What phrase must be included on compounded prescription labels?

The requirement for compounded prescription labels to include the phrase "Compounded per subscriber request" serves a critical purpose in ensuring transparency and communication regarding the nature of the medication. This phrase indicates that the prescription was specifically made for an individual patient based on a licensed practitioner's prescription, rather than being a mass-produced commercial product.

Including this statement helps to inform patients, pharmacists, and other healthcare providers that the medication has been tailored to meet the unique needs of the patient, which is a key characteristic of compounded medications. It clarifies that the formulation may not have undergone the same rigorous testing and approval process as standard pharmaceuticals, which can foster greater awareness and caution in the use of such products.

This distinction is particularly important in a regulatory context where compounded medications must comply with specific guidelines and standards to ensure safety and efficacy, thereby protecting patient health. Failing to include such wording might result in confusion about the product's usage, legality, and safety profile.

Other phrases such as "This medication is for external use only" and "Not for resale" focus on particular aspects of the medication but do not encompass the essential information about the compounding process. Meanwhile, stating that "the prescription is filled at a retail store" does not convey the customized nature of compounded medications