Differences Between Compounded Semaglutide and Branded Ozempic: Is It Safe?

There are free main differences between compounded Semaglutide and branded Semaglutide: form and dosage, cost, and storage. The safety of using compounded semaglutides is based on several factors including having an experienced provider, a reputable compound pharmacy, key ingredients, and medication side effects management.

Khang T. Vuong, MHA

Khang T. Vuong received his Master of Healthcare Administration from the Milken Institute School of Public Health at the George Washington University. He was named Forbes Healthcare 2021 30 under 30. Vuong spoke at Stanford Medicine X, HIMSS conference, and served as a Fellow at the Bon Secours Health System.

How is Compounded Semaglutide Different from Branded Semaglutide (Ozempic, Wevogy, Rebelsus)?

Difference in Form and Dosage

Branded Semaglutide, like Ozempic and Wegovy, are manufactured by Novo Nordisk and come in pre-dosed pens with different colors indicating a dosage similar to EpiPens. These pens have a built-in delivery system for subcutaneous injection.

Wegovy (semaglutide) comes in once-weekly one-dose pens ranging from 0.25mg/injection to 1.7mg/injection. Each pen has enough medication for one injection. Each injection takes 10 seconds and there are 2 clicks. You would need 1 pen per week or 4 pens per month.

Ozempic (semaglutide) comes in 3 multi-dose pens, 0.25mg - 0.5 mg red pen, 1mg blue pen, and 2mg yellow pen, with separate needles. Each pen has enough medication for 4 injections (6 injections for red pens). Each Ozempic pen will last you 4-6 weeks.

Mounjaro (Tirzepatide) also comes in colored once-weekly pre-dosed pens, ranging from 2.5mg/injection to 15mg/injection. Each pen has enough medication for one injection per week.

Compounded Semaglutide and Tirzepatide, on the other hand, come in a liquid vial with a specific concentration prescribed by your provider. Because there is no built-in delivery system, you are responsible for dosing and injecting the medication according to provider instructions.

It is important to note that the amount of liquid you need to withdraw from the vial for injection depends on the medication concentration and your dosage. For example, if the dosage is 0.25MG/week of Semaglutide and the concentration is 1mg/ml, you need 0.25ml or 25 units.

Difference in Storage

Both compounded and branded Semaglutide and Tirzepatide must be stored at a stable room or refrigerator's temperature, without light and vibration, and cannot be heated or frozen.

Wegovy pens must be stored between 36°F to 46°F (2°C to 8°C) and last up to a month or 28 days at room temperature between 46°F to 86°F (8°C to 30°C).

Ozempic pens must be stored in the refrigerator between 36°F to 46°F (2°C to 8°C) and last up to two months or 56 days at room temperature 59ºF to 86ºF (15ºC to 30ºC).

Mounjaro pens must be stored in the refrigerator between 36°F to 46°F (2°C to 8°C) and last up to 21 days at room temperature 59ºF to 86ºF (15ºC to 30ºC).

Compounded semaglutide and tirzepatide must also be stored in the refrigerator and last up to 29 days. Compounded GLP-1 could be stored at room temperature for transportation in a short amount of time. Recent studies have shown Semaglutide's stability at higher temperatures for a short period of time, 104°F (40°C) for up to three days.

Difference in Cost per Month

Compounded Semaglutide and Tirzepatide are 2 to 3 times cheaper compared to Branded versions when obtained via subscription services, and 5-8 times cheaper when obtained directly from the compound pharmacy.

It is important to note that to get compound GLP-1 directly with the pharmacy, your provider must be willing to transfer the script.

Semaglutide vs. Semaglutide Salts vs. Semaglutide Blends

Recently, the FDA has published guidance pertaining to the use of Semaglutide salts in compounded GLP-1 instead of semaglutide.

• Semaglutide: The approved medications like Ozempic and Wegovy contain semaglutide in its base form. This form mimics the GLP-1 hormone and is effective in reducing blood glucose levels and aiding weight loss.
• Semaglutide Salt Forms: These include semaglutide sodium and semaglutide acetate. These have not been approved by the FDA. They are sometimes used in compounded versions of the drug, especially during shortages of the approved drugs. However, the FDA has expressed concerns about their use as they do not meet the Federal Food, Drug, and Cosmetic Act requirements for compounding. There are no guarantees of their safety, efficacy, or quality.
• Semaglutide blends: several compound pharmacies market GLP-1 in combination with Vitamin B complex or glycine to mitigate fatigue and reduction in muscle mass. It is important to inquire your providers on the usage of multiple medications due to possible drug interactions.

Are Compounded Semaglutide & Tirzepatide Safe?

The safety of compounded Semaglutide and Tirzepatide depends on these factors:

• Do you have a medical provider who is experienced in prescribing and managing GLP-1?
• Is the medication compounded by a reputable licensed pharmacy?
• Was the raw ingredient manufactured by a reputable source?
• Is the active ingredient Semaglutide or Semaglutide Salt?
• Is there another active ingredient combined (a blend)?
• Do you know how to dose and inject medication yourself?
• How sensitive you are to medication side effects?

If you have clear answers to all of the above, it is likely an experienced provider can help you dose and manage the side effects of GLP-1. For the cost, compound GLP-1 would be a great choice for many who seek to manage Type 2 Diabetes or achieve weight loss.

Who Can Make Compounded Semaglutide?

How is it possible for compound pharmacies to sell GLP-1 if the drug just came out?

When a medication is in shortage as determined by the FDA, compounders might have the option to create a version of that drug, provided they adhere to specific criteria outlined in the Federal Food, Drug, and Cosmetic (FD&C) Act. As of May 2023, both Ozempic and Wegovy are included on the FDA’s list of drug shortages.

Who Oversees Compound Pharmacies?

The licensing of compounding pharmacies is primarily managed at the state level by respective State Boards of Pharmacy. Additionally, the Federal Food and Drug Administration (FDA) plays a role in regulating compounding pharmacies, particularly those that engage in large-scale operations that go beyond traditional pharmacy compounding.

Understand different types of Compound Pharmacy Certifications

1. Pharmacy Compounding Accreditation Board (PCAB): this is the gold standard offered by the Accreditation Commission for Health Care (ACHC), PCAB accreditation is one of the most prestigious recognitions a compounding pharmacy can achieve.

2. National Association of Boards of Pharmacy (NABP): NABP offers the Verified Pharmacy Program (VPP) which inspects and accredits pharmacies beyond state boards’ licensure.

3. LegitScript Certification: LegitScript offers a certification program that verifies and monitors healthcare products and online pharmacies to protect consumers from illegitimate operations, harmful products, or services.

Where Do Compound Pharmacies Source GLP-1?

Compound pharmacies do not manufacture GLP-1 on their own but source bulk raw ingredients from different vendors and test them for purity and efficacy. GLP-1 is manufactured in both the U.S. and overseas, it is important to ask where the raw ingredient is sourced and how it is tested.

In the U.S., companies like Biopeptek, Bachem, AmbioPharm, and CordenPharma are peptide specialists and likely supply compound pharmacies. China and Europe also play a big role in the manufacture of peptides worldwide.