Supply Chain Inspection

Protecting the public health against ongoing threats to our nation’s drug supply chain.

Benefits of Supply Chain Inspection

NABP’s Supply Chain Inspection is best suited for participants in the medical supply chain that store, handle, and ship prescription drugs and devices or own title to a drug or device while using a third party to store, handle, and ship on the facility’s behalf. Participants of the program will receive an inspection report detailing a facility’s observed practices that may satisfy an entity or agency’s inspection requirement.

• Signify customer and patient safety – Demonstrate your facility’s commitment to protecting customers from receiving prescription drugs and diagnostic over-the-counter (OTC) medical devices that have been contaminated, diverted, or counterfeited.
• Consolidate inspections – Applicants are provided an inspection report that may satisfy inspection requirements for multiple state agencies or other entities.
• Efficient process – Accomplished by qualified supply chain experts with minimal interruption to your staff and business.

Eligibility Requirements at Time of Application

The following business models are eligible for a Supply Chain Inspection:

• Prescription drug wholesale distributors 
• Prescription medical device distributors 
• Active pharmaceutical ingredient (API) distributors 
• API repackagers 
• Repackagers of finished prescription drugs 
• Veterinary prescription drug distributors 
• Reverse distributors 
• Sample distributors 
• Investigational drug distributors 
• Manufacturers
  • For prescription drugs and or prescription devices.
• Virtual distributors and manufacturers
  • For prescription drugs and or prescription devices.
• Third-party logistics providers (3PLs)
  • For prescription drugs and or prescription devices.
• OTC medical device distributors
  • Distributing OTC medical devices for diagnostic purposes (eg, diabetic test strips).
• Outsourcing Facilities (503B)

The following eligibility requirements must be met for NABP to conduct a Supply Chain Inspection. A facility that is unable to meet these eligibility requirements will have their application closed in accordance with the program terms and conditions.

1. Facility must be operating in the United States or Puerto Rico with an active license in its resident state (unless licensure is not required by law).
2. Business location must be operational (see definition below) in all its activities for at least 30 days.
   • If applicant is an Outsourcing Facility (503B), the facility must have been compounding for at least 30 days prior to applying.
3. The facility is currently not under investigation, subject to one or more health care-related disciplinary, pending administrative, civil complaint, criminal proceeding, regulatory or law enforcement investigation, including, without limitation, product or document seizures by a regulatory agency or governmental authority.
   • In general, civil complaints from patients, businesses, or other non-governmental agencies are not considered pending discipline (ie, a breach of contract, medication side effects, or adverse events).
   • 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 alleges no further violations (eg, piggybacked disciplinary action) may not make the facility ineligible.
   • Any disciplinary actions from a governmental authority are still considered pending, not considered finalized, unless signed for by the applicant and the governmental agency, and have been filed under local, state, federal, or jurisdictional requirements.
4. The facility cannot be located in a personal residence.
5. The facility completes and submits an online application, which includes agreeing to the program terms and conditions and applicable payment.

Operational Requirements at Time of Inspection

The following operational requirements must be met for NABP to conduct and complete a supply chain inspection. NABP publishes these requirements to support the preparedness of the applicant. NABP obtains applicant’s agreement to adhere to each of these operational requirements. At any time, whether upon arrival of the inspector at the facility or during the inspection, the applicant has not met all operational requirements, NABP will cease the inspection, retain the full inspection payment, not issue a refund to the facility, and have the facility sign an incomplete inspection form that will be made available for the Boards of Pharmacy to request from NABP.

1. The distributor or 503B facility must have sufficient records to demonstrate active distribution operations. A sufficient number of records shall not be less than 10 transaction documents for surveyor review for each of the following activities involving prescription drugs, prescription devices, or diagnostic over-the-counter (OTC) medical devices that are pursuant to a prescription:
   • Purchasing; 
   • Receiving;  
   • Storing;  
   • Selling; and 
   • Shipping.
2. The distributor is not actively engaged in construction/remodeling that impedes the activity of the distributor.
3. If Outsourcing Facility (503B),
   • The facility must have certification reports dated within 6 months of application payment date; and
   • All construction/remodeling on sterile compounding suites must be completed.