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HHS/FDA RIN: 0910-AA94 Publication ID: Fall 2005 
Title: Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products 
Abstract: This regulation is one component of the Secretary's initiative to reduce medical errors. The regulation would amend the regulations governing the format and content of professional labeling for human prescription drugs (including biological products that are regulated as drugs), 21 CFR 201.56 and 201.57. The regulation would require that such labeling include highlights of prescribing information and a table of contents for prescribing information. It would reorder currently required information, make minor changes to its content, and establish minimum graphical requirements. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 201   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 371    42 USC 262   
Legal Deadline:  None

Statement of Need: The current format and content requirements in sections 201.56 and 201.57 were established in 1979 to help ensure that labeling includes adequate information to enable health care practitioners to prescribe drugs safely and effectively. However, various developments in recent years, such as increasing product liability and technological advances in drug product development, have contributed to an increase in the amount, detail, and complexity of labeling information. This has made it harder for practitioners to find specific information and to discern the most critical information in labeling. FDA took numerous steps to evaluate the usefulness of labeling for practitioners and to determine whether, and how, its format and content can be improved. The agency conducted focus groups and a national survey of office-based physicians to ascertain how labeling is used by health care practitioners, what labeling information is most important to practitioners, and how labeling should be revised to improve its usefulness to practitioners. Based on the concerns cited by practitioners in the focus groups and physician survey, FDA developed and tested two prototypes of revised labeling formats designed to facilitate access to important labeling information. Based on this testing, FDA developed a third revised prototype that it made available to the public for comment. FDA received written comments and presented the revised prototype at an informal public meeting held on October 30, 1995. At the public meeting, the agency also presented the background research and provided a forum for oral feedback from invited panelists and members of the audience. The panelists generally supported the prototype. The proposed rule, published in 2000, described format and content requirements for prescription drug labeling that incorporate information and ideas gathered during this process. The comment period was extended until June 22, 2001, and the agency received close to 100 comments on the proposal.

Summary of the Legal Basis: The agency has broad authority under sections 201, 301, 501, 502, 503, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321, 331, 351, 352, 353, 355, and 371) and section 351 of the Public Health Service Act (42 U.S.C. 262) to help ensure that prescription drugs (including biological products that are regulated as drugs) are safe and effective for their intended uses. A major part of FDA's efforts regarding the safe and effective use of drug products involves FDA's review, approval, and monitoring of drug labeling. Under section 502(f)(1) of the Act, a drug is misbranded unless its labeling bears "adequate directions for use" or it is exempted from this requirement by regulation. Under section 201.100 (21 CFR 201.100), a prescription drug is exempted from the requirement in section 502(f)(1) of the Act only if, among other things, it contains the information required, in the format specified, by sections 201.56 and 201.57. Under section 502(a) of the Act, a drug product is misbranded if its labeling is false or misleading in any particular. Under section 505(d) and 505(e) of the Act, FDA must refuse to approve an application and may withdraw the approval of an application if the labeling for the drug is false or misleading in any particular. Section 201(n) of the Act provides that in determining whether the labeling of a drug is misleading, there shall be taken into account not only representations or suggestions made in the labeling, but also the extent to which the labeling fails to reveal facts that are material in light of such representations or material with respect to the consequences which may result from use of the drug product under the conditions of use prescribed in the labeling or under customary usual conditions of use. These statutory provisions, combined with section 701(a) of the Act and section 351 of the Public Health Service Act, clearly authorize FDA to promulgate a final regulation designed to help ensure that practitioners prescribing drugs (including biological products) will receive information essential to their safe and effective use in a format that makes the information easier to access, read, and use.

Alternatives: The alternatives to the final rule include not amending the content and format requirements in sections 201.56 and 201.57 at all, or amending them to a lesser extent. The agency has determined that although drug product labeling, as currently designed, is useful to physicians, many find it difficult to locate specific information in labeling, and some of the most frequently consulted and most important information is obscured by other information. In addition, the agency's research showed that physicians strongly support the concept of including highlights of the most important prescribing information, a table of contents and numbering system that permits specific information to be easily located, and other requirements, such as the requirement for a minimum type size. Thus, the agency believes that the requirements in the final rule will greatly facilitate health care practitioners' access and use of prescription drug and biological product labeling information.

Anticipated Costs and Benefits: The purpose of this rule is to make it easier for health care practitioners to access, read and use information in prescription drug labeling, thereby increasing the extent to which they rely on labeling to obtain information. FDA believes the revisions to the content and format of labeling will enhance the safe and effective use of prescription drug products, and in turn, reduce the number of adverse reactions resulting from medication errors due to misunderstood or wrongly applied drug information. The new requirements are important to the success of other initiatives aimed at improving patient care and decreasing the likelihood of medication errors. For example, revised labeling will facilitate initiatives to process, review and archive labeling electronically and provide a mechanism to facilitate the development of electronic prescribing systems. The potential costs associated with the final rule include the cost of redesigning labeling for previously approved products to which the proposed rule would apply and submitting the new labeling to FDA for approval. In addition, one-time and ongoing incremental costs would be associated with printing the longer labeling that would result from additional required sections. These costs would be minimized by applying the amended requirements only to newer products and by staggering the implementation date for previously approved products.

Risks: None.

Action Date FR Cite
NPRM  12/22/2000  65 FR 81082   
NPRM Comment Period End  03/22/2001    
NPRM Comment Period Reopened  03/30/2001  66 FR 17375   
NPRM Comment Period Reopening End  06/22/2001    
Final Action  11/00/2005    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
Agency Contact:
Elizabeth J. Sadove
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Office of Regulatory Policy, 10903 New Hampshire Avenue, Bldg. 51, Room 6368,
Silver Spring, MD 20993-0002
Phone:301 796-3522
Fax:301 847-8440

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