Update on FDA Compounding Catastrophe

July 1, 2021

Help us build support in Congress to ensure you can access the customized medicines you rely on. Action Alert!

As part of its effort to implement the Drug Quality and Security Act of 2013, the FDA is poised to implement a bad policy that will limit the amount of medicines like bioidentical hormones such as estriol that 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. There is a Congressional sign-on letter being circulated urging the FDA to delay the implementation of this rule—we must urge our representatives in Congress to sign on to this letter. See our previous coverage of this issue below for more details.

Last year, 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.

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.

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 your representatives in Congress and urge them to sign on to the letter from Reps. Cuellar and Dunn asking the FDA to delay implementation of its compounding MOU. Please send your message immediately.

Share This Post

21 responses to “Update on FDA Compounding Catastrophe”

  1. Many of these natural medicines are better than pharmacy bought medicines. It is UnDemocratic to choose for us and try to squeeze out competition.

  2. L. Pliska says:

    Compounding pharmacy meds are a necessity for those who cannot tolerate the strengths of synthetic or predetermined levels of certain meds. Getting the exact and tolerated levels of medications is vital.

  3. Scott Jon says:

    There is absolutely no need to prevent compounded items from being used anywhere in this country. State-to-state commerce is under the federal purview, but should not stop what has worked for decades. Stop messing with what works, folks.

  4. John Alexander says:

    Let people make their own designs. We don’t need a nanny state

  5. Claudia says:

    Once again, the FDA is violating our freedom. Compounded medicines are customized for the needs of the individual. They work very well. They are needed and we have a right to be prescribed what works for our own health.
    Get out of the way of improving health for Americans.

  6. Peter Booth Lee says:

    We Need Access to these Medicines!

  7. Dave Kisor says:

    Pharmaceutical Korporations don’t like supplements because they don’t make billions from them. What they do is determine what component of the supplement does the trick. Once isolated, they synthesize it and patent it. Once this is accomplished, they then vilify the natural remedy by using a government agency. The problem is supplements are considered food and not a drug. Here’s where the revolving door kicks us in the butt, because FDA organisms leave the government for the pharmaceutical industry to make the big bucks. FYI there are no such things as side effects of a drug. They are the actual effects of a drug.

  8. Judy Turk says:

    We rely on compounding pharmacies for medicines for our grandson who reacts to most ingredients in the ones from our local Walgreen’s, CVS and grocery stores. Please do not do anything to stop these pharmacies from providing safe alternatives for families like ours. Thank you.

  9. Laura Klett says:

    I have been going to doctors since I was 27. I am now 56 and just starting to feel human again. Compounding meds made this possible for me and many others. Finding a compounding pharmacy is difficult. Some states don’t have them or they may be few and far between. Why would you take something away that helps people?

  10. Linda says:

    One size does not fit all in the healing of the body.

  11. judy eby says:

    Stop

  12. francesca testa says:

    Limiting the interstate shipment of compounded medicines pursuant to a doctor’s prescription will prevent patients from getting the medicines they need.

    Pleases sign on to the letter from Reps. Cuellar and Dunn asking the FDA to delay implementation of its compounding MOU.

    Thank you!

  13. JOHN MATTHEW SCHWARZ says:

    Prevent Big Pharma and its financially compromised officials in the WHO and CDC from restricting our personal health choices.

  14. Janice Trimble says:

    I get a compounded allergy shot from an out-of-state pharmacy. If this access was cut off because of this rule, it would be life threatening to me.

  15. Mary Jane Brewster says:

    I know compounding pharmacies are good. I have taken compounded medications for years for allergies, hormones, immune system, etc. There are still some drugs I get from the regular pharmacy as well. I feel so much better than I did before taking these compounded medications. People always tell me I look so good and have plenty of energy. If the compounded medications are seriously lowered for out of state patients, the patients will surely suffer. Why would they want to control this? What is the reason when they work for so many people’s health. It would be nice if the individual’s health would become the primary concern for the FDA or Big Pharma as opposed to Big Money. We need your help!!!

  16. Bharat Adarkar says:

    FDA please delay implementation of its compounding MOU.

  17. Carolyn Weibye says:

    I’ve been using compounded drugs & bioidentical harmonies since 2007. They saved my life.
    Hotze Health & Wellness, Katy, Tx is a reputable sponsor of this.

  18. Kris Knoll says:

    Please, do not limit our access to compounded medicine. Big pharma has too much power over our health; limiting compounding only gives them more. Doctors and patients should have the ultimate say, NOT corporations.

  19. Margaret Batty says:

    Please sign the letter from Reps. Cuellar and Dunn asking the FDA to delay implementation of its compounding MOU.

  20. Judith Lavendar says:

    You people make me sick. Regulate everything from baby diapers to tea tree oil just because you can. LEAVE OUR HEALTH FOOD ALONE.

  21. Linda Yoder says:

    I am reading a small booklet called “Supreme Court Case for State Sovereignty” by Sheriff Richard Mack, retired. He gives quotes from the majority opinion in two different cases. It seems to me that the FDA’s actions are in violation of the Constitution of the United States. New York V. United States opinion reads, “The Federal Government may not compel the States to enact or administer a federal regulatory program.” It also says, The “Commerce Clause, for example, authorizes Congress to regulate interstate commerce directly; it does not authorize Congress to regulate state governments’ regulation of interstate commerce.” Here is a link to the book. There are many other valuable quotes in the booklet. https://cspoa.org/

Leave a Reply

Your email address will not be published. Required fields are marked *