FDA Moves to Eliminate Custom Medicine

June 11, 2020

This rule will make it harder for you to get the customized medications you need. Action Alert!

As part of its effort to implement the Drug Quality and Security Act of 2013, the FDA has taken the next step to implement a bad policy that will limit the amount of medicines like bioidentical hormones compounding pharmacies can send out of state, even when patients have a doctor’s prescription. This policy makes it harder for patients to get the medicines they need.

Last month, the FDA made available the final memorandum of understanding (MOU) with states regarding the interstate distribution of compounded drugs. It is largely unchanged from the last iteration of the MOU that was released late last year.

This rule concerns how much medicine traditional compounding pharmacies can send out-of-state. These sales are limited to 5% unless a state enters into an 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 set any limit?  Does the FDA know what it’s doing at all?

Importantly, the final 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 you get your estriol from a pharmacy 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.

The same goes for any number of crucial medicines for vulnerable populations. One of the main purposes of compounded medicine is so that patients with allergies, patients who have difficulty swallowing pills, patients who require specialized formulations not available elsewhere, such as autistic children, or patients who require other modifications to the dietary ingredients and medicines available in the market can get the individualized treatments they need. An FDA-approved product may have peanut oil in it, so patients could go to a compounding pharmacy to get a peanut-free medicine. Limiting out-of-state sales for these pharmacies severely limits the options for patients who already have limited options.

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 while the FDA threatens 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 read 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.

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32 responses to “FDA Moves to Eliminate Custom Medicine”

  1. David says:

    To whom it may concern: I am writing to request that you follow Congressional intent and stop limiting interstate shipment of compounds drugs pursuant to a doctor’s prescription.

    Thank you for your consideration.

  2. Lee Cummings says:

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

  3. Renata Murez says:

    The FDA is supposed to be making medicines sanctioned by the FDA and prescribed by doctors – easier for patients to get, not harder.

    Is this because the FDA isn’t receiving enough kickback from compounded medicines?….If so, it would be well worth it to the patient to pay a 5% tax on the med…or an extra $5, rather than not sanctioning the shipping of such medications interstate at all.

    Best,

  4. Suzy Lowe says:

    Please do not take away our compounded prescriptions, where ever they need to come from. Compounded prescriptions are as important to many peoples lives, as are big pharma drugs. If compounded prescriptions help us stay healthy, that is a win-win situation for all.

  5. Rev. Marilyn Redmond. says:

    We are not rubber stamps for needing medical prescriptions or solutions. Not being able to individualize medications necessary is doing harm. The medical profession is based on “Do no harm”. This fall clearly in the category or limiting help for those that need special formulation for their particular malady. Everyone has a right to get the best medical help possible through medications, alternative medicine, or energy medicine. Placing control over access to help is unethical and inappropriate domination in medical issues.

  6. Laura Kiholm says:

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

  7. We are not rubber stamps for needing medical prescriptions or solutions. Not being able to individualize medications necessary is doing harm. The medical profession is based on “Do no harm”. This fall clearly in the category or limiting help for those that need special formulation for their particular malady. Everyone has a right to get the best medical help possible through medications, alternative medicine, or energy medicine. Placing control over access to help is unethical and inappropriate domination in medical issues.

  8. Linda Pierce says:

    Please stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription. Please do not further restrict access to compounded medications including bio-identical hormone replacement therapy for those of us who use them for better health. We want the best affordable prescription options rather be limited to what the large pharmaceutical companies sell which are frequently less effective and more expensive remedies. Thank you!

  9. PAMELA J. SMITH says:

    We need natural medicine!! Stop buttering the big Pharma’s bread!!!

  10. Jay cino says:

    Enough control by big pharma already! This is just another example of our rights being stripped away by gov’t agencies who are captured and bought off by big pharma and corporations etc….. all disgusting, now more than ever!

  11. Pat Loverink says:

    How dare you block access to custom medicine!! Leave the natural drugs alone!!

  12. Anton McInerney says:

    This is foolish… If the triage events are any indication the need will be greater for refined analogous medicine that will be more critical than ever. I suggest the Medical Associations demand further development of the field so science will be ready as needed for all future events plus the readvancement of all degrees of medical science degrees!

  13. Khaya Davidson says:

    Please follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription. Patients with allergies (like me), patients who have difficulty swallowing pills, patients who require specialized formulations not available elsewhere, such as autistic children, or patients who require other modifications to the dietary ingredients and medicines available in the market can currently get the individualized treatments they need. Without this, we will have big problems!

  14. BJ Goudey says:

    Medicine and remedies are to be suited for each individual and their particular needs and body differences

    It is essential to be able to use more natural ingredients as well as ones with correct substitutions to avoid allergy reactions and other untoward physical reactions

    Even taking a lower dose amount of medication requires compounding. As the population ages the ability to modify and lower the dosage and percentages is important because the older body and other compromised communities are unable to tolerate the pre packaged Goods

    It is my right to have the best remedies possible. And given that these Pharmacy and facilities are licensed and clean and competent, the government has no right to interfere.

    Bj

  15. MaryAnne Glazar says:

    This sounds like it’s basically about rich corporations standing to lose some money, to which I say Hell Yes! It makes more sense to allow a larger range of medications, to heal more people. One size does not fit all.

  16. This action must be stopped = FDA Moves to Eliminate Custom Medicine

  17. francesca testa says:

    I also customize my medications. If you remove this right, more of us will not take medication at all!

  18. Robin Morton says:

    we all know natural medicine works. thats why they try to stop us. free medicine from nature mother earth

  19. Dawn Larsen says:

    FDA and Congress: Please follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription. Many people depend on these medicines, and limiting access could have a dangerous impact on their health. Thank you.

  20. Catherine Gould says:

    Compounded prescription medications have been lifesavers for many of my clients. Taking them away will certainly have negative health consequences for many people who rely on them.

  21. Ruth Reid says:

    The intent of Congress was for all patients, who have a doctor’s prescription, to be able to have a compounding pharmacy fill prescriptions. Limiting this hurts patients medically and financially. Please protect patients and stop this grab by Big Pharma

  22. Dianna Vagianos Armentrout says:

    Bioidentical hormones and other custom medicines are important for public health. Please support our compounding pharmacies and the people who rely on their medicines to support their health.

  23. The reason for doing this UNdemocratic action is Big Pharma doesn’t want competition. Outrageous ant totally UNDEMOCRATIC.Let people use what helps them.

  24. Patricia Chambers says:

    Actually I make most of my medication at home as big Pharma has almost killed me several times. My system doesn’t like a lot
    of pharmaceuticals.

  25. denise pratschner says:

    Don’t infringe on our right to choose medical care

  26. Jerilyn Bock says:

    This is just another ploy and push by the FDA to allow big pharma to control what Americans do for their personal health.
    I use one compounded RX and it’s NOT any of the FDA’s business. The FDA is not my medical doctor and should stop trying to limit consumer’s access to needed medications. Instead, the FDA should regulate dangerous drugs, many seen in TV ads, and pushed on consumers by drug companies regardless of the side effects.

  27. Toni Carisone says:

    Its not broke please leave it alone. Many of us depend on our compounded medications.

  28. Rossen Vassilev Jr says:

    Please stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription. Some people’s lives depend on these compound medicines.

  29. Holly Meany says:

    Hi,

    While I do believe there is a place for pharmaceuticals. I also believe that I should have the right to use natural medicines as well. I have in the past had doctors that are familiar with both. I believe that both can be beneficial. I also think that big pharma sometimes put the interest of money over science and that natural medicines that have been used for a long time, have there place as well.

  30. E. F. CAULFIELD says:

    JUNO 11, 2020

    HEY F D A.,

    SHAME ON YOUR LIMITING ACCESS TO COMPOUNDS POLICY CHANGE. THAT’s AN ANTI- HEALTH DECISION.

    WE HOPE D. TRUMP HAS THE GUTS TO DISSOLVE YOUR F D A: OVERDUE. BLOCKS CITIZENS’ HEALTH NEEDS FROM BEING CONTINUALLY ACCESSIBLE THEY NEED THOSE COMPOUNDS AS THEY ALWAYS HAVE IN THE RECENT PAST. THEIR LIVES DEPEND ON THOSE COMPOUNDS.

    TRYING TO DEPRIVE US OF OUR VITAMINS, MINERALS & HEALTHY COMPOUNDS TO WEAKEN OUR IMMUNE SYSTEMS FASTER, IS THAT YOUR UNDERLYING MOTIVE ? TO WHAT EXCUSES DO YOU ATTRIBUTE YOUR DRACONIAN CRACKDOWN ON SHIPPING COMPOUNDS ?

    YOUR GOAL OF DENYING THE AMERICAN PEOPLE THEIR ACCESS TO & CHOICE FOR HEALTHY, CUSTOMARY NUTRIENTS AND ESSENTIAL COMPOUNDS LOOKS LIKE ITS ALIGNED WITH THE TECH EXTERMINATORS, WHO ARE MAKING THEIR DE-POPULATING ANCESTORS’ MAD RUSH EUGENICS GAME THEIRS. ?.

    IF NOT, EXPLAIN THEN, HOW YOUR DENIAL OF AMERICAN”S CONSTITUTIONAL RIGHTS “TO ‘LIFE, LIBERTY & & PURSUIT OF HAPPINESS / HEALTH” IS DIFFERENT. WE HAVE THE NEED OF THE COMPOUNDS WE DEPEND ON FOR OUR HEALTHY IMMUNE SYSTEMS THAT WE ARE PRESCRIBED TO PURCHASE.

    STOP PUTTING SHIPPING LIMITS & RESTRICTIONS ON THEM. OR WE WILL ASSUME YOUR PLAN’S UNDERLYING MOTIVATION IS TO CULL THE POPULATION THAT WAY. NO COMPOUNDS, NO ACCESS TO CONTINUED GOOD HEALTH: THE GATEWAY TO PROXIMATE DEATH LOOMS FROM THE F.D.A.s DENIAL OF ACCESSIBILITY.

    STOP THE DIDOS NOW!

    WE ARE ASKING FOR AN INDEPENDENT INVESTIGATION TO BE STARTED ON THE F D A TO SEE WHAT AND WHO IS BEHIND THEIR TRICKY FASCISTIC MOVE TO TRY TO DENY AMERICANS THEIR HEALTHY REMEDIES, COMPOUNDS, & THEIR HEALTH FREEDOMS. ONE QUESTION THE ATTORNEY TEAM WILL PROBE YOUR F.D.A GROUP ON
    WILL BE “WHOSE MILLIONS ARE DRIVING YOUR DRACONIAN CHANGE OF POLICY RESTRICTION TO DENY CITIZENS’ THEIR NUTRIENTS, COMPOUNDS, AND HEALTHY SUPPLEMENT CHOICES AND LOCK THEM OUT OF THEIR PURCHASING RIGHTS TO OBTAIN NECESSARY COMPOUNDS, MINERALS, AND VITAMINS. ?

    SUCH A DEVIOUS F.D.A POLICY GROUP NEEDS TO BE DISSOLVED. IT HAS LONG OUTLIVED ITS SERVICE TO THE AMERICAN PEOPLE.

    TRUMP CAN DO THAT BY THE STROKE OF A PEN.

    THE MED-LEGAL RIGHTS ATTORNEYS COULD DEFINE YOUR NEW DRACONIAN POLICY TO DENY THE 99% THEIR HEALTHY COMPOUNDS AND NUTRIENTS AS A FORM OF “NUTRITIONAL TERRORISM”. IF THAT’S WHAT YOUR INFAMOUS DECISION WILL BE. ITS YOUR CHOICE.

    CHOOSE A HAPPIER OUTCOME. MAKE A SANE, CONSIDERATE DECISION BASED ON A VALUE FOR EACH LIFE OUT HERE. NOT ABOUT THE MONEY. VALUE EACH LIFE. LIFT THE SHIPPING LIMITS ON COMPOUNDS IMMEDIATELY !

  31. Paula Hicks MD says:

    make this letter easier to send get a clickable list of the congress so we can send easier

  32. Bharat Adarkar says:

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

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