Which type of risk level is allowed under the immediate use provision?

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The immediate use provision in sterile compounding is designed to allow the preparation of medications in emergency situations, where the patient's need for the medication is urgent, and there's a requirement for rapid administration. This provision permits the compounding of low-risk level preparations that can be administered within a short timeframe, typically 1 hour after preparation.

Low-risk compounding is characterized by the use of basic sterile ingredients and standard procedures that minimize the potential for contamination. In immediate use scenarios, the focus is on ensuring that the compounded products are safe and effective for immediate administration, which aligns with the low-risk criteria.

Higher risk levels, such as medium and high risk, involve more complex compounding processes that require additional testings, such as sterility and stability evaluations, making them unsuitable for immediate use under the provision. Thus, only low-risk compounded preparations are permitted in urgent situations to prevent unnecessary delays in patient care while ensuring safety standards are upheld.

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