The biopharmaceutical market is ever growing, thanks to constant scientific advancements in the field. As biopharma products become more common, so must biopharma packaging. Due to the sensitive nature of many biological products, there are strict federal regulations in place to ensure safe packaging and distribution. Here is a brief overview of biologics packaging and labeling requirements according to the Code of Federal Regulations.
General Regulations (From Section 112.1)
- Licensing: The CFR states that all packaging and labeling must be performed in a properly licensed facility.
- Label Accuracy: It is against regulations to apply, affix, or include (directly or indirectly) false or misleading information on any biologics packaging.
- Label Alteration: No person is permitted to alter or mark any approved labeling on a biopharma product prior to distribution.
- Label Legibility: All labeling on biological packaging must be legible. Any products with labels that are altered, removed, destroyed, or otherwise illegible must be withheld from the market.
Final Container Label, Carton Label, and Enclosure Regulations (From Section 112.2)
According to the CFR, biopharma packaging labels must include the following information, unless otherwise specified:
- Full name of the biological product
- Name and address of product producer and appropriate consumer contact information
- Proper storage temperature recommendations
- Instructions for safe use and product warnings
- Expiration date
- Serial number
Packaging Biological Products Regulations (From Section 112.6)
- Multi-Dose Packaging: The CFR states that multi-dose biological products are not required to be packaged one per carton, unless the product requires a carton to convey all of the required information to consumers. It
- Single-Dose Packaging: The CFR states that single-dose biological products are not required to be packaged one per carton.
- Final Containers: Biologics prepared or imported in a carton or other container must not be removed from the container for sale unless each individual product is affixed with the appropriate labeling.
For more in depth information about all of the CFR’s biological packaging requirements, click here.
Tjoapack US provides a variety of biopharma packaging services, including vial and ampule labeling, pharmaceutical kit assembly, pre-filled syringe packaging, and more. Get in touch with us today at (865) 494-6000 or marcelo.cruz@tjoapack.com.
