Pharmacy Affairs

Contracted Pharmacy Services

The Office of Pharmacy Affairs (OPA) will not review actual contracts between 340B Covered Entities and Contracted Pharmacies. Parties must have their own legal counsel review all contracts or other legal documents to ensure that all Federal, State and local requirements have been met.

• Contracted pharmacy services guidelines (Acrobat/pdf). These guidelines are designed to facilitate program implementation in covered entities that wish to utilize contracted pharmacy services to dispense 340B outpatient drugs but do not have access to an "in-house" pharmacy. The agreement between the covered entity and the pharmacy should include those elements outlined in the sample Contract and the Self-Certification Form.
• Sample contract (Acrobat/pdf)
• Self-certification form (Acrobat/pdf)
• Letter from Drug Enforcement Administration concerning DEA registration (dated 12/05/2001, Acrobat/pdf)

Self-Certification Process

To ensure that drug manufacturers and drug wholesalers recognize contracted pharmacy arrangements, covered entities that elect to utilize a contract pharmacy are required to submit to the Office of Pharmacy Affairs a self-certification that they have signed an agreement with the contract pharmacy.

The agreement must contain the provisions as noted in the Contracted Pharmacy Services Guidelines. Please download the Self-certification Form.

An original, signed certification must be sent to:

Office of Pharmacy Affairs
5600 Fishers Lane
Parklawn Building, Mail Stop 10C-03
Rockville, MD 20857