Department of the Treasury Internal Revenue Service
Public Charity Status and Public Support
Complete if the organization is a section 501(c)(3) organization or a section
4947(a)(1) nonexempt charitable trust.
Attach to Form 990 or Form 990-EZ. See separate instructions. Information about Schedule A (Form 990 or 990-EZ) and its instructions is at www.irs.gov/form990.
OMB No. 1545-0047
2013
Open to Public Inspection
Name of the organization
United States Pharmacopeial Convention
Employer identification number
13-1656692
Part I
Reason for Public Charity Status
(All organizations must complete this part.) See instructions.
The organization is not a private foundation because it is: (For lines 1 through 11, check only one box.)
1
2
3
4
5
section 170(b)(1)(A)(iv). (Complete Part II.)
6
7
8
9
receipts from activities related to its exempt functions—subject to certain exceptions, and (2) no more than 331/3% of
its support from gross investment income and unrelated business taxable income (less section 511 tax) from businesses
acquired by the organization after June 30, 1975. See section 509(a)(2). (Complete Part III.)
10
11
e
By checking this box, I certify that the organization is not controlled directly or indirectly by one or more disqualified persons other than foundation managers and other than one or more publicly supported organizations described in section 509(a)(1) or section 509(a)(2).
f
If the organization received a written determination from the IRS that it is a Type I, Type II, or Type III supporting organization, check this box
..................................................
g
Since August 17, 2006, has the organization accepted any gift or contribution from any of the following persons?
(i) A person who directly or indirectly controls, either alone or together with persons described in (ii)
Yes
No
and (iii) below, the governing body of the supported organization?
................
11g(i)
(ii)
A family member of a person described in (i) above?
......................
11g(ii)
(iii)
A 35% controlled entity of a person described in (i) or (ii) above?
................
11g(iii)
h
Provide the following information about the supported organization(s).
(i) Name of supported organization
(ii) EIN
(iii) Type of organization (described on lines 1- 9 above or IRC section (see instructions))
(iv) Is the organization in col. (i) listed in your governing document?
(v) Did you notify the organization in col. (i) of your support?
(vi) Is the organization in col. (i) organized in the U.S.?
(vii) Amount of monetary support
Yes
No
Yes
No
Yes
No
Total
For Paperwork Reduction Act Notice, see the Instructions for Form 990 or 990EZ.
Cat. No. 11285F
Schedule A (Form 990 or 990-EZ) 2013
Schedule A (Form 990 or 990-EZ) 2013
Page 2
Part II
Support Schedule for Organizations Described in Sections 170(b)(1)(A)(iv) and 170(b)(1)(A)(vi) (Complete only if you checked the box on line 5, 7, or 8 of Part I or if the
organization failed to qualify under Part III. If the organization fails to
qualify under the tests listed below, please complete Part III.)
Section A. Public Support
Calendar year (or fiscal year beginning in)
(a) 2009
(b) 2010
(c) 2011
(d) 2012
(e) 2013
(f) Total
1
Gifts, grants, contributions, and membership fees received. (Do not include any "unusual grants.") ....
2
Tax revenues levied for the organization's benefit and either paid to or expended on its behalf.......
3
The value of services or facilities furnished by a governmental unit to the organization without charge..
4
Total. Add lines 1 through 3
5
The portion of total contributions by each person (other than a governmental unit or publicly supported organization) included
on line 1 that exceeds 2% of the amount shown on line 11, column (f)..
6
Public support. Subtract line 5 from line 4.
Section B. Total Support
Calendar year
(or fiscal year beginning in)
(a) 2009
(b) 2010
(c) 2011
(d) 2012
(e) 2013
(f) Total
7
Amounts from line 4..
8
Gross income from interest, dividends, payments received on securities loans, rents, royalties and income from similar sources...
9
Net income from unrelated business activities, whether or not the business is regularly carried on..
10
Other income. Do not include gain or loss from the sale of capital assets (Explain in Part IV.)..
11
Total support (Add lines 7 through 10).
12
Gross receipts from related activities, etc. (see instructions)
..................
12
13
First five years.
If the Form 990 is for the organization's first, second, third, fourth, or fifth tax year as a 501(c)(3) organization,
check this box and stop here.................................................
Section C. Computation of Public Support Percentage
14
Public support percentage for 2013 (line 6, column (f) divided by line 11, column (f))
.........
14
15
Public support percentage for 2012 Schedule A, Part II, line 14
...............
15
16a
33 1/3% support test—2013.
If the organization did not check the box on line 13, and line 14 is 33 1/3% or more, check this box
and stop here. The organization qualifies as a publicly supported organization
.......................
b
33 1/3% support test—2012.
If the organization did not check a box on line 13 or 16a, and line 15 is 33 1/3% or more, check this
box and stop here. The organization qualifies as a publicly supported organization
.....................
17a
10%-facts-and-circumstances test—2013.
If the organization did not check a box on line 13, 16a, or 16b, and line 14
is 10% or more, and if the organization meets the "facts-and-circumstances" test, check this box and stop here. Explain
in Part IV how the organization meets the "facts-and-circumstances" test. The organization qualifies as a publicly supported
organization
.....................................................
b
10%-facts-and-circumstances test—2012.
If the organization did not check a box on line 13, 16a, 16b, or 17a, and line
15 is 10% or more, and if the organization meets the "facts-and-circumstances" test, check this box and stop here.
Explain in Part IV how the organization meets the "facts-and-circumstances" test. The organization qualifies as a publicly supported organization
................................................
18
Private foundation.
If the organization did not check a box on line 13, 16a, 16b, 17a, or 17b, check this box and see
instructions
.....................................................
Schedule A (Form 990 or 990-EZ) 2013
Schedule A (Form 990 or 990-EZ) 2013
Page 3
Part III
Support Schedule for Organizations Described in Section 509(a)(2) (Complete only if you checked the box on line 9 of Part I or if the organization
failed to qualify under Part II. If the organization fails to qualify under
the tests listed below, please complete Part II.)
Section A. Public Support
Calendar year (or fiscal year beginning in)
(a) 2009
(b) 2010
(c) 2011
(d) 2012
(e) 2013
(f) Total
1
Gifts, grants, contributions, and membership fees received. (Do not include any "unusual grants.") .
37,060,996
11,476,249
12,058,237
10,666,763
9,085,654
80,347,899
2
Gross receipts from admissions, merchandise sold or services performed, or facilities furnished in any activity that is related to the organization's tax-exempt purpose......
117,254,467
133,976,191
148,646,258
165,964,538
184,631,934
750,473,388
3
Gross receipts from activities that are not an unrelated trade or business under section 513..
31,125
31,125
4
Tax revenues levied for the organization's benefit and either paid to or expended on its behalf...
0
5
The value of services or facilities furnished by a governmental unit to the organization without charge..
0
6
Total. Add lines 1 through 5.
154,315,463
145,483,565
160,704,495
176,631,301
193,717,588
830,852,412
7a
Amounts included on lines 1, 2, and 3 received from disqualified persons...
0
b
Amounts included on lines 2 and 3 received from other than disqualified persons that exceed the greater of $5,000 or 1% of the amount on line 13 for the year.
0
c
Add lines 7a and 7b..
0
8
Public support (Subtract line 7c from line 6.)
830,852,412
Section B. Total Support
Calendar year (or fiscal year beginning in)
(a) 2009
(b) 2010
(c) 2011
(d) 2012
(e) 2013
(f) Total
9
Amounts from line 6...
154,315,463
145,483,565
160,704,495
176,631,301
193,717,588
830,852,412
10a
Gross income from interest, dividends, payments received on securities loans, rents, royalties and income from similar sources..
3,104,918
3,271,009
3,321,352
2,894,581
3,108,959
15,700,819
b
Unrelated business taxable income (less section 511 taxes) from businesses acquired after June 30, 1975.
0
c
Add lines 10a and 10b.
3,104,918
3,271,009
3,321,352
2,894,581
3,108,959
15,700,819
11
Net income from unrelated business activities not included in line 10b, whether or not the business is regularly carried on.
0
12
Other income. Do not include gain or loss from the sale of capital assets (Explain in Part IV.)
..
3,286,090
677,414
3,963,504
13
Total support. (Add lines 9, 10c, 11, and 12.)..
157,420,381
148,754,574
164,025,847
182,811,972
197,503,961
850,516,735
14
First five years.
If the Form 990 is for the organization's first, second, third, fourth, or fifth tax year as a 501(c)(3) organization,
check this box and stop here.............................................
Section C. Computation of Public Support Percentage
15
Public support percentage for 2013 (line 8, column (f) divided by line 13, column (f))
.........
15
97.688 %
16
Public support percentage from 2012 Schedule A, Part III, line 15
...............
16
97.869 %
Section D. Computation of Investment Income Percentage
17
Investment income percentage for 2013 (line 10c, column (f) divided by line 13, column (f))
......
17
1.846 %
18
Investment income percentage from 2012 Schedule A, Part III, line 17
.............
18
1.723 %
19a
33 1/3% support tests—2013.
If the organization did not check the box on line 14, and line 15 is more than 33 1/3%, and line 17 is not more than 33 1/3%, check this box and stop here. The organization qualifies as a publicly supported organization
........
b
33 1/3% support tests—2012.
If the organization did not check a box on line 14 or line 19a, and line 16 is more than 33 1/3% and line 18 is not more than 33 1/3%, check this box and stop here. The organization qualifies as a publicly supported organization
.....
20
Private foundation.
If the organization did not check a box on line 14, 19a, or 19b, check this box and see instructions
.....
Schedule A (Form 990 or 990-EZ) 2013
Schedule A (Form 990 or 990-EZ) 2013
Page 4
Part IV
Supplemental Information.
Provide the explanations required by Part II, line 10; Part II, line 17a or 17b; and Part III, line 12. Also complete this part for any additional information. (See instructions).
Facts And Circumstances Test
Explanation
Schedule A (Form 990 or 990-EZ) 2013
Additional Data
Software ID:
Software Version:
-
TIN:
SCHEDULE O (Form 990 or 990-EZ)
Department of the Treasury Internal Revenue Service
Supplemental Information to Form 990 or 990-EZ
Complete to provide information for responses to specific questions on
Form 990 or to provide any additional information.
Attach to Form 990 or 990-EZ.
Information about Schedule O (Form 990 or 990-EZ) and its instructions is at
www.irs.gov/form990.
OMB No. 1545-0047
2013
Open to Public Inspection
Name of the organization
United States Pharmacopeial Convention
Employer identification number
13-1656692
Return Reference
Explanation
Program Service Accomplishments
FORM 990, PART III, LINE 4A COMPENDIAL PROGRAMS - USP ESTABLISHES INTERNATIONALLY RECOGNIZED PUBLIC STANDARDS (BOTH DOCUMENTARY STANDARDS AND THE PHYSICAL REFERENCE MATERIALS THAT SUPPORT THE APPLICATION AND USE OF THESE DOCUMENTARY STANDARDS) TO HELP ASSURE GOOD QUALITY MEDICINES, DIETARY SUPPLEMENTS, FOOD INGREDIENTS, AND RELATED PRODUCTS USED TO MAINTAIN HEALTH AND TREAT DISEASE. THESE STANDARDS ARE DEVELOPED USING AN OPEN, PUBLIC PROCESS AND ARE APPROVED BY INDEPENDENT SCIENTIFIC EXPERTS. PRESCRIPTION AND OVER THE COUNTER MEDICINES AVAILABLE IN THE UNITED STATES MUST, BY FEDERAL LAW, MEET USP'S PUBLIC STANDARDS, WHERE SUCH STANDARDS EXIST. MANY OTHER COUNTRIES REQUIRE THE USE OF HIGH-QUALITY STANDARDS SUCH AS USP'S TO ASSURE THE QUALITY OF MEDICINES, FOOD INGREDIENTS, AND RELATED PRODUCTS. USP DISSEMINATES ITS STANDARDS TO PHARMACEUTICAL MANUFACTURERS, PHARMACISTS, FOOD MANUFACTURERS, AND OTHER USERS THROUGH ITS USP-NF, FOOD CHEMICALS CODEX (FCC), OTHER COMPENDIA AND PUBLICATIONS, AND OFFICIAL USP REFERENCE STANDARD MATERIALS. THESE STANDARDS ARE SHARED WITH OTHER COUNTRIES AROUND THE WORLD VIA THEIR DRUG REGULATORY AGENCIES AND COMPANIES. INCREASINGLY, DRUG REGULATORY AUTHORITIES IN OTHER COUNTRIES ARE RECEIVING ASSISTANCE FROM USP IN UNDERSTANDING HOW THEY CAN IMPROVE THE QUALITY OF MEDICINES PROVIDED TO THEIR CITIZENS BY USING USP STANDARDS. VOLUNTEER EXPERTS FROM THOSE COUNTRIES ARE ACTIVE PARTICIPANTS IN USP'S STANDARDS-SETTING BODIES. IN ADDITION, USP DEVELOPS STANDARDS THAT ARE VITAL TO ENSURING AND IMPROVING PATIENT SAFETY IN A VARIETY OF SETTINGS RELATED TO THE APPROPRIATE LABELING, STORAGE, DISTRIBUTION AND USE OF MEDICINES. HEALTH CARE CLINICIANS AS WELL AS PATIENTS RELY ON THESE STANDARDS TO HELP ENSURE THAT MEDICINES ARE DELIVERED AND USED APPROPRIATELY. Program Service Accomplishments FORM 990, PART III, LINE 4B ALLIED COMPENDIAL PROGRAMS - USP CONDUCTS VERIFICATION PROGRAMS FOR PHARMACEUTICAL INGREDIENTS, AND FOR DIETARY SUPPLEMENT INGREDIENTS AND PRODUCTS. THESE PROGRAMS INVOLVE INDEPENDENT TESTING AND REVIEW TO VERIFY THE IDENTITY, STRENGTH, QUALITY AND PURITY OF INGREDIENTS AND PRODUCTS FOR MANUFACTURERS WHO CHOOSE TO PARTICIPATE. THEY HELP TO IMPROVE THE QUALITY OF MEDICINES AND DIETARY SUPPLEMENTS THAT ARE MANUFACTURED AND THEN PROVIDED TO PATIENTS AND CONSUMERS THROUGH THE GLOBAL SUPPLY CHAIN. USP CONDUCTS EDUCATIONAL CLASSES AND PROGRAMS FOR CHEMISTS, SCIENTISTS, AND HEALTHCARE PRACTITIONERS IN THE UNITED STATES AND AROUND THE WORLD. USP SEEKS TO IMPROVE THE EFFECTIVE USE OF ITS STANDARDS THAT AFFECT BEST PRACTICES IN MANUFACTURING AND REGULATION OF PHARMACEUTICALS, DIETARY SUPPLEMENTS, AND FOOD INGREDIENTS. Program Service Accomplishments FORM 990, PART III, LINE 4C NON COMPENDIAL PROGRAMS - USP ENGAGES IN OTHER PUBLIC HEALTH INITIATIVES INCLUDING SERVING AS THE SECRETARIAT FOR A MAJOR GROUP OF OTHER NON-PROFIT ORGANIZATIONS THAT JOIN TO COORDINATE PATIENT SAFETY/MEDICAL ERROR EFFORTS. UNDER FEDERAL LAW, ONE OF USP'S HEALTH CARE INFORMATION INITIATIVES IS THE DEVELOPMENT OF A DRUG CLASSIFICATION SYSTEM THAT MEDICARE PRESCRIPTION DRUG BENEFIT PLANS MAY USE TO DEVELOP THEIR FORMULARIES. PROMOTING THE QUALITY OF MEDICINES (PQM): USP PARTICIPATES IN A COOPERATIVE AGREEMENT WITH THE US AGENCY FOR INTERNATIONAL DEVELOPMENT (USAID). UNDER THIS AGREEMENT USP WORKS IN DEVELOPING COUNTRIES TO STRENGTHEN QUALITY ASSURANCE AND QUALITY CONTROL SYSTEMS, INCREASE THE SUPPLY OF QUALITY ASSURED MEDICINES, COMBAT THE AVAILABILITY OF SUBSTANDARD AND COUNTERFEIT MEDICINES, AND PROVIDE TECHNICAL LEADERSHIP AND GLOBAL ADVOCACY. CENTER FOR PHARMACEUTICAL ADVANCEMENT AND TRAINING (CEPAT) ADDRESSES DEFICIENCIES IN HUMAN AND LABORATORY RESOURCES IN PHARMACEUTICAL QUALITY CONTROL AND SEEKS TO BUILD CAPACITY OF AFRICAN PROFESSIONALS IN QUALITY CONTROL AND QUALITY ASSURANCE OF MEDICINES. USPS TECHNICAL ASSISTANCE AND GLOBAL HEALTH IMPACT PROGRAMS PROMOTE THE USE OF QUALITY STANDARDS IN DEVELOPING COUNTRIES TO HELP AND IMPROVE THE DEVELOPMENT AND REGULATION OF MEDICINES AND FOODS IN SUCH REGIONS. Members or Stockholders Form 990, Part VI, Line 6 The members of USP are representatives from organizations in the US and abroad in the following categories: - Health Practitioner professional and scientific associations - Consumer and other public interest organizations - Manufacturer, trade, and affiliated associations - Governmental bodies, divisions, or associations - Non-government standards-setting and conformity assessment bodies
Members or Stockholders Who May Elect and Decisions Subject to Approval
Form 990, Part VI, Line 7a & 7b THE MEMBERS OF USP ELECT THE MEMBERS OF THE BOARD OF TRUSTEES AT EACH FIVE-YEAR MEETING OF THE CONVENTION. UP TO THREE ADDITIONAL TRUSTEES MAY BE APPOINTED BY THE BOARD DURING THE FIVE-YEAR CYCLE.
Form 990 Review Process
Form 990, Part VI, Line 11b The Form 990 was reviewed thoroughly by the organization's Vice President of Finance, Accounting & Treasury in initial draft and final form prior to filing. The Form 990 was provided to the audit committee for review and approval. The Form 990 was also made available electronically to all members of the board of directors before it was filed with the IRS.
Conflict of Interest Policy Monitoring & Enforcement
Form 990, Part VI, Line 12c USP's conflict of interest policy is reflected in its bylaws and in its code of ethics. This policy is implemented with respect to our employees and volunteers (members of the board of trustees and the council of experts and expert committees, USP's standard setting bodies) through specific provisions in the employee handbook, the rules of business practice for the board of trustees, and the rules and procedures of the council of experts. All trustees, members of the council of experts and expert committees, and employees in director level or above positions or positions where they work with expert committees are required to submit and keep current a disclosure statement identifying any conflict of interest. For USP's volunteers, a conflict of interest is defined broadly under the bylaws to include a financial interest in a company or any other relationship or interest that could interfere with the individual's ability to exercise independent judgment. Trustees, experts and employees are required to recuse themselves from any matter in which they have a potential conflict, and employees may also be required to divest themselves of interests that present a potential conflict. At each meeting of the board and all expert committees, the chair reminds member of the conflict of interest rules. The identification and resolution of conflicts of interest is handled as follows for USP employees and volunteers: Employees: Disclosure statements are collected annually by the legal department from employees at the director level and above and employees who work directly with USP's expert committees. If an employee discloses that he or she has a financial interest above the specified threshold, the Chief Legal Officer reviews the interest with the CEO. If the CEO determines that the interest is an isolated one and one that would be difficult to divest (e.g., a retirement plan from a former employer, or a spouse's employment), the employee is allowed to retain the interest but must recuse himself/herself in any situation where there is a potential conflict. In other cases, such as where there are multiple interests above the threshold, the CEO may ask the employee to divest. Members of the Board of Trustees: Disclosure statements are collected by the secretary, and the board members have an obligation to update them as necessary to keep them current. If a board member has a potential conflict, then in accordance with the bylaws he or she must recuse himself/herself from any final deliberation and vote in the matter. Council of Experts and Expert Committee Members: Disclosure statements are collected by the executive secretariat, and members have an obligation to update them as necessary to keep them current. The chair of each expert committee, working with staff (scientific liaison/executive secretariat/secretary), has responsibility for resolving conflict issues.
Process for Determining Compensation
Form 990, Part VI, Line 15A & 15B The USP Board of Trustees approved a total compensation philosophy with the following key provisions: - USP will link base pay and variable pay to performance in such a way that it aligns with USP's strategic planning process and outcome-based metrics, and results in differential rewards. - USP will continually evaluate and realign performance measures to conform to changing strategic goals and other business needs. - USP's total cash compensation program will be designed using a market-driven whole job family structure to deliver above average total compensation, direct and indirect, relative to those offered within various labor markets in which USP competes for talent. - The total compensation package will be established, reviewed, and approved in a manner that qualifies for the rebuttable presumption of reasonableness and will be reviewed periodically to ensure that it continues to be aligned with USP's strategic direction and financial limits and continues to be both reasonable and competitive. Under the rules of business practice of the board of trustees, the operations committee of the board is responsible for overseeing the organization's compensation and benefits systems and programs, including: 1. Reviewing and making recommendations to the Board regarding the overall compensation philosophy and principles of the organization. 2. Reviewing the structure of the staff compensation program, including salary levels, benefits, and the success sharing plan and the extent to which they are achieving desired purposes. 3. Reviewing and making recommendations to the executive committee and the board regarding employee benefit plans and employee benefits, with the board retaining responsibility for final approval of the insurer or insurers through whose policies the plan benefits are to be funded and the rules and procedures for administration of the plan. 4. Based on input from the evp-ceo, reviewing and making recommendations to the board regarding the proposed metrics for organizational performance under the success sharing plan, and the achievement of such metrics. In addition to periodic independent consultant evaluations, management annually uses published studies of the Human Resources Association of the National Capital Area, the American Research Company, and CEO Update to align and adjust the compensation structure and practices according to market trends. Further, individual compensation decisions are made in partnership between Human Resources and the hiring supervisor, reviewed by department vice presidents and/or division chiefs. All staff compensation actions are ultimately reviewed and approved by the CEO. For CEO compensation, the Board Chair annually receives current market data for chief staff executive positions which is shared with the Executive Committee. The Executive Committee makes all CEO compensation decisions and the Board Chair and Board Treasurer approve those decisions in writing. The 2014 compensation of USP officers and/or other key executives was based on a salary structure that was developed using external market data derived from a compensation study completed by PRM Consulting in the Fall of 2012. Additionally, in April 2014 PRM Consulting reviewed the salaries of USP's key executives to ensure that the compensation was still appropriate, and determined that the base salaries and total compensation were in line with the benchmark data and that the salary structure remained competitive and current with the market. That information was provided to the Operations Committee of the Board of Trustees who accepted PRM's findings. The CEO's compensation was reviewed and approved by the Chair of the Board of Trustees and the Executive Operations Committee of the Board of Trustees in September 2014.
How Documents are Made Available to the Public
Form 990, Part VI, Line 19 USP makes these documents available to the public to the extent required by law.
Other Changes in Net Assets or Fund Balances:
Form 990, Part XI, Line 9 Unrealized Foreign Exchange Losses $(657,167)
For Paperwork Reduction Act Notice, see the Instructions for Form 990 or 990-EZ.