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Product labeling is regulated by the FDA and compliance with existing regulations is required. Labeling of cell and gene therapy products as regulated biologics will be subject to these regulations. For biologics and devices (21 CFR 610 Subpart G and 21 CFR 801, respectively), the labeling requirements are separated into container labeling and package labeling requirements. Both the container label and the package label must include the expiration date. If the container is packaged, then the recommended storage conditions are included on the package label. If the container is not packaged, the recommended storage conditions and all other requirements of a package label must appear on the container label. Labeling must also comply with relevant national and international requirements.
If antibiotics are used in the cell processing and therefore may be present in the final product, the labeling should reflect this. For cell therapy products that must be applied to the patient in a particular physical orientation, labeling that indicates the correct orientation should be apparent even after the package is opened. Similarly, if a device should be only grafted in a defined area, that area should be made readily apparent by labeling that is evident once the package is opened. Unless the product has been screened for pathogenic or microbial contaminants prior to release, appropriate biohazard labeling may be required. For products with very short shelf lives, expiration dating will require adjustment and correction for time zones to provide the user an accurate assessment of shelf life. Clinical procedures will be scheduled around these crucial time frames. For patient-specific products, the patient's full name, initials, or a combination of these will need to appear on the labeling, in addition to lot designation, to ensure that the product will be administered to the appropriate patient.