From: H. D. Smith, LLC and its affiliates and subsidiaries, specifically including Smith Medical Partners, LLC and Valley Wholesale Drug Co., LLC (collectively “H. D. Smith”)
RE: Notice of traceability provision and request for acknowledgement by retail and institutional pharmacies
Dear H. D. Smith Customer:
H. D. Smith is a wholesale distributor subject to the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 USC § 360eee-1, et seq. Pursuant to the Act, dispensers must capture and provide certain product tracing information as of July 1, 2015. Accordingly, H. D. Smith is incorporating the following terms and conditions into every customer relationship and agreement:
Transaction Documentation. Beginning July 1, 2015, as permitted by 21 USC § 360eee-1(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the "Act"), H. D. Smith agrees to confidentially maintain transaction information, transaction history and transaction statements (collectively, the "Transaction Documentation") on behalf of Purchaser according to the product tracing requirements for a dispenser under 21 USC § 360eee-1(d)(1)(A)(i) of the Act. H. D. Smith reserves the right to charge a fee for its maintenance of Purchaser Transaction Documentation. H. D. Smith shall maintain the Transaction Documentation until the termination of its relationship and/or agreement with the customer or for a period of six (6) years following the applicable transfer of ownership of product by H. D. Smith to the customer, whichever is sooner. Upon termination, the applicable Transaction Documentation may be transferred to the customer upon written request in a manner determined in the sole discretion of H. D. Smith. Transaction Documentation will be available online via a web portal that the customer may securely access to obtain data for a specific transaction.
The parties understand and agree that H. D. Smith shall have no responsibility to maintain or provide Transaction Documentation in relation to subsequent transfers of ownership of the products by the customer and that the customer shall remain responsible for responding to all requests for information or Transaction Documentation by state or federal officials. The customer must maintain a copy of this notice and understands and agrees that the customer remains ultimately responsible for its obligations as a dispenser under the Act.
Terms used in this notice without definition shall have the respective meanings assigned to such terms under the Act.
H. D. Smith and the customer acknowledge and agree that these terms add to and constitute a part of their relationship and/or agreement.Except as expressly modified in this notice, all other terms and conditions of the relationship and/or agreement remain in full force and effect.
H. D. Smith © 2015