Prescription drug.

Prescription drug. Prescription drug means any drug, as defined in the FDCA section 201(g), that has been approved by the Food and Drug Administration pursuant to FDCA section 505 and is subject to the requirements of FDCA section 503(b)(1).

Source

42 CFR § 403.1201

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Scoping language

For the purposes of this subpart, the following definitions apply:

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