[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR208.24]

[Page 113-114]
 
                        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 B--General Requirements for a Medication Guide
 
Sec. 208.24  Distributing and dispensing a Medication Guide.

    (a) The manufacturer of a drug product for which a Medication Guide 
is required under this part shall obtain FDA approval of the Medication 
Guide before the Medication Guide may be distributed.
    (b) Each manufacturer who ships a container of drug product for 
which a Medication Guide is required under this part is responsible for 
ensuring that Medication Guides are available for distribution to 
patients by either:

[[Page 114]]

    (1) Providing Medication Guides in sufficient numbers to 
distributors, packers, or authorized dispensers to permit the authorized 
dispenser to provide a Medication Guide to each patient receiving a 
prescription for the drug product; or
    (2) Providing the means to produce Medication Guides in sufficient 
numbers to distributors, packers, or authorized dispensers to permit the 
authorized dispenser to provide a Medication Guide to each patient 
receiving a prescription for the drug product.
    (c) Each distributor or packer that receives Medication Guides, or 
the means to produce Medication Guides, from a manufacturer under 
paragraph (b) of this section shall provide those Medication Guides, or 
the means to produce Medication Guides, to each authorized dispenser to 
whom it ships a container of drug product.
    (d) The label of each container or package, where the container 
label is too small, of drug product for which a Medication Guide is 
required under this part shall instruct the authorized dispenser to 
provide a Medication Guide to each patient to whom the drug product is 
dispensed, and shall state how the Medication Guide is provided. These 
statements shall appear on the label in a prominent and conspicuous 
manner.
    (e) Each authorized dispenser of a prescription drug product for 
which a Medication Guide is required under this part shall, when the 
product is dispensed to a patient (or to a patient's agent), provide a 
Medication Guide directly to each patient (or to the patient's agent) 
unless an exemption applies under Sec. 208.26.
    (f) An authorized dispenser or wholesaler is not subject to section 
510 of the Federal Food, Drug, and Cosmetic Act, which requires the 
registration of producers of drugs and the listing of drugs in 
commercial distribution, solely because of an act performed by the 
authorized dispenser or wholesaler under this part.