The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This guidance describes the conditions under which FDA does not intend to take action regarding required stability studies for these repackaged products and the expiration date to
assign under those conditions.
This guidance addresses repackaging of prescription and over-the-counter solid oral dosage form drugs into unit-dose containers by commercial pharmaceutical repackaging firms that are required to register with FDA under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to comply with current good manufacturing practice (CGMP) regulations in 21CFR parts 210 and 211.
The guidance does not address repackaging involving the following:
- Other dosage forms (e.g., sterile, liquid, topical)
- Products repackaged by State-licensed pharmacies, Federal facilities, and outsourcing facilities as defined under section 503B of the FD&C Act.