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Castle Law Office

Q
What Are Compounding Pharmacies? Are They Regulated by the FDA?

A

Compounding pharmacies are those in which a pharmacist prepares a medication specifically for a patient’s individual needs. The customized medication — prescribed by a physician — is often created by combining, mixing, or altering ingredients to make a new formulation of an approved drug substance. For example, a dye may be removed because a patient is allergic to it, or a medication may be made in suspension (liquid) form if a child can't swallow a pill.

Although such medications are alterations of an approved formulation of the original drug, the FDA allows for legitimate forms of pharmacy compounding, which are regulated under state laws governing the practice of pharmacy.

However, while most pharmacists are qualified to compound certain medications, there are some compounding instances in which the risks of obtaining a product of substandard quality may outweigh the benefits.

Some big pharmaceutical drug companies have abused the system, manufacturing products under the guise of pharmaceutical compounding and creatively marketing compounded products as better than the original products.

Some compounded drugs are purposefully made with a form of an active ingredient that hasn't been approved by the FDA. Others continue to be compounded after the FDA has deemed them unsafe and removed them from the market.

Always use caution when obtaining a compounded drug. If you believe you have received a defective compounded drug, seek immediate medical attention and the advice of an attorney. Call us today at 816-842-7100 to speak with an attorney that will fight to get you the compensation you deserve. Or you can click here to email us and schedule your free consultation. 

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