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GUIDANCE DOCUMENT

Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 — Elimination of Certain Labeling Requirements July 1998

Final

Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 — Elimination of Certain Labeling Requirements

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

Section 126 of Title I of the Food and Drug Administration Modernization Act of 1997 (Modernization Act), signed into law by President Clinton on November 21, 1997, amends section 503(b)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(b)(4)) to require, at a minimum, that prior to dispensing, the label of prescription products contain the symbol “Rx only.” In addition, section 502(d) of the Act (21 U.S.C. 352(d)), which required the labels of certain habit-forming drugs to bear the statement “Warning-May be habit forming,” is repealed. The amendments to section 503(b)(4) and the repeal of 502(d) of the Act became effective February 19, 1998.


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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

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