Our supply chain inspection service is a regulatory inspection for facilities engaged in prescription drug and prescription medical device distribution. Participants of the program will receive an inspection report that may satisfy an inspection requirement from an entity or agency.
During the supply chain inspection, a facility’s operations are observed and the observations are compiled in a report that will be released to the applicant within 45 days. Each applicant has 30 days to respond to the report, and both the report and response will be made available to the boards of pharmacy or other state agencies.
The supply chain inspection is not an accreditation program. We do not make a determination of “passed” or “compliant” with regard to any specific state regulations. The state determines a facility’s compliance based on the findings of the inspection, and completion of the inspection does not imply NABP endorsement or approval.
Who is eligible to have an 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
- Virtual distributors and manufacturers
Businesses not currently eligible for a supply chain inspection include FDA-registered outsourcing facilities (503B), third-party logistics providers (3PLs), and over-the-counter (OTC) medical device distributors.
If a facility engages in a combination of eligible and ineligible activities, it can still have a supply chain inspection. For example, a facility that distributes both prescription drugs and OTC medical devices qualifies; however, the inspection will only encompass the prescription drug aspect of operations.