Reporting Organizational Changes and Adverse Actions
This policy identifies specific events that an Applicant or Accredited Entity must report to NABP after having applied for accreditation or while accredited.1
NABP requires an Applicant/Accredited Entity to provide Information to NABP for the purpose of accreditation. It is required that Applicants and Accredited Entities self-report changes to Information previously provided to NABP.
The following changes must be reported to NABP, via email to the applicable accreditation program, within 30 days. Failure to do so may result in the application or accreditation being canceled as outlined in the Accreditation Terms and Conditions.
- Change to legal business name or doing business as name.
- Change to any direct or indirect Owner(s), any individuals, partnerships, limited liability companies, and/or corporate Owners who own 5% or greater equity in the ownership or controlling interest of the Applicant/Accredited Entity and/or 5% or greater interest in the Applicant/Accredited Entity, which includes corporate restructuring.
- Relocation of a corporate office – included in the application or accreditation.
- Relocation or intention to relocate an applicant or accredited facility.
- Please note that the accreditation does not automatically transfer. It is recommended that applicants notify NABP as soon as possible, including when considering a relocation, to understand the impact on their accreditation.
- Change to the pharmacist-in-charge (PIC), designated representative (DR), or primary contact included in the application or accreditation.
- For corporate accreditations only, the PIC changes shall be provided upon request and/or during annual renewal (as part of licensure verification services within the accreditation review).
- Change in currently known services/activities provided by the facility on the application that would be considered a material change in business attributes and/or scope of services including, but is not limited to:
- DMEPOS Pharmacy Accreditation product categories;
- Addition of nonsterile compounding, sterile compounding, and/or hazardous drug compounding (as applicable);
- Ceases nonsterile compounding, sterile compounding, and/or hazardous drug compounding (as applicable);
- Newly added business models/attributes (such as a wholesale distributor is now adding 3PL activities or adding reverse logistics); and/or
- Addition of handling/distribution/dispensing of Controlled Substances.
- If a license or registration has been given any other status other than active/in good standing, not including voluntary cancelation or non-renewal, that limits, restricts, or prevents services. This also includes license or registration statuses that include probation, suspension, or revocation.
- Physical facility modifications to operations spaces subject to accreditation, such as:
- Changes/construction to the cleanroom suite;
- Addition of walls or doors; and/or
- Additional square footage or suite(s).
- Any new, amended, or revised Adverse Action, as defined in the Accreditation Terms and Conditions, for the accredited company, accredited facility, PIC of an accredited facility, DR of an accredited facility, or Owner, as defined in the Accreditation Terms and Conditions, including:
- Entering into an FDA MOU and/or MOA or similar notification; and/or
- Entering into an DEA MOU and/or MOA or similar notification.
- Issued an FDA 483 and/or FDA Warning letter.
1Please see the Accreditation Terms and Conditions definitions for certain terms used in this policy such as Applicant and Accredited Entity .