Supplier Requirements for Over-the-Counter Drugs, Dietary

Supplier Requirements for

Over-the-Counter Drugs,

Dietary Supplements, &

Medical Devices

Health & Wellness Product Safety

Purpose

The requirements described in this document apply to anyone that supplies product, as well as

any agents they use (collectively, “Suppliers”), to be sold in Walmart stores and on

Walmart.com by Walmart, Inc. (“Walmart”) and in Sam’s Clubs and on Samsclub.com by Sam’s

West, Inc. (“Sam’s Club”). This document sets out the expectations and requirements for

suppliers of Over-the-Counter (“OTC”) drugs, OTC homeopathic products, dietary supplements,

and consumer medical devices (“Health and Wellness Products”). These products may be sold

as National Brands, Private Brands, or via Direct Ship Vendors, as later defined. All products sold

by Walmart and Sam’s Club must comply with all applicable laws and regulations, but this policy

describes laws and regulations specific to the U.S. Food and Drug Administration (“FDA”) and

other regulatory agencies that apply to Health and 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 Health and Wellness 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 and Sam’s Club reserve 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 Responsible Sourcing Standards for

Suppliers.

Failure to comply with all federal, state, and local regulatory requirements as described in this

document and otherwise applicable to a Health and Wellness 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 you are unsure if the Health & Wellness Products supplied to Walmart or Sam’s Club are

subject to these requirements, please contact Health & Wellness Product Safety at

HWSCSAFETY@ wal-mart.com

Health and Wellness Product Supplier Types

Private Brand Suppliers:

Private Brand suppliers are those suppliers that manufacture, package, distribute, or direct ship

a Walmart or Sam’s Club product that is labeled under one of Walmart or Sam’s Club’s private

brands, as follows:

• Items with a brand name or logo that is owned by Walmart or Sam’s Club,

such as Equate or Member’s Mark.

• Items with a brand name or logo that are exclusively licensed to Walmart or

Sam’s Club, such as Spring Valley. In other words, these products are not

offered at any other retailer in the U.S. or Puerto Rico.

• Unbranded items labeled as “Distributed by” or “Marketed by” Walmart or

Sam’s Club.

Direct Import (“DI”) Suppliers:

Direct Import suppliers supply products under their own branding while Walmart or Sam’s Club

serves as the importer of record. These products are subject to the Walmart Supplier

Agreement. These products may be exclusive to Walmart or Sam’s Club or may be offered at

other retailers in the U.S. or Puerto Rico.

National Brand Suppliers:

National brand suppliers resell their products at Walmart or Sam’s Club under their own

branding. These products are subject to the Walmart Supplier Agreement. These products may

be exclusive to Walmart or Sam’s Club or may be offered at other retailers in the U.S. or Puerto

Rico.

Direct Ship Vendor (“DSV”) Suppliers:

DSV suppliers sell their products on Walmart.com and/or Samsclub.com under their own

branding and ship these products from their own facilities. These products are subject to the

Walmart Supplier Agreement + DSV Schedule. These products may be exclusive to Walmart or

Sam’s Club or may be offered at other retailers in the U.S. or Puerto Rico.

Supplier Requirements for Health and Wellness Products |

Private Brand, National Brand, and DSV Suppliers

Any Supplier that enters into a Supplier Agreement and intends to supply Health and Wellness

Products must provide the information required under this policy to receive an approved

Supplier Agreement. Supplying Health and Wellness Products that do not comply with this

policy may result in a termination of the Supplier Agreement and/or removal of Health and

Wellness Products from Walmart and/or Sam’s Club (stores or omnichannel).

Failure to comply with all federal, state, and local regulatory requirements as described in this

document and otherwise applicable to a Health and Wellness 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.

The following requirements apply to Health and Wellness Products supplied as Private Brands,

Direct Import, National Brands, or DSV pursuant to a Supplier Agreement.

(Pages 5

Supplier Requirements for

Over-the-Counter Drugs

Health & Wellness Product Safety

What is an OTC drug?

OTC drugs are sold directly to consumers without a prescription. Like prescription drugs, OTC

drugs are regulated by FDA. All OTC drugs must have a Drug Facts Label that instructs

consumers on how to properly choose and use them. OTC Drugs treat many common ailments

including pain, fever, cough and cold, upset stomach, and allergies. OTC Drugs should not be

confused with dietary supplements (vitamins, minerals, herbals, and botanicals), which have

different rules.

Can Some OTC Drugs Be Marketed Without FDA Approval?

Yes. Any OTC drug product that conforms to an OTC monograph may be manufactured and sold

without submitting an application for approval to FDA. A searchable list of all OTC monographs

can be found on FDA’s Website. A monograph is a regulatory standard for the labeling and

ingredients for products within a specific category such as antacids, analgesics, etc. It is a kind

of “recipe book” covering acceptable ingredients, doses, formulations, indications, and labeling.

Some OTC medicines do not fall within the monograph system and require approval via a new

drug application (NDA) or Abbreviated New Drug Application (ANDA).

What Requirements Apply to OTC Drugs Supplied to Walmart?

All Suppliers of OTC drugs must ensure that their products meet all legal and regulatory

requirements, including requirements under the Federal Food, Drug and Cosmetic Act (FD&C

Act) and FDA’s regulations and guidance. OTC Drugs that do not follow FDA’s regulations, such

as by not having a valid Drug Facts Label, or that are not manufactured in an FDA-registered

facility may be considered misbranded or adulterated and unlawful to sell in the U.S. Suppliers

of Private Brand and Direct Import OTC Drugs will undergo a full review and verification of all

labeling artwork in addition to the requirements set out below.

Legal and Regulatory Requirements for OTC Drugs:

Facility Disclosure and Registration

Suppliers of OTC Drugs must disclose to Health & Wellness Product Safety each facility that

engages in the manufacture, preparation, propagation, compounding, processing, packaging,

labeling, storage, and distribution of such products. This includes all subcontracted facilities or

any operations and facilities that are not owned by the Supplier, but from which OTC Drugs are

sourced. Once approved, Suppliers are responsible for disclosing any new facility to Health &

Wellness Product Safety. Private Brand and Direct Import Suppliers of OTC Drugs must receive

facility approval prior to supplying OTC drug products produced in that facility.

All OTC Drugs sold in the U.S. must be manufactured in facilities registered with FDA. Facility

information provided to Health & Wellness Product Safety must match the information on the

FDA Drug Establishments Registration Site and must remain accurate. Suppliers must provide

FDA drug registration information to Health & Wellness Product Safety prior to supplying

product and on an annual basis going forward. Email Health & Wellness Product Safety at

HWSCSAFETY@wal-mart.com to obtain the appropriate facility information form.

State Requirements

Certain states have licensing and registration requirements above and beyond federal

registration requirements. All Suppliers of OTC Drugs are responsible for ensuring compliance

with applicable state laws.

Suppliers must submit proof of any state registrations to Health & Wellness Product Safety prior

to supplying product as well as when those licenses are renewed. Suppliers are responsible for

completing and submitting all licensing and registration forms and paying all licensing and

registration fees on or before any applicable deadline.

Drug Listing

All OTC Drugs manufactured in FDA-registered facilities must also be listed with FDA. All

Suppliers of OTC Drugs are required to ensure that their products have been appropriately

listed with FDA. The FDA drug listing must match the name of the OTC Drug supplied.

Current Good Manufacturing Practices (CGMPs)

All OTC Drugs supplied must be manufactured in facilities that are in good standing with FDA

(i.e. not “Official Action Indicated” and no outstanding significant 483s) and manufactured in

accordance with FDA’s CGMPs. Suppliers may provide the information that is available on the

FDA website as evidence of a satisfactory compliance status for manufacturing facilities. In

addition, if the status of a manufacturing facility is “Voluntary Action Indicated” or there is an

outstanding 483, suppliers must provide a copy of the Establishment Inspection Report, 483,

and Supplier’s response.

Third Party Certification and Annual Audit

National Brand and DSV Suppliers of OTC Drugs marketed under an OTC monograph (not

approved under NDAs or ANDAs) must provide to Health & Wellness Product Safety a

certification of conformance with CGMPs, such as a letter from the Supplier’s Head of Quality

or from a third-party auditor, for each facility involved in the manufacturing process for an OTC

Drug supplied to Walmart or Sam’s Club.

Private Brand and Direct Import Suppliers of OTC Drugs marketed under an OTC monograph (not

approved under NDAs or ANDAs) must provide to Health & Wellness Product Safety full reports

of third-party CGMP audits showing conformance with CGMPs for each facility involved in the

manufacturing process for an OTC Drug supplied to Walmart or Sam’s Club. Additional social

audits may also be required by Walmart’s Responsible Sourcing team. The third-party audit

firms approved by Health & Wellness Product Safety for Private Brand and Direct Import are

provided in the Approved Third-party CGMP Audit Information.

Audits must have been conducted within the previous rolling 12-month time frame and be

reviewed and approved by Health & Wellness Product Safety. Items showing non-conformance

to standards will require submission of corrective measures acceptable to Health & Wellness

Product Safety to receive approval. Additional conformance audits may be required. Once

approved, Suppliers will be responsible for providing updated conformance audit and

certification documentation to Health & Wellness Product Safety annually. Additionally, CGMP

conformance audits must occur on or before the one-year anniversary of when the last audit

was conducted and be sent to Health & Wellness Product Safety on or before the anniversary of

the preceding audit. You may email HWSCSAFETY@wal-mart.com should you have any

questions regarding CGMP audit and certification conformance.

Marketing Authorization

Suppliers must have the right to market any OTC Drugs requiring marketing authorization under

an approved NDA or ANDA.

Any OTC Drug that is subject to an OTC Monograph must be marketed in accordance with that

OTC Monograph. Suppliers must certify compliance with the applicable OTC Monograph.

Labeling

All OTC Drugs must comply with FDA regulations and guidance regarding OTC Drug labeling

including:

• bearing a net quantity of contents statement;

• identifying the name and address of the manufacturer, distributor, or packer;

• containing information for the reporting of serious adverse events;

• containing a Drug Facts Label with all required information (e.g., purpose,

uses/indications/directions/warnings);

• containing the active ingredients, including the amount in each dosage unit;

and

• containing a list of the inactive ingredients.

OTC Drugs subject to an approved NDA or ANDA must be labeled in accordance with the FDA-

approved labeling.

OTC Drugs subject to an OTC Monograph must meet the general regulatory requirements for

OTC labeling and any specific labeling requirements of the relevant OTC Monograph.

Private Brand and Direct Import OTC Drugs will undergo a full labeling review by Health &

Wellness Product Safety.

Packaging

Most OTC Drugs must be packaged in tamper-resistant packaging, in accordance with

applicable regulations. The packaging must use an indicator or barrier to entry that is distinctive

by design (such as an aerosol container), or must employ an identifying characteristic (a

pattern, name, registered trademark, logo, or picture). Further, the regulations require a

labeling statement on the container (except ammonia inhalant in crushable glass ampules,

aerosol products, or containers of compressed medical oxygen) to alert the consumer to the

specific tamper-resistant feature(s) used. The labeling statement is also required to be placed

so that it will be unaffected if a TRP feature is breached or missing. The following products are

excepted from these requirements: dermatologics, dentifrices, insulin and throat lozenges (21

CFR 211.132); cosmetic liquid oral hygiene products and vaginal products (21 CFR 700.25); and

contact lens solutions and tablets used to make these solutions (21 CFR 800.12).

Suppliers must ensure that their orally administered products comply with the requirements of

the Poison Prevention Packaging Act, including, where applicable, the use of child resistant

caps. Suppliers must provide to Health & Wellness Product Safety a current General Certificate

of Conformity for each size container of an OTC drug with a child-resistant cap prior to initial

manufacturing with each container and annually thereafter. Certificates of Conformity should

reference the requirements for special packaging, 16 CFR 1700.14 and 1700.15.

OTC Drugs are also subject to Country of Origin labeling requirements per U.S. Customs and

Border Patrol.

Private Brand and Direct Import OTC Drugs will undergo a full packaging review by Health &

Wellness Product Safety.

Adverse Event Reporting

The manufacturer, packer, or distributor whose name appears on the label of an OTC Drug is

responsible for reporting to FDA “serious adverse events,” within 15 business days of receipt of

a report of such an event. All Suppliers of OTC drugs must have Standard Operating Procedures

(SOPs) in place or otherwise ensure compliance with federal adverse event reporting

requirements. If Walmart receives an adverse event report via the Walmart Care Center, it will

be immediately forwarded to the supplier.

Suppliers of OTC Drugs must inform Health & Wellness Product Safety via email at

HWSCSAFETY@wal-mart.com of any customer reports of adverse events or serious adverse events

within 48 hours of receiving such report.

Suppliers of Private Brand and Direct Import OTC Drugs must submit to FDA, on behalf of Walmart

and/or Sam’s Club, serious adverse event reports within 15 business days of receipt of the initial

complaint. Health & Wellness Product Safety must be copied on all serious adverse event reports

submitted to FDA on its behalf as well as all follow-up reports of additional information submitted to

FDA on behalf of Walmart and/or Sam’s Club.

Product complaints that are not adverse events or serious adverse events, but that may affect

product safety or quality, such as foreign objects or tampering, must be reported by Suppliers to

Health & Wellness Product Safety or via email at HWSCSAFETY@wal-mart.com.

Suppliers of Private Brand and Direct Import OTC Drugs are responsible for investigating product

complaints and must provide information regarding the investigative outcome to Health & Wellness

Product Safety upon completion.

Claims

Health-related advertising claims about Health and Wellness Products, which include claims in

an online product description, are regulated primarily by the Federal Trade Commission (FTC).

Statements made about Health and Wellness Products must be truthful and not misleading and

must have adequate substantiation by competent and reliable scientific evidence. FTC’s Health

Products Compliance Guidance is a helpful tool for figuring out what kinds of claims and

substantiation are appropriate for Health and Wellness Products. Claims about OTC drugs must

be consistent with the use described in the Drug Facts Labeling.

Private Brand and Direct Import OTC Drugs will undergo a substantiation review by Health &

Wellness Product Safety.

OTC Homeopathic Drugs

What are Homeopathic Drugs?

OTC Homeopathic Drugs are derived from botanical, mineral or biological substances. The

theory of homeopathy is that homeopathic products are more effective when they are diluted.

These products are usually diluted with purified water or an alcohol solution.

Are Homeopathic Drugs Regulated by the FDA?

FDA classifies homeopathic products as drugs, but regulates them via enforcement discretion,

meaning they are not reviewed or approved by FDA. Instead, FDA has identified in guidance the

types of homeopathic products that would be subject to FDA regulatory enforcement or action.

FDA has specifically identified categories of homeopathic products that the Agency will

prioritize for regulatory enforcement, such as those intended for populations at greater risk for

adverse reactions. OTC homeopathic medicines must be indicated for similar conditions as OTC

drugs. These conditions can be self-diagnosed and are generally not chronic in nature, for

example the common cold, upset stomach, or minor aches and pains.

What Requirements Apply to OTC Homeopathic Drugs Supplied to

Walmart and Sam’s Club?

Pharmacopoeia Certification

Suppliers must ensure that individual homeopathic ingredients supplied to Walmart or Sam’s

Club for sale in OTC Homeopathic Drugs in the U.S. have been reviewed for homeopathic

efficacy, toxicology, adverse effects, and clinical use by the Homeopathic Pharmacopoeia

Convention of the United States (HPCUS) and are listed (monographed) in the Homeopathic

Pharmacopoeia of the United States (HPUS). Listing in the HPUS is not a certification that a

homeopathic product is safe, effective, and not misbranded for its intended use.

Labeling

All OTC Homeopathic Drugs must comply with FDA regulations and guidance regarding OTC

Drug labeling including:

• bearing a net quantity of contents statement;

• identifying the name and address of the manufacturer, distributor, or packer;

• containing information for the reporting of serious adverse events;

• containing a Drug Facts Label with all required information (e.g., purpose,

uses/indications/directions/warnings);

• containing the active ingredients, including the amount in each dosage unit;

and

• containing a list of the inactive ingredients.

The potency must be included on the product label immediately following the product name

and include a number, followed either by an X or a C, to show the number of times the

medicine was diluted and the ratio of the dilution (i.e., 1/10 for X and 1/100 for C).

Private Brand and Direct Import OTC Homeopathic Drugs will undergo a labeling review by

Health & Wellness Product Safety.

Packaging

Most OTC Homeopathic Drugs must be packaged in tamper-resistant packaging, in accordance

with applicable regulations. The packaging must use an indicator or barrier to entry that is

distinctive by design (such as an aerosol container), or must employ an identifying characteristic

(a pattern, name, registered trademark, logo, or picture). Further, the regulations require a