Prescription Product Supplier Requirements
PrescriptionProduct SupplierRequirements
Prescription Product Suppliers:Prescription product suppliers are those suppliers that manufacture,package, or distribute a prescription pharmaceutical (drug) or otherproduct that requires a legitimate medical prescription to be dispensed bya licensed healthcare professional.These products are in contrast toover-the-counter products which canbe obtained without a prescription.Such suppliers include, but are notlimited to, direct-ship pharmaceutical ordevice manufacturers, brokers, wholesaledrug or device distributors, pharmaceutical & medical devicemanufacturers, labelers, repackagers, third-party logistic providers (3PL),or any entity arranging for the purchase of prescription pharmaceuticalsor devices by Walmart.Walmart Pharmacy Distribution NetworkPrescription product supplier on-boarding is required for all suppliersproviding prescription pharmaceuticals or devices directly or indirectly toany of Walmart’s Pharmacy Distribution Centers. This includes, but is notlimited to, product that is purchased directly or indirectly from a manufacturer or from a third-party wholesale distributor. All information mustbe provided to Health & Wellness Product Safety for review and approvalprior to placing any purchase orders and shipping product. Failure tocomply with the following requirements may make your company ineligible to supply to Walmart. Please note, these supplier requirements are inaddition to Responsible Sourcing Standards for Suppliers and applyto all current and new suppliers.Wal-Mart Stores, Inc. H&W Product Safety Requirements 2016Page 8
New Supplier ApprovalIn order to ship product into any of Walmart’s Pharmacy Distribution Centers, thesupplier must meet or exceed all applicable Federal, State, and local laws and regulatoryrequirements as well as adhere to any additional requirements stated in the supplieragreement. Additionally, new suppliers must provide requested information to Health& Wellness Product Safety regarding the manufacture and handling of prescriptionpharmaceuticals and devices. You may contact Health & Wellness Product Safety atHWPSAFE@email.wal-mart.com to obtain the appropriate supplier facility/productdisclosure form. Information required shall include, but may not be limited to: Facility Disclosure: Facility disclosure is essential to achieving true supply chaintransparency. Each facility that engages in the manufacture, preparation, propagation,compounding, processing, packaging, labeling, storage, and distribution of the sourcedproduct must be disclosed to Health & Wellness Product Safety. This includes allsubcontracted facilities or any operations or facilities that are not owned by your companywhich provide manufacturing, packaging, labeling, storage, distribution, or logisticalservices. United States Food & Drug Administration (FDA) Drug Establishment Registrationor Medical Device Manufacturing Registration for applicable facilities; Applicable Drug Enforcement Agency (DEA) registration; Facility Ownership/business relationship: Facility ownership/business entityrelationship disclosure is essential for verification of required licenses; State Board of Pharmacy Wholesale Drug Distributor license/registrationinformation for the state in which the applicable facility(s) operate as well as for AR, CA,GA, IN, and MD; Authorized Distributor of Record (ADR) status information if applicable;Wal-Mart Stores, Inc. H&W Product Safety Requirements 2016Page 9
New Supplier Approval Continued: New Drug Application (NDA) or Abbreviated NewDrug Application (ANDA) approval information; National Drug Code (NDC) registration information; 24 month recall history for sourced product; Facility regulatory enforcement/inspection historyinformation; DEA schedule classification applicable to controlledsubstances; VAWD accreditation.Health & Wellness Product Safety will review all supplier/product information and verifyapplicable licenses and registrations directly with the issuing State and/or Federalagencies. Once verified and approved, the supplier is responsible for disclosing new facilityinformation prior to use of the new facility as well as maintaining accurate facility andregistration information with Health & Wellness Product Safety. As always, it is the supplier’sresponsibility to renew and maintain all required licenses and registrations with the issuingagencies and provide renewal information to Health & Wellness Product Safety immediatelyupon renewal. Failure to maintain a required license or registration may make your companyineligible to supply to Walmart.Suppliers must also confidentially provide electronic transaction information, transactionhistory and transaction statements (Transactional Data) to Walmart’s RXDSCSA Repositoryas such Transactional Data is required to be maintained by Walmart for Drug Supply ChainSecurity Act eligible product as a “dispenser” pursuant to 21 U.S.C. § 360eee-1(d).Transactional data shall be electronically shared immediately upon shipping of product.Wal-Mart Stores, Inc. H&W Product Safety Requirements 2016Page 10
New Product ApprovalBefore a current supplier can ship a newly sourcedproduct into any of Walmart’s Pharmacy DistributionCenters, the supplier must provide the followinginformation to Health & Wellness Product Safety forreview and approval. You may contact Health & WellnessProduct Safety at HWPSAFE@email.wal-mart.com toobtain the appropriate supplier facility/product disclosureform. Information required shall include, but may not belimited to: Facility Disclosure: Each facility that engages in the manufacture, preparation,propagation, compounding, processing, packaging, labeling, storage, and distribution of thesourced product must be disclosed to Health & Wellness Product Safety. This includes allsubcontracted facilities or any operations or facilities that are not owned by your companywhich provide manufacturing, packaging, labeling, storage, distribution, or logisticalservices. United States Food & Drug Administration (FDA) Drug Establishment Registration orMedical Device Manufacturing Registration for applicable facilities; Applicable Drug Enforcement Agency (DEA) registration; Facility Ownership/business relationship: Facility ownership/business entityrelationship disclosure is essential for verification of required licenses; State Board of Pharmacy Wholesale Drug Distributor license information for theState in which the applicable facility(s) operate as well as for AR, CA, GA, IN, and MD; Authorized Distributor of Record (ADR) status information if applicable;Wal-Mart Stores, Inc. H&W Product Safety Requirements 2016Page 11
New Product Approval Continued: New Drug Application (NDA) or Abbreviated New DrugApplication (ANDA) approval information; National Drug Code (NDC) registration information; 24 month recall history for sourced product; Facility regulatory enforcement/inspection history information; DEA schedule classification applicable to controlled substances; VAWD accreditation.Health & Wellness Product Safety will review all supplier/productinformation and verify applicable licenses and registrations directlywith the issuing State and/or Federal agencies. Once verified andapproved, the supplier is responsible for disclosing new facilityinformation prior to use of the new facility as well as maintainingaccurate facility and registration information with Health & WellnessProduct Safety. As always, it is the supplier’s responsibility to renewand maintain all required licenses and registrations with the issuingagencies and provide renewal information to Health & WellnessProduct Safety immediately upon renewal. Failure to maintain arequired license or registration may make your company ineligible tosupply to Walmart.Suppliers must also confidentially provide electronic transactioninformation, transaction history and transaction statements(Transactional Data) to Walmart’s RXDSCSA Repository as suchTransactional Data is required to be maintained by Walmart for DrugSupply Chain Security Act eligible product as a “dispenser” pursuantto 21 U.S.C. § 360eee-1(d). Transactional data shall be electronicallyshared immediately upon shipping of product.Wal-Mart Stores, Inc. H&W Product Safety Requirements 2016Page 12
Direct-to-Store Wholesale Drug DistributorsDirect-to-Store Wholesale Distributors are full-line wholesalers who purchase, inventory,sell and deliver prescription products to the pharmacy retail level.In order for such wholesale drug distributors to supply prescription products to WalmartPharmacies or Sam’s Club Pharmacies; the distributor must meet or exceed all applicableFederal, State, and local laws and regulatory requirements as well as adhere to anyadditional requirements stated in an approved supplier agreement.Additionally, such distributors are responsible for establishing, maintaining, and enforcingpolicies and procedures that: Ensure the integrity, legitimacy, and authenticity of prescription drug and devicepurchase orders and deliveries; Ensure their suppliers are engaged in the lawful distribution of prescription drugsand devices obtained from legitimate sources; Ensure verification of vendor and customer licenses using data from appropriatestate and federal agencies, at least annually; Ensure all facilities engaged in interstate distribution of prescription products arelicensed by the applicable state licensing board as well as hold appropriate DEAregistrations; and Meet FDA annual prescription drug wholesale distributor reporting requirements.Finally, such suppliers must also confidentially provide electronic transaction information,transaction history and transaction statements (Transactional Data) to Walmart’sRXDSCSA Repository as such Transactional Data is required to be maintained byWalmart for Drug Supply Chain Security Act eligible product as a “dispenser” pursuant to21 U.S.C. § 360eee-1(d). Transactional data shall be electronically shared immediatelyupon shipping of product.Wal-Mart Stores, Inc. H&W Product Safety Requirements 2016Page 13
Product Removal Requirements forPrescription ProductsAt Walmart, we adhere to strict quality assurance controls and work with our supplierpartners to ensure that we provide safe, quality products. However, sometimes productremovals may be necessary in the event of a withdrawal or recall.Product removals are initiated by a supplier or regulatory agency and at their request areexecuted by the Walmart Food Safety & Health Recall team. In some cases however, arecall or withdrawal may be initiated by Walmart due to internal information (complaints,test results, etc.). If you become aware of a safety or quality issue with any product oringredients used in any product sold at Walmart or Sam’s Club, immediately contact theFood Safety & Health Recall Team at 479-644-9606 or FOODRECA7@wal-mart.com.Product removals are classified under two categories: Recall - safety-related product removals: Examples of reasons to recall product includebut are not limited to product that does not meet product specification, fails to haverequired warning, or packaging does not meet child safety requirements. Theseproducts may pose a potential safety risk if consumed or used. Withdrawal - non-safety-related product removals: Reasons to withdraw productsinclude but are not limited to product or package appearance. These products areperfectly safe to consume or use, but do not meet a non-safety related regulation orthe supplier’s desired quality.Wal-Mart Stores, Inc. H&W Product Safety Requirements 2016Page 14
Product Removals Continued:If a product removal is necessary for one of your products or ifyou have any concerns with the safety of your product, you mustimmediately contact the Walmart Food Safety & Health Recallteam at 479-644-9606 or FOODRECA7@wal-mart.com.You will be directed to either complete a product removal form viayour supplier access to Retail Link, or if you do not have access toRetail Link, contact the Food Safety & Health Recall team.Please have the following information ready to provide to theRecall team: Reason for the removal; Item number/UPC number or NDC number (whenapplicable); Lot code/expiration dates; Store/Club distribution list that received the implicatedproduct; DC facility list that received the implicated product; Disposition and handling instructions of the product; Press Release: Will there be a press release regarding therecall?The Food Safety & Health Recall team will promptly notify all impacted facilities using the information that you have provided. Do notdirectly notify any Walmart Pharmacy or Sam’s Club Pharmacy.All product removal notifications are handled centrally by Walmart’sHome Office Food Safety & Health Recall team.Wal-Mart Stores, Inc. H&W Product Safety Requirements 2016Page 15
Wal-Mart Stores, Inc. H&W Product Safety Requirements 2016 Prescription Product Suppliers: Prescription product suppliers are those suppliers that manufacture, package, or distribute a prescription pharmaceutical (drug) or other product that requires a legitimate medical prescripti
Single Supplier Scorecard (SSS) What is Single Supplier Scorecard (SSS) Single Supplier Scorecard reports the performance of the supplier. Internal user can select one of the Supplier Name for Single Supplier Scorecard. External user, the Supplier is pre-assigned to the dedicated Supplier. Supplier
2 Supplier Directory Services 3 Supplier User Management 4 Assessments 5 Managing Supplier Registration and Qualification 6 Managing Supplier Profiles 7 Managing Supplier Performance 8 Notifications 9 Managing Supplier Classifications 10 Managing Supplier Hierarchy. x
Expectations for supplier performance Action plans for supplier development These plans are also used by Supplier Quality Engineers as: A baseline to measure supplier growth The basis for Supplier Quality Engineer and Audit Group scheduling for supplier visits A platform for supplier assessments
S12832 AKH, INC. Supplier S95447 Akron Rubber Development Laboratory, INC. Supplier DC1150 Akron Tractor & Equip Inc DCC S36445 Alaska Marine Lines Supplier S19168 ALB KLEIN TECHNOLOGY GROUP INC Supplier S21261 Albar Industries M P A B Supplier S11106 ALBERICI CONSTRUCTORS INC HEADQUARTERS Supplier S55017 Albert Kahn Associates Inc Supplier
SUPPLIER PORTAL REFERENCE GUIDE 1.0. Overview About this Guide This guide is intended for use by those with B2P access to use the Supplier Portal including supplier searches, supplier invitations, supplier requests, and supplier maintenance requests. About Our Learning Objectives
Form 3-14-25-001 Rev 3 SUPPLIER QUALIFICATION AND APPROVAL FORM. SUPPLIER QUESTIONAIRE . Supplier Information . Supplier Name . Address . Website . State : Zip Phone . Fax : Contacts . President/Owner . . Is there an internal audit system in place for assessing effectiveness of the quality system and to assess compliance with documented
412014 and SMP Supplier Evaluation Form. Supplier Profile is a supplier evaluation and supplier requested to complete and return for one of the following reasons: (1) Preliminary Evaluation of a Potential Supplier. (2) Re-evaluation of an existing supplier. (3) Pre-Survey leading to an On-Site survey. Supplier Quality System development is .
sooner than China is ready to offer one; alternatively, China has been frustrated not to receive timely responses to its requests. 8 Center for American Progress U.S.-China Relations Finally, the expert group addressed the imbalance in the Asia-Pacific regional dynamic that has become a major concern in both Washington and Beijing: the notion that the United States is the center of the .
