The FDA requested a correction to the package size for four teriparatide injection products. The change involves updating the strength from 600 mcg/2.4 mL to 560 mcg/2.24 mL in the prescribing information and on package labels to accurately reflect the amount of drug delivered to patients. This update has several implications and challenges.

First, a change to the National Drug Code (NDC) was not required by the FDA, and second, no recall is required due to the package size change. This means that pharmacies and wholesalers may simultaneously have packages with the same NDC but two different quantities. This change will also pose several data challenges. Compendia publish information based on NDCs, but only a single total package size can be applied to each NDC. Consequently, both packaging types may exist, but only one will match the compendia details.  The NDCs affected by this change are as follows:

Previously, dispensing a full package required a quantity input of 2.4 mL. The compendia plan to implement the package size change to 2.24mL by April 1, 2025. After this date, it is crucial to check the drug file data in your pharmacy practice management system or prescription adjudication system to determine when the total package quantity changes from 2.4 mL to 2.24 mL. When the package size changes in the pharmacy system, the quantity adjudicated on teriparatide claims will need to change as well. For pharmacies, it will also be critical to check the package size of the product you have in your inventory.

When purchasing and dispensing teriparatide, pharmacies should take some key actions now and continuing for the next few months:

1. Review Prescription Refills: Consider how you will update the dispense quantity on prescription refills (create a new Rx or only a quantity change), and verify the refills are tracked correctly.
2. Document the physical package size dispensed: Focus on who is documenting and how to ensure accuracy and completeness of your records. Determine whether documentation should be made in your pharmacy system and/or on hard copy prescriptions, and know how to retrieve that information if needed in the future.
3. Establish policies and procedures: Review teriparatide claims closely to ensure data is exchanged as expected with the claims processor. Refer to documentation from claims processors to ensure you are in sync with their guidance.
4. Validate payment: Check the claim response and reconciliation to ensure proper payment. If payment seems too high or too low, reach out to the claims processor to be sure everything is in sync between your system and the claims processors’ system.
5. Monitor perpetual inventory: Plan to adjust on-hand quantities and ordering points after your pharmacy practice management system has been updated with the latest package size.

What other actions will you take to account for the package size change to existing NDCs?