Certain products fulfilled through an FDA-registered 503B outsourcing facility may be subject to additional purchaser eligibility, licensing, verification, documentation, shipping, or other regulatory requirements imposed by the outsourcing facility or applicable federal or state law.
The purchaser is responsible for providing complete, accurate, current, and legally sufficient documentation requested in connection with the order. Depending on the transaction, this may include facility information, professional or facility licenses, prescriber or practitioner information, NPI information, shipping information, attestations, or other documentation required by the applicable 503B outsourcing facility or governing law.
An order involving a 503B outsourcing facility may be placed on hold and will not be released for fulfillment until all required documentation has been submitted, reviewed, and accepted by the appropriate party.
Submission of payment does not guarantee that an order can be fulfilled. RevHealth and/or the applicable outsourcing facility may reject, suspend, or cancel an order if required documentation is incomplete, inaccurate, expired, unverifiable, inconsistent with the purchaser's eligibility, or otherwise insufficient to satisfy applicable requirements.
Customers must not submit another person's or entity's credentials without authorization or provide false, altered, misleading, or fraudulent documentation.
If an order cannot legally or operationally be fulfilled because the purchaser fails to provide required documentation, RevHealth may cancel the order and issue any refund or credit that is appropriate under this Policy and applicable law. Any non-refundable costs already incurred in connection with processing, payment, shipping, special handling, or fulfillment may be deducted where permitted by law.
Nothing in this section represents that a particular purchaser, facility, practitioner, product, or transaction is legally eligible for 503B fulfillment. Eligibility and fulfillment remain subject to the requirements applicable to the specific transaction and the policies and approval of the applicable outsourcing facility.