[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.33]

[Page 224]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 21_PROTECTION OF PRIVACY--Table of Contents
 
        Subpart C_Requirements for Specific Categories of Records
 
Sec.  21.33  Medical records.

    (a) In general, an individual is entitled to have access to any 
medical records about himself in Privacy Act Record Systems maintained 
by the Food and Drug Administration.
    (b) The Food and Drug Administration may apply the following special 
procedures in disclosing medical records to an individual:
    (1) The agency may review the records to determine whether 
disclosure of the record to the individual who is the subject of the 
records might have an adverse effect on him. If it is determined that 
disclosure is not likely to have an adverse effect on the individual, 
the record shall be disclosed to him. If it is determined that 
disclosure is very likely to have an adverse effect on the individual, 
he may be requested to designate, in writing, a representative to whom 
the record shall be disclosed. Such representative may be a physician, 
other health professional, or other responsible person who would be 
willing to review the record and discuss it with the individual.
    (2) The availability of the record may be subject to any procedures 
for disclosure to an individual of medical records about himself under 
part 20 of this chapter, in addition to or in lieu of the procedures in 
paragraph (b)(1), that are not inconsistent with Sec.  21.41(f).