If 25 CC is removed from a Roxanol (10 mg/5CC) 480 CC bottle and diluted to 100 CC, what classification does the compounded solution fall under?

The compounded solution in question is classified as C3, which refers to a compounded preparation that contains significant quantities of controlled substances but is not classified as a complex or sterile preparation.

In this scenario, Roxanol is a formulation of morphine sulfate (a controlled substance) and the original solution has a concentration of 10 mg per 5 CC. When 25 CC is removed from the 480 CC bottle, it contains 50 mg of morphine sulfate (since 25 CC of Roxanol contains 10 mg for every 5 CC, resulting in 10 mg x (25 CC/5 CC) = 50 mg).

Diluting this 25 CC to a total volume of 100 CC changes the concentration but does not eliminate the fact that controlled substances are present in the final compounded solution. A C3 classification applies to preparations where the primary active ingredient is a Schedule III or IV controlled substance or those that are combinations of controlled substances. As the diluted solution still retains characteristics of containing a controlled substance but is not classified as a simple strong solution or an injectable preparation, it fits the C3 classification criteria.

Understanding the classifications of compounded medications within the realm of pharmacy law is crucial for compliance and safety, particularly when handling controlled substances.