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.^1, 2, 3

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.^4, 8

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

 

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.

 

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