The Rise of GLP-1 Weight Loss Drugs: What You Need to Know

10/14/2025

Unapproved versions of GLP-1 drugs

FDA is cognizant that some healthcare professionals and patients may opt for unapproved GLP-1 medications such as Semaglutide and Tirzepatide as a weight loss treatment. However, using such an unapproved drug can pose serious risks and may bring about unwanted complications, as these drugs don’t undergo the safety measures and standards set by the FDA. They are sold on the market without the FDA’s comprehensive review for quality, safety, and effectiveness. Every drug must undergo a comprehensive check by the FDA to ensure its safety.

FDA’s recommendation for both patients and healthcare professionals: 

• Healthcare providers should prescribe compounded drugs only when the drugs approved by the FDA are insufficient to take care of the medical needs of the patient.

• A patient must have a prescription written by a certified medical professional, and the prescription should be filled at a licensed and authorized pharmacy.

• If you are getting your prescription filled online, be sure to thoroughly check the legitimacy of the online drugstore to avoid falling victim to a scam. If you make your purchase through an unauthorized or fake online pharmacy, there is a risk of receiving counterfeit drugs or drugs that may contain life-endangering ingredients.

• If you have any questions regarding dosage or treatment, ensure to consult your doctor.

Risk associated with compounded versions of GLP-1 drugs:

Using a compounded drug under the supervision of a healthcare professional is deemed appropriate if the medical needs of a patient can’t be met by the FDA-approved drugs available. Compounded drugs are not backed by the FDA, which means they don’t undergo a comprehensive safety and effectiveness check by the FDA, thereby increasing the risk of falsified and unsafe medications. The FDA has highlighted several major concerns associated with these drugs and is working in conjunction with state regulatory partners to address these concerns. The following are seen as the major concerns tied to the compounded versions of GLP-1 drugs:

Improper storage may result in decreased effectiveness of the drug.

The GLP-1 injections need refrigeration to keep the quality and effectiveness intact. Over the past few months, the FDA has received a plethora of complaints regarding improper storage of compounded GLP-1 drugs. A myriad of customers received compounded GLP-1 drugs warm or with improper ice packs, which, as a result, affects the effectiveness of the drug. The FDA has requested that people worldwide not use drugs that arrive warm or without sufficient refrigeration, as this may compromise the drug’s quality.

FDA operation at the border.

The FDA recently issued a green list import alert (66-80), which will help prevent GLP-1 active pharmaceutical ingredients that do not meet the highest standard of quality from entering the US. GLP-1 API from companies that are under the observation of the FDA and stand in line with the stringent standards for manufacturing practices are free from this import alert. 

This newly imposed norm will safeguard customers based in the USA from receiving substandard compounded drugs that come with foreign-made APIs that may be manufactured without meeting the standards set by the regulatory bodies. 

The rise in fraudulent compounded GLP-1 drugs.

The FDA is pretty much aware of the fact that fraudulent compounded Semaglutide and tirzepatide with false information on the label are marketed in the US. In some cases, compounding pharmacies mentioned on the label do not even exist, which means the drugs you received may have some other active ingredient and can exacerbate your health issues. In other instances, the labels on the fraudulent compounded medicines list a licensed pharmacy that did not actually prepare these products. 

Guidelines mentioned by the FDA for consumers:

The FDA has asked consumers to procure medication from legitimate sources and pharmacies that comply with the regulatory measures set by the relevant authorities.

• Make sure to check the labels of the compounded GLP-1 drugs vigilantly to identify red flags such as spelling errors or incorrect addresses.

• Be sure to place your order with a pharmacy operating in compliance with the norms and standards implemented by the regulatory bodies.

• If you get a product with a name of a licensed and authorized pharmacy on the label, be sure to contact them to confirm if it was compounded by them.

• If you are unsure of the dosing schedule, talk to your medical provider.

• Neither Mounjaro nor Ozempic is prescribed for weight loss primarily. The FDA approved Wegovy in 2021, which has the exact active ingredient as Ozempic for weight loss. On the other hand, in 2023, Zepbound got FDA approval for weight management treatment and has the same active ingredient as Mounjaro.

Dosing concerns associated with compounded Semaglutide and tirzepatide.

Over the past few months, the FDA has received many instances of adverse events, ranging from requiring hospitalization to experiencing severe allergic reactions, with the consumption of compounded Semaglutide and tirzepatide. The dosing errors arose from patients measuring and receiving incorrect doses of these drugs.

In addition to this, adverse events, as mentioned by the FDA, may also be linked to patients prescribed compounded Semaglutide and tirzepatide in doses beyond the recommended/safe bar. Therefore, healthcare providers must be careful while prescribing compounded drugs to minimize such risks.

Ingredients such as retatrutide and cagrilintide are prohibited from being used in compounding.

Retatrutide and cagrilintide shouldn’t be used in compounding as per federal law. These components are not approved by the FDA for use in any drug and may pose serious health risks. The FDA has given a warning letter to the companies that offer pharmaceutical ingredients such as reltrutide and other active GLP-1 drugs.

Illegally marketed versions of these drugs:

The US has seen a sharp rise in the illegal version of these drugs being marketed, which may pose serious health issues and can exacerbate underlying health conditions. Let’s break it down to understand it better:

Counterfeit Ozempic: 

The FDA is aware that counterfeit Ozempic is being marketed in the USA. Counterfeit drugs are life-endangering as they may contain the wrong ingredients or may have no ingredients. The FDA has implemented a wide range of policies to protect the US drug supply from these threats. 

Illegitimate sale of these drugs online:

The FDA is actively surveilling the internet for counterfeit/unapproved drugs and has sent warning letters to companies distributing the illegally marketed Semaglutide and tirzepatide. These illegally manufactured drugs may have unsafe active ingredients, may be counterfeit, and may have more active ingredients than what is recommended. 

Reporting issues directly to the FDA: 

The FDA urges healthcare professionals, patients, and compounders to directly report adverse events to the FDA’s MedWatch Adverse Event Reporting program.  You can either submit the report online or download the form & send it via fax at 1-800-FDA-0178 after completing it.

The takeaway:

Being overweight or obese can be a hurdle in your journey to achieving your goals, but it doesn’t spell the end of the world for you. WEIGHT LOSS is doable through a holistic approach that consists of a nutritious diet, regular exercise, and, sometimes, medications. You should never consider buying any medication online or offline without consulting your doctor, as it may harm your health greatly. There are many drugs available online that promise a lot of things, but the reality could be different. Many people use unapproved GLP-1 drugs for weight management, which may have unsafe active ingredients or no ingredients at all. You should buy approved GLP-1 weight loss drugs from legitimate online pharmacies, and only after receiving the prescription from a certified healthcare professional. It’s better to stay away from pharmacies that claim to sell the best weight loss medicines, as they may contain hazardous ingredients.