HORSE HEALTH Choosing Joint Health Products May 2, 2013 Find out how to make the best choice between FDA-approved innovator drugs, FDA-approved generic drugs, medical devices or compounded products.

From AQHA Corporate PartnerAdequan

When a horse or companion animal becomes sick or lame, you turn to your veterinarian for a diagnosis and the best, proven treatment to make your animal better.

But, just because a product is available for purchase doesn’t make it a proven product or the right product to treat the problem. So, do you treat with an FDA-approved innovator drug, an FDA-approved generic drug, a medical device or a compounded product?

In considering this question, Dr. Jeffrey Berk, a veterinarian at Equine Medical Associates in Lexington, Kentucky, says horse owners need to consider two things very carefully.

“When considering an alternative treatment, veterinarians and horse owners need to understand they are not guaranteed the same level of safety or quality — i.e. potency and purity — as you would with an FDA-approved product,” says Dr. Berk, who is a member of the Professional Conduct & Ethics Committee of the American Association of Equine Practitioners.

FDA-Approved Products

Some experts estimate that it takes four to six years and millions of dollars to get anFDA-approved animal drug from the laboratory to the marketplace. Most of the money is spent on conducting studies that prove the drug’s effectiveness in a form acceptable to the Food and Drug Administration, the governing body over both human and animal drug approval. The FDA approval process is the most extensive law of its kind in any country. All regulations are focused on protecting the end user and providing a safe, effective product. In short, the FDA will not allow a company to market a drug as FDA-approved if it has not proven its effectiveness in multiple scientific studies.

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FDA has wish list on regulating compounders Congress might be listening as quality control issues at compounders cause health-related death and illness -

By Eric F. Greenberg, Contributing Editor/Legal Columnist

 Those big news stories last fall about the contaminated injectable steroids from New England Compounding Center in Massachusetts might have been the first news you heard about compounding pharmacies, but it’s not hardly the start of the story. The U.S. Food and Drug Administration and industry have been struggling for years over the proper regulatory treatment for these facilities, and Congress and the courts have both helped change the shape of things as well. FDA is now asking for even more changes to give it a better ability to regulate compounding pharmacies.

The Massachusetts compounder marketed products that killed more than 50 people and made hundreds more sick. The company pretty clearly had poor quality procedures, but many people blamed FDA for not cracking down on them. FDA, in turn, lamented that its legal powers are more limited over compounders than over conventional drug manufacturers, even when, as in this case, the compounders were behaving much the same way as a manufacturer.

- See more at: http://www.packworld.com/trends-and-issues/regulatory/fda-has-wish-list-regulating-compounders.

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Question of the Day: 5/3/2013 Who Are The Key People That Congress Should Allow to Testify At the Hearing On May 9 Regarding the Proposed Federal Legislation on Compounding?

I think without a doubt Dr. Loyd Allen and Dr. Gigi Davidson.  Who else do you think should be on the list?

The Proposed Federal Legislation Regarding Compounding Is Focused More on Fees than On Making Advances to Protect the Health and Safety of the Public From Bad Compounders

Sue Tuck Richmond
May 3, 2013


A lot of people, including me, believe reform in the human and animal compounding world is greatly needed.  There are different views on how this reform should be accomplished.  Some think the reform needs to occur at the state level; others believe it will take the federal government's strong involvement to achieve the reform needed.  Still others believe a combination of reform at both the state and the federal government is necessary.

I have previously posted Ten Reasons This Legislation Should Not Be Passed in Its Current Form. Having previously drafting legislation on behalf of my U.S Attorney for the Department of  Justice to consider and having researched and briefed issues addressing statutory interpretation and legislative intent,  I know that drafting legislation is no easy task.  It is a lot easier to be on this side picking apart the legislation.  I also know that you have to start somewhere when trying to draft and pass new legislation.  I commend the  members of the HELP Senate Committee for starting the process of reform in the compounding world.  But this draft legislation is just that--the start of the process of reform.  The process of reform must include focusing on the health and safety of the public from bad compounders. I have to agree with the  Public Citizen Advocacy Group;  This proposed legislation is  "a major step backward for US drug safety."

No where in the draft of the legislation is it stated that protecting the health and safety of the public is the purpose of the legislation.  In the documents released with the draft legislation, it states that the "proposal would help improve the safety of compounded human and animal drugs by making clear the oversight responsibilities of state and federal authorities."  See Bipartisan HELP Senators Unveil Major Effort to Clarify Oversight for Pharmaceutical Compounding; Ensure Consumer Safety, p.1, The Section by Section, Summary of the Bipartisan Senate Discussion Draft, states:

This discussion draft establishes a clear boundary between traditional compounders and compounding manufacturers, which make sterile products without or in advance of a prescription and sell those products across state lines. It clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation. The draft creates a similar structure for oversight of compounded animal drugs, and clarifies the law on compounding from bulk chemicals for animals.

The mention of public health and safety is sparse in any of the released documents.  The sparseness wouldn't be as big an issue if the proposed legislation would ultimately accomplish protecting the health and safety of the public from bad compounders.  However, this does not appear to be true for several reasons. 

First, the language of the proposal is confusing and doesn't make sense.  Why create a new category of  "compounding manufacturers" that only muddies the waters? Why allow "compounding manufacturers" to mass-produce drugs and sell them across state lines without obtaining FDA approval intended to ensure safe drugs when manufacturers of drugs are currently required to get approval and meet federal labeling requirements?  Second, I envision that if this legislation is passed as is much time will be spent in court litigating which category a pharmacy fits into and which rules apply.  I also envision like the Public Citizen's group that some manufacturers may decide to skip the FDA's regulatory processes entirely and instead compound on a large-scale basis.  This certainly won't further the cause of drug safety.  I also envision some large-scale compounders may scale back and not be "large-scale" anymore to avoid having to pay the large fee for inspection.  All of this shifting could result in much needed drugs being in short supply or simply unavailable.  These once large-scale compounders won't be under the FDA's watch so again the legislation doesn't further drug safety.  

The fee issue is an another matter.  The FDA needs funding to conduct these inspections. We all know the state of the current federal budget.  I can't blame the FDA for trying to fund the legislation in the legislation.  But again, since this legislation appears to be more about "fees" than fixing the broken compounding regulatory process, it leaves one wondering is this more a "revenue producing piece of legislation" than a "fixing a broken process piece of legislation?"  

In sum, the process of reform has begun.  The needed reform cannot be achieved with the proposed federal legislation.  I have always advocated that the more input from more people, groups, associations, etc. the better the chance of a workable, piece of legislation that in fact makes advances to protect the health and safety of the public from bad compounders while allowing the good compounders to continue to operate. Please listen Congress to what experts across the country have to say about how to reform the compounding world. Please do not forget that just as there are bad compounders there are also very good, highly skilled compounders who play by the rules everyday producing essential drugs for animals and humans.  We need to keep these good compounders and not run them off as we are removing the bad compounders.  With everyone working together to come up with the best reform, the goal of better, safer compounds can be achieved.

Monthly Archives: May 2013 Congress Drafts Legislation that would Expand the FDA’s Role in Regulating Compounding Pharmacies posted by william p. conaboy jr. on may 02, 2013

Mr. Conaboy believes:

The Draft Legislation will likely undergo significant revisions before its adoption — if it is adopted at all.  What is clear, however, is that the FDA is moving toward regulating compounding practices that have traditionally been regulated by state agencies.  Federal intervention will likely come to fruition in the near future, and many compounders who are not currently subject to the FDCA’s GMPs and other requirements will be faced with the challenge of having to comply with new regulations and additional oversight.  Accordingly, it is important that compounding entities become familiar with and track the Draft Legislation as it progresses as it appears that increased federal oversight is imminent.

To read his entire blog post click here

Law 360 Says Compounding Bill May Hand FDA New Power Over Health Care

Compounding Bill May Hand FDA New Power Over Health Care

Share us on:TwitterFacebookLinkedInBy Rachel Slajda

Law360, New York (April 30, 2013, 8:07 PM ET) -- If enacted as is, new draft legislation to give the U.S. Food and Drug Administration explicit authority over compounding pharmacies could strip states of much of their authority over compounders, outlaw common compounding practices and give the FDA some power to regulate the practice of medicine, a power courts have long left to the states, experts say.

Leaders of the Senate Health, Education, Labor and Pensions Committee last week released a draft bill that would grant the FDA its request for more explicit authority to regulate...

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Members of the Senate HELP Committee--Write Them Now Re: Views on Proposed Compounding Legislation- Comments Due Tomorrow to Committee Re: Proposed Legislation

Democrats by Rank

Tom Harkin (IA)
Barbara A. Mikulski (MD)
Patty Murray (WA)
Bernard Sanders (I) (VT)
Robert P. Casey, Jr. (PA)
Kay R. Hagan (NC)
Al Franken (MN)
Michael F. Bennet (CO)
Sheldon Whitehouse (RI)
Tammy Baldwin (WI)
Christopher S. Murphy (CT)
Elizabeth Warren (MA)

Republicans by Rank

Lamar Alexander (TN)
Michael B. Enzi (WY)
Richard Burr (NC)
Johnny Isakson (GA)
Rand Paul (KY)
Orrin G. Hatch (UT)
Pat Roberts (KS)
Lisa Murkowski (AK)
Mark Kirk (IL)
Tim Scott (SC)

Senate Hearing Scheduled for May 9th to discuss draft legislation

Senate Drug Compounding Hearing Slated For Thursday

The Senate Health, Education, Labor and Pensions Committee will hold a hearing Thursday (May 9) to discuss the panel's recent bipartisan drug compounding proposal, . . .

source found here and here

HHS Official Pledges Guidance To Ease Compliance With HIPAA Privacy Rule

An HHS official responsible for writing the recently released omnibus rule for strengthening the privacy and security of patient data said the agency would soon be releasing a series of guidance documents to ease industry compliance with the new requirements that go into effect in September.

Source found here

Public Citizen Blasts Draft Compounding Rules, Says New Category Would Skirt Regulatory Requirements

Public Citizen Blasts Draft Compounding Rules, Says New Category Would Skirt Regulatory Requirements