Close

Distributor Accreditation Relocation Policy

Alternative Distributor Accreditation Process for Relocation of an NABP-accredited Facility

This policy outlines the limited circumstances under which NABP utilizes an Alternative Accreditation Process to issue either Drug Distributor Accreditation or OTC Medical Device Distributor Accreditation prior to the completion of an NABP Supply Chain Inspection and determination that a facility is eligible to apply for accreditation. Currently, NABP-accredited facilities may be eligible for an Alternative Accreditation Process if the facility relocates. Facilities should review the eligibility requirements below for this Alternative Accreditation Process.

Basis for Eligibility

  1. The currently accredited facility wishes to cease operations at its current facility and relocate operations to another facility that is not accredited by NABP; and
  2. The absence of accreditation at the new facility may delay its ability to fully operate.

Requirements for Eligibility

  1. The current facility must be NABP-accredited with a history of compliance with the applicable program standards in its current and most recently completed 3-year accreditation period.
  2. The new facility for relocation must be eligible for and complete an NABP Preoperational Inspection and demonstrate compliance with the following requirements.
    • the new location is in existence;
    • the land, building, fixtures, and equipment are adequate and appropriate for the type of business;
    • the facility has physical and/or electronic controls to safely secure drugs and records from unauthorized access;
    • the facility must be able to store drugs and devices according to their labeling, including temperature control;
    • personnel at the new location have experience and knowledge to properly operate the business model and facility; and
    • pays for the applicable accreditation program eligibility review fee(s).
  3. The current facility is not the subject of an adverse action, which means a current or pending criminal, civil, or administrative investigation, charges, indictment, or prosecution; discipline or conviction in the past 5 years by any governmental, regulatory, or law enforcement agency in any jurisdiction for a violation of Applicable Laws as defined in the Accreditation Terms and Conditions; or any adverse or potentially adverse legal, ethical, governmental, or regulatory action or pending action related to the accredited facility’s business, including suspensions, probationary statuses, exclusions, debarments, reprimands, warning letters, consent agreements, and other adverse or potentially adverse communications from any governmental or regulatory agency.
    • In general, civil complaints from customers, businesses, or other non-governmental agencies are not considered discipline, pending or final (ie, a breach of contract action is not considered “discipline,” etc).
    • Unless the pending discipline is from the facility’s resident state, minor violations that are a result of a finalized settlement or related disciplinary action that allege no further violations (eg, piggybacked disciplinary action) may not, in NABP’s discretion, make the facility ineligible.
  4. The current accredited facility and the new location must have maintained and will maintain current ownership, management structure, and operations, as indicated in the last inspection.

Notification to NABP

If the two Bases for Eligibility are applicable to the facility and the facility meets the eligibility requirements, the facility should notify NABP of an upcoming relocation as soon as possible.

The notification shall include the following information:

  • a statement of intent to relocate operations to a new facility,
  • the address of the new facility,
  • the approximate dates of occupancy (and/or completion of construction) of the new facility, and
  • the approximate date of closing the currently accredited facility.

Ineligible Facilities

The following business types are not eligible for the Alternative Accreditation Process for Relocation:

  1. Outsourcing facilities (registered or unregistered by FDA as 503B).
  2. Drug Distributor or OTC Medical Device Distributor applicants (ie, not yet accredited) that relocate in the middle of the accreditation process are not eligible for the Alternative Accreditation Process. Should they relocate, their applications will be closed or canceled, and they will need to start as a new applicant again following the standard accreditation process.

Approval for Alternative Accreditation Process

If NABP determines the facility is eligible for the Alternative Accreditation Process, it will inform the facility. NABP will then direct the facility to submit an accreditation application, which NABP will route through the Alternative Accreditation Process.

If NABP determines the facility is not eligible for the Alternative Accreditation Process, the applicant facility will be directed to the standard accreditation process.

If the facility believes that NABP’s determination of ineligibility for the Alternative Accreditation Process is factually in error, it may request a review within 2 weeks of NABP communicating its decision to the facility. NABP will review its decision for factual error and communicate its decision to the facility.

Approval for Alternative Accreditation Process and Alternative Accreditation Terms

  1. If a facility is approved for the Alternative Accreditation Process, and a complete accreditation application is received, then accreditation will be granted within 2 weeks to the new facility for a term of 1 year.
    • These Alternative Accreditation Terms are applicable during the Alternative Accreditation Process. The Alternative Accreditation Terms and Conditions apply while the facility is accredited during the Alternative Accreditation Process. If there is a conflict, the Accreditation Terms and Conditions control.
  2. Within 6 months from the date of accreditation, the new facility must apply for and complete an NABP Supply Chain Inspection.
    • If the facility does not meet this term, the accreditation granted through the Alternative Accreditation Process will be cancelled due to the facility’s ineligibility, and the facility may reapply through the standard accreditation process.
  3. Within 12 months from the date of accreditation under this process, the new facility must have been found eligible to apply for the Drug Distributor Accreditation or OTC Medical Device Distributor Accreditation through the standard accreditation process and have remediated all areas of non-compliance, including policies and procedures, to NABP’s criteria.
    • If the facility does not meet this term, the accreditation granted through the Alternative Accreditation Process will be cancelled due to the facility’s ineligibility, and the facility may reapply through the standard accreditation process.
  4. Once the new facility is deemed compliant with the Drug Distributor Accreditation or OTC Medical Device Distributor Accreditation criteria, the term of accreditation will then be extended for 2 years, for a total initial accreditation term of 3 years, with the beginning date of accreditation through the Alternative Accreditation Process as the start date of the 3-year accreditation term. This will result in the new facility being put on the standard accreditation path and process, which includes a year 2 and 3 annual compliance review.
  5. If active operations continue at the original accredited facility, then the facility must maintain and complete all standard accreditation processes and activities including annual compliance reviews and pay the annual participation fee during a reaccreditation year prior to the anniversary date.
    • The original accredited facility will have its accreditation canceled when NABP is notified the facility is voluntarily withdrawing from the program, the facility is closed, or within 15 months of the new facility being accredited, whichever occurs first.

Last updated: 04/22/2025