What is the maximum allowable quantity of codeine in a Schedule IV preparation?

A Schedule IV preparation that contains codeine must adhere to specific regulations regarding the maximum allowable dosage. According to federal regulations, the maximum concentration of codeine permitted in a Schedule IV preparation is 200 mg per 100 mL.

This limit is crucial as it helps distinguish between permissible low-dose codeine formulations used for cough suppression and those that might lead to abuse. The regulations ensure that while codeine can be utilized for therapeutic purposes, such use remains within controlled limits to prevent misuse and potential dependency.

Understanding these regulatory distinctions is vital for pharmacists and healthcare professionals to ensure compliance and to promote safe medication practices.