The increasing popularity of weight loss medications, particularly glucagon-like peptide-1 receptor agonists (GLP-1RAs) like Wegovy, has led many to explore alternative options due to high prices, supply shortages and limited insurance coverage. Compounding pharmacies, which create customized medications, have emerged as a potential solution. This article examines the benefits and risks associated with using compounding pharmacies for weight loss medications, specifically GLP-1RAs.
What are Compounding Pharmacies?
Compounding pharmacies specialize in creating customized medications tailored to meet individual patient needs. The FDA defines "traditional" pharmacy compounding as "combining, mixing, or altering ingredients to create a customized medication for an individual patient based on a licensed practitioner’s prescription.” These pharmacies use FDA-approved ingredients to prepare medications that are not commercially available in the required dosage form or strength. Compounded drugs themselves are not FDA-approved, meaning they have not undergone the same rigorous review process for safety, effectiveness, and quality as manufactured drugs.
Benefits of Compounding Medications
Compounding pharmacies offer several potential benefits:
- Alternative Dosage Forms: They can prepare medications in various forms, such as liquids for patients who have difficulty swallowing pills.
- Allergen Removal: Compounding allows for the removal of allergens found in commercially manufactured products.
- Customized Doses: They can create specific doses that are not commercially available.
- Re-flavoring medications: To improve taste
Community pharmacies vary in their capacity to perform compounding, with more complex preparations typically handled by specialized compounding pharmacies.
GLP-1RAs: A Popular Weight Loss Solution
GLP-1RAs (glucagon-like peptide-1 receptor agonists) are a class of medications that mimic a naturally occurring hormone in the body. They work by:
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- Slowing down the rate at which food leaves the stomach
- Increasing insulin release when needed
- Reducing unnecessary glucagon signaling
- Sending fullness signals to the brain
Initially approved for managing type 2 diabetes, some GLP-1RAs, such as semaglutide and tirzepatide, have also been approved as weight-loss drugs. Compounded GLP-1RAs are often marketed for weight management because insurance plans typically cover the manufactured versions only for type 2 diabetes.
Compounded GLP-1RAs: An Alternative Approach
Compounded GLP-1RAs are produced by outsourcing pharmacies that are independent of the brand-name manufacturers. While designed to mimic the original products, they are not FDA-approved generic medications.
Legality and Shortages
Normally, it is illegal to copy a medication if the original product is still under patent. However, during an FDA-declared drug shortage, these medications can legally be compounded. The FDA does not consider a medication “commercially available” if there is a shortage of that medication. Currently, semaglutide is in shortage, and tirzepatide was previously in shortage but is no longer. Despite this, tirzepatide is still being compounded because the FDA agreed not to prosecute compounding pharmacies while a lawsuit filed by one of these pharmacies is ongoing.
This provision exists to ensure continuity of care when a patient's prescribed medication is in short supply and unavailable at regular pharmacies.
Accessibility and Affordability
Concerns about the accessibility of GLP-1 medications, related to affordability and shortages, have led healthcare providers and patients to consider compounding pharmacies. Compounded medications can help with continuity of care and allow more patients to get started on a GLP-1. The makers of Wegovy report limited quantities of the lower dosages, typically prescribed when first starting the medication, as a way to control demand for the higher dosages. The cash price for GLP-1s can be prohibitive for people who don’t have insurance coverage for them. Compounded GLP-1 prices (without insurance) vary depending on the pharmacy but are typically sold at a significantly reduced price.
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Risks Associated with Compounded GLP-1RAs
While compounded GLP-1RAs may offer increased access and affordability, they also pose several risks that patients and healthcare providers must consider.
Adulteration and Misbranding
Compounded GLP-1RAs have been the subject of numerous lawsuits. Manufacturers like Novo Nordisk (semaglutide) and Eli Lilly (tirzepatide) have sued compounding pharmacies for producing adulterated (contaminated or tainted) or misbranded products and for dispensing medications without proper prescriptions. The most commonly cited adulteration is compounding manufacturers dispensing contaminated medications or producing medications in unsanitary conditions. The most common instances of misbranding has been when compounded medications contain less active ingredient than advertised.
Dosing Errors
Reports of adverse events, including hospitalizations, have been linked to dosing errors with compounded GLP-1ra products. Across the country poison control centers saw a nearly 1,500 percent increase in calls in 2023 related to accidentally overdosing on injected weight-loss drugs. The FDA dispersed an alert highlighting that these errors often stem from confusion with units of measurement (e.g., milliliters, milligrams, and units) and the variation in concentrations offered by different compounders. Unlike FDA-approved GLP-1ra, which are available in standard concentrations and prefilled pens, compounded versions may come in multiple-dose vials or prefilled syringes with varying strengths. This lack of standardization increases the risk of miscalculation or unintentionally drawing up an inappropriate dose. For example, patients unfamiliar with using syringes have accidentally administered 5-20 times the intended dose, and providers have miscalculated conversions from milligrams to units, leading to severe side effects and in some instances hospitalization. The FDA estimates that 10 deaths and 100 hospitalizations may be linked to the use of compounded GLP-1RAs.
Lack of FDA Oversight
The FDA has issued safety alerts when they become aware of specific compounding pharmacies operating illegally or notice safety issues, such as increased medication overdoses. However, their responses are often reactive, meaning action is usually taken only after a patient experiences a negative outcome. This delay is partly due to how the law defines the FDA’s authority over outsourcing compounding pharmacies. The FDA states “as with all compounded drugs, drugs compounded by outsourcing facilities have not undergone FDA premarket review for safety, effectiveness, and quality, and lack a premarket inspection and finding of manufacturing quality that is part of the drug approval process. Because they are subject to a lower regulatory standard, compounded drugs should only be distributed to health care facilities or dispensed to patients to fulfill the needs of patients whose medical needs cannot be met by an FDA-approved drug.”
Medication Delivery Differences
Unlike Wegovy, Ozempic, and Zepbound, which come in easy-to-use pen injectors, compounded versions will not be in the same delivery tool as a manufactured version; those tools, like an injection pen, are typically patented by the manufacturer. There are also novel formulations only available from compounding pharmacies, such as sublingual semaglutide and tirzepatide tablets that may be placed under the tongue. This technically isn’t illegal and could be very enticing for someone with a needle phobia. Still, keep in mind that the sublingual formulation has not been extensively studied nor approved by the FDA.
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Other potential issues
- Lack of FDA approval: Although compounded drugs are intended to be chemical “copies” of available medications, they do not have the same safety, quality, and effectiveness assurances as medications approved by the FDA. The FDA oversees and regulates the manufacturing and distribution process, as well as ingredient quality.
- Regulation of compounding pharmacies varies by state
- Affordability (yes, here too): While price breaks on GLP-1s may seem like a welcomed relief, prioritizing price as the main factor in using compounded formulations does not account for safety and efficacy. Some compounded formulas may include unapproved add-ins or exclude key components to cut costs. These alternatives have not undergone the rigorous research required for FDA approval and may not be overseen in the same way the FDA oversees manufacturing and distribution of medication. It's also worth noting that compounded GLP-1s may not be a more affordable option for all patients, because not all insurance plans cover compounded medications, and not all compounding pharmacies take insurance.
- Continuity of care: A benefit of using compounded GLP-1s is continuity of care when there is a shortage of the manufactured medication and a person is already on the medication. This is especially true when we consider the titration schedule and side effects associated with starting GLP-1s, and the weight regain that can happen when the medications are stopped. Suddenly losing access to GLP-1s can significantly hinder a patient’s progress and health goals.
How to Choose a Compounding Pharmacy
If you and your doctor decide that a compounded medication is right for you, it’s important to choose a reputable pharmacy. Here are some tips:
- Ask your doctor for a referral. Your doctor may already use a compounding pharmacy with other patients and may be able to refer you to one they know is reliable.
- Check the pharmacy’s credentials. All compounded pharmacies must be licensed and regulated by their state’s pharmacy board. Compounding pharmacies must also follow rules set out by US Pharmacopeia (USP).
- Ask about the pharmacy’s training and accreditation. What training do your pharmacists have? What other accreditation does your pharmacy have?
- Be wary of online pharmacies. You should also be wary of buying compounded drugs online, whether it's through an online pharmacy or a telehealth platform.
- Verify the source of the ingredients: The drugs should be coming from 503A or 503B pharmacies, the latter of which are compounding pharmacies with outsourcing facilities that may manufacture large batches.
- Ensure registration in your state: Also, make sure the supplying pharmacy is registered to do business in the state.
The Importance of Medical Oversight
Regardless of whether you choose brand-name or compounded weight loss medications, medical supervision is crucial. Doctor Scott Isaacs, the president-elect of the American Association of Clinical Endocrinology, emphasizes the importance of keeping your doctor informed. Losing weight can affect the management of other health conditions, requiring adjustments to medication dosages.
Isaacs also stresses the need for physical examination of the thyroid, as these obesity drugs, whether brand-name or compounded, carry a rare risk of thyroid cancer.
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