Your Voice Matters.
You are probably aware that the due to recent changes in FDA’s guidance, many medication which were once available to physicians and patients are no longer able to be produced by compounding pharmacies and therefore will become unavailable to patients who need them.
This change started with the implementation of the FDA’s guidance surrounding bulk drug substances. They intended to make a list of products which could or could not be compounded.
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In order to get already nominated products a fair hearing for their nomination on the bulk drug substances list, we need a concerted and overwhelming effort to direct a coordinated response. We are asking for you to put in your personal stories through the website, through filming yourself, and to share this website so we can meet our goals and save us all.
If these medications are no longer available, what will you do and how will this affect your patients lives?
“Me and my patients will have to go without or use alternatives that have not worked or were less effective or had side effects. Our quality of life will be severely impacted!” – Dr. Heidi G.
“I may have to close up my clinic or drastically alter my ability to treat patients successfully. I may have to use more expensive products which many patients cannot afford” – Dr. Paul K.
“If peptided no longer available then my patients would not have the help needed to fight the weight gain or rebuild neuroplasticity returning brain function after a TBI.” – Dr. Debra D.
“Not sure how to answer this. There are no alternatives to these peptides. That is, they fill a unique therapeutic niche, provide very significant key benefits, and have essentially zero side effects. So clearly, it will adversely affect my patients and my ability to treat their chronic immune disorders, chronic infections, fatigue, pain, and cognitive impairment.” – Dr. David K.
Please tell us in your own words how our peptides have impacted your life and your patients lives.
“I have been able to achieve therapeutic results that weren’t possible with other therapies. Such as, I have a patient who has Lyme disease and has severe brain fog. She works as a social worker and manages many different cases. Through the use of peptides, cerebrolysin being one of them, she has lessened her brain fog and has no doubt improved the lives of those she serves.” – Dr. Lee H.
“Game changing set of treatments. So central now in how we manage our patients” – Dr. Darren L.
“The availability of these peptides, that come from a certified pharmacy has been priceless because previously, these were only available via underground websites and alias websites, vs. legitimate pharmacies, such as TMC. Because these are natural substances, and in essence, they either work or not, with no side effects, this type of treatment option is invaluable. By using these peptides, we offer non chemical or pharmaceutical support that have improved patient’s immune system, helped heal tendonopathies and helps patients have improved vitality and quality of life.” – Dr. Michael G.
While the list is only guidance, not law, the FDA is trying to enforce this now on compounding pharmacies to limit what physicians can prescribe and what patients may receive to treat their conditions.
This includes medications which help with life threatening diseases such as ALS, resistant bacterial infections, addiction, and even viruses such as COVID19.
Some of these drugs have over 100+ clinical trials with demonstrated efficacy and safety. Yet, they can’t be used to help patients.
The FDA’s overreach becomes worse when you realize that they won’t let compounding pharmacies use products you can find on supplement shelves or in food products. Stevia is unable to be compounded when you can buy it by the kilogram from Walmart.
Most of the Peptides that are questioned have been nominated to that Bulk Drug Substance (503A) list but haven’t heard anything back.
We believe that these medications should be available to patients when physicians determine them to be appropriate through their medical expertise.
Without the opportunity to receive these products as prescribed by their physicians from regulated sources, the FDA is effectively limiting supply which may eventuate actually hurting patients making them source these from shady and unregulated websites.
We have created this website to gather support for these medications and organize action together. Many of these medications effect our health and quality of life on a daily basis and limiting this choice will impact patients lives.
Soon we will send out information and letting you know of updates on how we can move forward. Please fill out the information above to stay up to date and involved.