Module 6: Product Returns
Inventory and Disposal Management for Transition to Traditional Commercial Distribution
Lagevrio
- USG-distributed supply should be dispensed to patients until depletion or expiration, whichever comes first
- USG-distributed supply cannot be returned/disposed of unless expired (first expiry February 2024,
ASPR searchable expiry database)
- Once expired, should be disposed of through manufacturer's return process or on site in accordance with all federal, state, and local regulations
Paxlovid
- Any expired product should be disposed of through manufacturer's return process or on site in accordance with all federal, state, and local regulations
- As of March 9, 2024, EUA-labeled Paxlovid (nirmatrelvir co-packaged with ritonavir) no longer authorized for use, regardless of expiry data
Data Reporting Requirements
In accordance with the COVID-19 Therapeutics Provider Agreement, providers are responsible for adhering to all requirements outlined in the agreement while dispensing USG-distributed product.
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Providers are expected to provide reporting of all USG-distributed courses that they received and should report inventory, administration/dispensing, and disposal data until the provider's USG product inventory is fully reconciled.
- USG supply used to support the Paxlovid USG PAP program is
not subject to provider agreement reporting requirements.
Guidelines for Product Return/Disposal
- All USG distributed COVID19 Therapeutics are property of USG and must be used in accordance with the EUA.
- Sites of care cannot donate products to entities outside the U.S. or for use outside the U.S.
- After checking for true expiration date online, dispose of any expired product.
- Non-expired product
not currently authorized for use is eligible for disposal or returns to the manufacturer if no longer able to be stored.
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No returns or disposal of non-expired product currently in distribution by the USG.
- Jurisdictions can transfer product to other jurisdictions/states/territories
- Doses of USG-product discarded on site and doses returned
need to be recorded in HPOP
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If undamaged product needs to be disposed of, destroy it on-site in accordance with the HPOP attestation, or follow the returns instructions below:
On Site Destruction of Expired or Unauthorized Product
- For licensed provider locations with destruction procedures in place that follow all federal, state, and local regulations, therapeutics can be destroyed on site only if:
- Guidelines are followed on what product can be destroyed
- Only expired product or unauthorized product that can no longer be stored
- No unexpired product that is currently authorized for use can be destroyed
- Sites are to follow established protocols for destruction and attest in HPOP to following all regulations
- Quantities of any product destroyed is recorded in HPOP
- The established returns process for each product is still an option for sites who do not have an established method for proper destruction or otherwise prefer to go through the returns process
- Returned product must also be recorded in HPOP
- This process has been enabled in HPOP
Learn more in the
COVID-19 Therapeutics Transition Guide
