FDA has published final draft guidance for industry on mixing, diluting, or repackaging biological products outside the scope of an approved Biologics License Application (BLA)
FDA in February has published new draft guidance for industry on Mixing, Diluting, or Repackaging Biological Products outside the scope of an approved Biologics License Application. Biological products have a complex set of structural features and are very sensitive to changes to their manufacturing process. Accordingly, diluting or mixing a biological product with other components, or repackaging a biological product by removing it from its approved container-closure system and transferring it to another container-closure system in the absence of manufacturing controls, highly likely to affect the safety and/or effectiveness of the biological product. Certain licensed biological products may need to be mixed or diluted or repackaged in a way not described in the approved labeling for the product to meet the needs of a specific patient. Like other drugs, biological products are sometimes repackaged for various reasons including for pediatric or ophthalmic use. Repackaging a drug or biological product could change its characteristics in ways that have not been evaluated during the approval process and that could affect the safety and effectiveness of the product. This guidance sets forth FDAâ€™s policy regarding the mixing, diluting, and repackaging certain types of biological products that have been licensed under section 351 of the Public Health Service Act (PHS Act) when such activities are not within the scope of the productâ€™s approved biologics license application (BLA) as described in the approved labeling for the product.
This guidance does not address the following:
- Products intended for use in animals.
- Mixing, diluting, or repackaging biological products by entities that are not state-licensed pharmacies, Federal facilities, or outsourcing facilities; and preparation of allergenic extracts by entities that are not state-licensed pharmacies, Federal facilities, outsourcing facilities, or physicians.
- Removing a biological product from the original container at the point of care for immediate administration to a single patient after receipt of a patient-specific prescription or order for that patient (e.g., drawing up a syringe to administer directly to the patient). FDA does not consider this to be â€śrepackaging,â€ť for purposes of this guidance document.
- Upon receipt of a patient-specific prescription, a licensed pharmacy removing from one container the quantity of solid oral dosage form biological products necessary to fill the prescription and placing it in a smaller container to dispense directly to its customer.
- Mixing, diluting, or repackaging a licensed biological product when the product is being mixed, diluted, or repackaged in accordance with the approved BLA as described in the approved labeling for the product. FDA considers this to be an approved manipulation of the product.
- Mixing, diluting, or repackaging of blood and blood components for transfusion, vaccines, cell therapy products, or gene therapy products. The guidance does not alter FDAâ€™s existing approach to regulating the collection and processing of blood and blood components. In addition, FDA intends to consider regulatory action if licensed vaccines, cell therapy products, and gene therapy products are subject to additional manufacturing, including mixing, diluting, or repackaging, in ways not specified in the productâ€™s approved BLA as described in the approved labeling for the product.
You can View the full final guidance Click here.