Ohio Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Test

Question: 1 / 610

What is the maximum expiration date for a low-risk compounded drug at room temperature?

24 hours

48 hours

The maximum expiration date for a low-risk compounded drug at room temperature is indeed 48 hours. This guideline is based on standards put forth by the United States Pharmacopeia (USP) regarding sterile compounding. For low-risk compounded injections prepared in non-sterile conditions, the stability and sterility of the product can be compromised if not used within this time frame.

In the context of compounding pharmacy practice, low-risk preparations typically involve minimal manipulation with sterile ingredients and equipment. The 48-hour limit at room temperature helps ensure that the compounded medication maintains its integrity and effectiveness while minimizing the risk of contamination. After 48 hours, the likelihood of microbial growth increases, potentially rendering the product unsafe for patient use.

It's important for pharmacists and pharmacy technicians to adhere to these compounding standards to ensure patient safety and compliance with regulatory requirements. The other choices—24 hours, 72 hours, and 14 days—do not align with the established guidelines for low-risk compounded sterile preparations at room temperature. Hence, the 48-hour standard is the most appropriate duration to ensure the safety and quality of the compounded drug.

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72 hours

14 days

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