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ISSUE PAPER

Beyond-Use Dating of Repackaged Oral Solids

United States Pharmacopoeia Revises Guidelines for Beyond-Use Dating The first supplement to the USP 24 -- NF 19 was recently issued by the United States Pharmacopoeia. There are two significant changes to the USP guidelines for beyond-use dating for dispensers who repackage nonsterile solid and liquid medications in unit-dose and single-unit containers. First, this supplement states that repackaged medications may have a beyonduse date of one year, or the manufacturer's original expiration date, whichever is less, when two conditions are met: · · The dispenser must maintain the facility at a mean kinetic temperature no greater than 25 degrees Celsius; and The dispenser must use packaging material that affords better protection than polyvinyl chloride (PVC).

In addition, the USP monograph which contained the prior beyond-use requirement (six months or 25% of the remaining time provided by the expiration date on the manufacturer's container, whichever is less) has been revised and no longer contains this guideline. This means that USP does not have guidelines for beyond-use dating for medications that are repackaged in PVC materials. The vast majority of pharmacies use PVC packaging materials because alternative materials, such as aclar or PVDC type material, can cost 6 to 10 times as much as PVC. For a discussion of guidelines for repackaging solid oral drug products, including explanations of the various packaging materials used, see <1146> Packaging Practice -- Repackaging a Single Oral Drug Product into a Unit-Dose Container. Pharmacopeial Forum 25(5):8738-8746, Sept-Oct. 1999. So where does this leave pharmacies? How long should the beyond use date be for repackaged oral solid and liquid medications in PVC materials? The USP no longer has guidelines for pharmacies, but some states have incorporated the old USP guidelines into regulations of the state board of pharmacy or other authorities. In those states, the state guidelines are still valid until they are

ASCP Fact Sheet Beyond-Use Dating of Repackaged Oral Solids

changed or withdrawn. ASCP has communicated with the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) about this issue in light of the change in USP policy. JCAHO has indicated that, in the absence of guidance from USP in this area, surveyors are expecting long-term care pharmacies to use an expiration date of no more than one year, or the manufacturer's expiration date, whichever is less, for medications repackaged in PVC materials. The exception is if there is a more restrictive state law or regulation that indicates otherwise. The American Society of Consultant Pharmacists has not issued a position on beyond-use dating of repackaged medications. However, we do intend to keep our members updated on developments as they occur. Check your copy of state board regulations, or contact your state board of pharmacy if you are unsure whether your state has specific guidelines for beyond-use dating on repackaged oral solid or liquid medications in unit-dose or single-unit containers. References 1. Reamer, Jeanne T. and Grady, Lee T., Moisture Permeation of Newer Unit Dose Repackaging Materials, AJHP, Vol. 35, pp. 787-793, July 1978. 2. Reamer, Jeanne T. and Grady, Lee T., Moisture Permeation of Typical Unit Dose Repackaging Materials, AJHP, Vol 34, pp. 35-42, January 1977. 3. Pharmacopeial Forum. Vol. 24, No. 1. Jan-Feb. 1998 4. Medwick, Thomas, Okeke, Claudia and Grady, Lee. A Scientific Basis for Beyond-use Dating. Pharmacopeial Forum. Vol 24, No. 1, pp. 5643-4. JanFeb. 1998. 5. The Consultant Pharmacist, Vol. 4, p. 440, August, 1989. Expiration Date Labeling for Extemporaneous Unit-Dose Packages. 6. The Consultant Pharmacist, Vol. 5, pp. 69-73, February 1990, Forum letters. 7. Dexter, Patricia D, Repackaging Oral Medications for Unit Dose Use, APTJ, March/April 1992, p. 35-38. 8. ASCP Statement on Return and Reuse of Medications in Long-Term Care Facilities 9. Okeke, Claudia, et al., "USP Standards and Activities Affecting Pharmacy Practice" AJHP, 1997; 54:1633-8. 10. Okeke, Claudia, Srinivasan, V. Srini. Expiration and Beyond-use Dates. AJHP, Vol 55, pp. 433-4. March 1, 1998. 11. USP 24 -- NF 19, First Supplement, January 2000, pp. 2587-90. Prepared by: Thomas R. Clark, RPh, MHS, Director of Professional Affairs

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Microsoft Word - ASCP Issue Paper Beyond-Use.doc