What is a compounded medication?

As defined by the Food and Drug Administration, compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.

This can be a beneficial process when medically necessary, like when a patient has an allergy to one of the ingredients in their needed medication, or when there is a shortage of certain medications. However, there are many potential risks that come with using compounded medications. Continue reading for an overview of these risks.

Are compounded medications FDA-approved?

No. Compounded medications have not undergone the safety, efficacy or quality testing that FDA-approved medications have. This means that the quality of the manufacturing process is also not standardized.

Poor quality compounding practices can lead to drug quality problems, like drug contamination or a drug that contains too much of the active ingredient. This can lead to patient injury or death. For example, in 2012, a compounded steroid medication that was contaminated with a fungus was administered to patients throughout the country, resulting in over 750 patients contracting fungal infections and more than 60 deaths.

Why shouldn’t I use compounded semaglutide?

-Compounded drugs are exempt from Good Manufacturing Practices, the federal statutes that govern the production and testing of pharmaceutical products.

-Compounded products are not clinically evaluated for safety or efficacy.

-Compounded preparations do not have standard product labeling or prescribing information with instructions for safe use.

-Compounding pharmacies are not required to report adverse events that occur with their products.

-Compounders may be using salt forms of semaglutide (semaglutide sodium and semaglutide acetate), which have not been shown to be safe or effective. These salts are different active ingredients than the FDA-approved drugs, which contain the base form of semaglutide.

-There have been reports of counterfeit semaglutide in the US drug supply chain.

In short, with compounded medications, there is no guarantee you are receiving the medication you think you are. There could be variations in ingredients or dose, or incorrect labeling, or incorrect instructions for use. There could be issues with sterility, which is especially important to consider with injectable medications, like semaglutide. The only way to guarantee the safety, efficacy and quality of a medication is by FDA-approval.

How do I know if I’m taking a compounded medication? What do I do if so?

Ask your prescriber or your pharmacy. Sometimes, the medication will be labeled as “compounded.”

If you are taking a compounded medication, ask why. If for a necessary reason (like an allergy), you can ask if the compounding pharmacy has been accredited by the Pharmacy Compounding Accreditation Board, which ensures the compounding pharmacy adheres to the highest measurements of performance and accuracy in their manufacturing process. Think of this as a “reputation verification” of the pharmacy, however, it still does not provide the guarantees that FDA-approval does.

If you would prefer not to take a compounded medication, ask your prescriber to transition to the FDA-approved medication. Another option is to change your prescriber.

Dignity Weight Center only prescribes FDA-approved medications.

For a full list of compounding inspections, recalls and other actions, visit this link: https://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions

If you are interested in learning more about metabolic health and weight loss, please consult us at Dignity Weight Center! We would be honored to meet you, and we take most insurances!

If you are interested in learning more about metabolic health and weight loss, please consult us at Dignity Weight Center. We would be honored to meet you, and we accept most insurances.

References

• https://www.goodrx.com/drugs/medication-basics/compound-medications
• https://www.pharmacist.com/Practice/Patient-Care-Services/Compounding/Compounding-FAQs#:~:text=A%20widely%20accepted%20standard%20of,the%20compounding%20pharmacy%20is%20accredited.
• https://www.fda.gov/drugs/human-drug-compounding/drug-compounding-and-drug-shortages#:~:text=Compounded%20drugs%20are%20not%20FDA,in%20an%20FDA%2Dapproved%20drug.
• https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
• https://pubmed.ncbi.nlm.nih.gov/23526368/
• https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-losshttps://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain