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Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • 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USP’s mission is to improve global health

through public standards and related

programs that help ensure the quality,

safety, and benefit of medicines and foods.

Copyright © 2015 The United States Pharmacopeial Convention

At USP, we are committed to

implementing our Core Values. All

USP employees, volunteers, and

representatives are responsible

for promoting the USP Core Values

in our daily activities. In addition,

our Core Values should guide our

decision making when there is no

explicit applicable rule or policy.

Please review the USP Core Values

section on the Intranet for details.

Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards • Improved Health • Global Expertise • Trusted Standards

Foster Stewardship

Act Courageously

Passion for Quality

Commit to Others

USP’S CORE VALUES

i

Business Conduct 14International Trade 14

Trade Sanctions and Embargoes 14Boycotts 15

Anti-Bribery and Anti-Corruption 15Anti-Kickback 16Travel, Gifts, and Entertainment 17

Government Officials 18Employees and Volunteers 19

Intellectual Property 19Anti-Trust and Competition 20Insider Trading 20Financial Reporting and Record-Keeping Policy 21Accurate Statements, Submissions, and Representations 21Political Contributions 22Use of Company Assets 22

Business Conduct –Government Clients 23

Workplace Conduct 25Equal Employment Opportunity and Affirmative Action 25Accommodation for Disabilities 26Anti-Harassment 27Privacy 27Environmental Health and Safety 28Drug-Free Workplace 29Workplace Violence 29Workplace Weapons 29

Waivers 30

Reporting Policy 31Speaking Up 31Investigations 32Non-Retaliation Policy 33Confidentiality of Reports 33Using the Helpline 34Anonymity of the Helpline 34

Mission and Core Values i

A Message from the CEO iii

Introduction 1Where to Go for Help 1

Understanding Our Code 2Scope 3Implementing the Code of Ethics 3Management Responsibilities 4Employee Responsibilities 5Volunteer Responsibilities 5Representative Responsibilities 5

Standards-Setting Activities 6Scientific Integrity 6Quality Management Systems 7Official Statements and Interpretations 7Document Disclosure 7Public Participation in Open Meetings 8

Conflicts of Interest 9Personal Relationships 9Organizational Relationships 10Donations 10Donations of Reference Standard Material 11

Confidentiality 12Social Media 13

Table of Contents

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iii CODE OF E TH ICS

L E T T E R FRO M T H E CE O

Dear Colleagues,

Thank you for your commitment to USP and to our mission of improving global health

through public standards and related programs that help ensure the quality, safety,

and benefits of medicines and food. Each of us plays an important day-to-day role

in strengthening and growing our organization, and our individual and collective

contributions are making an impact on the lives of millions of people around the world.

As we set the course for 2020 and beyond, it is important that we remain true to the

principles that have made us a trusted and respected standards-setting organization

for nearly 200 years. Our impact and achievements are deeply rooted in the rigorous

evaluation of scientific data, collaboration and transparency in the standards-setting

process, and the honest reporting of results. Throughout our history, USP has been

recognized and relied upon because of our integrity as an organization.

This Code of Ethics reflects our continued commitment to integrity and includes

resources we are all expected to use when faced with ethical questions or if we observe

illegal or unethical conduct. By holding true to our Core Values and operating with

integrity every day we not only safeguard USP’s role as a global public health leader,

but also ensure that we treat each other fairly and with respect.

Given the unique degree of public trust bestowed upon us at USP, I feel we have an even

greater responsibility to set and adhere to a higher degree of ethics. Our USP executive

team is committed to this Code and to implementing these policies in our daily tasks,

and I know that I can count on each of you to join us in this commitment.

Ronald T. Piervincenzi, Ph.D.Chief Executive Officer

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Introduction

Where to Go for Help

Many issues can easily be prevented or resolved if appropriate guidance and direction is obtained at an early stage. This Code of Ethics document is intended to provide guidance as well as tools to help you make the right decision. If you have a question or are unclear about the appropriate nature of any conduct, about the scope or applicability of the USP Code of Ethics (referred to as the Code), or about the Standard Operating Procedures (SOPs) for implementing it, you must obtain guidance from the USP resources listed below before proceeding.

Your immediate supervisor is generally in the best position to provide you with guidance on any issue you may encounter while carrying out daily responsibilities. We hope you feel comfortable discussing the issue with him or her, but if you do not, many other resources exist at USP, such as:

• The next level of management in your division

• Your Divisional Chief

• Any manager in USP

• Human Resources

• Global Legal Affairs (GLA)

• Global Compliance and Ethics (GCE)

• The USP Helpline (See the “Reporting Policy” section for details.)

“This USP Code of Ethics document is intended to provide guidance as well as tools to help you make the right decision.”

If you have a question or are unclear about the appropriate nature of any conduct ... you must obtain guidance from USP resources before proceeding.

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Understanding Our Code

“We must perform all of our daily activities with the same excellence we require for our standards-setting activities and related programs.”

USP’s global activities affect many countries and are often subject to differing legal obligations, cultures, and business pressures. Making the right decision when faced with an ethical dilemma can be difficult in such circumstances, unless there is a consistent set of ethical standards for all to follow. The Code represents our shared values and expectations on ethical conduct. By consistently following these values, we ensure that our mission is carried out with integrity and that our employees, volunteers, and representatives are treated fairly and with respect.

The values in this Code are minimum standards that must be implemented whenever you carry out any USP activity. USP is committed to complying with all laws, so in instances where the local laws are more stringent than this Code, USP will always follow local laws. Our Code provides guidance on how to carry out our mission globally in compliance with the letter and spirit of applicable legal requirements, USP Core Values, and SOPs. We believe that our role as a leader in the standards-setting community is reflected in how we behave as employees, volunteers, and representatives of USP. This means that we must perform all of our daily activities with the same excellence we require for our standards-setting activities and related programs.

By consistently following these values, we ensure that our mission is carried out with integrity and that our employees, volunteers, and representatives are treated fairly and with respect.

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We are committed to dealing with our representatives with integrity and expect them to hold themselves to equally high standards. The term representatives includes vendors, suppliers, consultants, and other third parties hired to act on behalf of USP.

The Code reflects this purpose and is intended to promote:

• Honest and ethical conduct

• Compliance with laws, rules, and regulations

• Independence, integrity, reputation, and credibility as a science-based standards-setting organization

• Commitment to further the mission of the organization rather than our own personal interests

• An environment of mutual respect for one another

• An environment where individuals can raise concerns or ask questions without fearing retaliation

• Prompt internal reporting of actual or potential violations of the law, the Code, and SOPs.

Scope

Our reputation is one of USP’s most valuable assets and will always be critical to our ongoing success. To safeguard our reputation and our brand, we must hold ourselves to standards of behavior that go well beyond legal minimums. We therefore expect our employees, volunteers, and representatives to understand and model that philosophy every day. To help implement these values, you are expected to be familiar with the law, the Code, and SOPs that apply to your daily responsibilities at USP.

Implementing the Code of Ethics

This Code is intended to be a practical tool that you can refer to if you have questions or need guidance. It is further implemented through our rules and procedures, including the Rules of Business Practice for the Board of Trustees, the Rules and Procedures of the Council of the Convention, the Rules and Procedures of the Council of Experts, the Employee Handbook, the Quality Manual, and SOPs. In addition, the examples throughout this document—highlighted in “Our Code in Action” sections—are designed to help you better understand and make the right decisions when faced with questions about how to apply the Code.

Our reputation is one of USP’s most valuable assets and will always be critical to our ongoing success.

Examples throughout this document—highlighted in “Our Code in Action” sections—are designed to help you better understand and make the right decisions.

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Periodically, employees, volunteers, and representatives may be asked to provide a written certification that they have received, have read, and understand the Code and are not personally aware of (or have duly reported) any non-compliance. The Code certification is your pledge to live up to the law and our Code, and to promptly raise concerns about any situation you think may be a violation of law or our Code. Employees who violate the law, our Code, or our SOPs put themselves, their colleagues, and USP at risk and will be subject to disciplinary action up to and including termination of employment. Volunteers and representatives who violate the law or our Code put the integrity of USP at risk and their relationship with USP may be subject to review, up to and including termination.

Management Responsibilities

If you are responsible for managing employees at USP, you have a special responsibility to always lead with integrity. It is not enough for you to merely behave legally and ethically; you must also take affirmative steps to influence employees to do the same. This means that you must:

• Be a positive role model. We all know that actions speak louder than words, so let your actions demonstrate your belief that business goals never trump legal requirements, or our Code, Core Values, and SOPs.

• Set the right tone from the top and inspire performance with integrity. Seek opportunities to talk about the importance of complying with our Core Values, the law, the Code and SOPs. Explain how our Code supports our mission and Core Values, and ensures our success.

• Promptly and thoughtfully complete your own compliance training, and make sure your team members do the same.

• Show leadership by following compliance processes.

• Create an environment in which employees know they can ask questions or raise concerns without fear of reprisal.

• Be available to answer employee questions and listen to and address their concerns.

• Never retaliate against anyone who reports a good-faith concern or who cooperates with internal investigations or audits. Don’t tolerate others who do.

• Promptly report behavior that you know is illegal or that violates the Code to GCE. Respond swiftly and appropriately to misconduct.

Set the right tone from the top and inspire performance with integrity.

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• Never ask or pressure an employee to engage in conduct that is a violation of the law or the Code.

• Facilitate a collaborative and open environment.

Employee Responsibilities

As a USP employee, you are expected to comply with both the letter and the spirit of our Code. This means that you must:

• Understand and comply with the law, the Code, and SOPs that apply to your job.

• Seek guidance from resources at USP if you have questions or concerns about the appropriate nature of any conduct or decision.

• Cooperate fully in any investigation of suspected misconduct that may arise in the course of your employment.

• Promptly report any violation of the law, the Code, and SOPs as soon as you become aware of it.

• Treat employees, volunteers, and representatives respectfully and in a professional manner.

• Complete compliance training within allotted timelines.

Volunteer Responsibilities

All volunteers, whether elected or appointed, are expected to adhere to the letter and the spirit of the law, Core Values, Code, and applicable SOPs in their governance or standards-setting activities. This will enable volunteers to support our governance activities and establish standards through processes that are science-based, credible, and unbiased.

Representative Responsibilities

USP is committed to integrity and high standards when dealing with representatives, and we expect all representatives doing business with or on behalf of USP to act with integrity and hold themselves to equally high standards. Representatives are expected to comply with the law and the values contained in the Code when acting on behalf of USP.

Seek guidance from resources at USP if you have questions or concerns about the appropriate nature of any conduct or decision.

We expect all representatives doing business with or on behalf of USP to act with integrity and hold themselves to equally high standards.

Our Code in Action

What happens if I am faced with a situation where acting ethically conflicts with meeting USP SSP goals?

You must always engage in legal and ethical conduct no matter what the circumstances. USP’s long-term success depends on our reputation. If you feel that there is a conflict between meeting a goal and acting ethically, you should discuss the matter with any of the resources listed in this Code so that steps can be taken to appropriately adjust the goal.

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S TA N DA R D S - S E T T I N G AC T I V I T I E S

USP is a global leader in public standards-setting to help ensure the quality, safety, and benefit of medicines and foods. To maintain our excellence as a standards-setting organization, USP will establish standards and information through processes that are open, rigorous, science-based, and unbiased. USP will design, implement, and maintain quality management systems to continuously monitor, improve, and measure the quality and impact of USP products and services. USP will hold open meetings and publish standards impartially. USP will not provide information about our standards, or standards-setting activities, in a manner that will allow any stakeholder to have an undue advantage over another stakeholder.

Scientific Integrity

At USP, we are committed to ensuring that our standards are based on accurate, reliable scientific data and other supporting information, to help ensure the medicines used are of needed and expected quality. The currency of our standards are maintained through a continuous revision process reflective of the technological changes in manufacturing and testing procedures. All employees and volunteers who contribute to our standards-setting activities must rigorously evaluate scientific data and any other input to decision

Standards-Setting Activities

To maintain our excellence as a standards-setting organization, USP will establish standards and information through processes that are open, rigorous, science-based, and unbiased.

“At USP, we are committed to ensuring that our standards are based on accurate, reliable scientific data and other supporting information.”

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making, honestly report results of their analysis, and adhere to SOPs for preserving the quality of USP standards. Any employee found to have intentionally submitted false or misleading information in support of a USP standards-setting activity will be subject to appropriate disciplinary measures, up to and including termination.

Quality Management Systems

At USP, we operate under a rigorous quality management system. As USP employees, we are all responsible and accountable for reading, understanding, and complying with the USP Corporate Quality Manual and all standard operating procedures applicable to our specific functions. Everyone is responsible for the quality of the work they produce. Everyone is expected to be familiar with the Quality Policy and understand how their jobs relate to it.

Official Statements and Interpretations

USP text and publications may have legal implications in the United States and elsewhere; therefore, their language must stand on its own. As USP employees, volunteers, and representatives, we may not provide an official after-the-fact interpretation to one party, thereby placing other parties who have not received that interpretation at a possible disadvantage.

In addition, we may not provide an official opinion as to whether a particular article does or does not comply with compendial requirements, except as part of an established USP verification or other conformity assessment program that is conducted separately from, and independent of, USP’s standards-setting activities.

Document Disclosure

USP provides disclosure of information and records regarding USP standards-setting activities consistent with:

• The rights of individuals to privacy

• USP’s need to protect the confidentiality of trade secrets and other proprietary commercial or financial information

• USP’s need to promote frank internal deliberations and to pursue standards-setting activities without disruption

Pursuant to this policy, general information pertaining to standards-setting and other activities, including information regarding the work and deliberations of USP’s Council of Experts and Expert Committees, is posted and maintained on the USP website.

Everyone is expected to be familiar with the Quality Policy and understand how their jobs relate to it.

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In addition, communications between USP and third parties relating to standards-setting activities will be made available upon specific written request, including copies of written correspondence to and from third parties and memoranda of telephone conversations and meetings with third parties. Such third-party communications do not include communications of any kind among or between USP staff and members of the Board of Trustees, Council of Experts, or Expert Committees. Furthermore, unless required by law, USP will not disclose documents containing any trade secrets or confidential commercial secrets of third parties, if the confidentiality was specifically stated when the documents were submitted to USP. However, documents submitted to USP by a third party containing trade secrets or confidential commercial secrets that ordinarily would be contained in a New Drug Application or Supplement thereto may be disclosed to the U.S. Food and Drug Administration upon its request in its review of any revision or proposed revision of the United States Pharmacopeia, National Formulary, or other USP compendium.

All requests for documents shall be made to the USP Executive Secretariat, which shall be responsible for decisions about disclosure of information. A request may be refused solely on the basis that it is unduly burdensome or if USP determines that diversion of personnel from higher-priority duties would be unreasonable.

USP reserves the right to charge reasonable fees for disclosure of any documents requested under this policy, including photocopying charges; charges for time spent by

USP personnel to locate, review, and copy such documents; postage fees; and other expenses associated with responding to the request.

Public Participation in Open Meetings

All meetings of USP Expert Committees shall be open to the public, except that a meeting or a portion of a meeting may be held in closed session if the Chairperson of the Expert Committee or the Chairperson of the Council of Experts determines in his or her discretion that there is good and sufficient reason for closure. Such reasons may include review or discussion of trade secrets or confidential, commercial information or review or discussion of matters whose premature disclosure could be detrimental to USP’s standards-setting activities. If a determination is made to close a meeting, then the reason for such closure shall be noted in the minutes of the meeting. Attendance at a meeting of an Expert Committee shall be subject

to the provisions set forth in the Rules and Procedures of the Council of Experts and the procedures posted on USP’s website. A public calendar shall be maintained and posted on the USP website showing, to the extent feasible, future Expert Committee meetings.

Audio and video recordings may be made at any open meeting or conference if approved in advance by USP so as to avoid disruption of the proceedings. The Chairperson of the Expert Committee or the Chairperson of the Council of Experts may decline permission for audio or video coverage that would adversely affect the meeting.

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CO N F L I C T S O F I N T E R E S T

USP’s reputation as a trusted standards-setting organization and provider of public health activities depends on our independence as an organization, and as individual employees, volunteers, and representatives. As an organization, we must avoid conflicts of interest that have the potential to interfere with the impartiality and objectivity of the organization. As individuals, we must avoid conflicts of interest that interfere with our loyalty to the organization. Conflicts of interest are situations in which an employee’s personal interest is competing with USP’s interests. Such situations have the potential to undermine the actual or perceived impartiality of the employee.

Personal Relationships

To ensure USP’s independence and objectivity as a standards-setting organization, we all have an obligation to avoid actual or perceived conflicts of interest in the performance of our duties. Annually, employees and volunteers will be asked to provide written conflict of interest and financial disclosure statements in accordance with the respective rules and SOPs that apply to their positions.

Conflicts of Interest

...we all have an obligation to avoid actual or perceived conflicts of interest in the performance of our duties.

“We must avoid conflicts of interest that have the potential to interfere with the impartiality and objectivity of the organization.”

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CO N FL I C T S O F I N T E R E S T

The following are examples of situations that may, depending on the facts and circumstances, involve conflicts of interest if an individual receives a personal benefit to the detriment of USP:

• Employment, consulting, or service on the board of a customer, supplier, or service provider

• Owning, directly or indirectly, a significant financial interest in any entity that does business, seeks to do business, or competes with USP

• Soliciting or accepting gifts, favors, loans, or preferential treatment from any person or entity that does business or seeks to do business with USP

• Soliciting contributions for any charity or for any political candidate from any person or entity that does business or seeks to do business with USP

• Taking personal advantage of USP business opportunities

• Conducting USP business transactions with a family member

• Exercising supervisory or other authority on behalf of USP over a coworker who is also a family member or with whom you are romantically involved

USP employees are also expected to comply with the conflict of interest provisions in the Employee Handbook. If you think you may have a conflict of interest, or that others could perceive an activity you are engaged in as a conflict of interest, you must promptly disclose this to USP’s Vice President, GCE. Many conflicts of interest can easily be resolved in a mutually acceptable way, but they must be addressed.

Organizational Relationships

USP may enter into relationships with other organizations if the relationship does not pose a conflict of interest and does not bias the objectivity and independence of USP. This means we must also make reasonable efforts to avoid any arrangement or activity that creates an impression of partiality, conflict of interest, or USP endorsement of a particular organization’s products or services.

We may enter into a financial arrangement with an organization whose products are subject to USP standards only if the transaction is negotiated at arm’s length and in a manner consistent with the values in this Code and if the organization provides a bona fide business product or service to USP.

Donations

USP may solicit or accept donations in furtherance of our standards-setting and global public health activities. Donors place an enormous amount of trust in us whenever a

Our Code in Action

I would like to buy stock in a publicly listed pharmaceutical company. The company donates bulk materials to USP. Will that create an actual or potential conflict of interest?

Yes, buying stock in a company that is involved in the standards-setting process potentially creates a conflict of interest and is discouraged by USP. If you own stock in a pharmaceutical or other company for which USP sets standards, then you are required to report this fact to the Vice President, GCE, so that appropriate measures can be taken to mitigate the conflict.

It is your obligation to disclose any potential conflict of interest as soon as you become aware of it.

We must also make reasonable efforts to avoid any arrangement or activity that creates an impression of partiality, conflict of interest, or USP endorsement of a particular organization’s products or services.

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financial or material donation is made; USP is therefore committed to dealing with all donations with integrity, with honesty, and in adherence to the agreed purpose and applicable state or federal laws. We will not solicit or accept donations for activities that actually undermine or have the potential to undermine USP’s integrity and independence as a standards-setting organization. Also, because certain USP publications may have legal implications in the United States and elsewhere, USP reserves to itself editorial control over any information or activity generated using donated resources.

When soliciting or managing donated resources, we must:

• Ensure that all communications made in any fund-raising activities accurately characterize USP’s mission and intended use of solicited donations.

• Ensure the eventual use of a donation is consistent with representations made at the time the donation is solicited or obtained.

• Ensure proper stewardship of all donations by following internal SOPs.

• Make appropriate and accurate reports on the use and management of donations within time frames agreed to or otherwise requested by the donor.

To the extent feasible, sponsorship of a particular program, publication, event, or activity should be from multiple sources. We retain sole control over any program, publication, event, or activity sponsored by any organization that may be affected by USP standards-setting or other activities. In addition, we may disclose funding from any organizations that are affected by USP activities.

We will not solicit or accept donations that:

• Require USP to endorse, or appear to endorse, the products or services of the funding organization.

• Require USP to exclude competitors of the donor from participating in the program or project being funded.

• Are from organizations whose principles, policies, or objectives conflict with those of USP.

• Create an actual or perceived conflict of interest.

• Undermine or have the potential to undermine USP’s integrity and independence as a standards-setting organization.

Donations of Reference Standard Material

As an organization, USP seeks donation of material for the development of Reference Standards. To obtain the highest-quality material consistent with the purposes described in the monograph for which the Reference Standard is used, we seek donations of materials for development of Reference Standards first from the sponsor of the compendial monograph, if there is one. When it is not feasible to obtain materials from the sponsor, we seek donations for the development of Reference Standards uniformly throughout the industry, and multiple donors are solicited when possible.

Our Code in Action

What steps can I take to avoid giving the impression that USP is endorsing a particular organization’s products?

Simple measures—such as providing disclaimers when particular equipment, vendors, or materials are identified in scientific posters, standards, or other forms of communication—can easily address such issues. Please contact GLA for guidance.

USP is committed to dealing with all donations with integrity, with honesty, and in adherence to the agreed purpose and applicable state or federal laws.

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In carrying out USP activities, employees, volunteers, and representatives often have access to confidential information. We are obligated to protect confidential and proprietary information, whether generated by USP or by third parties, unless disclosure is authorized or legally mandated.

All information about USP and our core and allied compendial activities is considered confidential unless it is made publicly available by USP or it is known to be publicly available outside of our organization.

We all are responsible for safeguarding confidential information by marking it “Confidential,” keeping it secure (within USP or when accessible to volunteers), limiting access to the information, and disposing of it in an appropriate manner. Confidential information may be shared with employees, volunteers, and representatives only on a need-to-know basis. Failure to adequately protect confidentiality may result in significant competitive or legal harm to USP or third parties.

Confidentiality

“We are obligated to protect confidential and proprietary information, whether generated by USP or by third parties, unless disclosure is authorized or legally mandated.”

We all are responsible for safeguarding confidential information.

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SOPs, with respect to the protection of confidential and proprietary information, are not intended to restrict employee rights to address compliance and ethics issues or other workplace concerns. Specific confidentiality provisions applicable to USP volunteers are located in the Rules of Business Practice for the USP Board of Trustees and the Rules and Procedures of the Council of Experts. USP employees must comply with the confidentiality provisions set forth in other USP SOPs.

Social Media

Social media provides an interactive platform for users to communicate to a broad audience on a variety of topics. Because there is no control over messaging once it has

been sent, it is always a good idea to think first before posting anything on social media sites.

When engaging in social media activities on behalf of USP, you must always use good judgment and comply with the USP SOP on Use of Social Media and with the Code.

Although USP does not seek to restrict the personal use of social media, when engaging in social media on your own behalf, you are nevertheless obliged to comply with all USP confidentiality requirements concerning the sharing of USP information.

You should always use good judgment and:

• Make it clear that you are not acting on behalf of the USP, whether expressly or impliedly.

• Do not use your USP email address as your means of identification or for receiving or sending messages.

• With the exception of protected speech—such as on wage, hours, and working conditions—do not make negative comments about USP, refer to USP, or identify your connection to USP.

• Maintain the confidentiality of business and proprietary information.

• Respect the privacy of your colleagues.

Our Code in Action

What are examples of confidential information?

Confidential information may include but is not limited to:

• Financial information that is not required to be made publicly available

• Scientific, research, and medical information

• Donor and prospective donor information

• Customer and supplier information lists

• Commercial marketing strategies

• Certain personnel and consultant data

• Proprietary computer software and technology

• Correspondence between and among USP staff and members of its Board of Trustees, Council of Experts, and Expert Committees

• Contractor bid, proposal, and source selection information in government contracts

• Other information that USP or a third party deems confidential

USP employees must comply with the confidentiality provisions set forth in other USP SOPs.

When engaging in social media activities on behalf of USP, you must always use good judgment and comply with the USP SOP on Use of Social Media and with the Code.

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B U S I N E S S CO N D U C T

As an organization that provides products and services globally, USP will comply fully with all United States and international laws, rules, and regulations affecting USP’s business activities and operations. As USP employees, volunteers, and representatives, we are expected to be aware of and comply with the Code and any laws or SOPs related to our USP responsibilities, as applicable.

International Trade

Trade Sanctions and Embargoes

The governments of the United States and other countries in which USP operates have laws and regulations that restrict trade and business transactions with certain individuals, organizations, and countries. These laws may restrict travel to certain countries or imports and exports of certain goods, technology, information, and services. USP adheres to all applicable laws and SOPs to ensure compliance in this area. The laws, rules, and regulations that extend to our international trade activities include:

• Embargoes that restrict or prohibit USP’s global locations from doing business with certain sanctioned countries, organizations, or individuals

Business Conduct

“As USP employees, volunteers, and representatives, we are expected to be aware of and comply with the Code and any laws or SOPs related to our USP responsibilities, as applicable.”

USP adheres to all applicable laws and SOPs to ensure compliance.

Our Code in Action

What actions would be considered boycott requests?

The following are examples of statements that could be considered boycott requests:

• USP will not supply goods or materials that have been manufactured or processed in Israel.

• USP will not use services of an Israeli organization.

• USP confirms that it does not have any office or business activities in Israel.

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• Export controls that restrict travel to designated countries or that prohibit or restrict the export or reexport of U.S. origin goods, services, and technology to designated countries, persons, or entities

Boycotts

United States law also prohibits USP from furthering or supporting another country’s boycott that is not sanctioned by the United States. Boycott requests can arise in oral conversations, email exchanges, or commercial or other documents. The prohibitions include:

• Agreements to refuse or actual refusal to do business with or in Israel or with blacklisted companies

• Agreements to furnish or actual furnishing of information about business relationships with or in Israel or with blacklisted companies

• Agreements to furnish or actual furnishing of information about the race, religion, sex, or national origin of another person

• Agreements to discriminate or actual discrimination against persons based on race, religion, sex, national origin, or nationality

In all trade and business transactions, you must know and comply with all trade restrictions and export controls. Any request to participate in a boycott must be politely declined and promptly reported to GCE or GLA so that prompt action can be taken.

Anti-Bribery and Anti-Corruption

USP is committed to the highest standards of business conduct in all aspects of our business dealings throughout the world. It is USP’s policy to comply with the U.S. Foreign Corrupt Practices Act and other federal and state anti-bribery and anti-corruption laws wherever USP does business globally. The fact that corrupt practices may be common in some countries or that some countries may not enforce their anti-bribery and anti-corruption laws is not an excuse for non-compliance.

Employees, volunteers, and representatives may not directly or indirectly engage in bribery or other corrupt business practices, including authorizing, offering, or giving a government official or private individual anything of value for the purpose of influencing them to misuse their position or to gain an improper advantage to benefit USP. The term “improper advantage” includes a benefit to which USP is not entitled or a benefit to which USP is entitled but that is obtained through improper means.

Our Code in Action

I have just been told that a number of Reference Standards in my portfolio are subject to United States government export restrictions. May I send a sample of a Reference Standard and technical information that is subject to these restrictions to a contract lab outside of the United States?

No. You must obtain guidance from GCE before shipping any item or technical information that is subject to export restrictions. GCE will help you evaluate the export restrictions and obtain any applicable licenses and permits.

Employees, volunteers, and representatives may not directly or indirectly engage in bribery or other corrupt business practices.

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B U S I N E S S CO N D U C T

Our policy also prohibits employees, volunteers, and representatives from receiving anything of value for the purpose of providing favorable treatment in connection with any USP activity. We are also prohibited from encouraging or requiring others to engage in such conduct or ignoring indications that others may be engaging in such conduct on our behalf. Additionally, we do not make facilitating or “grease payments” to expedite or secure the performance of a government action. Any exceptions to the policy on facilitating or grease payments require review and written approval according to the Waiver Policy, below.

Anti-Kickback

USP complies with the U.S. Anti-Kickback Act, which strictly prohibits us from providing or receiving anything of value for the purpose of obtaining or rewarding favorable treatment in connection with the award of a government contract, subcontract, grant, or cooperative agreement. The Anti-Kickback Act makes giving or accepting a kickback illegal. A “kickback” is defined as any money, fee, commission, credit, gift, gratuity, thing of value, or compensation of any kind, provided directly or indirectly, to any contractor, contractor employee, subcontractor, or subcontractor employee, for the purpose of improperly obtaining or rewarding favorable treatment in connection with the award of a government contract or subcontract.

Favorable treatment may include the following:

• Receiving confidential information on competitor bids, such as prices, delivery schedules, or other non-public information

• Obtaining placement on a bidder’s list without meeting the requisite qualifications

• Obtaining the removal of a competitor who meets requisite qualifications from a list of eligible bidders

• Obtaining unwarranted waivers of delivery deadlines

• Obtaining unwarranted price increases

• Recovering improper expenses

• Improperly obtaining the award of a subcontract or order under a subcontract

• Obtaining acceptance of substandard goods and services

USP complies with the U.S. Anti-Kickback Act, which strictly prohibits us from providing or receiving anything of value for the purpose of obtaining or rewarding favorable treatment in connection with the award of a government contract.

Our Code in Action

Who would be considered a government official?

A government official would include:

• Employee of a local, state, regional, or federal government, or any department, agency, or ministry of a government;

• Employee of a public international organization, such as the European Pharmacopoeia, United Nations, etc.;

• A political party official or any candidate for political office;

• Any officer or employee of a government-owned, government-funded, or government-controlled entity (for example, a government testing lab, air- or seaport, utility, energy, water, power companies);

• Any individual with dual capacity in a government agency and a private business; or

• Any member of a royal family (please note that such individuals may lack formal authority but may otherwise be influential in advancing USP’s business interests, either through partially owning or managing state-owned or state-controlled companies).

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In addition, the Anti-Kickback Act imposes obligations on USP to report reasonable suspicions of kickbacks and to implement internal procedures to detect kickbacks. Therefore, USP employees who know of any violations of the Anti-Kickback Act or who suspect that a violation has taken place or could take place must immediately report the matter in accordance with our Reporting Policy.

The Anti-Bribery and Anti-Corruption, Anti-Kickback, and Travel, Gifts, and Entertainment requirements in this Code do not prohibit reasonable business expenses, entertainment, and gifts that are ordinary and customary in local business relationships and not in violation of U.S. law, the laws of the local country, or the guidelines of the receiving employee’s organization. However, care must always be taken to ensure that these expenditures are not used as a means to conceal improper payments or to inappropriately influence private individuals or government officials to take or refrain from taking certain actions.

If you are involved in international operations, you must be familiar with anti-bribery and anti-corruption requirements applicable to your responsibilities. You must also adhere to all USP procedures relating to these laws and always display the highest level of integrity in your business dealings.

Travel, Gifts, and Entertainment

Reasonable business travel, gifts, and entertainment expenditures may play an important role in strengthening our business relationships and promoting our mission and products. Indeed, in some cultures it is considered discourteous if token gifts are not exchanged by business partners. Nevertheless, the provision of business travel, gifts, and entertainment, if not done properly, has the potential to create the appearance of an actual or potential conflict of interest or impropriety. In certain instances, it may also be viewed as an attempt to corrupt the receiver. Additionally, it may also make it harder to be objective about the provider. Many organizations and governments have restrictions on their employees receiving or giving gifts. It is your responsibility to fully understand these restrictions before offering gifts or entertainment to anyone. When offering or receiving such courtesies, always follow a rule of reasonableness and the following requirements.

Our Code in Action

What are facilitating, or grease, payments?

Facilitating, or grease, payments are payments made to further routine governmental action that does not involve the exercise of discretion. Examples are:

• Processing governmental documents—such as visas, licenses, or permits—that would allow USP to conduct business

• Obtaining police protection, phone service, power and water supply, and mail pickup or delivery

USP employees who know of any violations of the Anti-Kickback Act or who suspect that a violation has taken place or could take place must immediately report the matter in accordance with our Reporting Policy.

...gifts, and entertainment, if not done properly, have the potential to create the appearance of an actual or potential conflict of interest or impropriety.

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B U S I N E S S CO N D U C T

The gift or entertainment must:

• Be given or received in an open and transparent manner

• Be consistent with the customary practices of the giver and receiver

• Be only offered or received infrequently

• Not violate local laws or the guidelines or procedures of the giver and receiver

• Not obligate or appear to obligate the recipient to provide favorable treatment

• Be modest in value

• Be accounted for appropriately in USP’s books and records

• If made public, not embarrass USP

• Not be cash or cash equivalent (for example, a gift card)

Employees or volunteers who receive a gift valued at more than $50 (or $100 per annum, cumulatively) while acting on behalf of USP must promptly notify their supervisor and GCE.

Government Officials

When given to a government official, gifts and entertainment that are normal and otherwise acceptable in general business settings could be viewed as an inappropriate means of trying to influence the official’s decisions. Additionally, many governments have implemented strict laws and regulations limiting their employees from giving or receiving travel, gifts, or entertainment. USP will comply with all laws that restrict it from providing travel, gifts, and entertainment for any government official globally. It is your responsibility to understand these restrictions before offering any gift or entertainment to a government official.

Unless covered by an SOP, employees must obtain guidance from GCE or GLA before offering travel, gifts, or entertainment to any government official.

Our Code in Action

How do you define “gifts and entertainment”?

The phrase “gifts and entertainment” includes any gratuity, favor, discount, hospitality, loan, forbearance, or other item having monetary value. It includes services, training, transportation, lodging, and meals, whether provided in kind, by purchase of a ticket, by payment in advance, or by reimbursement after the expense has been incurred.

When given to a government official, gifts and entertainment that are normal and otherwise acceptable in general business settings could be viewed as an inappropriate means of trying to influence the official’s decisions.

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Employees and Volunteers

When carrying out responsibilities for USP, employees and volunteers must exercise independence and objectivity. We do not request or accept any payment, honoraria, or loan from a third party because of any act performed within the scope of our volunteer or employment duties for USP. In addition, we do not request personal gifts or entertainment from third parties for acts performed within the scope of our employment or volunteer duties.

For additional guidance on business travel for USP employees or volunteers, please refer to the USP Travel Manual and USP Volunteer Travel and Reimbursement Policy for Members of Convention Committees, Council of Experts, Expert Committees, and Advisory Panels.

Restrictions on gifts and entertainment do not prohibit you from entering into a bona fide, arms-length arrangement with any third party or from receiving compensation from a third party for activities outside the scope of your USP duties. However, you must at all times comply with USP’s conflict of interest policy and any other applicable provisions of the Rules of Business Practice, the Rules and Procedures of the Council of Experts, and the Rules and Procedures of the Council of the Convention.

Intellectual Property

At USP, we respect patents, trademarks, and copyrights and will not knowingly violate the intellectual property rights of others. We do not reproduce copyrighted materials unless the materials are covered by USP’s Copyright Clearance Center license or the reproduction is otherwise allowed under USP’s copyright procedures. We are not allowed to install

or use computer files or software not licensed by USP or to use approved software in a way that goes against our licenses or copyright agreements.

At USP, we are committed to defending our copyright and trademark rights in the United States and elsewhere. USP’s name and trademarks may be used only in accordance with applicable USP procedures.

The work product that employees, volunteers, and representatives of USP create for USP is the intellectual property of the organization if it is created or developed,

We do not request personal gifts or entertainment from third parties for acts performed within the scope of our employment or volunteer duties.

We respect patents, trademarks, and copyrights and will not knowingly violate the intellectual property rights of others.

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in whole or in part, on USP time, as part of work duties or through the use of organizational resources or information. “Work product” includes inventions, discoveries, ideas, improvements, software programs, artwork, and works of authorship. Representatives must promptly disclose to USP, in writing, any such work product and cooperate with our efforts to obtain intellectual property protection for USP. To ensure that USP receives the benefit of work done by representatives, it is essential that an appropriate agreement or release is in place before any work begins.

Anti-Trust and Competition

At USP, we believe in free and open competition. Most of the countries where we operate have strict laws prohibiting collusive or unfair business behavior that restricts free competition. U.S. anti-trust and other countries’ competition laws are complicated, and failure to adhere to these laws could result in significant penalties.

In most circumstances, it is illegal to agree with competitors to fix prices, terms of sale, or production output; to divide markets or customers; or to intervene in the contractor selection process by manipulating the contents of the bids or illegally controlling the selection process in any other manner. Also, it may be illegal to attempt to discriminate in prices or terms of sale among our customers, or to otherwise restrict the freedom of our customers to compete. We will not discuss any of these issues with customers or competitors, or participate in a meeting where anti-competitive topics are discussed. It is important to note that the violations of anti-trust and competition laws carry severe civil and criminal penalties. Should you find yourself in a circumstance where these illegal topics are being discussed, you must notify the other party(ies) that you are unable to participate in the discussion and promptly report the event to any of the resources listed in this Code.

Insider Trading

As a USP employee, volunteer, or representative, we may receive confidential information about a USP donor or business partner before it is publicly available to ordinary investors. Some of this information may be considered material and could be important to an investor deciding to buy, sell, or hold securities. “Material” information is information that a reasonable investor would likely consider important in deciding whether to purchase or sell a security. Examples of material information include:

• Product or manufacturing developments

• A major lawsuit or regulatory investigation

• Financial information

• Management changes

• Gain or loss of a significant customer or supplier

At USP, we believe in free and open competition.

Our Code in Action

Does an anti-competitive agreement have to be in writing to be illegal?

No, an agreement does not need to be in writing for it to be illegal. An oral or informal agreement, or even just an understanding, may be considered illegal.

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• Merger, purchase, sale, or joint venture

• Information that may positively or negatively affect the stock price

At USP, we do not use material inside information for personal benefit, trade securities based on material inside information, or provide material inside information to others outside of our organization. Doing so will violate our Code and your obligation to protect confidential information. It may also expose you to criminal or civil liability.

Financial Reporting and Record-Keeping Policy

At USP, we are committed to full, fair, accurate, and timely financial disclosures in reports or documents we create, make public, or file with any governmental authority. We maintain accounting, internal control, and audit systems to ensure the accuracy of our financial statements and records. All reported financial information must conform to generally accepted accounting principles (GAAP) and established USP financial SOPs. Transactions and disbursements must be reported accurately, completely, and in appropriate detail in order to ensure full accountability for all assets and activities of USP and to supply the data needed in connection with the preparation of its financial statements. We do not record any false or misleading statements or entries in USP’s books and records that do not comply with GAAP or local statutory requirements.

Accurate Statements, Submissions, and Representations

In the ordinary course of USP activities, we make numerous submissions, certifications, and representations to federal, state, and local governments and to the prime contractors retained by these entities. Examples of submissions, certifications, and representations include:

• Proposal information

• Pricing data and estimates

• Invoices

• Sourcing information

• Statements regarding USP products and services

At USP, we do not use material inside information for personal benefit, trade securities based on material inside information, or provide material inside information to others outside of our organization.

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While we always strive to ensure that the information we provide is truthful, current, accurate, and complete, we have special obligations whenever we submit information (including invoices, certifications, or reports) to government entities or to private or commercial entities that receive government funds. There are severe criminal and civil sanctions for submitting a false claim when government funds are used to pay or reimburse a portion of the price.

To avoid allegations of false statements or false claims, we must always be truthful and accurate in any communication or submission in our daily responsibilities. If there is any doubt

about the accuracy of a statement, we do not make the statement or represent it to be accurate. In negotiations requiring the supply of “certified cost or pricing data,” all reports, certifications, and proposals must contain complete, accurate, and up-to-date pricing and information.

Political Contributions

At USP, we encourage contribution to the community and participation in local, national, and international political processes. However, USP as an organization may not make any direct or indirect contributions to, or expenditure on behalf of, any:

• Candidate for elective office

• Political party

• Political action committee

USP employees may not use USP property, facilities, or employee time to support a political cause or candidate.

Use of Company Assets

USP provides equipment and technology resources intended for use and efficiency when carrying out employment or volunteer duties for USP. These resources include:

• Computers

• Software

• Telephones

• Mobile devices

• Office equipment and supplies

• Laboratory equipment and supplies

USP resources are to be used only for their legitimate, intended business purposes. We are permitted limited personal use of these resources, but it may not interfere with our work performance or that of our colleagues, or lead to an additional cost to USP. Inappropriate or illegal use of USP resources is strictly prohibited. We reserve the right to monitor and inspect the use of USP resources, as provided by local law and in compliance with this Code.

USP resources are to be used only for their legitimate, intended business purposes.

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B U S I N E S S CO N D U C T – G OV E R N M E N T CL I E N T S

USP is committed to the highest standards of integrity in all dealings with government clients, including with respect to the solicitation and performance of any contract, cooperative agreement, and prime and subcontracts. USP expects all employees who deal with government clients to act with honesty and openness and to comply with applicable government contracting rules and regulations. To ensure compliance, you must:

• Follow federal laws and regulations.

• Follow the U.S. Procurement Integrity Act and not deal in “off-limits information.”

• Follow all applicable bid and tender rules and regulations.

• Not intervene in the contractor selection process by manipulating the contents of the bids or controlling the outcome in any other manner.

Business Conduct – Government Clients

USP expects all employees who deal with government clients to act with honesty and openness and to comply with applicable government contracting rules and regulations.

“USP is committed to the highest standards of integrity in all dealings with government clients.”

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• Not intervene in the bidding process, directly or indirectly, by favoring one approved/certified/elite or other authorized contractor over another in the pricing of USP products.

• Not initiate employment discussions with a government official who currently has or in the immediate past has had discretionary or regulatory responsibilities over USP, without getting guidance from Human Resources, GCE, or GLA.

If you are involved with government clients, you are expected to fully understand and comply with applicable provisions of the relevant government contract, rules, and regulations that affect your responsibilities at USP.

Any employee who believes that he or she is aware of a violation of applicable law or government contractual requirement when dealing with government clients must promptly bring it to the attention of the appropriate resources in this Code. Failure to

report is itself a violation of USP policy and could subject an employee to disciplinary action up to and including termination.

If you are involved with government clients, you are expected to fully understand and comply with applicable provisions of the relevant government contract, rules, and regulations.

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Workplace Conduct

USP is committed to fostering a workplace that is safe, is professional, and promotes diversity and trust. We seek a diverse base of employees and volunteers, and we ensure equal opportunity to all qualified individuals. We provide a supportive working environment where our personal information is safeguarded and we are free from harassment, discrimination, drugs, weapons, or violence.

Equal Employment Opportunity and Affirmative Action

At USP, we are committed to a program of equal employment opportunity without discrimination based on race, ethnicity, color, national origin, gender, gender identity, religion, age, sexual orientation, marital status, veteran status, genetic information, physical or mental disability, or any other personal characteristic protected by law. It is our policy not merely to refrain from discrimination but to take positive affirmative action to realize equal employment opportunity for women, minorities, individuals with disabilities, and veterans.

“USP is committed to fostering a workplace that is safe, is professional, and promotes diversity and trust.”

At USP, we are committed to a program of equal employment opportunity without discrimination.

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In furtherance of this policy, we will:

• Recruit, hire, train, and promote persons of all job classifications without regard to personal characteristics or protected status.

• Ensure that promotion decisions are in accordance with principles of equal employment opportunity by imposing only job-related requirements for promotion opportunities.

• Ensure that all personnel actions, such as compensation, benefits, transfers, layoffs, return to employment, leaves, and USP-sponsored training and education programs will be administered without regard to personal characteristics or protected status.

• Take affirmative action on behalf of women, minorities, individuals with disabilities, and veterans to actively recruit qualified members of these groups for employment with USP.

• Provide for the prompt, thorough, and impartial consideration of all complaints.

• Provide a program of action for the achievement of equal employment opportunity in accordance with the spirit of the law.

• Reasonably accommodate the physical and mental disabilities of any employee or applicant for employment unless such accommodation imposes an undue hardship on the conduct of our business.

Employees interested in consideration under our Affirmative Action Plans for Employees with Disabilities and Covered Veterans should indicate this to their manager or to Human Resources. Submission of this information is voluntary and refusal to provide it will not subject you to adverse treatment.

Accommodation for Disabilities

At USP, we support laws that prohibit discrimination against disabled individuals, such as the Americans with Disabilities Act. We treat all employees, volunteers, and applicants with disabilities in accordance with the requirements of these laws. We evaluate individuals based on abilities, not disabilities, and give full and equal employment and volunteer opportunities to each person with the ability to perform the essential functions of a role, with reasonable accommodations. As a result, we urge employees, volunteers, and applicants to declare any special needs to allow discreet, confidential, and prompt consideration of reasonable accommodations.

At USP, we support laws that prohibit discrimination against disabled individuals.

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Anti-Harassment

At USP, we are committed to a work environment where all individuals are treated with respect and dignity. We all have the right to work in a professional atmosphere that prohibits harassment. Harassment is an unpleasant or hostile situation created by unwelcome written, verbal, or physical conduct. Therefore, we expect that all relationships among USP employees, volunteers, and representatives will be business-like and free of bias, prejudice, and harassment. We do not tolerate any form of harassment on the basis of race, ethnicity, color, national origin, gender, gender identity, religion, age, sexual orientation, marital status, veteran status, genetic information, physical or mental disability, or any other personal characteristic protected by law. Our zero-tolerance policy extends to all employees, volunteers, and representatives.

Harassment may include but is not limited to:

• Inappropriate jokes, threats, or whistling

• Gestures and unwelcome touching

• Inappropriate posters, email messages, or similar material

• Requests for sexual favors in exchange for promotions or raises

• Use of title or position to harass employees

If any such harassment is encountered, do not ignore the behavior. Stop the offender and make clear that any repetition will be reported (and do so if the behavior is repeated). If you are uncomfortable with this step,

or have been unable to do so, we strongly encourage you to report the incident to your manager or to Human Resources. If this is not a reasonable option for you, report the incident in accordance with our Reporting Policy.

Privacy

At USP, we respect your personal information and treat it with care. International laws regarding the treatment of personal information vary. USP will treat personal data in accordance with applicable law.

There are circumstances that require USP to receive, or have access to, personal information to administer various programs, such as payroll, health benefits, time off, and career development. Examples of personal information include your home phone number, address, family information, benefit elections, medical conditions, salary, and performance ratings.

At USP, we are committed to a work environment where all individuals are treated with respect and dignity.

If any such harassment is encountered, do not ignore the behavior. Stop the offender and make clear that any repetition will be reported.

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Personal information may be accessed only by authorized employees for business purposes or for other purposes permitted by law. Personal information will be shared with outside organizations only in a manner that is consistent with applicable law.

While we respect employees’ privacy, all data stored on USP’s computers, including email sent or received on our network or using a computer or device that is connected to our network and stores the data on our equipment, is USP’s property and is not private, except as defined by local law. We reserve the right to inspect our facilities and property, such as computers, telephone records, emails, files, business documents, and workspaces. Employees should not expect privacy when using company-provided services or equipment, except as provided by local law.

For USP employees, we have specific SOPs concerning the use of email, the Internet, and other electronic information sources while on USP time or using USP computers.

Environmental Health and Safety

At USP, we conduct our operations in an environmentally sound manner and comply with all applicable environmental laws and regulations. As employees, we are responsible for knowing the environmental responsibilities of our job and conducting business in accordance with environmental laws, international standards, and best practices for:

• Reducing water and energy use

• Controlling air emissions

• Controlling wastewater discharges

• Properly managing hazardous waste

• Minimizing solid and hazardous waste generation

• Preventing spills or releases

In addition, we are committed to providing our employees with a safe and secure work environment. Our laboratories comply with all health and safety laws and regulations, as well as our own health and safety SOPs that go beyond the minimum legal requirements. To achieve this result, we must follow USP safety rules and procedures, cooperate with employees who enforce safety rules and procedures, attend required safety training, and report all safety concerns.

At USP, we conduct our operations in an environmentally sound manner and comply with all applicable environmental laws and regulations.

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Drug-Free Workplace

To provide a safe work environment, it is USP’s policy to maintain a drug-free workplace. The use, possession, sale, or distribution of illegal controlled substances is expressly prohibited while on USP time. Legal or illegal substances, including alcohol, may not be used in a manner that impairs your performance of assigned tasks or creates a safety hazard for others.

Workplace Violence

At USP, we are all expected to solve conflict responsibly. It is not acceptable to threaten violence in any manner or to engage in actions that create an actual or potential hazard for others in the workplace. You should contact your manager, Human Resources, or any of the other resources listed in this Code, for assistance in solving problems if you are

unable to do so yourself. If threatening or violent behavior does occur, you should immediately report the behavior to local law enforcement and management at your site.

If you receive a threat or suffer violence from someone who is not a USP employee, volunteer, or representative while at USP, through the phone, voicemail, email, physical presence on USP property, or otherwise, it should be reported to your manager, or local law enforcement. USP may be able to take steps to reduce the other person’s ability to contact you at work. For matters outside of work, you should contact local law enforcement officials.

Workplace Weapons

At USP, we prohibit the wearing, transporting, storage, or presence of firearms, knives, or other weapons in our facilities or on our property. Any employee in possession of a firearm, knife, or other weapon while at our facilities or properties, or while otherwise fulfilling job responsibilities, may face disciplinary action up to and including termination. Possession of a valid concealed weapons permit authorized by the government is not an exemption under this policy.

It is not acceptable to threaten violence in any manner or to engage in actions that create an actual or potential hazard for others in the workplace.

We prohibit the wearing, transporting, storage, or presence of firearms, knives, or other weapons in our facilities or on our property.

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WA I V E R S

USP will waive application of the SOPs set forth in this Code only where circumstances warrant granting a waiver based on the best interests of USP. In no case will USP grant a waiver to allow any violations of law or regulations. Any waiver pertaining to an employee must be approved by the Chief Legal Officer and by the Chief Executive Officer. Waivers of the Code for the Board of Trustees and executive officers may be made only by those members of the Board of Trustees not involved in the conduct giving rise to the possible waiver and must be promptly disclosed. Waivers of the Code for volunteer members of the Council of Experts, Expert Committees, and Expert Panels may be made only by the Chair of the Council of Experts and must be promptly disclosed.

Waivers

“Any waiver pertaining to an employee must be approved by the Chief Legal Officer and by the Chief Executive Officer.”

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R E PO R T I N G PO L I CY

Speaking Up

In addition to knowing the legal and ethical standards that apply to your position, you are expected to speak up if you have a good-faith concern regarding the following types of misconduct:

• Fraud or misuse of USP resources

• Violations of law or regulations

• Questionable or improper accounting or auditing matters

• Known or suspected instances of improper billing on a government contract or subcontract

• Failures to comply with the Code, Rules of Business Practice for the Board of Trustees, the Rules and Procedures of the Council of Experts, the Rules and Procedures of the Council of the Convention, the Employee Handbook, the Quality Manual, or SOPs

We ask that you report any alleged, suspected, or known misconduct to any of the resources provided in this Code, or anonymously through the USP Helpline (see Using the Helpline). Failure to report a known violation of law or of USP policy is itself a violation of USP policy and could subject you to disciplinary action, up to and including termination. Every effort will be made to respond to your report within 10 business days. If an investigation is undertaken, it will be conducted promptly and thoroughly.

Reporting Policy

“You are expected to speak up if you have a good-faith concern.”

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R E PO R T I N G PO L I CY

Anyone reporting potential misconduct must act in good faith and have reasonable grounds for believing the information disclosed. “Good faith” is an honest belief in performing your duty or obligation. Making allegations maliciously, recklessly, or with the knowledge that the allegations are false is a serious offense and may result in appropriate disciplinary measures.

The Code does not cover every situation that may arise and the Helpline and this Reporting Policy is primarily intended for reporting illegal or unethical conduct. If you have a question or concern related to strategic direction, management style, personnel grievance, or other management considerations we encourage you to consider first talking to your management chain, Human Resources, or other senior USP managers.

Investigations

When called for, investigations are handled on a case-by-case basis, depending on the nature of the alleged or suspected misconduct. In each case, USP will try to determine if misconduct has occurred, respond in a timely manner, and make corrections and/or recommendations, if required. No person will direct or conduct the investigation of a matter if he or she is a subject of the report, or if management deems that a potential conflict

of interest exists. Outside legal counsel, accountants, investigators, or other resources may be retained if necessary to conduct a full and complete investigation of the potential misconduct. Due process and appropriate protections will be afforded to those named or implicated in any investigations. Additional information about the receipt and handling of reports of misconduct may be found in the Guidelines for Referral and Investigation of Reported Misconduct. The results of all investigations, along with any recommended corrective action, will be reported to the Audit Committee of the Board of Trustees.

At times USP may require you to assist in the internal or external investigation of a violation of the law, Code, SOPs, or other misconduct. You are expected to cooperate with these requests. You may never interfere in an investigation, knowingly offer false information, or alter or destroy any relevant documents or information.

You may never interfere in an investigation, knowingly offer false information, or alter or destroy any relevant documents or information.

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Non-Retaliation Policy

At USP, our policy is to encourage and enable employees, volunteers, and representatives to report suspected or known misconduct of the type described in this Reporting Policy, for investigation and appropriate action. No one who submits a report in good faith will be subject to retaliation or, in the case of an employee, adverse employment consequences.

Our policy also prohibits retaliation against any individual who assists in an investigation. Anyone who retaliates against someone who has reported in good faith, or who assists in an investigation, will be subject to appropriate disciplinary measures, up to and including termination.

Confidentiality of Reports

Reports of misconduct, the fact that an investigation has been initiated, as well as information gathered during an investigation are kept confidential to the extent possible, consistent with the need to complete an adequate investigation, provide appropriate due process to anyone accused of misconduct, protect witnesses, and implement any corrective action. If you report potential misconduct, a summary of your report may be shared with the subject of the report in order to provide that person with an opportunity to respond. In addition, the results of all investigations, along with any corrective action, will be reported to the Audit Committee of the Board of Trustees. USP will keep all investigative information confidential to the extent possible but may be required to disclose such information as a result of court orders, government inquiries, or other similar events.

Our Code in Action

What are examples of retaliation and acceptable conduct?

Retaliation can include:

• Identifying an employee as the person who made the report if that information was confidential

• Lowering or deducting pay • Not promoting an employee

because he or she reported a concern or cooperated in a compliance investigation

• Terminating an employee because he or she raised a concern

Retaliation does not include:

• Disciplining an employee for knowingly making a malicious or fraudulent accusation

• Asking an employee to do something already in his or her job description

• Continuing to manage performance after an employee reports a concern to the USP Helpline

No one who submits a report in good faith will be subject to retaliation.

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Using the Helpline

To report suspected or known misconduct using the Helpline:

• By telephone from the United States, call the Direct Dial Number at 1.866.492.3365. International dialing instructions to reach the Direct Dial Number are located at www.usp.ethicspoint.com.

• Online, complete the reporting form located at www.usp.ethicspoint.com.

The Helpline is hosted by a third-party provider and operates globally 24 hours a day, 7 days a week, 365 days a year. You may submit a report

via telephone or online in any language. When you file a report, the operator or online reporting system will gather the information and give you a reference number so that you may call back or log in to receive follow-up information or questions.

Anonymity of the Helpline

In most countries, you may make a call to the Helpline anonymously. USP does not track or record calls or online traffic to the Helpline. However, local laws in some countries, particularly in Europe, discourage anonymous reporting and restrict the scope of what may be reported through the Helpline to:

• Improper financial or audit concerns

• Fraud

• Violations of law

As noted above, it may be necessary to share a summary of your report (whether anonymous or not) with the person or persons accused of wrongdoing to provide them with an opportunity to respond. Therefore, if you choose to report anonymously, you should be careful not to include any identifying information in your report. If it is not possible to report without including identifying information, you should indicate that in your report, so the investigators may redact the identifying information from any report shared with the respondent(s). If you chose to report anonymously, it is important that you include sufficient details to allow USP to identify the time, place, and parties involved in the conduct so that appropriate action can be promptly taken.

The Helpline is hosted by a third-party provider and operates globally 24 hours a day, 7 days a week, 365 days a year.

USP does not track or record calls or online traffic to the Helpline.

1-866-492-3365

I N-PE RSON

Management, HR, GLA, GCE

PHON E

1-866-492-3365

E MAI L

compliance@usp.org

ONLI N E

www.usp.ethicspoint.com

WAYS TO SEEK HELP

U.S. and Canada only

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