21 CFR 21.33 - Medical records.

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There is 1 rule appearing in the Federal Register for 21 CFR 21. View below or at eCFR (GPOAccess)
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§ 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 § 21.41(f).

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2013-07-01; vol. 78 # 126 - Monday, July 1, 2013
    1. 78 FR 39184 - Privacy Act, Exempt Record System; Implementation
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary
      Final rule.
      This rule is effective July 31, 2013.
      21 CFR Part 21

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES
U.S. Code: Title 15 - COMMERCE AND TRADE
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 21 after this date.

  • 2013-07-01; vol. 78 # 126 - Monday, July 1, 2013
    1. 78 FR 39184 - Privacy Act, Exempt Record System; Implementation
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary
      Final rule.
      This rule is effective July 31, 2013.
      21 CFR Part 21