Comments, Opinions, and Brief Case Reports |

Legal Considerations in Off-Label Medication Prescribing

Richard S. Blum, MD
Arch Intern Med. 2002;162(15):1777-1779. doi:.
Text Size: A A A
Published online


There is considerable confusion in the medical profession about the legal ramifications of prescribing off-label medications. Many of us have been told by pharmaceutical companies that a drug is appropriate for this or that indication. However, the label "indication" reflects only the manufacturer's advertisement for that use for that product in that fashion and does not list all of the medical indications for the use of that drug product.

In 1820, the United States Pharmacopoeia (USP) was formed to set standards for the manufacture, nomenclature, indications, and chemical characteristics of drugs. Federal law still has the USP setting those standards in 2002. In 1938, the Pure Food and Drug Act created the Food and Drug Administration (FDA), the mission of which is to assure the safety, efficacy, and appropriate labeling and advertising of pharmaceutical products before approving them for sale. These products must meet the standards set by the USP.

Sign In to Access Full Content

Don't have Access?

Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more

Subscribe for full-text access to content from 1998 forward and a host of useful features

Activate your current subscription (AMA members and current subscribers)

Purchase Online Access to this article for 24 hours

First Page Preview

View Large
First page PDF preview





Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).
Submit a Comment


Some tools below are only available to our subscribers or users with an online account.

Web of Science® Times Cited: 9

Sign In to Access Full Content

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Topics
PubMed Articles