Repackaging Product into Unit Dose Packaging and Stability Requirements – Final Guidance Issued

Today, the FDA finalized an older draft guidance from August 2017 on repackaging of solid oral dosage form product from original containers into unit dose packaging that provides firms the ability to do so without (in most cases) performing additional stability studies.  The Agency notes that it “received a few comments on the revised draft guidance and has modified this guidance by: (1) describing why liquid dosage forms are excluded; (2) indicating approaches that may be used when conducting stability studies; and (3) making editorial changes to update references and improve clarity.  Liquid dosage forms are substantially more susceptible to degradation than solid dosage forms.  Because of the inherent stability risks, FDA does not intend to exercise enforcement discretion regarding the stability and expiration dating requirements in 21 CFR 211.137 and 211.166 for repackaging liquid dosage forms.” (See FR notice here).

The final guidance is essentially the same as the draft with the exception of those issues noted above with regard to assigned expiration dating allowed without generating additional supporting stability data.  For solid oral dosage forms, the Agency does not generally intend to take enforcement action “if these products are assigned, and labeled with, an expiration date that does not exceed (1) 6 months from the date of repackaging; or (2) 25 percent of the time between the date of repackaging and the expiration date on the container of the original manufacturer’s product, whichever time period is shorter”.  Expiration dates that extend beyond these limits must have sufficient stability data generated using sound scientific principles to support any excursion from the limits provided for in the guidance, but in no case can the expiration date exceed the manufacturer’s original expiration date.

The guidance also outlines the additional criteria that must be met as summarized below:

• The container complies with USP Class A or B standards, as defined in USP <671>.
• If the product is sensitive to light, the unit dose container provides light protection that is as good as or better than the original container closure system.
• The product must come from the original manufacturer’s approved package container and is completely used for unit dose packaging in a single operation.
• The repackaging operation is done under appropriate environmental conditions consistent with the product’s labeling.
• There is no caution in the drug product’s label against repackaging.

Again, it must be reiterated that this guidance applies only to solid oral dosage forms and not liquid dosage forms of any type.  The final guidance can be found here.  If you are or have been repackaging liquid products into unit dose containers, it may be a good time to reevaluate your practices.  In addition, “[P]roducts repackaged by State-licensed pharmacies, Federal facilities, and outsourcing facilities as defined under section 503B of the FD&C Act are also not covered by this guidance”.