For the purposes of this part, the following definitions shall apply:

Authorized dispenser means an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to provide drug products on prescription in the course of professional practice.

Dispense to patients means the act of delivering a prescription drug product to a patient or an agent of the patient either:

By a licensed practitioner or an agent of a licensed practitioner, either directly or indirectly, for self-administration by the patient, or the patient's agent, or outside the licensed practitioner's direct supervision; or

By an authorized dispenser or an agent of an authorized dispenser under a lawful prescription of a licensed practitioner.

Distribute means the act of delivering, other than by dispensing, a drug product to any person.

Distributor means a person who distributes a drug product.

Drug product means a finished dosage form, e.g., tablet, capsule, or solution, that contains an active drug ingredient, generally, but not necessarily, in association with inactive ingredients. For purposes of this part, drug product also means biological product within the meaning of section 351(a) of the Public Health Service Act.

Licensed practitioner means an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to prescribe drug products in the course of professional practice.

Manufacturer means for a drug product that is not also a biological product, both the manufacturer as described in § 201.1 and the applicant as described in § 314.3(b) of this chapter, and for a drug product that is also a biological product, the manufacturer as described in § 600.3(t) of this chapter.

Medication Guide means FDA-approved patient labeling conforming to the specifications set forth in this part and other applicable regulations.

Packer means a person who packages a drug product.

Patient means any individual with respect to whom a drug product is intended to be, or has been, used.

Serious risk or serious adverse effect means an adverse drug experience, or the risk of such an experience, as that term is defined in §§ 310.305, 312.32, 314.80, and 600.80 of this chapter.