Cromolyn Sodium Concentrate Shortage Update # 2 & Tips to Navigate a Drug Shortage

UPDATE- April 2025

Back in 2023, we became aware of a shortage of Cromolyn Sodium Concentrate (Cromolyn) and began trying to work on helping patients access this important medication. Things seemed to get better in mid-2024. However, over the past couple of months, we have started hearing from community members again that the shortage was continuing or getting worse. We decided to reach back out to our contacts and see if we can get some answers for the community.

Our first step was to see what the FDA had posted on their page related to the shortage and reach out to our contacts there. Based on the information on the FDA’s shortage page for Cromolyn, all but one manufacturer had the drug available to distributers.

We reached out to the manufacturers to get more information and see what we could find out. For many of the manufacturers we spoke with the challenge seems to be related to the high demand for the medication. They are doing all they can to keep up with this demand but there are infrastructure challenges. Microlabs and Gastrocrom should have availability now in most places. The version made by Rising Pharmaceuticals did have limited availability. I haven’t yet been able to chat with their representative, but the FDA website includes a notation from the company that they expect to have more drug in distribution in April.

Finally, we were able to uncover one possible cause of the lack of availability in the version distributed by Omnivium Pharmaceuticals. The “NDC” number for the product has been changed. We believe that pharmacies are requesting the old NDC and are being told it has been discontinued. A representative from Omnivium asked me to pass on the following guidance for those that are taking Cromolyn from this distributer:

“Please advise your patients to let their pharmacies know to contact their wholesaler (Customer service line or their rep.) and to provide the new NDC.”

Please see below NDC information:

We hope that this information is helpful as patients attempt to navigate these shortage challenges.

For more information about this shortage, our previous blog post and Tips for Navigating a Drug shortage is copied below

December 2023 Blog: Cromolyn Sodium Shortage Update and Tips for Navigating a Drug Shortage

In an ideal world, every patient would have seamless (and affordable) access to the needed medications. Unfortunately, drug shortages do happen, and over the past several months the mast cell disease community has been impacted by a shortage of Cromolyn Sodium Concentrate.  When a shortage like this happens, it means that the medication you rely on might not be readily available at your local pharmacy or healthcare facility. This situation can be stressful and potentially life-threatening for some patients.

We started hearing from community members regularly that they were struggling to access Cromolyn Sodium over the summer.  We immediately began reaching out to the FDA and to manufacturers to understand what was happening with the Cromolyn Sodium supply.  We also surveyed the community to try and understand how widespread the problem was and how it was impacting the community.

We want to share with you all that we have learned so far and some action steps you can take if you are being impacted by this drug shortage or other drug shortages that may happen in the future.

Cromolyn Sodium Shortage Impact

The survey we shared with the community was not designed to be part of scientific research, it was for informational purposes only.  It was extremely valuable in helping TMS to understand how this shortage was impacting the community.  More than 300 community members responded, here is what we heard:

• Lack of access was spread fairly evenly across all manufacturers and pharmacy retailers.
• 20% of respondents had attempted to access Cromolyn Sodium from every single manufacturer and had been unable to.  
• Respondents lived in 43 states and the DC.
• The median time people were without Cromolyn and searching for it was 30 days.

We asked respondents to describe how going without Cromolyn Sodium impacted their health. The responses to this question were gut-wrenching.  The word cloud below summarizes these responses.

Understanding Drug Shortages

Drug shortages can occur for various reasons, including manufacturing issues, shipping delays, regulatory challenges, or unexpected spikes in demand for the drug. We learned that sometimes these challenges can happen at once and unfortunately,  this is the case with the Cromolyn Sodium shortage. The best source of information regarding drug shortages is from the FDA Drug Shortages page.  There you can search the database of current drug shortages and learn about the actions the FDA can take to try to help resolve them. Additional resources from the FDA on drug shortages can be found below.

Unfortunately, Cromolyn Sodium Concentrate is still experiencing a shortage.  For the FDA information on the Cromolyn Sodium Concentrate shortage click here.  You can also download an app and sign up for alerts to stay up to date on the shortage.

Drug shortages are very tricky to manage, especially for our community members who are limited in the medication that works for them and is well tolerated. Below we have listed some tips that may help you get through this challenging time.  Don’t forget to discuss any plans you make with your healthcare providers.

Tips to Navigate a Drug Shortage

1. Communicate with Your Healthcare Providers

It bears repeating, that the first and most crucial step when you encounter a drug shortage is to reach out to your healthcare provider.  They may be able to come up with an alternative medication, and they can adjust your treatment plan. It is important to communicate with them about any challenges you face in obtaining your medication.

2. Ask your local pharmacists for help.

Your local pharmacist might be able to keep an eye out for when your medication becomes available or might be willing to search and see if it is available in a nearby town/city.  However, you should ask them if you could talk with them during a slow time of day for the pharmacy so that they have time to assist you.

You also might want to talk to your pharmacist about the possibility of compounding your medications.  Compounded medications are made by combining the ingredients of a drug to make a formulation tailored to you.  Your regular pharmacy may not be able to compounded the medication directly, so you may have to look into compounding pharmacies in your area. It’s also important to note that compounded medications may not be covered by your insurance plan, so be sure to find out the costs beforehand.

3. Connect with TMS and our Support Resources

TMS  tries to stay informed about issues that might have an impact on our community.  Reach out to us at info@tmsforacure.org and let us know the challenges you are facing accessing your medications. We may be able to share information or resources and hearing from you helps us to advocate for the community.  

We are working on expanding our resources around drug shortages and will share more about that when it is available. In the meantime, we have many support resources available for the community:

• You can attend a virtual Zoom support group. There are more than a dozen meetings hosted each month. To register for our Support Groups please visit: https://tmsforacure.org/support-group-meetings/
• You can email our staff and volunteer Registered Nurses who can connect you to resources and information. To contact one of our nurses, email: nurses@tmsforacure.org
• You can connect to our Inspire forum, which is also moderated by our nurses. It is an anonymous page for patients. There you can share your personal experiences, doctor recommendations, and learn from your peers.
• You can join our private peer support group on Facebook.

4. Stay Informed

Stay informed about the status of the drug shortage. The situation can evolve, and knowing when your medication might become available again is essential. Here are some ways to stay in the know:

• Regularly check with your pharmacy,
• Regularly check the FDA’s drug shortage list.
• Keep up with the latest news from TMS by signing up for the newsletter, checking our site for news, or following us on Facebook, Instagram or Inspire.

5. Advocate

If you continue to struggle with access to your medication and it is not yet listed as an official FDA drug shortage, notify the FDA about your challenges by emailing drugshortages@fda.hhs.gov.

6. Be Prepared for Emergencies

As you all know, even without a drug shortage, mast cell disease patients need to be prepared for emergencies. During a drug shortage, it is even more important that your emergency plan be in writing, or that you update the one you have. This plan should include the list of alternative medications or adjusted treatment from your provider, contact information for your healthcare team, and the steps to take if you encounter a flare during the drug shortage.

Remember, you’re not alone in this journey, TMS is here for you and so is our amazing patient community. We understand that facing a drug shortage can be a terrifying and frustrating experience, hopefully, the steps above will help provide some support.