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What is Custom-Compounded Therapy?

Many consumers and some healthcare providers believe that the term bioidentical hormone refers to a custom-mixed (“custom-compounded”) recipe containing one or more of various hormones in differing amounts, depending on an individual prescriber’s order. The recipe not only contains the active hormone (or hormones), but also other ingredients that either holds everything together (in the case of a rectal suppository, an under-the-tongue tablet, or an under-the-skin pellet) or provides a vehicle for applying the product onto the skin (such as a cream or gel) or into the body (such as a liquid for a nasal spray).

Custom-compounded hormones may provide certain benefits, such as individualized doses and mixtures of products and dosage forms that are not available commercially. However, there may be risks to the consumer. These compounds do not have government approval because individually mixed recipes have not been tested to prove that they are absorbed appropriately or provide predictable levels in blood and tissue. And there is no scientific evidence about the effects of these hormones on the body, both good and bad. Preparation methods vary from one pharmacist to another, and from one pharmacy to another, which means that patients may not receive consistent amounts of medication. In addition, inactive ingredients may vary and there can be batch-to-batch differences. Reliable sterility and freedom from undesired contaminants are also concerns. Expense is also an issue, as many custom-compounded preparations are viewed as experimental drugs and are not covered by insurance plans.

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