GOOD HEARTS HEALTH


Phone: (786) 747-7904

Email: Dr.Q@goodheartshealth.com

GOOD HEARTS HEALTH


Phone: (786) 747-7904


Email: Dr.Q@goodheartshealth.com

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©2023 by Good Hearts Health.

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Peptides For All?

 

If you have been on social media lately and your algorithm has you pegged as someone interested in health, you may have been inundated with content regarding Peptides.  It reminds me of the old apple commercial but instead of “There is an app for that” it seems that these days no matter what you are feeling…  “There is a peptide for that.” 

Want to be stronger, cut fat, and stay young forever? Try something from the Morelin family of peptides.  Stimulate your Pituitary gland, release some Growth Hormone, build muscle, and stay young forever. 

Want shiny skin? Try the ‘Glow Blend’. A combination of BPC-157, TB-500, and GhK-CU.  This combination promises anti-inflammatory, tissue repair, and increased Collagen.

Do your joints hurt? How about a ‘Wolverine Stack’! A combination of BPC-157 and TB500.  This combination promises to accelerate injury recovery, reduce inflammation, and support the healing of tendons, ligaments, and muscle tissue.

Do you want a boost of energy?  How about MOT-C or NAD+ (not a peptide by the way!).  Get your mitochondria fired up and maximize your metabolic efficiency. 

Want a tan without going in the sun and increased libido?  Melonotan may be right for you.  Inject this to stimulate your melanocytes, increase your libido, and look bronzed year long without having to go in the sun.

The list goes on and on.  We will discuss Retatrutide in a separate post, but I just wanted to give my take and the reasons why I am not currently prescribing non-FDA approved peptides.

 

Inside the World of Peptides

 

I use and prescribe peptides every day in my clinical practice.  Insulin, Semaglutide, Tirzepatide are common FDA approved peptides.  Insulin changed the treatment of Diabetes over a century ago.  GLP-1’s like Semaglutide and Tirzepatide have changed the landscape regarding treatment of type 2 Diabetes and Obesity and I think we are just scratching the surface when it comes to the benefits of these medications. 

It’s incredible how many of my patients have asked me recently about “peptides” not even realizing that the GLP-1 they are taking and has changed their life is a peptide.  In my opinion Tirzepatide is the best FDA approved peptide ever produced, far better, safer, and more effective than anything on your Instagram or TikTok feed promising to cure your ills.

Before I go any further let me define a peptide.  Peptides are short chains of amino acids that serve as signaling molecules.  They help regulate essential bodily functions like hormone production, immune response, tissue repair, and metabolism.  They are generally best administered subcutaneously to maximize their bioavailability and avoid degradation in the stomach that occurs when taken orally.  Peptides can either be produced naturally or synthetically.  Natural peptides are produced in the human body, animals, plants, or microorganisms.  Synthetic peptides are created in a lab artificially to target specific receptors.  GLP-1’s like Semaglutide and Tirzepatide are FDA approved synthetic peptides.  Everything else I listed above like BPC-157, GhK-CU, MoT-C, TB-500, Ipamorelin, etc are non- FDA approved peptides.  There are currently about 80 FDA approved peptides, 200 in clinical development, and at least another 600 in pre-clinical trials.  What is being advertised on your social media is clearly just the tip of the iceberg within the context of a much larger peptide space.  Some of these peptides will have proven clinical use, others may prove to be ineffective, and others may be shown to cause harm prohibiting their use. 

Why don’t I prescribe non-FDA approved peptides?

  1. I cannot honestly tell my patients that they work and/or are safe to use either short or long term.  Most of the medications listed to start this article and being sold to you on social media were banned by the FDA in September of 2023.  The FDA tightened restrictions on compounding many of these popular peptides labeling them as “having significant safety risks.”  These medications have not undergone clinical trials to demonstrate either their efficacy or safety.  Some people may feel benefits, others may not.  Anyone telling you they are safe to use short or long term is lying to you because they simply do not have that information.  Just like they have theoretical benefits based on the signaling pathways they target, they also have theoretical harm.  Growth Hormone production may make you feel younger and help you build muscle, but it can also help an undiagnosed tumor or precancerous cells grow.  Something like Melotonan may make your skin darker without going in the sun but stimulating melanocytes may also increase your risk of skin cancers like Melanoma.
  2. Since they are banned by the FDA, they are not being produced by credentialed pharmacies. Instead, they are being produced for “research use only” and typically labeled “not for human consumption”.  Prior to being banned by the FDA, it was possible to source many of these popular peptides from credentialed compounding pharmacies like the ones who produce many of the GLP-1 medications that are so popular today.  These peptides required a doctor’s prescription, were produced by a credentialed pharmacy, and were being taken under the supervision of a physician.  Prior to the ban, I was reluctant to prescribe many of these peptides due to efficacy and safety concerns (which is why they were ultimately banned) but at least there was a process to safely prescribe them if you felt that was in the best interest of your patient.  Currently, the process has become completely unregulated and most of the source material for these “research use” peptides is coming from China.  This leads to even greater concerns regarding both safety and purity.  Personally, I think it is completely unethical to prescribe a medication to a patient that is being produced for “research use” and “not for human consumption”.  As a matter of fact, since these peptides are banned by the FDA, most of these peptides do not require a doctor’s prescription.  You can just go online and purchase them yourself after clicking a few boxes saying you are not going to use them for human consumption and that you are purchasing them for research purposes only.

 

Dr. Q’s Take:

What’s my official take when my patients ask me about non-FDA approved peptides?  I see it as an experiment at your own risk space.  There are some theoretical benefits as well as theoretical risks.  Anyone who tells you that they have data showing that these peptides work and are safe to use is lying to you because that data simply does not exist. Imagine if Arnold Schwarzenegger had a TikTok account in the 1970’s documenting his body building and anabolic steroid use without any knowledge of the cardiovascular side effects these substances had long term.  That’s what is happening with FDA banned peptides right now by so called health experts and healthcare influencers.

 

Arnold aka ‘Mr. Olympia’

Any doctor “prescribing” you these medications is probably lying to you since you cannot prescribe something that is banned by the FDA for human consumption and is being sold for research use only.  Every physician who graduates from Medical School takes an oath to do no harm.  I don’t see prescribing unproven peptides produced by unregulated pharmacies and being sold under the guise of being used for research purposes as fulfilling that oath so I have stayed away from the unregulated peptide market.  I don’t promote unproven treatments to make more money, I don’t take health advice from social media influencers, and I don’t experiment with my patient’s health.  Without data it is very hard to know what is cutting edge and what is the next healthcare cautionary tale.  Proceed with caution.  If you do decide to take non FDA approved peptides make sure to ask where they are coming from and who is producing them.  If you are going to take unproven peptides I would at the minimum do so under close supervision of a physician who specializes in the field and who can screen you before and during treatment to monitor for adverse reactions to these experimental therapies.

 

Stay safe, Stay educated, and Stay healthy.

 

  • Medically Authored by Dr. Mario Quiros. Board certified Emergency Medicine and Obesity Medicine physician.  Owner and operator of Good Hearts Health.

 

Links:

https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

https://www.npr.org/2026/02/23/nx-s1-5716162/peptides-science-muscle-growth-longevity-wellness

https://www.cnn.com/2025/11/15/health/peptides-unregulated-influencers

https://djholtlaw.com/the-unregulated-world-of-peptides-what-you-need-to-know-before-you-inject/

BPC-157: Experimental Peptide Prohibited


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Article Summary:

The FDA has officially declared the end of the tirzepatide shortage and semaglutide shortage, meaning that brand-name medications like Mounjaro®/Zepbound® (tirzepatide) and Ozempic®/Wegovy® (semaglutide) are now widely available. This decision impacts compounding pharmacies and outsourcing facilities, which were previously allowed to produce copies of these medications under emergency provisions.

 

How Compounding Pharmacies Continue to Serve Patients with Unique Needs:

The FDA recently declared the shortages of tirzepatide and semaglutide officially resolved, marking a turning point in the availability of these widely used medications for weight management and type 2 diabetes. While this announcement ensures that FDA-approved products like Mounjaro®/Zepbound® (tirzepatide) and Ozempic®/Wegovy® (semaglutide) are now readily accessible, it also signals a shift in the role of compounding pharmacies and outsourcing facilities. The physicians and pharmacies, which played a critical role during the shortages, are now adapting to continue serving patients with unique healthcare needs through clinically differentiated formulations.

 

The FDA’s Decision and Its Implications:

The semaglutide and tirzepatide shortages, which began in 2022 due to high demand, initially allowed compounding pharmacies and outsourcing facilities to produce copies of these medications under provisions of Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act. 4

However, the FDA has determined that by December 2024 for tirzepatide and February 2025 for semaglutide, manufacturers will be able to meet national demand, leading to the removal of these drugs from the shortage list.

As a result, compounding pharmacies and outsourcing facilities will no longer be able to produce copies of these drugs under the emergency provisions.123

Specifically:

  • Compounding pharmacies will no longer be able to make copies of semaglutide after April 22, 2025, and tirzepatide after March 19, 2025, unless they can demonstrate a documented clinical difference that addresses specific patient needs, in accordance with Section 503A of the Federal Food, Drug, and Cosmetic Act.
  • Outsourcing facilities will no longer be able to produce semaglutide after May 22, 2025, and tirzepatide after March 19, 2025.

This regulatory shift means that outsourcing facilities can no longer produce these drugs in any form and compounding pharmacies can no longer produce copies of these drugs unless they provide a documented clinical difference that meets specific patient needs under Section 503A of the Federal Food, Drug, and Cosmetic Act.4

Role of Compounding Pharmacies Post-Shortage: 

Even as enforcement tightens, compounding pharmacies remain essential for patients who require customized versions of tirzepatide or semaglutide. Here’s how they continue to make a difference:

Differences in Formulations: 

Compounding pharmacies can continue to legally produce tirzepatide or semaglutide with modifications that address unique patient needs. For example:

  • Adding Active Pharmaceutical Ingredients: Some compounded formulations include niacinamide (a form of vitamin B3), which may offer additional metabolic benefits.

Orally Disintegrating Tablets (ODTs): For patients who struggle with injections or have needle phobia, ODTs may provide a convenient alternative delivery method.48

These modifications are not available in FDA-approved GLP-1 products but may improve treatment adherence and outcomes for certain patients.

Personalized Dosages:

While many commercial products are available in fixed doses, compounded medications can be tailored to provide precise dosages that align with individual medical requirements.

This flexibility is particularly valuable for patients who experience side effects at standard doses or require gradual titration.

To learn more about customized medication dosing book your free consult at:

WWW.GOODHEARTSHEALTH.COM

 

Challenges Ahead:

Despite their critical role during shortages, compounding pharmacies face increasing scrutiny from regulatory agencies. Both Eli Lilly (maker of Mounjaro®/Zepbound®) and Novo Nordisk (maker of Ozempic®/Wegovy®) have raised concerns about counterfeit or substandard compounded versions of their drugs.1, 8

To address these concerns, compounding pharmacies must continue to prioritize transparency and adherence to legal requirements.

 

Conclusion:

The resolution of the tirzepatide and semaglutide shortages marks a new chapter in patient care. While FDA-approved products are now widely available, compounding pharmacies remain indispensable for those who require personalized formulations. By offering options like niacinamide-enhanced injections or orally disintegrating tablets, these pharmacies may help ensure that personalized care remains accessible to all patients. As the healthcare landscape evolves, compounding pharmacies will continue to adapt, demonstrating their commitment to meeting unique patient needs while adhering to high standards of safety and quality.

 

References:

1. https://www.healio.com/news/endocrinology/20241220/fda-confirms-end-of-tirzepatide-shortage

2. https://www.bipc.com/fdas-removal-of-semaglutide-and-the-evolving-tirzepatide-decisions-what-compounders-need-to-know

3. https://www.healio.com/news/endocrinology/20250221/fda-removes-semaglutide-from-drug-shortage-list

4. https://www.techtarget.com/pharmalifesciences/feature/Understanding-tirzepatide-compounding-restrictions

5. https://time.com/6301552/weight-loss-drugs-compounding-pharmacies/

6. https://ncpa.org/newsroom/qam/2025/03/13/fda-ends-compounding-discretion-tirzepatide-maintains-discretion

7. https://www.mwe.com/insights/semaglutide-shortage-resolved/

8. https://www.medpagetoday.com/special-reports/exclusives/111577

9. https://www.yahoo.com/lifestyle/millions-of-people-are-taking-compounded-weight-loss-drugs-now-theyre-about-to-disappear-202621562.html

10. https://www.blogs.joinmochi.com/blogs/tirzepatide-vs-semaglutide

11. https://qz.com/ozempic-glp1-shortage-compounded-tirzepatide-1851769293

12. https://www.fiercepharma.com/pharma/compounders-sue-fda-again-over-declaring-end-shortage-novos-semaglutide

13. https://abcnews.go.com/GMA/Wellness/compound-versions-weight-loss-drugs-longer-fda-rules/story?id=119665010

14. https://www.drugs.com/medical-answers/you-tirzepatide-compounding-pharmacy-3575862/

15. https://newdrugloft.com/tirzepatide-injections-an-alternative-to-compounded-semaglutide/

16. https://www.cbsnews.com/news/fda-declares-end-to-wegovy-and-ozempic-shortage/

17. https://www.pharmacytimes.com/view/fda-ends-semaglutide-shortage-listing-contributing-to-ongoing-legal-challenges

18. https://sesamecare.com/blog/semaglutide-shortage


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How do I know how many milligrams or units of Semaglutide or Tirzepatide to take?

This is a question I get every day as part of my weight loss practice.  There are two very important things to keep in mind when discussing Semaglutide and Tirzepatide dosing.  First, how many milligrams (mg) of the medication do I take.  Second,  how do I figure out this dose in milliliters (mL) or units on a syringe.

What is your Semaglutide or Tirzepatide dose in milligrams?

Both Semaglutide and Tirzepatide are dosed in milligrams (mg).  You should be starting on the lowest dose and titrating up depending on 3 factors:

  1. How many weeks have you been at your current dose? It is recommended that you stay at each dose for a minimum of 4 weeks before increasing the dose.  This allows your body to acclimate to the medicine and prevents any unwanted side effects that can occur by increasing the dose too quickly.
  2. Are you having any side effects at your current dose?  If you are having side effects at your current dose it is not recommended that you increase your dosage until these side effects have resolved.  Doing so will likely make any side effects you may be experiencing worse.
  3. Are you losing weight at your current dose?  I recommend a consistent weight loss of 1.5 lbs to 2 lbs per week as a target weight loss goal.  If a patient is losing this much weight consistently, I do not recommend increasing the dosage.  I only recommend a dosage increase if you fall below this threshold or your weight loss plateau’s.

How do I convert my dose in milligrams to milliliters or units on a syringe?

Every medication has a concentration that is expressed in mg/mL.  To put it simply this reflects how many milligrams of Tirzepatide or Semaglutide is in 1 mL of the liquid medication.  Every 1 mL of liquid is equal to 100 units on a syringe.

By knowing both the concentration of the medication in mg/mL and how many mg of medication you wish to inject you can calculate how many units of medication to draw up in the syringe for the appropriate dose.

The calculation is as follows:

Your Desired dose in mg / Concentration of the medication in mg/mL = # mLs of medication to administer

An example for the starting dose of Semaglutide would be:

0.25 mg / 5 mg per mL = 0.05 mL of medication.

To get this number in units on your syringe you can simply take the medication dosage in mL and multiply it by 100.  1 mL of medication equals 100 units on the syringe.

So 0.25 mg of Semaglutide is 5 units on the syringe for a bottle with a concentration of 5 mg/mL

How do I figure out my dose of Tirzepatide or Semaglutide in mg based on how many units I am taking weekly?

This is another common question I get from patients that are new to my practice.  I have a lot of patients that join my practice that were previously being given the medication by another provider or med spa.  It is a common occurrence that patients are being told how many units of the medication they are being given but they are uncertain what this equates to in milligrams (mg).  To calculate this you will need both the number of units you are taking and the concentration of medication you are being provided..

The calculation is as follows:

(Dose in units / 100) x ( Concentration of the medication in mg/mL) = Dose in mg

An example for one of my patients taking 44 units of Tirzepatide with a concentration of 17 mg/mL would be:

(44 units / 100) x (17 mg/mL) = 7.5 mg. 

So 44 units of Tirzepatide drawn up on a syringe is equal to 7.5 mg of the medication.

 

Semaglutide Dosing

Tirzepatide and Semaglutide Dosing for Good Hearts Health Patients:

The following are dosing guidelines I use for my patients based on the concentrations of Semaglutide and Tirzepatide that we currently prescribe.

For Semaglutide: The initial dose of the medication is 0.25 mg weekly. This is 5 units (0.05mL) on the insulin syringe provided.

Fore Tirzepatide: The initial dose of the medication is 2.5 mg weekly. This is 15 units (0.15 mL) on the insulin syringe provided.

 

Semaglutide 5 mg/mL Dosing Schedule:

0.25 mg or 5 units weekly for the first 2-4 weeks.

0.5mg or 10 units weekly for 4 weeks

1 mg or 20 units weekly for 4 weeks

1.7 mg or 34 units weekly for 4 weeks

2.4 mg or 48 units weekly for 4 weeks

Tirzepatide 17 mg/mL Dosing Schedule:

2.5 mg or 15 units weekly for 2-4 weeks

5 mg or 30 units weekly for 4 weeks

7.5 mg or 45 units weekly for 4 weeks

10 mg or 60 units weekly for 4 weeks

12.5 mg of 74 units weekly for 4 weeks

15 mg or 88 units weekly for 4 weeks

Please remember, the goal is to take the lowest effective dose of the medication. If you are tolerating the medication well and losing weight you do not need to increase the dose of the medication.  My recommendation is to continue taking your current dose as long as you are seeing consistent weight loss in the 1.5lb to 2 lb per week range.  If you plateau at any point after 4 weeks on your current dose you have the option to increase your dose.

 

One of my mentors used to tell me, “Life is complicated, but medicine makes sense!”  I hope you found this review on Semaglutide and Tirzepatide dosing helpful.  Thanks for taking time to read it and I look forward to helping you on your weight loss journey.

 

This Post was Prepared by:

Dr. Mario Quiros

Good Hearts Health

Diplomate of the American Board of Obesity Medicine

 

 

For more Info regarding Semaglutide and Tirzepatide click below:

Semaglutide Clinical Trials

Tirzepatide Clinical Trials













Copyright by VMG 2024. All rights reserved.



Copyright by VMG 2024. All rights reserved.