West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

Under what conditions can a pharmacy compound CII-V drugs for a prescriber's office?

1. Compound does not contain more than 10% controlled substance

2. Compound is in any dosage form

3. Compound does not contain more than 20% controlled substance

4. Compound is only distributed to prescribers not authorized to dispense controlled substances

The correct answer is: Compound does not contain more than 20% controlled substance

The correct answer is based on the regulatory framework surrounding the compounding of controlled substances in a pharmacy setting. In West Virginia, as well as under federal regulations, a pharmacy can compound a drug containing a controlled substance if the compound does not exceed a certain percentage of the controlled substance by weight or volume. In this case, a compound that contains no more than 20% controlled substance is permissible for distribution to a prescriber’s office, where it can be administered to patients or used in the practice, but not for resale or as part of a retail pharmacy operation. This regulation aims to ensure that the primary purpose of compounding is for patient treatment rather than for creating a commercial product, which might undermine the integrity of drug compounding practices. This 20% threshold is a critical limit that differentiates acceptable compounding practices from potentially unlawful manufacturing of drugs. Thus, the proper understanding of these regulations is essential for compliance in the pharmacy practice and prevents the diversion of controlled substances.