Prescription Product Supplier Requirements

Health and Wellness Supply Chain/DSCSA Compliance

Scope

The requirements described in this document apply to any supplier that distributes prescription products to a Walmart Inc. facility, including Walmart subsidiaries, located in the United States or Puerto Rico (collectively “Walmart”). This document describes the expectations, onboarding, and requirements for the supplier entity and their prescription products.

Detailed Requirements

All Prescription Products dispensed by Walmart and Sam’s Club pharmacies must comply with all applicable laws and regulations, including laws and regulations specific to the U.S. Food and Drug Administration (“FDA”) and other regulatory agencies that apply to Health & Wellness Products. Walmart and Sam’s Club do not provide legal advice to Suppliers. Suppliers are responsible for compliance with this document and all federal, state, and local regulatory requirements throughout their operations and throughout the entire product supply chain. Suppliers must seek their own legal counsel to ensure compliance with all legal requirements applicable to their Prescription Product.

A signed supplier agreement, acceptance of a purchase order, and/or provision of merchandise to Walmart or Sam’s Club constitutes acceptance and acknowledgement of these supplier requirements and serves as the Supplier’s continuing affirmation of compliance. Walmart reserves the right to audit or inspect Suppliers’ books and records, and any facilities they use, at any time. This document is incorporated by reference into the Walmart Supplier Agreement Standard Terms and Conditions (“Supplier Agreement”) and is in addition to the Walmart’s Standards for Suppliers.

Failure to comply with all federal, state, and local regulatory requirements as described in this document and otherwise applicable to a Prescription Product supplied to Walmart or Sam’s Club violates the terms of the Supplier Agreement. This could result in removal from Walmart or Sam’s Club stores or omnichannel sales.

If a supplier is unsure if the Prescription Products supplied to Walmart or Sam’s Club are subject to these requirements, please contact Health & Wellness Supply Chain/DSCSA Compliance at HWRXSCC@smiedemann.shop.

Definitions

Prescription Products – are prescription pharmaceuticals, dietary supplements, medical devices, or other products to be dispensed or administered by a licensed healthcare professional as a prescription.

Prescription Product Suppliers - include, but are not limited to, manufacturers of Prescription Products, bulk pharmaceutical manufacturers, brokers, wholesale distributors, labelers, repackagers, third-party logistic providers (3PL), or any entity selling or shipping Prescription Products to Walmart.

Walmart Pharmacy Distribution Network - The Walmart Pharmacy Distribution Network includes a network of Walmart-owned pharmacy distribution centers located across the United States. The distribution centers hold Drug Distributor Accreditation (DDA) and are licensed by applicable State Boards of Pharmacy for intra-company distribution of prescription products. It also includes Walmart’s bulk repackager, Walmart Pharmacies, Central Fill, Specialty, and Mail Order Pharmacies and Sam’s Club Pharmacies.

Direct-to-Store Pharmaceutical Distributors - Sometimes Walmart and Sam’s Club pharmacies are serviced by accredited and licensed suppliers such as manufacturers via direct or drop-ship deliveries, and wholesale distributors that meet both State Board of Pharmacy and FDA wholesale distributor requirements. These suppliers are called Direct-to-Store Distributors (DSD).

Drug Supply Chain Security Act - U.S. federal law enacted in 2013 as Title II of the Drug Quality and Security Act (DQSA) that establishes a national system for tracing prescription drugs as they move through the United States supply chain.

Prescription Product Supplier Onboarding

Onboarding is required for all Prescription Product Suppliers distributing Prescription Products to the Walmart Pharmacy Distribution Network. All products must be reviewed and approved by Health & Wellness Supply Chain/DSCSA Compliance prior to purchase orders or shipments. Failure to meet the requirements may result in ineligibility to supply to Walmart. These requirements are in addition to those listed at corporate.smiedemann.shop/suppliers/requirements and apply to all current and new suppliers.

Key Requirements:

New suppliers must provide details regarding the manufacture and handling of prescription products. Suppliers may obtain a Prescription Product Information Sheet from Retail Link following this path: Retail Link > Docs > Supplier Replenishment Information > Standard Templates > Prescription Product Information Sheet.
Prescription Product Information Sheets must be accurate and complete. Incomplete or inaccurate information will delay or deny approval and purchase orders.
Required information includes:
- Facility Disclosure. Facility disclosure is essential to achieving true supply chain transparency. Each facility that engages in the manufacture, preparation, propagation, compounding, processing, packaging, labeling, storage, and distribution of the sourced product must comply with applicable FDA Current Good Manufacturing Practices (cGMPs) and must be disclosed to Health & Wellness Supply Chain/DSCSA Compliance. This includes all subcontracted facilities or any operations or facilities that are not owned by the supplier which provide manufacturing, packaging, labeling, storage, distribution, or logistical services.
- FDA Registration and Listing for applicable facilities.
- Facility Ownership/Business Relationship. Facility ownership/business entity relationship for verification of required licenses/registrations.
- Facility regulatory enforcement/inspection history information for all applicable facilities.
- Third-party U.S. FDA cGMP facility audit/certifications.
- Drug Enforcement Agency (DEA) registration (if applicable).
- State Board/Agency Manufacturer/Wholesale Drug Distributor /Third-Party Logistics Manager license/registration information for the state in which the applicable facility(s) operates as well as for AR, CA, GA, IN, and MD. Additional licenses are required for DSD suppliers.
- Authorized Distributor of Record (ADR) or supplier information.
- New Drug Application (NDA), Abbreviated New Drug application (ANDA), Biologics License Application (BLA), or Abbreviated Biologics License Application (aBLA) number or FDA approval letter.
- National Drug Code (NDC) information. NDC shall be disclosed in the same format that would be transmitted in the Advanced Shipping Notice (ASN).
- 24-month recall history for sourced product.
- Link to products on the DailyMed website.
- Drug Distributor Accreditation (DDA) if applicable.
- Additional information may be requested as needed to facilitate review.
Suppliers must not appear on the Office of Inspector General (OIG) Federal Exclusion List

Ongoing Responsibilities:

Health & Wellness Supply Chain/DSCSA Compliance will review all Prescription Product Supplier information and verify applicable licenses and registrations directly with the issuing state and/or federal agencies.
Suppliers must disclose new facility information prior to supplying Prescription Products produced in that facility.
Suppliers must maintain accurate facility information and registration with Health & Wellness Supply Chain/DSCSA Compliance.
Suppliers are responsible for maintaining and renewing all required licenses and registrations, and providing renewal information as required.
Failure to maintain required licenses or registrations may result in ineligibility to supply to Walmart or Sam’s Club.

Drug Supply Chain Security Act (DSCSA) Data Exchange

Prescription Product Suppliers must electronically provide transaction information and statements for all prescription product transactions, as required by DSCSA.

Walmart uses the Electronic Product Code Information Services (EPCIS) standard to capture and exchange information. Prescription Product Suppliers must be able to use EPCIS messaging to transmit transaction data.

Transaction data must be transmitted electronically prior to shipping product into the Walmart Pharmacy Distribution Network. The timing and accuracy of data submission is critical to the success of pharmacy product flow.

Prescription products received without complete and accurate transaction data cannot be received and will be placed into Quarantine until the data is received, or Walmart determines that they must be returned to the supplier at the supplier’s cost.

To avoid disruption of pharmaceutical product distribution, Prescription Product Suppliers must:

Transmit transaction data electronically in advance of shipping freight to allow sufficient time to detect and resolve potential message failures before the pharmaceutical products enter the Walmart Pharmacy Distribution Network.
Timely address message failures and resubmit transaction data within 48-hours of learning of a failure. Resubmitting transaction data more than 48 hours after an EPCIS failure may result in pharmaceutical products being returned at the supplier’s expense.
Ensure that physical products shipped match the electronic transaction data. Overages will cause freight to be quarantined. Overage product will be sent back at the supplier’s expense. The supplier will provide a call tag within 24 hours. If a call tag is not provided within 24 hours, Walmart shall be entitled to ship back the entire order at the supplier’s expense.

For technical support, contact Walmart EDI Support Help-desk at 479-273-8888 or via email at edi@smiedemann.shop. Additional resources can be found in the DSCSA ASN Guide published on Retail Link: Retail Link > Apps > EDI-B2B > Guides > RX DSCSA ASN.

For EPCIS messaging and serialization onboarding questions, email serialization_onboar@wal-mart.com.

Pharmaceutical Packaging and Labeling

Walmart follows a standardized approach to packaging and labeling to ensure that all inbound loads entering the Walmart Pharmacy Distribution Network comply with DSCSA requirements. The complete DSCSA Labeling Standards can be found on Retail Link under: Retail Link > Academy > Help Docs > Secondary Packaging Standards.

Below is a summary of packaging requirements; however, suppliers must review and comply with the full DSCSA Labeling Standards.

Each homogeneous case and smallest salable unit is labeled according to the Healthcare Distribution Alliance (HDA) "Guidelines for Barcoding in the Pharmaceutical Supply Chain”. Both GS1-128 and GS1 Data Matrix should be used at the homogeneous shipping case level.
Product identification labels are required on at least two adjacent sides of each case; wrap labels are acceptable.
A Serialized Shipping Container Code (SSCC) label must be affixed to each individual shipped case, mixed case, or pallet.
All prescription products must meet DSCSA product identifier and serialization requirements, unless the product is otherwise exempt or grandfathered.
Prescription Products received with missing product identifiers in both human and machine-readable form are subject to quarantine and return at the Prescription Product Supplier’s expense.
Product identifiers must be legible and scannable for the entirety of the product’s shelf life.

For questions regarding prescription product labeling requirements, email: serialization_onboar@wal-mart.com.

Supplier Resources:

Product Recalls: RXRECALLS@wal-mart.com

Suspect and Illegitimate Product Investigations: pom0819@smiedemann.shop

Health & Wellness Supply Chain/DSCSA Compliance: HWRXSCC@smiedemann.shop

DSCSA Onboarding and EPCIS Specifications: serialization_onboar@wal-mart.com

OTC drug, OTC homeopathic drug, dietary supplement, and OTC medical device Supplier Requirements

Product Recalls and Removals

Walmart and Sam’s Club maintain strict quality standards and collaborate closely with suppliers to ensure the safety and quality of all products. Despite these efforts, product removals may be necessary in the event of a withdrawal or recall. Such removals can be initiated by a supplier, regulatory agency, or, in some cases, by Walmart or Sam’s Club based on internal findings (such as customer complaints or test results). Health & Wellness Supply Chain/DSCSA and Food Safety Compliance oversee the execution of these removals.

If a safety, regulatory, or quality issue is identified with any product or ingredient sold at Walmart or Sam’s Club, immediately contact the Health & Wellness Recall Team at RXRECALLS@wal-mart.com.

Recalls

A recall occurs when a supplier removes or corrects a marketed product that violates laws or regulations and could be subject to regulatory action (such as seizure).

FDA-related recalls are classified into three categories (I, II, or III) to indicate the relative degree of health hazard presented by the product being recalled.

Class I - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class II - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

If a recall has been classified by FDA, the supplier must share the classification with Walmart and/or Sam’s Club immediately and Walmart and/or Sam’s Club will cooperate with the Supplier in carrying out the recall.

Withdrawals

A withdrawal occurs when a supplier removes or corrects a distributed product due to a minor violation not subject to a regulatory action, or for reasons unrelated to regulatory violations (such as business reasons, routine stock rotation, or routine equipment maintenance, etc.).

If a product removal is necessary or if there are any concerns about product safety, suppliers should immediately contact the Health & Wellness Compliance Recall Team at RXRECALLS@wal-mart.com and complete a Product Removal Form in AegisOne Product Removals.

Process

If a withdrawal or recall notification needs to be submitted to any Walmart Pharmacy Distribution Center, Walmart Pharmacy, Sam’s Club Pharmacy, Vision or Optical Center, or Hearing Center, suppliers will be instructed to complete a Product Removal Form in Retail Link. To access the form, suppliers should use their supplier Retail Link credentials and follow this path: Retail Link > Apps > AegisOne Product Removal > Initiate.

The following information will be required when completing the Product Removal Form in Retail Link:

Reason for the removal
Item number/NDC number or UPC number when applicable
Lot codes and expiration dates
Distribution date for the implicated product
Walmart Pharmacy, Sam’s Club Pharmacy, Vision Center or Optical Center, or Hearing Center facility list for product shipped directly to locations by DSD distributors
Walmart Pharmacy Distribution Center list that received the impacted product if shipped to the Walmart Pharmacy Distribution Center(s)
Disposition and handling instructions for the product
Press Release: Will there be a press release regarding the recall?

The Walmart Health & Wellness Recall Team will promptly notify all impacted facilities using the information provided by the supplier. Suppliers should not contact any Walmart Pharmacy, Sam’s Club Pharmacy, Vision or Optical Center, or Hearing Center locations directly. All product removal notifications are managed centrally by Walmart’s Corporate Office.

Contact RXRECALLS@wal-mart.com for effectiveness check inquiries.