Compounded Drugs and the Role of Compounding Pharmacies

The ongoing shortages of Ozempic and Wegovy, popular for their weight-loss properties, have led to an increase in the availability of compounded semaglutide. Compounding pharmacies, which are permitted by the FDA to create off-label versions of drugs in short supply, are producing these alternatives. However, the safety and efficacy of these compounded versions remain a concern.

 

Rise of Telehealth and Medical Spas

With the summer season approaching, telehealth outlets and medical spas are heavily advertising compounded semaglutide. This trend has emerged due to the high demand and limited supply of the brand-name drugs, manufactured by Novo Nordisk. These compounded alternatives, although legal, are prompting caution among experts.

 

Understanding Compounding

Compounding involves combining ingredients to create a customized medication tailored to an individual patient’s needs. For instance, converting a pill into a liquid form for someone who has difficulty swallowing. While compounding pharmacies can replicate commercially available drugs during shortages, these compounded versions are not FDA-approved.

 

FDA Warnings and Consumer Caution

The FDA has cautioned against the use of compounded semaglutide, citing reports of counterfeit and improperly formulated products. Consumers are advised to verify that the drugs are sourced from accredited pharmacies. These warnings are significant, considering the past issues with compounding pharmacies, such as the 2012 fungal meningitis outbreak linked to the New England Compounding Center.

 

Differences Between Compounded and Generic Drugs

A common misconception is that compounded semaglutide is a generic equivalent of Ozempic. However, generic drugs undergo FDA approval for safety and efficacy, unlike compounded drugs, which are not evaluated by the FDA. State boards of pharmacy generally oversee the day-to-day operations and practices of compounding pharmacies.

 

Potential Risks with Compounded Semaglutide

The FDA has reported adverse events linked to compounded semaglutide, including the use of different salt forms of the drug. The safety and efficacy profiles of these salts compared to the approved drug are unknown, posing potential risks to consumers. Additionally, the convenience of online ordering without proper medical consultation exacerbates these concerns.

 

Ensuring Safety When Ordering Online

Consumers interested in compounded semaglutide should conduct thorough research. It’s crucial to ensure that the compounding pharmacy is licensed and accredited by organizations such as the Pharmacy Compounding Accreditation Board. Accredited pharmacies adhere to stringent standards, providing some assurance of safety and quality.

As shortages of Ozempic and Wegovy persist, compounded versions of semaglutide have become more prevalent. While compounding pharmacies offer a legal alternative, the safety and efficacy of these drugs are under scrutiny. Consumers should exercise caution, consult their medical providers, verify the legitimacy and accreditation of the compounding pharmacies, and understand the differences between compounded and FDA-approved generic drugs.

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