Appendix E:USP Document Disclosure Policy The general policy of the United States Pharmacopeial Convention (USP)is to make available documents containing third party communications for public inspection.USPwill make the fullest disclosure of records possible,consistent with the rights of individuals to privacy,the property rights of persons in trade secrets and confidential commercial or financial information,and the need of the Convention to promote frank internal deliberations and to pursue its activities without disruption.The term USPpersonnel as used in this policy statement includes members of the USP Board of Trustees,the Council of Experts,Expert Committees,and Advisory Panels,individuals assigned text-review responsibilities,and staff.Such documents and records will be made available in accordance with the following:
  1. Documents available for public viewing Listed below are documents available for public viewing at USPheadquarters during regular office hours,8:30am to 5:00pm.Machine readable or electronic versions of the documents listed below may be made available for viewing if such exist.[NOTE:Because of space limitations,permission to utilize the library shall be obtained at least 24hours in advance from the Manager of Library Sciences,telephone (301)881-0666.Permission is freely given.]
    1. All volumes and periodicals contained in the library.
    2. The official compendia,supplements,addenda,and interim revision announcements.
    3. Copyrighted publications derived or abstracted from the USP DIdatabase.
    4. The USP Dictionary of USANand International Drug Names.
    5. Pharmacopeial Forum(PF)and USP DI Review.
    6. Other volumes published by the USP.
    7. USP Material Safety Data Sheets and other information required to be maintained by the Department of Labor,Occupational Safety and Health Administration,or other government law or regulation regarding substances on the USPpremises.These documents are disclosable only on a need-to-know basis.
    8. The book,USP People,Policies,and Procedures.
    9. USP Reference Standards Catalog.
    10. Proceedings of USP Convention Meetings,the USPcurrent membership list,and the USP Annual Report.
    11. List of current members of the Board of Trustees and of the Council of Experts,Expert Committees and Advisory Panels.
    12. Rules and Procedures of the Council of Experts,its Division Executive Committees,and Expert Committees.
    13. List of names of USPstaff members.
    14. Weekly meeting schedule.
    15. USP Quality Review,News from the Pharmacopeial Forum,Pharmacy Board bulletins,news releases,and other USPprepared,mass-produced materials mailed to third parties.
    16. USPmember memos.
    17. Any other document required by government law or regulation to be publicly available.
  2. USP Documents available only on written request Except as indicated in Part 4below,copies of the following documents are ordinarily available upon written request only:
    1. Correspondence between USPpersonnel and third parties.
    2. Memoranda of telephone conversations between USPpersonnel and third parties.
    3. Memoranda of meetings between USPpersonnel and third parties.
    4. Copies of requests for documents.
    5. Copies of speeches or public presentations by USPpersonnel.
    6. Copies of USP Convention committee reports:
      1. Report of the Nominating Committee for the Council of Experts.
      2. Report of the Constitution and Bylaws Committee.
      3. Report of the Nominating Committee for the Board of Trustees.
    7. The auditors'financial statements for the USP Convention.
    8. Edited text prepared from reports submitted to the USP Practitioners'Reporting NetworkSM(USP PRN)after deletion of names and any information that would identify the person submitting the information or third parties involved with the report (e.g.,a patient,physician,hospital,etc.).
  3. Documents not disclosable or available for public inspection
    1. Internal or interoffice communications,including:
      1. USP Council of Experts and Expert Committee communications,including e-mail,ballots,memoranda,letters,and marginal comments and communications on pages of USP DI Reviewand Pharmacopeial Forum.
      2. Communications of the USP Board of Trustees and its committees,including all letters and memoranda.
      3. Reports of the USP Research and Development Laboratory and the Reference Standards Laboratory unless,in the judgment of the secretary of the Convention,special scientific reason exists for disclosure.
    2. Except as indicated in Sections 1and 2,documents containing financial information relating to USPor any other entity.
    3. Scientific data on Reference Standards unless,in the judgment of the secretary of the Convention,special scientific reason exists.
    4. Documents containing data about USPpersonnel whether or not originating at USP.
    5. Conflict of interest statements submitted by the Council of Experts,Expert Committee members,advisory panelists,members of the Board of Trustees,or staff.
    6. Documents proposing candidates or nominees for election or appointment to USPcommittees or advisory panels.
    7. Documents revealing the location of USP Reference Standards,identity of suppliers or purchasers of the materials,amounts of individual reference materials purchased or distributed,inventory control procedures,or identity of information sources for USP Material Safety Data Sheets unless such disclosure is determined to be necessary by the secretary.
    8. Documents containing any trade or commercial secrets or security arrangements.Except,documents submitted to USPby 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 Food and Drug Administration upon its request in its review of any revision or proposed revision of the United States Pharmacopeia,the National Formulary,or the USP DIupon approval of the secretary.Documents containing any trade secrets or confidential commercial secrets shall be specifically designated as such when submitted to USP.Only such documents so designated will be handled in accordance with this provision and that contained in 4(d)below.
    9. Documents submitted to,or reflecting communications with,the USPby personnel or officials of governments concerning the establishment or harmonization of USPstandards or methods of analyses with other requirements,or the development of information,unless such documents are considered public by the government involved or,unless permission is granted by the government involved.
    10. Reports to the USP Practitioners'Reporting Network (USP-PRN)and communications relating thereto,except if in the judgment of the secretary such disclosure is in furtherance of the objectives of the reporting program.Such disclosure shall not contain the name or other identification of the reporter or third party mentioned in the report,(e.g.,patient,pharmacist)except in accordance with their indications in the report or without their written consent.
    11. Documents containing the terms of business arrangements or agreements between USPand third parties.
    12. All communications between USPpersonnel that are in written form or subsequently reduced to writing.
    13. The home addresses and home telephone numbers of USPpersonnel.
    14. Specific assignments of Council of Experts or Expert Committee members without the permission of the member.
    15. Results of elections for officers and Board of Trustees members,except in accordance with the Bylaws of the Convention.
    16. Unaggregated data received by the MedMARx program.
  4. Miscellaneous Provisions
    1. It is USPpolicy that staff not appear as expert witnesses in any case regarding or relating to drugs or other articles for which USPsets standards or disseminates information.
    2. If a record contains both disclosable and nondisclosable information,the nondisclosable information will be deleted and the remaining record will be disclosed,unless the two are so inextricably intertwined that it is not feasible to separate them or unless release of the disclosable information would compromise or impinge upon the nondisclosable portion of the record.
    3. Requests for access to records should be made to:

        United States Pharmacopeial Convention
        12601Twinbrook Parkway
        Rockville,Maryland 20852
      who shall be responsible for making the decision as to the disclosure of the records.
    4. Documents submitted to the USPspecifically designated as confidential will be available only to USPpersonnel and will be distributed on a need-to-know basis to Council of Experts and Expert Committee members and advisory panelists as determined by the secretary.
    5. Names of USPstaff ordinarily will not be deleted from disclosable records,except where it is deemed necessary for the protection of the individual.
    6. Because of staff and financial limitations,it is the policy of the USPnot to conduct searches of its files in response to requests for general information regarding the effects of drugs,unless it is determined by the secretary that the request is directed to the content of a USPpublication.
    7. The secretary shall have ultimate authority to refuse to grant a request for disclosure.In situations where the confidentiality of the data or information is uncertain and there is a request for disclosure,the USPwill consult the party who has submitted the data or information,and/or any other party who may be affected by such disclosure.
    8. Only copies of existing records may be made available.All existing records are subject to routine or planned destruction.
    9. Because of the workload and duties of both clerical and scientific/professional staff,document disclosure requests are given a lower priority than official USPwork and therefore will be completed as time permits.Arequest may be refused solely on the basis that it is unduly burdensome or if it is determined by the secretary that diversion of personnel from higher priority duties would be unreasonable.
    10. Requests for disclosure of records will ordinarily be acknowledged within ten (10)working days of the date the request is received.Such acknowledgment will include any information regarding any necessary computer searches.
  5. Fees

      The following fees shall be imposed for disclosure of any record pursuant to these rules.
      1. Copying:25¢per copy of each page.
      2. Clerical Personnel:$20.00for each quarter-hour spent searching for and/or producing a requested record,including time spent copying any such records.
      3. Scientific or Professional Personnel:$50.00for each quarter-hour spent searching for and/or producing a requested record,including time spent reviewing,preparing,and copying any such records.
      4. Postage,insurance,and special fees will be charged on an actual cost basis.
      5. For computerized records,add to the above (a)through (d)the costs of the computer time involved and the supplies or materials necessary to produce the requested records.
      6. In lieu of fees imposed by 5(a)through (e)above,the secretary may establish uniform fees for any particular type of document (e.g.,compendial monographs and chapters,Material Safety Data Sheets,edited text from USP Practitioners'Reporting Network,etc.).
      7. The secretary may waive payment of any fee or part thereof.
      8. For requests of records involving a fee of greater than $200.00,the USPshall retain the right to require prepayment from the person requesting the records.
      9. For requests for copies of published documents,USPshall retain the right to require prepayment from the person requesting the copies.