covered outpatient drug
For covered entities described in subparagraph (M) (other than a children’s hospital described in subparagraph (M)), (N), or (O) of subsection (a)(4), the term “covered outpatient drug” shall not include a drug designated by the Secretary under section 360bb of title 21 for a rare disease or condition.
Source
42 USC § 256b(e)
Scoping language
None identified, default scope is assumed to be the parent (subpart vii) of this section.