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GIAPREZA WASTAGE PRODUCT REPLACEMENT PROGRAM TERMS AND CONDITIONS
La Jolla Pharmaceutical Company (La Jolla) will replace eligible vials of GIAPREZA free of charge in the event that GIAPREZA vials are spoiled, or are otherwise unable to be administered.
Eligibility
This program applies to GIAPREZA vials purchased from an authorized distributor of GIAPREZA (full list of authorized distributors available at https://www.giapreza.com/).
Each replacement requires completion of the GIAPREZA (angiotensin II) Wastage Product Replacement Program Form. In order to receive GIAPREZA replacement vials, the hospital must certify that the GIAPREZA vials to be replaced:
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Were purchased to be used in accordance with the GIAPREZA FDA prescribing information;
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Spoiled, or were unable to be administered due to one of the following Wastage Events:
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GIAPREZA was mishandled, dropped or broken;
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GIAPREZA was inappropriately stored or frozen;
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GIAPREZA was diluted but not administered due to unforeseen patient condition; or
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A dosage preparation error occurred;
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Were not administered (including bolus) and are not intended to be administered to another patient; and
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Were not billed to the patient or a payor.
To submit a claim seeking GIAPREZA replacement vials, an authorized representative of the hospital must submit the GIAPREZA (angiotensin II) Wastage Product Replacement Program Form within 30 days from the date on which the GIAPREZA Wastage Event occurred.
Limitations and Conditions
GIAPREZA replacement vials will only be shipped to facilities that provide a copy of their state license. Hospitals may not receive more than 15 GIAPREZA replacement vials during any 12-month period.
Issuance of Replacement Vials
Upon receipt of a completed GIAPREZA (angiotensin II) Wastage Product Replacement Program Form and verification of eligibility for the GIAPREZA (angiotensin II) Wastage Product Replacement Program, the hospital will receive a confirmation email with a link to a GIAPREZA (angiotensin II) Certificate of Destruction Form. Following the destruction of GIAPREZA vials and submission of the GIAPREZA (angiotensin II) Certificate of Destruction Form, La Jolla shall issue a replacement vial of GIAPREZA to the hospital bearing the same NDC code as the originally purchased vial of GIAPREZA. The GIAPREZA replacement vials shall be shipped to the hospital by La Jolla’s third-party logistics provider at no cost to the hospital.
Term
The GIAPREZA (angiotensin II) Wastage Program is currently in effect and shall extend to December 31, 2023. La Jolla may extend, shorten, discontinue or otherwise modify the GIAPREZA (angiotensin II) Wastage Product Replacement Program at any time, for any reason or no reason, in its sole discretion.
Adverse Reactions
You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact:
La Jolla Pharmaceutical Company
U.S. Food and Drug Administration
Compliance with Law
The hospital shall comply with all applicable federal, state and local laws and regulations governing its activities related to the GIAPREZA (angiotensin II) Wastage Product Replacement Program, including without limitation: (i) HIPAA, and state and local privacy and data protection laws; (ii) the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), and analogous state laws; (iii) the Food Drug & Cosmetic Act and regulations promulgated thereunder; and (iv) all Federal healthcare program reporting obligations, including without limitation, the Medicare requirements prohibiting billing for no cost items (42 U.S.C. 1395y(a)(2)). The hospital shall not provide Protected Health Information (PHI), as that term is defined under HIPAA, or information that is considered patient-identifiable under any applicable state laws, to La Jolla.
Questions
For questions about the GIAPREZA Wastage Product Replacement Program, please email fieldops@ljpc.com.