Supply Chain Inspection Terms & Policies
Terms & Conditions
1. Terms of Service
Please read these terms and conditions (T&C) carefully. These T&C describe the rights and obligations of the National Association of Boards of Pharmacy® (NABP®) and the organization (Business) that is requesting NABP Supply Chain Inspection (SCI) services. SCI services consist of review and verification of certain information in Business’s application and business e-Profile, performance of an on-site unannounced inspection, and provision of an inspection report (SCI Services). Current requirements for the SCI program, which may be updated from time to time at NABP’s sole discretion, are posted on the NABP website, www.nabp.pharmacy, and are hereby incorporated by reference into these T&C. These T&C also may be updated from time to time at NABP’s sole discretion. NABP and Business are each a “Party” and collectively are “Parties.” By requesting SCI Services, Business agrees to comply with these T&C, as amended from time to time.
2. SCI Services
- 2.1 General
- 2.1.1 Business represents that all information it provides to NABP, including but not limited to information provided on the application, in connection with the inspection, and on Business’s e-Profile, is accurate, truthful, current, and complete to the best of Business’s knowledge. Knowing provision of false information or deliberate omission of material information will result in refusal, revocation, or suspension of the SCI Services at the discretion of NABP.
- 2.1.2 Business authorizes federal, state, provincial, or local regulatory agencies in each state or jurisdiction where Business does business, or seeks to do business, to release to NABP and its contractors any and all information requested by NABP and its contractors in connection with the SCI Services, including but not limited to information requested for the purpose of verifying information regarding Business; evaluating any noncompliance with these T&C or applicable laws and regulations; or identifying disciplinary actions involving Business or any person or entity associated with Business or its affiliates. Business will execute any documentation necessary to support this authorization for release. Business releases from liability and waives its claims against any regulatory agency for releasing such information to NABP and its contractors, and releases from liability and waives its claims against NABP for acting in good faith upon such information.
- 2.1.3 Business will notify NABP in writing if Business, Business owners, Business senior management, or Business staff become the target of a regulatory or law enforcement investigation or are subject to a disciplinary or criminal proceeding, a criminal indictment, prosecution, or conviction, or a disciplinary order immediately upon learning of such investigation, proceeding, indictment, prosecution, conviction, or disciplinary order. Business is not required to report investigations that do not constitute public information.
- 2.1.4 NABP does not provide consultation services pursuant to these T&C or for SCI.
- 2.1.5 NABP may refuse to provide Business with SCI Services on any grounds that NABP finds within its professional judgment disqualifies Business from receiving SCI Services.
- 2.1.6 Unless otherwise specified in these T&C, the obligations herein extend until the SCI application is closed or 30 days after NABP uploads the SCI inspection report, whichever comes first.
- 2.2 Application and Inspection
- 2.2.1 Business will authorize a representative to complete and submit the SCI application on its behalf. This representative will be a permanent employee of Business and not a consultant or temporary employee.
- 2.2.2 Once accessed, the SCI application must be completed, and payment submitted, within sixty (60) days. NABP will close any SCI application that has been open more than sixty (60) days.
- 2.2.3 While its SCI application is open, Business will notify NABP immediately of any material changes to the information provided to NABP on the application, including, but not limited to, changes in Business location, name, designated representative/warehouse manager, ownership, facility licensure, critical equipment, compounding volume, distribution volume, customer base, sources of prescription drugs and/or devices, significant remodeling, or disciplinary action. Business will submit such changes via email to email@example.com. If Business changes location prior to the inspection, NABP will close Business’s SCI application and will not issue a refund.
- 2.2.4 Business will respond to NABP requests for clarification or information about the SCI application within the timeframe specified in the request. If Business does not timely provide a full and complete response, as determined in NABP’s sole, reasonable discretion, NABP will notify Business in writing of the closure of its SCI application. NABP’s decision to close Business’s SCI application is final, and NABP will not reconsider its decision. If Business reapplies, it must pay the then-applicable fee and provide a full and complete response to the requests for clarification or information made by NABP in connection with Business’s previous application.
- 2.2.5 NABP reserves the right to refuse an inspection while Business is subject to an ongoing or pending investigation or healthcare-related disciplinary or criminal proceeding unless, where required, notified in writing by the applicable agency that NABP’s inspection will not interfere with or be part of its investigation or proceeding. In these scenarios, it is Business’s responsibility to procure said notification in writing from the applicable agency, if required. In cases where NABP cannot perform an inspection due to ongoing/pending investigations or proceedings, Business may place its application on hold for up to six (6) months. If six (6) months passes and the investigation or proceeding is still not complete, Business agrees that NABP will close its application. Any refund will be issued in accordance with the refund policy posted on the NABP website. If NABP closes Business’s SCI application under this Section 2.2.5, NABP will not accept a new application from Business until all investigatory, disciplinary, and criminal matters described herein are concluded.
- 2.2.6 Business may request a hold on Business’s SCI application for a period of not more than six (6) months. Fees for the application hold, if any, are published on the NABP website. If Business’s SCI application is placed on hold at Business’s request and six (6) months passes without action on the part of Business, Business agrees that NABP will close its application and will not issue a refund.
- 2.2.7 If Business’s SCI application is closed, costs that NABP incurs prior to closure, including without limitation administrative, travel, and staff costs, will be deducted from any refund that NABP issues. The current NABP SCI refund policy is posted on the NABP website.
- 2.2.8 NABP will perform an unannounced inspection typically within eight (8) weeks of receipt of a completed SCI application. If Business does not allow NABP to perform the unannounced inspection, or to complete its unannounced inspection, NABP will close Business’s application and will not issue a refund. If NABP closes Business’s SCI application under this Section 2.2.8, Business must submit a new SCI application, including applicable fees, for NABP to conduct an SCI inspection.
- 2.2.9 Should Business require reinspection for any reason, including but not limited to the request of a third party, it is Business’s responsibility to complete the then-applicable SCI application and submit the then-applicable payment.
- 2.3 Business e-Profile
- 2.3.1 Business agrees to create, regularly review, update, and maintain its business e-Profile and to supplement it upon NABP’s request.
- 2.4 Inspection Report
- 2.4.1 As soon as feasible following completion of the inspection, typically within forty-five (45) days, NABP will send an SCI inspection report to Business via email and simultaneously upload it to the business e-Profile, where it may be viewed by those with access to the Inspection Sharing Network (ISN). Once uploaded, the SCI inspection report is final. Business has no right of appeal or any similar right to contest the SCI inspection report.
- 2.4.2 Business may provide a response to the SCI inspection report, which may include steps taken to correct any noncompliant items as well as any findings Business believes were made in error, within thirty (30) calendar days of the date Business is provided the SCI inspection report. No extensions will be granted. Business’s response, if any, will be included as a supplement to the SCI inspection report.
Business will pay all required fees for SCI Services in U.S. dollars through the NABP website or other method approved by NABP. Business will not require NABP to use any vendor registration, invoicing, or purchase order system or similar process for any purpose under these T&C. Business agrees that the submission of any invoice or the receipt of any payment under these T&C shall not be conditioned upon NABP accepting terms or conditions that are not already set forth in these T&C. Business shall not impose any fees upon NABP in connection with any particular method of providing an invoice to Business or receiving payment from Business.
Business acknowledges that:
- 4.1 Information that Business provides or has previously provided to NABP or that NABP otherwise acquires or has previously acquired about Business, including, without limitation, application, inspection, and e-Profile data, may be used internally by NABP for any purpose (including provision to Member Boards of Pharmacy), and may be made available at any time and for any reason to regulatory agencies, to governmental authorities, and to participating third parties from which Business is seeking certification or accreditation or renewal thereof.
- 4.2 In performing the SCI Services, NABP may use information provided by one facility about another to verify information or reconcile conflicting information. For avoidance of doubt, this means that information supplied by Business may be used in NABP’s performance of SCI Services for another facility, and information supplied by another facility may be used in NABP’s provision of SCI Services for Business.
- 4.3 If NABP receives or obtains information about Business that leads NABP to reasonably believe in good faith that Business is engaging in or has engaged in conduct that violates federal, state, or local laws or regulations or that endangers the public health, NABP may report such information to applicable regulatory, law enforcement, and/or governmental agencies. Business waives any claim against NABP for release of information to a regulatory, law enforcement, or governmental agency. This provision does not in any way limit NABP’s ability to release information as otherwise provided in these T&C.
- 4.4 NABP’s provision of SCI Services are in no way affected or influenced by virtue of Business’s payment of any fees to NABP.
- 4.5 NABP’s provision of SCI Services does not constitute a warranty or an endorsement by NABP of Business or its products, services, or operations, or Business’s compliance with any law or regulation.
- 4.6 NABP provides no guarantees or warranties pursuant to these T&C.
- 4.7 NABP is not responsible for licensure, regulatory, governmental, or third-party accreditation or certification decisions of third parties.
- 5.1 Business agrees to indemnify and hold harmless NABP, its employees, agents, contractors, officers, and directors against all third-party claims, losses, lawsuits, damages, and expenses, including, without limitation, reasonable attorneys’ fees, arising out of (a) any failure on the part of Business or its employees, agents, contractors, officers, and directors to comply with these T&C; (b) the sale, offer to sell, or provision of any product or service of or by Business or its affiliates; or (c) the operations, practice of distribution, or other business activities of Business or any of its affiliates.
- 5.2 NABP agrees to indemnify and hold harmless Business, its employees, agents, contractors, officers, and directors against only third-party claims, losses, lawsuits, damages, and expenses, arising out of intentional or reckless failure on the part of NABP or its employees, agents, contractors, officers, or directors to comply with these T&C.
- 5.3 WITH THE EXCEPTION OF THE PARTIES’ INDEMNIFICATION OBLIGATIONS DESCRIBED IN THIS SECTION 5.3, NEITHER NABP NOR BUSINESS SHALL BE LIABLE TO THE OTHER OR ANY THIRD PARTY FOR ANY INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGE OR DAMAGES FROM LOST PROFITS OR LOST USE IN CONNECTION WITH THESE T&C. THE MAXIMUM AGGREGATE LIABILITY OF NABP FOR ALL CLAIMS ARISING OUT OF OR RELATING TO THESE T&C, REGARDLESS OF THE FORM OR CAUSE OF ACTION, SHALL BE THE TOTAL FEES PAID BY BUSINESS TO NABP FOR SCI SERVICES DURING THE TWELVE-MONTH PERIOD IMMEDIATELY PRECEDING THE DATE OF THE FIRST CLAIM.
Business agrees that NABP may send all notices, communications, and notifications under these T&C to the business e-Profile User account email and/or the contact email provided by Business in its SCI application. Business agrees to maintain the valid operation of and regularly check these email accounts for purpose of receiving such notices.
- 7.1 Business represents that the person or entity submitting the SCI application and related documents is fully authorized by Business to do so.
- 7.2 Business further represents that it is duly organized, validly existing, and in good standing under the laws of its jurisdiction of organization, that it has full corporate power to conduct its business and perform its obligations under these T&C, that it is operating in compliance with all applicable laws, rules, and regulations, that it has been operational for thirty (30) days or more, and that its Business address is not a personal residence.
- 7.3 The headings contained in these T&C are for the purpose of convenience only and are not intended to define or limit the contents of the provisions contained therein.
- 7.4 The failure of NABP to exercise any of its rights regarding a breach of these T&C shall not be deemed to be a waiver of such rights nor shall the same be deemed to be a waiver of any subsequent breach.
- 7.5 With the exception of any accreditation, Verified Pharmacy Program® (VPP®), or .Pharmacy agreements between the Parties, these T&C, along with the initial and final attestations associated with the SCI application, constitute the entire agreement between the Parties relating to the subject matter hereof and supersede all prior and contemporaneous oral and written negotiations, commitments, and understandings of the Parties with respect to the same subject matter.
- 7.6 These T&C are not assignable by Business without the prior written consent of NABP.
- 7.7 Nothing in these T&C shall be construed to create a joint venture, partnership, or an employee-employer or agency relationship between the Parties.
- 7.8 The validity, interpretation and performance of these T&C shall be controlled and construed under the laws of the state of Illinois without reference to any conflict of laws principles. The courts located in Cook County, Illinois, shall have jurisdiction over any dispute regarding these T&C or the SCI program. All provisions contained in these T&C shall extend to and are binding on Business and its respective successors and assigns. Business expressly waives all objections to the choice of law or personal jurisdiction of these courts and shall not contest the choice of law or venue chosen for the hearing of the case.
- 7.9 The provisions of these T&C are severable. If any provision is determined by a court of competent jurisdiction or a governmental regulatory entity to be invalid or unenforceable, in whole or in part, that provision shall be construed or limited in such a way as to make it enforceable and consistent with the manifest intentions of the parties. If such construction or limitation is impossible, the unenforceable provision will be stricken, and the remaining provisions of these T&C will remain valid and enforceable.
By submitting its SCI application, Business hereby accepts and agrees to be bound by these T&C as they may be amended from time to time.
Version 1.0; 28Jan2020
If your facility’s supply chain inspection application is closed, NABP may incur costs, including, without limitation, administrative, travel, and staff costs. These costs may be deducted from any refund that we issue.
There are three refund scenarios for a given application: full refund, partial refund, and no refund. A full refund may be issued in scenarios where:
- an application is submitted in error and the error is caught prior to application processing;
- an inspection applicant or facility is deemed ineligible to participate in the program; or
- the application is submitted under the wrong fee category and will be resubmitted under the correct fee category.
A partial refund may be issued in scenarios where:
- the application hasn’t yet been processed by staff;
- processing of the application has started but not finished; or
- the application has been fully processed but the inspection has not been initiated.
A refund will not be available in scenarios where:
- the inspection process has begun (ie, the inspector has initiated travel);
- the inspector has attempted to conduct the inspection, but is unable to complete it for whatever reason (eg, the inspector was denied access to the facility);
- the inspection has been completed; or
- an application was put on hold and the facility is not prepared to reinitiate the application within the six-month timeframe, except in scenarios where an application was put on hold due to an ongoing investigation or drug- or device-related disciplinary or criminal proceeding.
If you need to place your application on hold, consult this FAQ about our hold policy for more information.