Compounding Sterile Preparation: Beyond-Use Date and Documentation
A hospital pharmacy in Juneau prepares a batch of sterile intravenous cefazolin 2 g in 100 mL normal saline for a patient with a central line. The pharmacy uses a horizontal laminar airflow hood in an ISO Class 5 environment. The pharmacist calculates a beyond-use date (BUD) of 7 days at room temperature based on USP <797> guidelines for a low-risk preparation. The pharmacy does not perform sterility testing. The batch is prepared on Monday and stored in the refrigerator. On Thursday, a nurse requests a dose for the same patient. The pharmacist checks the bag and notes no visible particulates. The pharmacy's policy is to assign a BUD of 7 days for refrigerated low-risk preparations. The pharmacist is unsure if Alaska law has additional requirements for sterile compounding.
1. Is the 7-day BUD appropriate for this compounded sterile preparation? Explain the applicable standards and any Alaska-specific rules.
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Under USP <797>, for a low-risk compounded sterile preparation (CSP) without sterility testing, the BUD is 48 hours at room temperature or 14 days if refrigerated. The pharmacist assigned 7 days refrigerated, which is within the 14-day limit, so it is acceptable under USP <797>. However, Alaska law (12 AAC 52.400) adopts USP <797> for sterile compounding. The pharmacy must follow USP <797> standards. The BUD of 7 days refrigerated is conservative and acceptable. The pharmacist should ensure that the preparation was compounded in an ISO Class 5 environment and that all personnel followed proper garbing and aseptic technique. The BUD should be documented. If the pharmacy is not compliant with USP <797> (e.g., no environmental monitoring), the BUD may be invalid. The pharmacist should verify that the hood is certified and that the pharmacy meets all requirements. The 7-day BUD is not prohibited, but the pharmacist must ensure the compounding process was compliant.
2. What documentation and labeling requirements apply to this compounded preparation? What should the pharmacist do before dispensing the dose on Thursday?
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The pharmacist must ensure the CSP is labeled with the patient name, drug, strength, volume, BUD, storage conditions, and preparation date. The pharmacy must maintain a compounding record that includes the ingredients, lot numbers, expiration dates, personnel involved, and the BUD. Under USP <797>, the pharmacist should perform a visual inspection before dispensing. On Thursday, the pharmacist should verify that the BUD has not been exceeded (7 days from Monday is the following Monday, so Thursday is within BUD). The pharmacist should check for any signs of contamination and confirm storage temperature. The pharmacist should also review the patient's profile for allergies and interactions. Alaska law requires that compounding be done by or under the supervision of a pharmacist. The pharmacist should document the dispensing and ensure the CSP is transported properly. If there is any doubt about sterility, the dose should be discarded.