Compounding Pharmacy Bill: Third Draft, Still Some Major Problems—and No Time to Lose!

compoundingThe compounding pharmacy bill (S.959) passed the Senate Health Education Labor and Pensions Committee on Wednesday, May 22 with no substantive changes.  The bill will likely be taken up in the Senate soon—Action Alert!


Senate bill S. 959 is a large and complex piece of legislation on compounded drugs.  As we reported last week, the second draft was much improved over the first, thanks to your messages, but unfortunately the final draft does not fix the remaining problems. In particular, the bill allows the FDA to disallow entire categories of compounding drugs in “complex dosage forms” such as extended release products or transdermal patches. Millions of women and men depend on compounded time-release thyroid medications in both the complete and active forms, neither of which is available in standard drug form.

Another concern: estriol (the bioidentical hormone) has a USP-NF monograph, so legally it can be compounded. But this bill would allow FDA to identify bulk ingredients that are “drugs not suitable for compounding” based on unnecessarily vague “public health concerns,” even though they have a monograph as estriol does! In the past, the FDA has attempted to ban bulk bioidentical estriol at the request of a pharmaceutical company. The current language of the bill could allow FDA to regulate away your access to that medication, currently used by millions of women who refuse to take the synthetic hormone drugs that have been proven to be so dangerous. We must not let the FDA take away bioidentical estriol.

We believe this bill simply provides the FDA, which has been historically biased against supplements and integrative medicine, too much discretion to ban compounded drugs, including complete thyroid medications as well as estriol and other hormones. We still need to amend the language to ensure that only compounded drugs for which there is very good reason to believe they can cause harm to consumers should be banned, but we urgently need your help once again—and this alert goes out to the entire Senate, not just the HELP Committee.

Your message to your senators is critical. Please take action immediately!

Take-Action1

26 comments

  1. Another knee jerk reaction by the Government ….obviously this is about the tragic deaths caused by some compounded pharmaceuticals in Mass. …but what about the huge number of deaths and other health issues caused by FDA Approved prescription drugs everyday, that have given Attorneys just another way to make millions of dollars? The FDA apparently cannot prevent tragedies, but think they can. There have even been lots more health problems and deaths from over the counter drugs (of course made by big pharmacy) .

  2. Please don’t deprive us of supplements we need unless they are truly harmful to us – nto to Big Pharma!

  3. Millions of women and men depend on compounded time-release thyroid medications in both the complete and active forms, neither of which is available in standard drug form. I suffer from thyroid problems. PLEASE save this option!!

  4. I use compound products such as progesterone. I believe that the FDA will try and ban these compounded products. I have a right to choose what I want to use and this does wonderful things for me and I don’t want it taken away. The average doctor could do nothing for me except offer a hysterectomy . Please don’t take my compounding products away. Linda Sutton

  5. The FDA should be helping the American people maintain their health, not protecting the pharmaceutical companies, so they can make more money.We need the compounding drugs which are personalised for our specific needs.

  6. Bill s-959 – the bill to restrict or end compound pharmacies – will probably hurt and even kill a lot of folks. You guys may not think we notice but you have a furtive habit of being not very concerned about that. Hold your horses and proceed cautiously. Americans can only take so much before they start protecting their own.

  7. Senate bill S. 959 is a large and complex piece of legislation on compounded drugs. We received the third draft moments ago. As we reported last week, the second draft was much improved over the first, thanks to your messages, but unfortunately the third draft does not fix the remaining problems. In particular, the bill allows the FDA to disallow entire categories of compounding drugs in “complex dosage forms” such as extended release products or transdermal patches. Millions of women and men depend on compounded time-release thyroid medications in both the complete and active forms, neither of which is available in standard drug form.
    Another concern: estriol (the bioidentical hormone) has a USP-NF monograph, so legally it can be compounded. But this bill would allow FDA to identify bulk ingredients that are “drugs not suitable for compounding” based on unnecessarily vague “public health concerns,” even though they have a monograph as estriol does! In the past, the FDA has attempted to ban bulk bioidentical estriol at the request of a pharmaceutical company. The current language of the bill could allow FDA to regulate away your access to that medication, currently used by millions of women who refuse to take the synthetic hormone drugs that have been proven to be so dangerous. We must not let the FDA take away bioidentical estriol.
    We believe this bill simply provides the FDA, which has been historically biased against supplements and integrative medicine, too much discretion to ban compounded drugs, including complete thyroid medications as well as estriol and other hormones. We still hope to get this message across and are working with the Senate HELP Committee to amend the language, to ensure that only compounded drugs for which there is very good reason to believe they can cause harm to consumers should be banned, but we urgently need your help once again—and this alert goes out to the entire Senate, not just the HELP Committee.

  8. Dear Senators,
    Please stop trying to pass any legislation. As our Representatives you should be focused on getting a balanced budget passed instead of wasting yoiur time on other things that should be left alone until you have your financial house in order.
    Respecfully,
    Richard Calhoon
    Fort Collins, CO 80524

  9. The FDA is increasingly trying to give the pharmaceutical industry complete control over our health care; please reject this costly oversight.

  10. As a citizen of the United States and a user of hormone replacement with bio-indentical compounded hormones for the last 8 years…….I ask you to recognize this as a right for individuals to choose other options on a more holistic and alternative basis……compounded hormones has helped tememdously through this transition and uphold and manage my career in the most healthy way that I have researched…….pharmasuitical hormones are not right for me, and in a free country I should be able to choose the right option for me…….alternative methods and medicine should be known to all and available to all! I am stating this message to let those who are trying to stop this to know that all people have a right to choose the healthiest way to take care of their health needs and not be told what they can and cannot use…….as far as my opinion this is the way our country and medical community should be leading us as a country……WE HAVE THIS RIGHT TO CHOOSE!!! NO ONE SHOULD BE ABLE TO DECIDE FOR YOU……
    Sincerely, Cheryl Holder

  11. We have every God given right to choose what we put into our bodies. Let us choose compounded drugs if we desire. Let this go!

  12. It’s time for the eugenicist criminals who have hijacked our government to get the message: LEAVE US ALONE! We have a right to choose for ourselves when it comes to our health and wellness. We are perfectly capable of making wise choices when it comes to nutrition. Leave the compounding pharmacies ALONE! Instead, we need to shut down the real problem: the FDA approved drug cartel that is the Pharmaceutical Industry (“Big Pharma”) with all of their deadly toxins and poisons that kill more people every year than war, famine, disease, etc.! Until they are put “out of business”, we will never be “drug free”!

  13. Everytime I fill out an action alert I have to re-enter all of my information even though I request with the checked box to be remembered What else do I need to do?

    1. I use autofill. Don’t know if this helps you as I have a mac and don’t know how windows works

  14. It is time to let ‘us’ decide how to treat the conditions and we have every right to use compounding. Let’s get out of the pocket of the drug companines and allow they health system to work for us not against us. Prevention is better than disease, and definatley more afforable. Treat people not drug companies pockets!

  15. Please consider also the jobs that are at stake. How many of us depend on our jobs currently? This will hurt us immediately with the huge influx of pharmacists and technicians into the job market considering how saturated most places are that we currently live. Furthermore the lack of help offered to our patients to obtain a better quality of life will be terrible.

  16. Nathan Knowles I use supplem contral blood suger help me sleap at night and low ldl cleocoirs.

  17. Dear Senators:
    With all due respect, it is imperative that you change your minds on rescinding bio-identical hormones. First reason, they are much healthier than the allopathic meds. Second reason, I have severe multiple chemical sensitivities and cannot tolerate regular hormones (I’ve tried). The bio-identical are made specifically for me and my problems and I seriously cannot be without them. You would be causing major, major problems for thousands of people when there is no good reason to do so, except in bowing down to Big Pharma. Please consider the PEOPLE that would be adversely affected by this. Big Pharma is quite powerful….they will survive. I thank you for your time and consideration.

  18. I also think this bill would be good if compounding pharmacies are continued in America. There are very good and experienced pharmacists namely Compounding Pharmacy Virginia providing good and trustable compounding medicines to people.

  19. To big pharma, and the government which allows you to exist:
    Again, you are exerting your control over branches of REAL medicine that seeks to actually HEAL people, rather than focusing any attention on the death and disease destroying lives with your vaccines containing formaldehyde, mercury and aluminum, rampant anti-biotic usage, and the many conventional, chemically-laden pharmaceuticals that have caused death and permanent, painful disability, in beautiful, innocent, and trusting people.
    Evil will not win, I can assure you.
    The strong and independent people of the United States will only be pushed so far.
    There will be a revolution.
    The fear-mongers, LIARS, and drug dealers, that work within the government, and the corporately controlled sick-care industry, are going to SEE exactly what happens when citizens push back for real.
    So, just keep up your attempts to make us sick and weak with your poisons.
    Keep stripping us of our God given rights and freedoms, and just see what happens when we have nothing left to lose, and we fight back!
    If you think you can keep taking away our freedoms without backlash, you are sadly mistaken.
    True social unrest, is brewing right now, and I can assure you, Americans are not as weak and docile as you’ve assumed for so long.
    The multi-headed monster called “modern medicine”, which has been strangulating the american people for so long now, I can PROMISE you, will be overcome by the AMAZING unity and infinite power of the collective HUMAN SPIRIT.
    None of your poisonous deeds, or toxic medicines, can ever hold a candle to the beauty and power that we all have inside of us.
    Collectively united, WE are unstoppable.

  20. Its nothing more than plain old GREED! And they dont care who they have to hurt or kill along the way!
    We should start by passing a law that locks up people who attempt in ANY way other than scientifically or medically to influence our laws, guidelines, restrictions or politicians. The FDA has turned into a spineless shell of something that once had a noble purpose. Its become simply a rubber stamp for the pharmaceuticals!

  21. This bill is completely useless, a seriously negative waste of tax dollars and time, and a disgustingly pathetic move by the fda to support big pharma. More people die everyday from car accidents, suicide, and other accidents- not to mention big pharma’s drugs. Why on EARTH such a disgraceful and pathogenic law is even being considered makes me very sad for where our beloved country is headed. It makes absolutely no sense to legalize marijuana in states yet determine that ‘compounding drugs are unsafe’. This will not stand if passed- an excessive amount of people will die and have more miserable lives as a result.
    Dear fda and politicians, stop meddling where your nose doesn’t belong. This is a civil rights issue, not a government issue. Go do something useful with our tax dollars. We must remove all politicians promoting this bill asap. They obviously do not have our best interest at heart.
    Fellow citizens, never elect or support ANY politicians promoting this bill. See these fools lose their jobs and write letters, blogs, newspaper articles, etc demonizing any fda employees promoting such legislature to voice our profound disgust for this circumvention of rights. Find out WHO the key players are in this fiasco and do every peaceful move possible to tear these people away from this power. Stand up for our rights, loud and clear. I know I will- join me.

  22. Hello @ ANH,
    Tried to send a message to the address you contact me with your email… anh-usa.org
    My email was returned with a message saying use a different email because anh-usa.org receives too much “junk mail”. I then sent my message to the address you gave me http://www.anh-usa.org/contact The mail was not delivered saying this was an invalid email address. The message I was trying to send to you was pertaining to the compounding bill and how it is voted on and how the votes are tallied. That emailing and phone calls do not receive as much attention as FAXES to our senators and congressman. If this is correct then I wish to know the FAX number to contact my senator in the state of NY. Perhaps all of us need to have the FAX numbers to our politicians if this is the best way for them to get our votes against this bill tallied.
    Thanks for your help in this matter.
    Concerned healthcare provider

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