamination," according to a Boston Globe report published Oct. 31.

Other articles revealed the Massachusetts-based company had been accused of producing tainted medicine in the past, along with mass producing medicines when it wasn't authorized to do so.

In 2004, a lawsuit filed against the company in Monroe County, N.Y., claimed it was responsible for the 2002 death of William Koch, 83, who received a shot that is said to have caused him to contract bacterial meningitis, according to the Boston Herald.

The company settled with Koch's widow in 2007 before the case went to trial. The terms were confidential.

• Related: Michigan attorney general pushes for probe of fungal meningitis outbreak

The Boston Globe also reported that four family members that co-founded the New England Compounding Center received more than $16 million in wages and profits from the company from December 2011 through November 2012.

The company filed for Chapter 11 bankruptcy late last year as a result of the fungal meningitis outbreak.

Quoted from here

Pharmacy instructors working to prevent contamination in prescription drugs

Pharmacy instructors working to prevent contamination in prescription drugs: In the last week, prescription drugs were recalled in states including Massachusetts, Connecticut, Delaware, and Georgia where drugs were reportedly distributed to doctors' offices in South Carolina.

Compounding Pharmacies Contaminations Continue with Avastin Recall

Compounding Pharmacies Contaminations Continue with Avastin Recall

Michigan seeks criminal charges in meningitis outbreak From Dave Alsup, CNN updated 11:02 AM EDT, Wed March 27, 2013

(CNN) -- Michigan's attorney general has requested a criminal investigation into the conduct of an embattled Massachusetts company linked to a recent deadly fungal meningitis outbreak.

Michigan had at least 259 infections and 14 deaths, leading the nation in people affected by the outbreak last year, said Bill Schuette, the state's attorney general.

The outbreak, linked to tainted steroid injections from New England Compounding Center, killed 51 people and infected 730 people in 20 states, the Centers for Disease Control and Prevention said.

Massachusetts drug compounder recalls some of its injectables

"Hundreds of Michigan citizens and their families have endured terrible pain and deaths of loved ones suffering from illnesses caused by these tainted steroid injections," said Schuette. "This investigation is necessary to uncover the truth as to how this unspeakable tragedy happened and to restore public faith in our healthcare system."

Continue reading here

HOT off Press!! New Rules in Texas effective March 17, 2013

The Board met on February 5, 2013, in Austin, Texas. To view the meeting agenda and additional materials, click here.Rules adopted at the February Board meeting were published as adopted in the March 8, 2013, issue of theTexas Register and became effective March 17, 2013. Rules proposed at the February Board meeting are posted in the March 8, 2013, issue of the Texas Register and areavailable for public comment until April 30, 2013. The proposed rules will be considered for adoption at the next TSBP board meeting on May 7, 2013. You may view a summary of the adopted and proposed rules here. You may also view the adopted and proposed rule language from the February agenda. Please note underlined language is new language and language that is being deleted is lined out.  All other language is currently in the rules and is not being changed.

Second Update to Updated: A Lawyer Cannot Let a Flawed Argument Go By--IACP's Argument Is Unfair--A Note on the Criminal Side

There are just so many aspects and things to cover regarding court orders, subpoenas and warrants and how they work in the federal system and as I have mentioned before it is far beyond the scope of this blog to cover it all, but one more important thing to mention relates to criminal investigations.  If there is a federal criminal investigation ongoing, then most of the time the documents will be sealed if and until a federal grand jury returns an indictment or a complaint is filed.  Thus, the FDA would not be at liberty in these types of cases to disclose whether such court orders, subpoenas or warrants had been sought.  And if this information were to be disclosed, the party  disclosing it would be jeopardizing a federal investigation not to mention exposing oneself to extreme sanctions by the court.

See here

Meningitis Outbreak: Michigan Attorney General Launches Investigation into Contaminated Steroids

Following the death of 17 Michigan residents who contracted meningitis from contaminated steroids, the states attorney general said on Tuesday he is launching a criminal investigation into a Massachusetts pharmaceutical company linked to the deadly outbreak of meningitis.

Bill Schuette filed a request with the Michigan Court of Appeals for a rare, four-county grand jury to conduct a confidential probe into the New England Compounding Center (NECC) that produced tainted steroids which left 51 people dead nationwide and 730 sick.

Continue reading here

Question of the Day: Has the Sky Fallen on Compounders and Compounding Pharmacies Because of Greed or Is it Simply a Failure to Police Ones Own by Enforcing the Laws on the Books or Is it Both?

Recalled Woburn compounding pharmacy products were shipped to 21 states

By Chelsea Conaboy, Globe Staff

A recall by a Woburn compounding pharmacy where inspectors found visible contaminants in drug vials is more expansive than originally reported by the company on Monday, applying to 25 products distributed to patients and doctors in 21 states, including all New England states.
A Pallimed Solutions spokesman told Travis Andersen of the Globe staff that the more complete company press release posted on the US Food and Drug Administration’s recall website late Tuesday evening was not an indication of an expanded recall.
But, the list of affected products includes several drugs not part of the announcement that the company made independent of regulators on Monday, when state officials said they thought Pallimed was operating in 15 states. The company is recalling all sterile compounded products dispensed since Jan. 1.
The latest announcement said unidentified particulates, or filaments, were observed in five vials of drugs, including two products used in treating erectile dysfunction and a batch of what is supposed to be sterile water used for injection. No injuries or illnesses have been reported resulting from the contamination.
“The potential public health risks are unknown as the particulate matter has not yet been identified,” the release said. “However, particulate matter has the potential to damage or obstruct blood vessels, which could induce emboli, cause systemic allergic reaction, or cause tissue responses to the foreign material.”
Pallimed was already under review by state regulators after producing a super-potent painkiller that caused two people to be hospitalized. In November, the state ordered the company, owned by James Nahill, to stop making a generic form of Viagra because it was found to be using “improper components.”
The company said it is working to contact patients and urged people to stop using the recalled products. The release did not say how many people received the drugs. For more information, see the company’s website or call (781) 937-3344.
Chelsea Conaboy can be reached at cconaboy@boston.com. Follow her on Twitter@cconaboy.

Quoted form here

You Will Also Want to Read the Complaint Mentioned in DePaolo's Work Comp World

found here.  I think there are a whole lot more issues in false claims acts that we could be seeing filed in the future if employees will just start talking.

Ultimately the mom and pop compounders have been pointing the fingers at the fingers at the mega compounders saying they are manufacturing, they are the bad guys in this deal--  when in fact there maybe some mom and pop compounders and compounding pharmacies that are guilty in other areas. I think Congress needs to do a whole lot more investigating into what is going on in the compounding world--not only how the drugs are being made, but how the profit is being made.  How are small mom and pops in the United States making millions and millions of dollars each year off these compounded medications in the human world.

We have so much more work to be done than I ever imagined.  Hopefully, Congress and the State Board of Pharmacy realize that also.

I am Starting to Thinking There is Way More Research and Investigation of Compounders and Compounding That Needs And Must Be Done: You will want to read this blog post by Richard Krasner at his blog: Compounding and Medical Tourism What To Watch Out For--

Compounding and Medical Tourism: What to watch out for.

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After a short hiatus, I am back to writing, and today’s post concerns another issue that is plaguing the workers’ compensation industry in the US, the compounding of drugs.

Joe Paduda, whom I have mentioned before, wrote today about the problem in his Managed Care Matters blog. The article, entitled, Just how dangerous Is compounding?, says that compounding is much more dangerous than compounding pharmacies and their supporters have led the workers’ compensation and health care industries to believe.

He cites a Washington Post investigation that reported that  shoddy practices and unsanitary conditions at three pharmacies have sickened and killed patients.

Paduda also stated that compounding is a growing phenomenon, especially in workers’ comp, and pointed to research from the California Workers’ Compensation Institute (CWCI) and CID Review indicate that despite the lack of any evidence-based research justifying widespread use, compound meds are becoming a larger part of pharmacy spending

What has happened in California, Paduda says, can be used to forecast the future for compounding in other states.

He states that California recently tried to address the issue legislation which specifically focused on the ingredient cost. The result of that legislation was, the number of scripts dropped 35% (from 3.1% of all scripts to 2%)…however the cost per script zoomed.  Compounds now account for one out of every eight dollars spent on drugs…

(see CWCI’s February 2013 report for details on what happened and why)

Joe also cites David DePaolo’s blog that reported on a criminal case involving payments to physicians for prescribing compounds;

“The complaint, filed by the owners of a medical billing company in the U.S. District Court in New Hampshire, alleges that Cyrus Sorat is a part owner of Health Care Pharmacy and Deutsche Medical Services in Tustin, Calif., and paid 208 doctors to prescribe compound drugs to injured workers needing topical analgesics. Sorat promised to pay the doctors an unreported fee for each prescription they wrote, and also agreed to handle billing and recover receivables on behalf of the physicians, according to the complaint.”

continue reading here