[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR208.3]

[Page 132-133]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 208_MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  208.3  Definitions.

    For the purposes of this part, the following definitions shall 
apply:
    (a) 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.
    (b) Dispense to patients means the act of delivering a prescription 
drug product to a patient or an agent of the patient either:
    (1) 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
    (2) By an authorized dispenser or an agent of an authorized 
dispenser under a lawful prescription of a licensed practitioner.
    (c) Distribute means the act of delivering, other than by 
dispensing, a drug product to any person.
    (d) Distributor means a person who distributes a drug product.
    (e) 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.
    (f) 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.
    (g) Manufacturer means for a drug product that is not also a 
biological product, both the manufacturer as described in Sec.  201.1 
and the applicant as

[[Page 133]]

described in Sec.  314.3(b) of this chapter, and for a drug product that 
is also a biological product, the manufacturer as described in Sec.  
600.3(t) of this chapter.
    (h) Medication Guide means FDA-approved patient labeling conforming 
to the specifications set forth in this part and other applicable 
regulations.
    (i) Packer means a person who packages a drug product.
    (j) Patient means any individual with respect to whom a drug product 
is intended to be, or has been, used.
    (k) Serious risk or serious adverse effect means an adverse drug 
experience, or the risk of such an experience, as that term is defined 
in Sec. Sec.  310.305, 312.32, 314.80, and 600.80 of this chapter.