Compounding personnel ascertain that ingredients for CSPs are of the correct identity and appropriate quality using the following information: vendors' labels, labeling, certificates of analysis, direct chemical analysis, and knowledge of compounding facility storage conditions.
STERILE INGREDIENTS and COMPONENTS
Commercially available sterile drug products, sterile ready-to-use containers and devices are examples of sterile components. A written procedure for unit-by-unit physical inspection preparatory to use is followed to ensure that these components are sterile, free from defects, and otherwise suitable for their intended use.
NONSTERILE INGREDIENTS and COMPONENTS
If any nonsterile components, including containers, devices, and ingredients are used to make a CSP, such CSPs must be compounded at a high-risk level. Nonsterile active ingredients and added substances, or excipients, for CSPs should preferably be official USP or NF articles. When nonofficial ingredients are used, they must be accompanied by certificates of analysis from their suppliers to aid compounding personnel in judging the identity, quality, and purity in relation to the intended use in a particular CSP. Physical inspection of a package of ingredients is necessary in order to detect breaks in the container, looseness in the cap or closure, and deviation from the expected appearance, aroma, and texture of the contents.
Bulk, or unformulated, drug substances and added substances, or excipients, must be stored in tightly closed containers under temperature, humidity, and lighting conditions that are either indicated in official monographs or approved by suppliers; also the date of receipt in the compounding facility must be clearly and indelibly marked on each package of ingredient. After receipt by the compounding facility, packages of ingredients that lack a supplier's expiration date cannot be used after one year, unless either appropriate inspection or testing indicates that the ingredient has retained its purity and quality for use in CSPs.
Careful consideration and evaluation of nonsterile ingredient sources is especially warranted when the CSP will be administered into the vascular, central nervous system, and eyes.
Upon receipt of each lot of the bulk drug substance or excipient used for CSPs, the individual compounding the preparation performs a visual inspection of the lot for evidence of deterioration, other types of unacceptable quality, and wrong identification. The bulk drug substance or excipient visual inspection is performed on a routine basis as described in the written protocol.