For those of us that have been around a while and are well versed in the FDA’s expectations on repackaging of solid oral dosage forms into unit dose (UD) packaging, there is really nothing new in the recently published Guidance for Industry – Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products. (see full guidance here). The recommendations have been informally discussed by the FDA in various letters and other documents. However, expectations are different for repackagers, depending on the nature of how the product is packaged and what data is available to support the selected expiration date. The safest bet is no more than a 6-month date with required data and there needs to be at least 25% more of the manufacturer’s-labeled expiration dating period left beyond that. With certain exceptions, and with the documentation of additional data on the protective nature of the proposed unit dose system, it is possible to have a longer expiration date. So, if you are a repackager of solid oral dosage forms into UD packaging from the manufacturer’s original container, you must understand the FDA’s current expectations, so you do not risk an enforcement action.
The FDA states that “[t]he 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.
The guidance goes on to define the requirements of application of the USP standards, the moisture and light-resistant nature of the container (if appropriate), as long as the original container is not opened and all the product in the container is packaged at the same time. The environmental conditions must be consistent with the labeled storage conditions of the original product and if there should not be a caution on the approved package warning against repackaging.
For expiration dating beyond the 6-month period, the FDA expects that appropriate data will be generated to support the proposed longer period, but in no case, can the expiration date exceed the original manufacturer’s expiration date.
As noted above, this guidance formalizes the FDA’s long-standing expectations regarding assignment of expiration-dating period for repackaging unit dose solid oral dosage forms. It is handy to have the expectations in one handy guidance which should eliminate any confusion from industry on this topic.