Review the policy information and VPP program terms and conditions and Supply Chain Inspection terms and conditions prior to starting your inspection application(s):

• Inspection Eligibility
• Partial Inspections
• Jurisdictions NABP Conducts Inspections
• Extending Unannounced Inspection Window
• Pharmacy or 503B Outsourcer not Actively Compounding
• Inspection Programs Application Hold
• Additional Inspection Fees
• Request for Expedited Inspection Application
• Inspection Refund
• Inspection Response Acceptance
• Inspection Report Amendments

Inspection Eligibility

• Supply Chain Inspection
• Verified Pharmacy Program (VPP)
• Preoperational Inspection

Partial Inspections

This policy outlines what must be included in inspections for VPP, Supply Chain Inspection, and Preoperational Inspection.

When an applicant submits an application for an inspection, a partial inspection will not be conducted unless the inspection is a Texas Class E-S specific pharmacy inspection only. This means that all pharmacy or distribution activities of the licensed location will be included in the inspection. NABP does not allow applicants to choose which activities will be included in the inspection.

Applicants that fail to indicate all activity types on their application or notify NABP of a change or new activity prior to inspection, may be required to submit a new application with the correct activity types or sign a denial of entry form.

Texas Class E-S Licensure “Option B”

Pharmacy applicants that select “Option B” under Texas Class E-S option of the VPP application to satisfy Texas State Board of Pharmacy (TSBP) requirements will only have a sterile inspection conducted on the TSBP inspection form per the Texas contract.

Effective Date: 3/10/2023

Jurisdictions NABP Conducts Inspections

NABP inspection programs will conduct inspections in all 50 states, the District of Columbia, and Puerto Rico.

Effective Date: 9/8/2023

Extending Unannounced Inspection Window

If a facility submits an inspection program application that has blackout dates, an inspection extension window is available as follows:

• Less than 3 blackout dates = no extended inspection window
• 4-7 blackout dates = extend the application by 1 week
• 8-11 blackout dates = extend the application by 2 weeks
• 12-15 blackout dates = extend the application by 3 weeks
• 16-20 blackout dates = extend the application by 4 weeks

(Note: This time frame for inspection application extension is an estimate and is subject to change pending inclement weather, a significant number of facility black-out dates, or other unforeseen circumstances.)

Additionally, if the facility has limited compounding hours. For example, if the facility can only demonstrate compounding 1 day a week the inspection window will be for 16 weeks.

Effective Date: 3/10/2023

Pharmacy or 503B Outsourcer not Actively Compounding

Should a pharmacy or 503B outsourcer apply for nonsterile and/or sterile activities and notify Inspection staff that it is not actively compounding, Inspection staff will confirm with the pharmacy or 503B outsourcer that it is able to demonstrate compounding.

For example, a facility may want to keep a sterile compounding licensure but may not have any prescription orders. NABP will be able to inspect the facility if it is able to demonstrate sterile compounding (ie, simulate and do a mock compound in front of the inspector).

If the facility is not able to demonstrate compounding, the facility will have to put its application on hold or withdraw the application.

If the facility has not had a sterile compounding order and has no records for Inspection staff to review, NABP will be unable able to move the facility to the inspection queue, and facility would have to put it application on hold or withdraw the application until they have at least one record for NABP to review.

Effective Date: 3/10/2023

Inspection Programs Application Hold

Should an applicant request to put an inspection program application on hold, the request must be made in writing from the facility’s main point of contact, including the reason for the requested hold. Some examples of reasons for a hold request include but are not limited to pending investigation or disciplinary action, construction, not being fully operational, staffing issues, or not being ready for inspection.

An inspection program application can be placed on a one-time hold at the facility’s expense, in accordance with the additional fee policy for a period of not more than 6 months from the date of request.

If the facility requested the inspection application hold due to pending investigation or disciplinary action, the facility needs to have had all outstanding board orders fully resolved and able to demonstrate the resolution through written documentation when the hold expires.

The facility would then need to submit all appropriate updates and additional information to proceed with the re-initiation.

Once an application is placed on hold, the facility agrees that no refunds will be issued. Should the facility not be prepared to re-initiate the application by the deadline, NABP will need to close the inspection program application. If the facility wishes to still have an inspection of the facility, the facility must reapply to the inspection program and submit all applicable fees at that time.

Effective Date: 3/2/2022

Additional Inspection Fees

Below are additional or expanded services that go beyond the typical inspection application fee and an administrative fee will be assessed.

• If the facility adds blackout dates after it has been informed that its inspection has been sent to scheduling an administrative fee ($250) will be assessed.
• If the facility requests additional blackout dates after it has been informed that its inspection has already been scheduled during any of the requested additional blackout dates, an administrative fee ($500) and any travel-related costs ($TBD) will be assessed to cover travel change fees incurred by the inspector.
• If the facility requests a one-time hold, of no more than 6 months, of their NABP inspection, the applicant will not be issued a refund, and an administration fee ($500) will be assessed.
• Change in ownership (see Change in Ownership Policy for specific pricing).
• If facility has changed their business model before the inspection or while NABP is onsite at the applicant’s facility, it is observed the facility is performing nonsterile, sterile, and/or hazardous compounding, and/or nuclear/radiopharmaceutical activities, or is an outsourcing facility, that was not indicated on the application, the application will be cancelled, and an administrative fee ($500) will be assessed. If the applicant re-applies indicating the correct facilities’ activities, a refund of the previous application may be processed.
• If the facility requests to add to their accreditation application, Compounding, Drug Distributor, and/or OTC Medical Device Accreditation eligibility review, an additional fee will be charged. See current accreditation eligibility review fee.
• An extended inspection fee ($1,500) may be charged if NABP determines the work needed to complete the inspection process at the applicant’s facility requires additional time to prepare for the inspection, onsite and/or to write the report. Examples of additional time to complete the inspection process include numerous or complex pharmacy activities, large facilities, and facilities with high volume. Specifically,
  • When an inspection will require a second overnight stay for the inspector to complete;
  • When the facility is a nuclear pharmacy but also performs non-nuclear activities (requiring 2 VPP inspection reports);
  • When the facility is a manufacturer;
  • Complexity of inspection due to previous disciplinary actions, inspections by nonresident states, or FDA inspection (With FDA Form 483 observation and/or ODA Warning Letter); or
  • An Inspection that requires more than one onsite inspector to participate.
• Expedited
  • The expedited inspection fee add-on for VPP inspection is $17,000.
  • The expedited inspection fees for a Supply Chain Inspection are:
    • Application Fee: $5,000
    • Inspection Fee: $25,000

Effective Date: 3/10/2023

Request for Expedited Inspection Application

NABP can expedite applications for most of the VPP and Supply Chain Inspection program activity types for an additional payment if NABP staffing allows.

Verified Pharmacy Program non-eligible expedited application:

• Pharmacy activity types that are not eligible to apply for an expedited NABP VPP Inspection include:
  • Nuclear Pharmacies are entities that handle, prepare, reconstitute, repackage, compound, dispense, or otherwise manipulate a radiopharmaceutical.
  • Outsourcing Facilities are entities that are an FDA registered establishment as an outsourcing facility, compound at least 1 sterile preparation, and follow the requirements of the Food, Drug, and Cosmetic Act Section 503B.
• Applicant has a history of significant noncompliance with state, federal, and local laws and regulations.

Supply Chain Inspection non-eligible expedited application:

• Facility activity types that are not eligible to apply for an expedited NABP Supply Chain Inspection include:
  • Outsourcing Facilities are entities that are FDA registered as an outsourcing facility, compound at least 1 sterile preparation, and follow the requirements of the Food, Drug, and Cosmetic Act Section 503B.
• Applicant has a history of significant noncompliance with state, federal, and local laws and regulations.

If a facility is seeking an inspection as the prerequisite for an Accreditation (Compounding, Drug Distributor Accreditation, or OTC Medical Device Distributor) the expedited accreditation eligibility review fee will also be assessed for that program as well as expedited accreditation program fees.

For pricing, visit the pricing pages of the website.

Effective Date: 08/18/2023

Inspection Refund

More information on inspection refunds can be found on the NABP Refund Page.

Inspection Response Acceptance

Inspection Response Acceptance

NABP inspection applicants are allowed to submit an inspection response to the Inspection Report. Below indicates when the Inspections staff will no longer accept the inspection response and upload it to the Information Sharing Network (ISN).

Inspection responses within 30 calendar days:

If the facility sends an inspection response for an inspection within 30 calendar days from the date of the cover letter, inspection staff will make available the additional information to the boards of pharmacy or state regulators (“government entities”) in the ISN if the government entities request the materials and the facility has authorized NABP to share the information with those entities. If the facility has not authorized NABP to share the information, the government entities will be directed to seek the materials directly from the facility.

If the facility also applied due to an NABP accreditation inspection, staff will notify the Accreditation team that a response is available to be viewed.

Inspection responses past 30 calendar days:

If the facility sends an inspection response for an inspection past 30 calendar days from the date of the cover letter, NABP staff will NOT make available the information/documentation to the government entities in the ISN.

Though, if the facility also applied for an NABP Accreditation inspection, staff will notify the accreditation team that a response is available.

NABP inspection programs are allowed to receive the following formats as a response in conjunction to the response template sent to them:

• Word
• PDF
• Excel
• Videos
• Photos (.jpg)

Note: If protected health information or personally identifiable information (PHI/PII) is sent in the response documentation NABP, staff will not accept the response and the facility will have to resubmit it with the PHI/PII redacted. The facility will have to submit the redacted response immediately.

Effective Date: 6/21/2023

Inspection Report Amendments

NABP does not make changes to the VPP Inspection Report, Supply Chain Inspection report, or Preoperational Inspection Report.

Applicants may request an amendment if they believe there is a factual error to the NABP Inspection Report in writing via email within 45 calendar days of receiving the Inspection Report. Upon receipt, the Inspection Report will be reviewed, and a decision made if an amendment is appropriate.

If it is determined that an amendment is appropriate, an amendment is sent to the main point of contact at the facility and uploaded to the Information Sharing Network. If the facility indicated they were interested in accreditation, the amendment is shared with the applicable accreditation program.

Effective Date: 3/10/2023