[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: 21CFR208.26]

[Page 135]
 
                        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.  208.26  Exemptions and deferrals.

    (a) FDA on its own initiative, or in response to a written request 
from an applicant, may exempt or defer any Medication Guide content or 
format requirement, except those requirements in Sec.  208.20 (a)(2) and 
(a)(6), on the basis that the requirement is inapplicable, unnecessary, 
or contrary to patients' best interests. Requests from applicants should 
be submitted to the director of the FDA division responsible for 
reviewing the marketing application for the drug product, or for a 
biological product, to the application division in the office with 
product responsibility.
    (b) If the licensed practitioner who prescribes a drug product 
subject to this part determines that it is not in a particular patient's 
best interest to receive a Medication Guide because of significant 
concerns about the effect of a Medication Guide, the licensed 
practitioner may direct that the Medication Guide not be provided to the 
particular patient. However, the authorized dispenser of a prescription 
drug product subject to this part shall provide a Medication Guide to 
any patient who requests information when the drug product is dispensed 
regardless of any such direction by the licensed practitioner.