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Microbiological Quality of Drug Products after Penetration of the Container System for Dose Preparation Prior to Patient Administration
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Microbiological Quality of Drug Products after Penetration of the Container System for Dose Preparation Prior to Patient Administration
John W. Metcalfe, Ph.D. Review Microbiologist CDER/OPS/New Drug Microbiology Introduction For many sterile products, preparation of the patient's dose in a hospital setting requires breaching the container and closure system long before the dose is administered. Examples of such products include solids which are constituted with a diluent, and admixtures of liquid products. Recently, the Center for Drug Evaluation and Research (CDER) has reviewed several New Drug Applications (NDAs) for nonpreserved products intended for final preparation and storage in a hospital pharmacy prior to patient administration. The types of these products vary widely with regard to drug product family and diluent(s), as well as proposed holding times and conditions. When preparing these types of drug products, the hospital pharmacist relies on the product label to provide the following information related to the drug product's final preparation and storage:
q q q q q
The process of penetration(s) of the container (e.g.: needle gauge). The choice of diluent(s). The diluent volume. The temperature(s) at which the final product may be stored prior to administration. The duration(s) for which the final product may be stored prior to administration.
Following is an example of selected sections from the Dosage and Administration portion of a redacted product label. This example is included here to illustrate the use in this paper of the phrase “final drug product preparation and holding/storage conditions”. Preparation of Solutions ____ ? does not contain a bacteriostatic preservative. Aseptic technique must be followed in preparation of the infusion solution....