Are there unique requirements for non-traditional business models?
Yes, some non-traditional business models, while eligible for Drug Distributor Accreditation, are subject to considerations consistent with their operations.
Prior to applying for Drug Distributor Accreditation, outsourcing facilities must meet all of the below conditions.
- Must be registered with FDA as an outsourcing facility
- Must be the recipient of an inspection that occurred subsequent to registration with FDA that indicates compliance with current Good Manufacturing Practices and required provisions of the Federal Act
- Must have no open FDA actions or must be able to substantiate ongoing communication with FDA towards resolution. This includes unresolved 483s, warning letters, or recalls.
- Must not be the subject of serious FDA regulatory actions or any criminal investigation prior to registration
- Must ship in accordance with their home state’s (and states to which they ship product) current license requirements for outsourcing facilities (pharmacy, wholesaler, or both)
Failure to meet these conditions may result in the application being closed or loss of the Drug Distributor Accreditation.
Pharmacy Co-located with Wholesale Distributor
Co-located pharmacies and wholesale distributors are subject to additional scrutiny, potentially requiring the submission of additional documentation to demonstrate they are in compliance with the below stated state and federal laws and Drug Distributor Accreditation criteria. This might lengthen the time it takes to become accredited.
- The pharmacy cannot meet the definition of a public or private hospital pharmacy or other health care entity.
- The pharmacy must comply with state record-keeping and audit trail laws for prescription drugs, including authorized trading partners and transaction documents.
- The wholesale distributor and pharmacy must have physical separation adequate for securing drugs.
- The pharmacy and wholesale distributor transactions must employ separate account numbers to distinguish prescription drug purchases made by the two entities.
- Wholesale distributors cannot sell drugs that were at any time purchased by a pharmacy. Specifically, wholesale distributors that have a license issued in the same name and address as a pharmacy cannot sell drugs purchased under the pharmacy account.
- Pharmacies purchasing drugs as part of a Group Purchasing Organization or certain programs such as the federal 340B Drug Pricing Program must demonstrate they are not limited in the use of drugs purchased under these contracts.
Third Party Logistics Providers (3PLs)
Any 3PL seeking and maintaining Drug Distributor Accreditation may distribute only on behalf of
a. FDA-registered manufacturers, or
b. NABP accredited drug distributors, or
c. drug distributors that purchase the 3PL distributed product directly from the manufacturer, and
d. drug distributors that possess licenses in all states into which the 3PL will distribute its product.
For requirements c and d, the 3PL is required to demonstrate how it determines they are met by its sources (ie, businesses for whom the 3PL performs services).
Reverse Distributors (RDs)
To seek and obtain Drug Distributor Accreditation, a RD must receive an itemized inventory similar to what is required for DEA 1304.22 for all full packages of incoming prescription drugs and devices subject to the accreditation. Partial container amounts of prescription drugs can be estimated using the same requirements per DEA 1304.22 CS 3-5 drugs.