New Compounding Bill in the House—and More Work to be Done!

September 24, 2013
Category: Uncategorized

We’re still talking with our allies on the Hill to get more improvements, but we need your help to make sure your rights are protected. Action Alert!



We’ve been telling you about the Senate bill that places bioavailable estriol, so important to millions of women, and other important natural compounded medications in grave peril. Now the House of Representatives has released its own compounding bill, HR 3089.



It is likely that the Senate version will pass very soon, and the House bill won’t be far behind. We have heard from our allies on the Hill that there is very strong bipartisan support to pass a compounding bill this session. But you know what George Carlin said about the word “bipartisan,” don’t you?


bipartisan




The House bill is much better than the Senate bill, which is all about giving freebies to Big Pharma under the pretense of making compounding safer. Very importantly, the House bill does not endanger estriol. We are very grateful to our congressional ally, Congressman Morgan Griffith (R-VA) for that. However, there are still some areas of major concern in the House bill, and we are working on Capitol Hill to address them:


  • As in the Senate bill, compounders must receive the names of patients who received compounded drugs “for office use.” But in the House bill, they have only seven days to obtain them instead of the Senate’s fourteen days. Logistically and administratively, this is a nightmare.
  • Compounded versions of FDA-approved drugs may be banned as “copies of FDA-approved drugs” depending on how strictly that term is interpreted. As in the Senate version, the House’s definition is far too broad, and we fear that it could eliminate access to much less expensive pregnancy medications such as 17P in favor of outrageously expensive FDA-approved drugs like Makena, which costs $690 per dose, or as much as $14,000 over the course of a pregnancy. We are working to tighten the language as to what qualifies as a “copy” of a drug.
  • The bill prevents pharmacies from compounding non-standardized dosages of commercially available, FDA-approved drugs. This means that consumers are left to play with the dosages of drugs on their own (such as cutting a pill in half), instead of receiving an accurate, tailor-made dosage from a compounding pharmacy.
  • The bill makes the falsification of a prescription a federal criminal act. This may not seem controversial until you realize that prescriptions fall under the practice of medicine, which is regulated by the states, and making such a law allows the FDA to interfere in states’ autonomous practice of medicine. This is especially ominous in light of our recent article highlighting the collusion between state medical boards and the FDA.




Meanwhile, the Senate version of the bill remains the biggest problem, for the following reasons:


  • Limits office use: The bill says pharmacies can compound only 10% of the products they dispense each month for doctors’ office use. And compounders must receive, within fourteen days, the name of the patient who received the compounded medication. We are working to get the bill amended to remove the limitations on compounding for “office use” and increase the amount of time pharmacies have to reconcile patient records with the compounded drugs from fourteen to ninety days.
  • Bulk ingredients: The bill would allow FDA to identify bulk ingredients not suitable for compounding based on “public health concerns” even if they have a USP monograph which, under current law, is sufficient to allow compounding. The FDA has already attempted to ban bioidentical estriol based on vague “health concerns.” A USP monograph provides ample evidence of safety, so there is no reason it should be overruled in the government’s misguided effort to ban bioidentical estriol.




Let’s keep in mind that the FDA-approved drugs whose monopoly the FDA is trying to safeguard are not bioidentical and have been proven by extensive medical research to be very dangerous for women, specifically representing heart and cancer risks. The FDA is not a department of Big Pharma. And this kind of behavior is really reprehensible when the risks of the FDA approved drugs are at this point settled science and beyond dispute.


  • “Difficult to compound”: The bill allows the FDA to disallow entire categories of drugs that are supposedly “difficult to compound,” and specifically names extended-release products (i.e., time-release thyroid medication) and transdermal patches. We are working to remove extended-release products and patches from this classification. Millions of patients rely on these products, which would simply disappear.



  • Places limitations on selling out-of-state compounded drugs: Pharmacies that compound for interstate commerce face stricter scrutiny from the FDA. This could affect everyone, but especially those who do not have a compounding pharmacy within their state that can supply all their needs. Those of us on the ANH staff who use compounding pharmacies often have to go out of state to find what we need.




We have already been successful in making some very positive changes to the Senate bill because of the thousands of messages from our readers and grassroots activists like you, together with our meetings with Capitol Hill decision-makers. We got lawmakers to create a standard for the phrase “difficult to compound” so that FDA is forced to meet a burden of proof before they limit consumer access to medications based on this provision. Specifically, we included language that exists in current law: compounding must be “reasonably likely to lead to an adverse effect on the safety or effectiveness of that drug or category of drugs, taking into account the risks and benefits to patients.” We also made sure that the provision that compounders needed to perform random controlled trials in order to meet a “safety and efficacy” standard was removed. This was a real “poison pill” in that no one could afford to pay for these trials. Such a requirement would have inevitably led to the disappearance of many compounded medications, as the FDA (and the drug industry) know well. We were also able to remove the requirement that doctors must substantiate the need for a compounded prescription. This was another gross federal interference in the practice of medicine, which is supposed to be regulated by the states.



As you can see, there is still a lot of work to be done on this bill on both sides of Capitol Hill. Action Alert! We need to flood both the House and the Senate with emails, highlighting our various concerns over each of the bills. Please send your messages to Congress today, even if you sent a message about the Senate version previously!

Action Alert to the House:

Take-Action1

Action Alert to the Senate:

Take-Action1

19 responses to “New Compounding Bill in the House—and More Work to be Done!”

  1. Tina Coleman says:

    I do not need the government to dictate what type of health services i can and cannot use. Please stop trying to make my decisions for me. It is up to each and everyone to educate themselves on the best type of treatment to seek out when being faced with any type of health issues.

  2. Nancy Crom says:

    No compounding restrictions! This is just a stupid reaction to a compounding pharmacy that wasn’t properly regulated by the FDA> But, instead of getting their own house straight, they want to restrict MY rights to compounded medicine! This is obnoxious! Stop it! Tell the FDA to get their own house in order, preferably by firing the head of the FDA< who is a previous Monsanto employee. See any problems there, bright boys?

  3. V Brandt says:

    I depend on compounded thyroid medicine – -I’ve tried all sorts of available versions, and the compounded one works best.
    Compounded versions of FDA-approved drugs may be banned as “copies of FDA-approved drugs” depending on how strictly that term is interpreted. As in the Senate version, the House’s definition is far too broad, and we fear that it could eliminate access to much less expensive pregnancy medications such as 17P in favor of outrageously expensive FDA-approved drugs like Makena, which costs $690 per dose, or as much as $14,000 over the course of a pregnancy. We are working to tighten the language as to what qualifies as a “copy” of a drug.
    The bill prevents pharmacies from compounding non-standardized dosages of commercially available, FDA-approved drugs. This means that consumers are left to play with the dosages of drugs on their own (such as cutting a pill in half), instead of receiving an accurate, tailor-made dosage from a compounding pharmacy.
    These rulings would severely limit physicians’ and patients’ ability to get the medication that is most suitable for a particular case. We do not yet know why different individuals respond differently to the same medication – -sometimes even at different times in the life the same med doesn’t work the same way for the same individual. Please do not try to “standardize” drugs by removing the ability to compound them.

  4. Richard Koda says:

    Please do NOT pass the drug compounding bill as written. There are many changes that must be made to improve the both the House and Senate bills to improve the ability of Americans to obtain compounded drugs from their pharmacies in a reasonable manner.

  5. melissa says:

    I depend on compounding drugs to liive! My body started shutting down 6 years ago until after 5 doctors, I found one that recognized it was my hormones. (I knew but the doctors wouldn’t listen to me! I couldn’t walk 15 feet until I started taking estrogen, progesterone, cortisol and thyroid. Now I can work 2 jobs! Please, let’s do what we can! I can’t go back to not living again! I tried even synthetic but my body rejected them and make me worse. The compounds are the only things that allow me to live!

  6. Alice Mitchell says:

    my yahoo is blocking me from “Take Action”. This should be illegal. I copied the whole message, made modifications, and I am sending it to my senators and representatives. Thanks.

  7. Elizabeth Miller says:

    Am unable to get either of the action alerts to work. Gives me a page that says improper URL.

  8. Sam Sheldon says:

    I am in favor of limiting pharmacist ability to supply Doctor’s offices with “for office use only” meds. Most of these meds are more than a 72 hour supply and somehow get charged to another payer. An example are the pain gels (Ketoprofen + other ingredients) that Workmens Comp or private insurance pay thru various schemes. California Workmens Comp had a law passed in order to curb these abuses, i hope you are familiar with what happened. Also when physicians or pharmacist compound in their office, who has jurisdiction. Is it the Board of Pharmacy or the Medical Board? This is a pharmacy issue not a medical issue. If the Doctor wants to be a pharmacist, then let pharmacy laws and enforcement apply. Let’s protect patient safety.

  9. Lisa Kavanaugh says:

    As someone relying on several compounded medications to survive a rare disorder, I’m concerned about the creation of this bill. More care needs to be taken to accommodate the wide range and needs of the consumer. Compounded medications are purposely used to be tailored to each person’s individual needs. Please allow as much flexibility as possible to the companies manufacturing our compounds, as well as the healthcare professionals ordering and the consumers using them.
    Your decisions will directly affect my wellness. Please be so advised. As a constituent, my hope is to be heard and considered by my public servants. Thank you.

  10. Mari Mennel-Bell says:

    Good evening, I have been using compounding medicines for several decades. All have been extremely beneficial to my health. I encourage you to allow citizens to take the more natural route with their medicines and stay on the path of good health!

  11. Mike says:

    Both bills would allow for estriol and other products to be banned. Also, BOTH bills have the complex dosage form clause. Please read HR 3089 more closely.

  12. Deirdre Ryan says:

    I am an Australian and have had experiences of synthetic Meds re Hypothryoidism and Adrenal Insufficiency as have my 2 sons and the Compunded medicines returned us to health. OI cannot send a message to your political representatives as your Form applies only to USA based citizens .
    Safety in numbers applies to this matter and it would be beneficial if people outside of the USA could make their voice heard on this universal matter.
    Sincerely,
    Deirdre Ryan

  13. Kevin S O'Donnell says:

    Let’s not dismiss science and empirical evidence when it comes to treatment with compounding drugs that work!

  14. Elizabeth says:

    Since compounding requires more of a pharmacist’s time and intellect, I’m not surprised that they want this practice stopped- especially with the advent of the ACA/Obamacare just on the horizon. Pharmacists are inundated with prescriptions every day of the year and imagine what the toll on our pharmacies will be with the ACA. I suppose we could interpret this as an indicator of how our legislators plan to further degrade our medical system and compromise our health with that ‘ one size fits all’ mindset. Such a shameful sham.
    PS…note too that the original drafters of the ACA are now working for the pharmaceutical companies and it is expected that the drug companies will reap an additional 1-3 billion in profits each year over the next decade.

  15. Dr. Judith Sutherland says:

    I have menopause related ocular hypertension IOP). Research has demonstrated that bio-identical estrogen in small, topical doses reduce elevated ocular hypertension – and so it has with me. I must have access to compounded estradiol which is safer and reduces my IOP.
    Please support compounding pharmacies which provide vital health support for many of us.
    Thank you.

  16. To who it may Concern:
    I have been using holistic means of health for years after finding conventional medicine did to cure or aide my health. It would be a travesty to see government now intervene and cut one if the most useful means for healing and personal preference for maintaining our choices of how we wish to heal and remain healthy!!!!!!!
    Lets be fair here and allow this form of medicine which has been used for countless years among people and allow us natural healing!
    Thank you…..Dimitria Letsos-Davisdson
    Piano Teacher and Educator

  17. Cinda Nichols says:

    I have tried to “Take Action” with both the House and the Senate. However, when I click on the hot button for both it knocks me out and back to Yahoo News.

  18. Sandy Lee Sanderson says:

    I have used compounded hormones under a doctor’s care for several years. I can honestly say they saved my life–at least my quality of life. I strongly urge you to keep my right to have these compounded hormones.

  19. Janet says:

    My best kitty friend had lymphoma and the only way the chemo was affordable was through a compounder. All this is, is a shakedown implemented by Big Pharma to shut small competition down. They have no legit reasons to punish everyone other than just greed.

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