Will the FDA Close Your Pharmacy?

October 7, 2019

It may come to that if a key policy isn’t changed. Action Alert!

As part of its effort to implement the Drug Quality and Security Act of 2013, the FDA issued a revision of a bad policy that will limit the amount of medicines compounding pharmacies can send out of state. The revision offers some improvements, but still makes it harder for patients to get the medicines they need. This benefits Big Pharma at the expense of the consumer.

The rule concerns how much medicine traditional compounding pharmacies can send out-of-state. These sales are limited to 5% unless a state enters into a Memorandum of Understanding (MOU) permitting additional sales.  In exchange, however, the state assumes some of the responsibility for overseeing pharmacies within their borders that send a certain amount of medicine to other states.

Previously, pharmacies in states that signed the MOU could send 30% of their sales interstate, but the FDA has increased that number to 50%. In an earlier proposal in 1999, the number was 20%. It is good that the number has increased, but these changes also highlight the arbitrary nature of this process. Why not 60%, or 80%? Why include any limit?  Does the FDA know what it’s doing at all?

Importantly, the revised MOU does not address a key issue, which is that it shouldn’t be limiting the interstate shipment of medicines for which there is a doctor’s prescription at all; the law only allows the FDA to place some limitations on how many medicines a traditional pharmacy can send out-of-state without patient-specific prescriptions.

Why does this distinction matter? Limiting the interstate shipment of compounded medicines pursuant to a doctor’s prescription will prevent patients from getting the medicines they need. Certain pharmacies specialize in specific areas, such as bioidentical hormones. If that pharmacy is in Michigan, and you live in New Jersey, there’s a real risk that you will no longer be able to get that medicine, even if you’ve taken it for years. If that pharmacy has already sent 50% of their sales out-of-state, you’d be out of luck.

Remember, too, that the 50% limit will only apply in states that actually sign the MOU—otherwise the 5% limit applies. Early indications are that many states will not sign the MOU. In a comment submitted to the FDA, the National Association of Boards of Pharmacy reported that 20 states informed them that they would be unwilling to sign the MOU in its current form, meaning that if the MOU is not revised, almost half the country will be subjected to the FDA’s draconian 5% interstate shipment limit.

All of this is happening simultaneously to the FDA threatening to eliminate consumer access to compounded bioidentical hormones such as estriol and progesterone. These and other hormones have been nominated to the agency’s “Difficult to Compound List”; items that appear on the final list will not be able to be compounded at all. You can consult our previous coverage for more details.

As we’ve said all along, it is our opinion that the objective in all of this is to shut down compounding because it threatens Big Pharma profits, and Big Pharma funds the FDA. We have to fight back and ensure that patients can get the medicines they need.

Action Alert! Write to FDA with a copy to Congress, telling them to follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription. Please send your message immediately.

75 responses to “Will the FDA Close Your Pharmacy?”

  1. peter freer says:

    The current suggested revision to the Drug Quality and Security Act of 2013 doesn’t serve the public. It serves Big Pharma. Rethink your actions and leave this alone.

  2. Gabrielle C Swanberg says:

    I as a citizen request FDA to follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription.

  3. John Read says:

    Congress, telling them to follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription. Please send your message immediately.

  4. Cassandra Silva says:

    Please don’t close CVS and Walgreens,Rite Aid now too?

  5. Twila Roth says:

    Please follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription.

  6. Jane F Flynn says:

    What happened to my freedom to choose the type of medical care and services I want? Surely the FDA actions are against the US constitution.

    We have used successfully compounded pharmaceuticals for over 20 years without any problems. But we live in a state controlled by HCA Columbia, Vanderbilt U. Medical Center and some pharmaceutical companies, etc. We have to travel 3000 miles to the MD who practices the biochemical medicine which we want. Obviously we need to have the natural medicines sent interstate.

    Obviously, the FDA agents who propose these limitations on compounding pharmacies have unlawful connections with big-dharma.

  7. G. Matthew Hall says:

    Leave our medicines alone!

  8. Sallie Robbins-Druian says:

    ATTENTION FDA & CONGRESS:

    PLEASE FOLLOW CONGRESSIONAL INTENT AND STOP LIMITING THE INTERSTATE SHIPMENT OF COMPOUNDED DRUGS PURSUANT TO A DOCTOR’S PRESCRIPTION! THE PEOPLE OF THE UNITED STATES OF AMERICA DO NOT TRUST BIG PHARMA NOR DO WE WANT THEIR OVERPRICED MEDICATIONS THAT ARE APPARENTLY BEING SUPPORTED BY PROFITS AND THE FDA FUNDING! PLEASE DO SOMETHING FOR THE PEOPLE OF AMERICA WHO NEED SUCH MEDS AND CANNOT AFFORD THEM.

    THANK YOU.

  9. Richard Eng says:

    The same compounds should be available in all 50 states.

  10. Mike LaBrier says:

    Personally, I think the government should butt out of the doctor/patient/pharmacy relationship UTTERLY AND COMPLETELY.

  11. Joan Holland says:

    Please follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription.This would be disaster for me and loved ones.

  12. Robert Vernan says:

    Please stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription.

  13. J. Holland says:

    Please follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription.This would be disaster for me and loved ones.

  14. Pam says:

    Arbitrarily limiting access to bioidentical hormones and other beneficial drugs via a percentage approach is nonsensical and threatens the well-being of patients who depend on those drugs for health in their golden years. The proposed restriction does not appear to be aimed at helping patients but at enlarging the power of large pharmaceutical companies. I oppose these restrictions and believe that they will trigger multiple negative impacts, including patients purchasing foreign-made drugs via Internet to get around this ridiculous obstacle.

  15. Vicky says:

    Please stop the FDA from limiting compounding pharmacies to only 5% out of state deliveries. Compounding pharmacies should be able to send as many shipments as are ordered by customers. Do not limit the shipments.

  16. Geoffrey Rogers says:

    Importantly, the revised MOU does not address a key issue, which is that it shouldn’t be limiting the interstate shipment of medicines for which there is a doctor’s prescription at all; the law only allows the FDA to place some limitations on how many medicines a traditional pharmacy can send out-of-state without patient-specific prescriptions.

    Why does this distinction matter? Limiting the interstate shipment of compounded medicines pursuant to a doctor’s prescription will prevent patients from getting the medicines they need. Certain pharmacies specialize in specific areas, such as bioidentical hormones. If that pharmacy is in Michigan, and you live in New Jersey, there’s a real risk that you will no longer be able to get that medicine, even if you’ve taken it for years. If that pharmacy has already sent 50% of their sales out-of-state, you’d be out of luck.

    Remember, too, that the 50% limit will only apply in states that actually sign the MOU—otherwise the 5% limit applies. Early indications are that many states will not sign the MOU. In a comment submitted to the FDA, the National Association of Boards of Pharmacy reported that 20 states informed them that they would be unwilling to sign the MOU in its current form, meaning that if the MOU is not revised, almost half the country will be subjected to the FDA’s draconian 5% interstate shipment limit.

  17. Suzanne Lamuniere says:

    It’s old news that the FDA is Big Pharma’s lapdog, who is surprised at this latest attack on people with prescription needs? The entire industry is corrupt and happily indifferent, couldn’t care less at how their money grubbing affects actual people? Our deaths only matter when a lawsuit is involved. I want to see the pharmacist, not pray that the Utterly Inefficient USPS hasn’t lost my box of little packets every month. What happens when your prescription needs to be changed immediately? This has happened to me twice.

    This whole idea stinks, and all the sociopathic people pushing for it should be ashamed of themselves for their role in creating this ugly situation.

  18. Susan says:

    Is this taking away Americans Freedoms more and more? Taking away Choices? Free Speech? Who does the FDA really protect? These are all questions I ask myself. If a compounded medicine helps a American in one State why should it be denied to another American in a different State?
    Are States rights being ignored here? Freedom to choose how and with what Americans choose to help themselves to good health seems to be slipping away. Freedoms get eroded slowly by small laws created by a few who wish to control behavior and beliefs. Until like the frog in a pot that is slowly heated. It does not notice until it is way too late….. or not at all. This is not the America I was born into.

  19. Ronald Steinbach says:

    I agree. The FDA should not be allowed to limit the interstate shipment of prescription medications!

  20. wendy whyko-marolda says:

    Follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription.

  21. I can understand the importance of putting limits on international trade (between countries), and most of this has to do with fair trade involving money and politics, because not all countries play fair (tariffs, restrictions, currency manipulation, etc). . .

    IN CONTRAST, I do not understand why the FDA is limiting interstate trade involving compounding pharmacies. I hope the FDA is not using politics and money as pawns to restrict capitalism within the United States causing only the consumer to suffer. I hope that is not the case, because that is actually illegal. I need to know why the FDA is restricting interstate trade by compounding pharmacies.

    We need fair and legal trade of all products within the USA without discrimination. Only in this way can we better insure fair competitive prices, quality, access, and safety of competing pharmaceutical products that are produced within the USA – so US citizens are not being punished be FDA politics.

  22. Barbara Ochs says:

    Please follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription.

  23. Lauren Cummins says:

    What about seizure medications?

  24. Christine Kuhlman says:

    I am a Naturopathic Dr as well as a advanced registered nurse practitioner so I value and am knowledgeable about both types of medicine. i rely heavily in my practice for compounded natural female hormone replacement therapy and thyroid meds. i also ask for compounding of a number of conventional meds in liquid form etc for some of my elderly and young children patients. If these medications natural and conventional are legal anyway why penalize a compounding pharmacy for how much is sent out of state. We have plenty of examples of national pharmacies. This seems a blatant attempt of restriction of trade to make big pharmacy richer and disallow patient access to already approved meds

  25. Jaya says:

    In the much bigger, universal scheme of things, no one will get away with these greedy restrictions. Karmic payback is a bitch!

  26. Rebecca Darchuk says:

    No reason for this! FDA is totally corrupt and run by Big Pharma, which only cares about profits. Any reasonable person knows this.

  27. Denise Beard says:

    I have been taking bio identical hormones now for a few years with wonderful results! My local compounding pharmacy is now sending my compounding prescription to one central pharmacy, which happens to be out of state. this could adversely affect my ability to get what I need.

  28. Rollin Shultz says:

    The FDA, yet another agency the Trump administration needs to drain the swamp by making some serious personnel changes.

  29. Rebecca Fults says:

    I take bioidentical hormones. I feel awful without them. You have no right to make a decision that would effect my health. If the drugs are FDA approved everyone should have access to them if their doctor prescribes them.

  30. Terry Bickel says:

    Please do not limit the interstate shipment of compound drugs pursant to a doctor’s prescription. We have the right to choose.

    Thank you!

  31. Susan Gridley says:

    Please let my access to compounded medicines continue! They have made my life so much better. I went from disability to near normal activity by being able to have medicines and hormones prescribed in doses that were right for MY body! Pharmacists are the experts in medications–much more than MDs–and I say this after being on the faculty and teaching at a medical school for 20 years.
    Also, my animals have benefited greatly from compounded medicines for cancer, asthsma, diabetes, and more. I always find a local small pharmacy when possible. Big Pharma isn’t in the business to design for biochemical individuality. And Big Box pharmacies mostly specialize in being on hold on the phone or in line for hours to pick up a Rx. HELP!!!

  32. aris Campbell says:

    Limiting a specialty pharmacy means less access to well made products.

  33. Karen Bauer says:

    This is utterly ridiculous. As both a patient and a primary healthcare provider in NY State, I strenuously urge you to stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription.

    I for one am allergic and sensitive to many ingredients in standard drug formulations. I have to have things compounded, and often the cheapest way to buy compounded medicines is to buy them out of state.

    Don’t sacrifice patients for the sake of already fantastically successful Big Pharma. They don’t need your help. And if you sell your soul to the devil, he will take it. If you believe you are a Christian or believe in any other religion, or if you are an avowed humanist, IN ANY CASE, THIS WOULD BE WRONG, a sin against God and against humanity. A HUMAN RIGHTS VIOLATION!

    Do what’s right FOR PATIENTS, NOT PROFITS.

    Thank you for your consideration. Be brave. Do the right thing. God will reward you.

  34. stan glazner says:

    I want the freedom of choice to buy needed medication from any pharmacy I choose regardless of location. FDA should not be able to restrict my doctor from prescribing compounded medicine necessary for my health.

  35. Mary Dziugis says:

    Stop limiting compound pharmacies!

  36. Please follow Congressional intent and stop limiting the interstate shipment of compounded medicines and drugs pursuant to a doctor’s prescription that so many people need, that conventional medicines do not work for special health issues.
    Thank You.

  37. Please follow the Congressional intent and stop limiting the interstate shipment of compounded medicines and drugs pursuant to a doctor’s prescription that many people will need for various health issues that traditional medications or drugs will not help them.

  38. Linda Pierce says:

    I like having the freedom to choose my pharmacy in order to monitor what I have to pay for prescriptions and would hate for shipping restrictions to close businesses that I use.

  39. Please follow Congressional intent and stop limiting the interstate shipment of compounded medicines and drugs pursuant to a doctor’s prescription. There are many people who have or may come into a serious illness that only compounded medicines can cure.

    Thank You.

  40. Julie Snyder says:

    What is the reason for limiting the amount of medicine that can be shipped across state lines? Seems like you are just taking away more rights so Big Pharma can get richer! Your corruption knows no bounds.

  41. Please follow the Congressional intent and stop limiting the interstate shipment of compounded medicines and drugs pursuant to a doctor’s prescription. There are instances when many people need fresh compounded medicines because of their unique and different health issues, when traditional medicine or drugs will not work for them.

  42. anna davis says:

    Physicians must be able to choose and decide what is the best type medicine for
    their patients.

  43. Ann Brannan says:

    Follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription! You need to stop regulating and use some common sense!

  44. J B says:

    Big Pharma also gets or make their drugs in India; etc. No quality control; Big Pharma charges you the full monetary amount (cheaper to make in India) in the United States.

    Big Pharma as wells Healthcare companies ; CEOS and Board of Directors get a nice salary and compensation packages.
    It is one of the primary reasons why American healthcare is expensive.

    HOW CAN YOU CONTROL HEALTHCRE COSTS ;WHEN THEIR SALARIES ARE SO OUT OF WHACK.

  45. The big pharma profits, are disturb when the pharmacy is compounding medication,for the well being of the patient. It has gone on for years and works on those patients that need that combination to be beneficial for the patients health. They are going against the doctor prescribing these medications for his or her patients.
    The big pharma is only concerned about their monies versus a patients well being and his or her doctor would know better.

  46. Jack Tips says:

    Freedom to order from any pharmacy is a fundamental right. Access to compounding pharmacies is a free choice of an individual to support their health. Do NOT support the limiting of access to pharmacies because of state borders. This is one country. Thank you.

  47. Lisa D Heller says:

    I am asking you to stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s perscription.

  48. Marvin Zinn says:

    I recognize drugs are sold for profits, not health. How many medical doctors own stock on a pharmacy they make prescriptions for? (I refuse all of them unless it is a serious problem I have not found herbs that solve them. It was only twice in 20 years I took any.)

  49. Drew Keller says:

    The FDA continues to demonstrate that it doesn’t have the best interests of consumers at heart and instead is the lapdog for Big Pharma.

  50. Cece Williams says:

    I have suffered this problem for a number of years since Indiana compounding pharmacy stopped shipping to California where the same drug is 3 times more expensive.
    The way around it is to have it sent to a friend in the state where the pharmacy is, and then have them re-send it to you.
    Pain in the rear, but it works.

  51. Shan Albert says:

    It seems big pharma really does make the rules here — well, of course, it’s the golden rule: he who has the gold makes the rules. I am writing to ask that you not allow them to limit the interstate shipment of compouded drugs pursuant to a doctor’s prescription. A doctor’s prescription is given to a patient for the patients’ benefit and the patient should be able to get it filled anywhere he or she chooses.

  52. J. Holland says:

    PLEASE STOP limiting interstate shipment of compounded drugs prescribed by my doctor! My loved ones and I depend on them.

  53. J. Holland says:

    PLEASE STOP limiting interstate shipment of compounded drugs prescribed by my doctor! My loved ones and I depend on them.

  54. Mayme Pace says:

    BFollow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription.

  55. Susan Hegna says:

    This is suppose to be a free country, not a dictatorship/ We feel that compounded drugs are better for us than what big Pharma pushes. They are greedy and don’t care about the people, they just want money at our expense. We are not asking for you to do away with Big Pharma, if some people want to use their drugs, they can but don’t take our choices away.

  56. Nancy Sugahara says:

    Don’t you think it would be more efficient if you wrote the message and we could amend or add to as needed.
    Many of us will not write our own message but will sign and send a pre-written message.

    • Ila Kimata says:

      Hi Nancy,

      Thank you for your comment. We do write the message and then allow readers to edit it before they send if they would prefer. The Action Alert button links to the page where readers can send the message we’ve drafted to their elected officials and the FDA. I hope that helps!

  57. Janice Banks says:

    Will the FDA close any pharmacy? Please focus on this and do all you can to prevent it.

  58. Jan Weisel says:

    Stop trying to limit the interstate shipment of compounded drugs. Consumers should be able to choose where they get their prescriptions filled.

  59. Molly Hauck says:

    Follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription. I rely on compounded medications. We need to be able to choose what kind of medications and supplements we take and compounding pharmacies play an important role.

  60. Normajean Bowen says:

    Follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription!!!

  61. Kevin Grimes says:

    This is horrible for those who depend on their local pharmacy

  62. Leslie Edison says:

    To Whom It May Concern at the FDA:
    Please follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription. Please do not eliminate efficacious hormones which are helping many patients, ie., estriol and progesterone.
    Patients have a right to have safe, beneficial treatments, which are safer and more efficacious than what is commercially available. Please review many years of research from Europe where these hormones have been studied.

  63. Elizabeth Bush says:

    Please follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription.

  64. Allan Campbell says:

    Please limiting the interstate shipment of compounded drugs based on a prescription

  65. Melissa Cleaver says:

    As part of its effort to implement the Drug Quality and Security Act of 2013, the FDA issued a revision of a bad policy that will limit the amount of medicines compounding pharmacies can send out of state. The revision offers some improvements, but still makes it harder for patients to get the medicines they need. This benefits Big Pharma at the expense of the consumer.

    The rule concerns how much medicine traditional compounding pharmacies can send out-of-state. These sales are limited to 5% unless a state enters into a Memorandum of Understanding (MOU) permitting additional sales. In exchange, however, the state assumes some of the responsibility for overseeing pharmacies within their borders that send a certain amount of medicine to other states.

    Previously, pharmacies in states that signed the MOU could send 30% of their sales interstate, but the FDA has increased that number to 50%. In an earlier proposal in 1999, the number was 20%. It is good that the number has increased, but these changes also highlight the arbitrary nature of this process. Why not 60%, or 80%? Why include any limit? Does the FDA know what it’s doing at all?

    Importantly, the revised MOU does not address a key issue, which is that it shouldn’t be limiting the interstate shipment of medicines for which there is a doctor’s prescription at all; the law only allows the FDA to place some limitations on how many medicines a traditional pharmacy can send out-of-state without patient-specific prescriptions.

    Why does this distinction matter? Limiting the interstate shipment of compounded medicines pursuant to a doctor’s prescription will prevent patients from getting the medicines they need. Certain pharmacies specialize in specific areas, such as bioidentical hormones. If that pharmacy is in Michigan, and you live in New Jersey, there’s a real risk that you will no longer be able to get that medicine, even if you’ve taken it for years. If that pharmacy has already sent 50% of their sales out-of-state, you’d be out of luck.

    Remember, too, that the 50% limit will only apply in states that actually sign the MOU—otherwise the 5% limit applies. Early indications are that many states will not sign the MOU. In a comment submitted to the FDA, the National Association of Boards of Pharmacy reported that 20 states informed them that they would be unwilling to sign the MOU in its current form, meaning that if the MOU is not revised, almost half the country will be subjected to the FDA’s draconian 5% interstate shipment limit.

    All of this is happening simultaneously to the FDA threatening to eliminate consumer access to compounded bioidentical hormones such as estriol and progesterone. These and other hormones have been nominated to the agency’s “Difficult to Compound List”; items that appear on the final list will not be able to be compounded at all. You can consult our previous coverage for more details.

    As we’ve said all along, it is our opinion that the objective in all of this is to shut down compounding because it threatens Big Pharma profits, and Big Pharma funds the FDA. We have to fight back and ensure that patients can get the medicines they need.

  66. Laura Borst says:

    Compounding pharmacies should not be subjected to limits on out-of-state sales. I think these limits are protectionism for large corporate pharmacies.

  67. Edward Puc says:

    You people need to stop messing with we the people rights to natural meds…we are sick and tired of ripping off governments! STOP NOW!

  68. Please do not set limits on compounding pharmacies.

  69. Robert Paggen says:

    It is time to stand up to the corrupt drug companies. It seems the FDA stands for For Drugs Always.

  70. Irene Dobronski says:

    Private pharmacies are also being taken over by the gigantic Mail Order pharmacies, e.g. Optim RX which has took it upon itself to call my doctors to get prescriptions from them for me without consulting me. How do we stop this from happening? It is egregious and takes away my right as a person/patient to decide where I want my prescription filled. Do something about this issue. Thank you

  71. Ellen Fernandez Sacco says:

    re: Revision of Drug Quality and Security Act of 2013
    As your constituent, I ask that the FDA follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription.

  72. Rachael Pappano says:

    I urge the FDA to follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription.

  73. Jason says:

    Do you care about the truth and us more than money?

  74. Cari Smedley says:

    DOCTORS WORKING WITH THEIR PATIENTS GET TO DECIDE WHAT IS BEST FOR THAT PATIENT. DO NOT PUT LIMITS ON COMPOUNDING PHARMACIES. THEY ARE AFTER ALL SMALL BUSINESSES THAT SUPPORT MANY OF OUR FELLOW AMERICANS!
    GOD BLESS AMERICA!

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