[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: 21CFR208.20]

[Page 112-113]
 
                        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. 208.20  Content and format of a Medication Guide.


    (a) A Medication Guide shall meet all of the following conditions:
    (1) The Medication Guide shall be written in English, in 
nontechnical, understandable language, and shall not be promotional in 
tone or content.
    (2) The Medication Guide shall be scientifically accurate and shall 
be based on, and shall not conflict with, the approved professional 
labeling for the drug product under Sec. 201.57 of this chapter, but the 
language of the Medication Guide need not be identical to the sections 
of approved labeling to which it corresponds.
    (3) The Medication Guide shall be specific and comprehensive.
    (4) The letter height or type size shall be no smaller than 10 
points (1 point = 0.0138 inches) for all sections of the Medication 
Guide, except the manufacturer's name and address and the revision date.
    (5) The Medication Guide shall be legible and clearly presented. 
Where appropriate, the Medication Guide shall also use boxes, bold or 
underlined print, or other highlighting techniques to emphasize specific 
portions of the text.
    (6) The words ``Medication Guide'' shall appear prominently at the 
top of the first page of a Medication Guide. The verbatim statement 
``This Medication Guide has been approved by the U.S. Food and Drug 
Administration'' shall appear at the bottom of a Medication Guide.
    (7) The brand and established or proper name of the drug product 
shall appear immediately below the words ``Medication Guide.'' The 
established or proper name shall be no less than one-half the height of 
the brand name.
    (b) A Medication Guide shall contain those of the following headings 
relevant to the drug product and to the need for the Medication Guide in 
the specified order. Each heading shall contain the specific information 
as follows:
    (1) The brand name (e.g., the trademark or proprietary name), if 
any, and established or proper name. Those products not having an 
established or proper name shall be designated by their active 
ingredients. The Medication Guide shall include the phonetic spelling of 
either the brand name or the established name, whichever is used 
throughout the Medication Guide.
    (2) The heading, ``What is the most important information I should 
know about (name of drug)?'' followed by a statement describing the 
particular serious and significant public health concern that has 
created the need for the Medication Guide. The statement should describe 
specifically what the patient should do or consider because of that 
concern, such as, weighing particular risks against the benefits of the 
drug, avoiding particular behaviors (e.g., activities, drugs), observing 
certain events (e.g., symptoms, signs) that could prevent or mitigate a 
serious adverse effect, or engaging in particular behaviors (e.g., 
adhering to the dosing regimen).
    (3) The heading, ``What is (name of drug)?'' followed by a section 
that identifies a drug product's indications for use. The Medication 
Guide may not identify an indication unless the indication is identified 
in the indications and usage section of the professional labeling for 
the product required under Sec. 201.57 of this chapter. In appropriate 
circumstances, this section may also explain the nature of the disease 
or condition the drug product is intended to treat, as well as the 
benefit(s) of treating the condition.
    (4) The heading, ``Who should not take (name of drug)?'' followed by 
information on circumstances under which the drug product should not be

[[Page 113]]

used for its labeled indication (its contraindications). The Medication 
Guide shall contain directions regarding what to do if any of the 
contraindications apply to a patient, such as contacting the licensed 
practitioner or discontinuing use of the drug product.
    (5) The heading, ``How should I take (name of drug)?'' followed by 
information on the proper use of the drug product, such as:
    (i) A statement stressing the importance of adhering to the dosing 
instructions, if this is particularly important;
    (ii) A statement describing any special instructions on how to 
administer the drug product, if they are important to the drug's safety 
or effectiveness;
    (iii) A statement of what patients should do in case of overdose of 
the drug product; and
    (iv) A statement of what patients should do if they miss taking a 
scheduled dose(s) of the drug product, where there are data to support 
the advice, and where the wrong behavior could cause harm or lack of 
effect.
    (6) The heading ``What should I avoid while taking (name of drug)?'' 
followed by a statement or statements of specific, important precautions 
patients should take to ensure proper use of the drug, including:
    (i) A statement that identifies activities (such as driving or 
sunbathing), and drugs, foods, or other substances (such as tobacco or 
alcohol) that patients should avoid when using the medication;
    (ii) A statement of the risks to mothers and fetuses from the use of 
the drug during pregnancy, if specific, important risks are known;
    (iii) A statement of the risks of the drug product to nursing 
infants, if specific, important risks are known;
    (iv) A statement about pediatric risks, if the drug product has 
specific hazards associated with its use in pediatric patients;
    (v) A statement about geriatric risks, if the drug product has 
specific hazards associated with its use in geriatric patients; and
    (vi) A statement of special precautions, if any, that apply to the 
safe and effective use of the drug product in other identifiable patient 
populations.
    (7) The heading, ``What are the possible or reasonably likely side 
effects of (name of drug)?'' followed by:
    (i) A statement of the adverse reactions reasonably likely to be 
caused by the drug product that are serious or occur frequently.
    (ii) A statement of the risk, if there is one, of patients' 
developing dependence on the drug product.
    (8) General information about the safe and effective use of 
prescription drug products, including:
    (i) The verbatim statement that ``Medicines are sometimes prescribed 
for purposes other than those listed in a Medication Guide'' followed by 
a statement that patients should ask health professionals about any 
concerns, and a reference to the availability of professional labeling;
    (ii) A statement that the drug product should not be used for a 
condition other than that for which it is prescribed, or given to other 
persons;
    (iii) The name and place of business of the manufacturer, packer, or 
distributor of a drug product that is not also a biological product, or 
the name and place of business of the manufacturer or distributor of a 
drug product that is also a biological product, and in any case the name 
and place of business of the dispenser of the product may also be 
included; and
    (iv) The date, identified as such, of the most recent revision of 
the Medication Guide placed immediately after the last section.
    (9) Additional headings and subheadings may be interspersed 
throughout the Medication Guide, if appropriate.