Is reconstitution of a medication considered compounding under pharmacy regulations?

Reconstitution of a medication is typically not classified as compounding under pharmacy regulations. In the context of pharmacy practice, reconstitution refers to the process where a pharmacist combines a powdered drug with a specified amount of diluent (such as water) to create a liquid form of the medication, as indicated on the product’s label or by the manufacturer.

This procedure is considered a routine practice that follows standardized instructions rather than a customized preparation. As such, it does not meet the regulatory definitions of compounding, which generally involve creating a medication in a form other than its original or intended form and are done based on a prescriber’s specific request for an individual patient. Compounding typically requires a greater degree of discretion and alteration than the straightforward task of reconstituting a medication.

Thus, reconstitution is seen as a fulfillment of a manufacturer’s specifications rather than an independent compounding activity. This crucial distinction is why it is categorized differently within pharmacy regulations, reinforcing the understanding that not all modifications to medication are considered compounding.