Ceiling price means the maximum statutory price established under section 340B(a)(1) of the PHSA.
Covered entity means an entity that meets the requirements under section 340B(a)(5) of the PHSA and is listed in section 340B(a)(4) of the PHSA.
Covered outpatient drug has the meaning set forth in section 1927(k) of the SSA.
Group purchasing organization (GPO) is an entity that contracts with purchasers, such as hospitals, nursing homes, and home health agencies, to aggregate purchasing volume and negotiate final prices with manufacturers, distributors, and other vendors.
Manufacturer has the same meaning as set forth in section 1927(k)(5) of the SSA.
Orphan drug means a drug designated by the Secretary under section 526 of the Federal Food, Drug, and Cosmetic Act (FFDCA).
Participating drug manufacturer means a manufacturer that has entered into a Pharmaceutical Pricing Agreement with the Secretary.
Pharmaceutical Pricing Agreement (PPA) means an agreement described in section 340B(a)(1) of the PHSA.
Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated.
Section 340B means section 340B of the PHSA.