Arizona MPJE (Pharmacy Jurisprudence) Practice Exam

What is the maximum permissible concentration of codeine in mg/ml for it to be categorized as a CIII substance?

1. 10 mg/ml

2. 15 mg/ml

3. 18 mg/ml

4. 20 mg/ml

The correct answer is: 10 mg/ml

The maximum permissible concentration of codeine for it to be classified as a Schedule III substance is indeed 10 mg/ml. This regulation is specified under federal law, which dictates that codeine-containing products can be classified as Schedule III if they meet certain concentration criteria. To elaborate, products containing up to 1.8 grams of codeine per 100 milliliters or per 100 solid doses, or not more than 90 mg per dosage unit when combined with another non-narcotic medication, qualify as Schedule III drugs when these concentration limits are adhered to. Therefore, for codeine concentrations specifically, maintaining it at or below 10 mg/ml ensures the substance remains classified within the Schedule III category, allowing for certain regulatory and prescribing practices to apply. This classification is important in determining the scheduling of controlled substances and ensuring that they are subject to appropriate controls regarding dispensing and use.