Drug Distributor Accreditation
NABP’s Drug Distributor Accreditation plays a role in preventing counterfeit drugs and devices from entering the United States medical supply.
The US supply of prescription drugs and prescription devices is produced and delivered to patients via a complex distribution path, and this accreditation verifies that accredited facilities operate legitimately, are licensed in good standing in the United States, with current and active licenses, in all jurisdictions in which it is conducting business, and practice secure storing, handling, and shipping prescription drugs and devices.
NABP’s Drug Distributor Accreditation is a 3-year accreditation for participants in the medical supply chain that store, handle, and ship prescription drugs and devices.
State-Specific Requirement
The state boards of pharmacy, or other state agencies, play an important role in regulating the medical supply chain. State laws and regulations, often developed by the boards, help protect the public from receiving medications and devices that can lead to patient harm. In some states, it may be necessary to possess NABP accreditation to obtain a license. For further information on state-specific licensing requirements, inquire with each of the states in which your facility conducts business.
Drug Distributor Eligibility
To apply for an NABP accreditation, you must meet and maintain basic eligibility requirements. Review the eligibility requirements listed below.
- Review and self-assess your eligibility.
- You are compliant with the program criteria and requirements at the time you apply for accreditation, throughout the application process, and accreditation period.
- You are a licensed drug distributor operating in the United States, with current and active licenses, in all jurisdictions in which you are conducting business.
- You are operational in all activities for at least 30 days and compliant with all state regulations, laws, and rules (eg, federal, state, local, and jurisdictional requirements) applicable to the business.
- You completed our prerequisite Supply Chain inspection within the past 12 months and received a Drug Distributor Accreditation eligibility letter.
- Your facility should know the drug approval status for each prescription drug you market, offer, produce, compound, receive, purchase, hold, store, ship/deliver, sell, distribute, and/or dispense. For prescription drugs that have not undergone the FDA drug approval process, self-assess your eligibility for Accreditation within the principles outlined in NABP’s policy titled Unapproved Prescription Drug Evaluation.
If your facility is planning to relocate, review the requirements in our relocation policy page.
Criteria
Click on the links below to learn about each criterion:
- Licensure
- Facility
- Virtual Manufacturers and Wholesale Distributors
- Personnel
- Record Keeping
- Authentication and Verification
- Returned, Damaged, and Outdated Drugs
- Policies and Procedures
- Nontraditional Business Models
- History of Criteria Revisions
Information for Nontraditional Business Models
Some business models not designated as “wholesale distributors” may have unique requirements. These business models include:
- Third-Party Logistics Providers (3PLs),
- Manufacturer,
- Virtual Manufacturers.
- Virtual Distributors,
- Outsourcing Facilities,
- Reverse Distributors, and
- Wholesale Distributors Co-located With a Health Care Provider.