Stop and Regrow Response to John Oliver's September 29 Segment on Compounding Pharmacies

With a popular and trusted following in the millions, your opinions resonate throughout American households. Your investigative journalism uncovers wrongdoing with intelligence and humor, shining light on hidden secrets and vital knowledge and for this, you are to be applauded. 

When covering health-related issues, getting it correct really matters. After all, our health is more valuable than gold or any other measure of wealth. So, it is with great appreciation and good will that we add to your recent episode on “compounding pharmacies” our first-hand knowledge regarding the current landscape of our American healthcare system, in light of recent modern medical scientific advancements.

Working alongside biochemists, geneticists and nutritionists from southern California,Dr Ray Nettles, Chief Medical Scientist of Stop and Regrow, was able to harness the strengths of the FDA by providing access to the necessary active “ingredients” with the flexibility of “custom” specialty compounding to develop individualized formulas to stop hair loss while also regrowing healthy hair for both men and women.  

Tracey Lipnicki, Senior Pharmaceutical Marketing Executive, explains “Thanks to technology in other fields, such as TELEMEDICINE, innovative one-of-a-kind programs like dr nettles’ StopandRegrow Hair is able to provide PRECISE effective formulas to patients suffering hair loss on 6 continents, spanning the globe.” And herein, lies the rub. As the scale and the scope of PRECISION medicine increases, how do we best provide SAFE and EFFECTIVE formulas? 

Big Mass Manufacturing Pharma (corporate business run for profits over people), uses FDA approved active “ingredients” to create MULTIPLE copies of ONE formula that works for most, unaware of individual Biochemical differences that could cause side effects, then gives it a name, “HeadacheAway” formula.

503.A Personalized Compounding Pharma (professional practitioners under oath to serve people over profits), uses FDA approved “ingredients” to create ONE copy of ONE personalized formula based on individual Biochemistry, optimizing efficacy, avoiding side effects, but does not give it a name other than “Patient Name” Formula.

Gene Braddy, a Senior Pharmacy Compliance Officer with over 40 years compounding experience, explains the strict compounding pharmacy regulations in place today. “Today, we gown up in a near spacesuit, enter a negative pressure sealed room in a sterile environment to mix FRESH “FDA approved “ingredients” in specifically tailored ways for our patients. Speaking for the 1000s of pharmacists I know personally, there may be a rotten few, not the plenty”

Over time, a few personalized formulas become common enough to make in larger batches to optimize consistency.

503.B Mass Manufactured Personalized Compounding Pharmacy is a relatively new compounding pharma emerging in the United States, a blend of FDA and personalized compounding pharma, which is the crux of the issue. Large batches using FDA approved ingredients, but still individually personalized.  

One simple SAFETY Resolution would be Posting of Pharmacy Inspection Date and Condition, similar to restaurants.  

Jim Sandino, FDA regulations specialist sheds a unique perspective to this medication delivery model. “Not all compounding pharmacies are the same. Top compounding pharmacies go through an ACHC certification, providing PCAB accreditation, equivalent to the Hospital JACHO accreditation, retail pharmacies like CVS don’t have.”

In closing, with science our opportunities abound, and while many, the problems are manageable. SAFETY and EFFICACY for patients is our ultimate goal which can be achieved when we reign in the politics controlling profits within Big Pharma, America’s most poorly regarded industry, above airlines and the federal government. *So, we hold out an olive branch to you, John Oliver, the FDA, and the United States government to meet the needs of patients by providing the most EFFECTIVE formulas while best protecting the SAFETY of our public. 

Respectfully, 

Scientific Community of Concerned Physicians and Pharmacists