South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

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What are the maximum limits for codeine in C5 drugs per dose?

  1. 200 mg

  2. 90 mg

  3. 100 mg

  4. 50 mg

The correct answer is: 90 mg

In the context of controlled substances, particularly for cough preparations that contain codeine classified as Schedule V (C5), the regulations stipulate specific limits on the amount of codeine per dose. For a formulation to qualify as a Schedule V substance, it must contain no more than 200 mg of codeine per 100 mL or per 100 grams, or no more than 90 mg of codeine per dosage unit. This is why the correct answer is focused on the 90 mg limit per dose. This limit is set to ensure that products containing codeine are used safely and effectively for conditions like cough suppression while minimizing the potential for misuse and abuse that is associated with higher amounts of codeine. Understanding these limits is crucial for pharmacy practice, as dispensing errors can have significant legal and health implications. The other options exceed the permissible dosage limits defined by regulatory standards for Schedule V drugs, and thus are not acceptable in the context of this question regarding maximum doses of codeine in C5 preparations.