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.