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FDA Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

蒋千琴 3/10/2022 浏览 299 FDA U.S

标准简介

Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format[附网盘链接]是Food And Drug Administration于不久前发布的FDA标准，适用于U.S。

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Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format[附网盘链接]
Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format[附网盘链接](截图)

 

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标准部分原文

Draft — Not for Implementation 1 Drug Abuse and Dependence Section of Labeling for Human 2 Prescription Drug and Biological Products — 3 Content and Format 1

4 Guidance for Industry 5 6 7 8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 9 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 10 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 11 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 12 for this guidance as listed on the title page. 13 14 15 16 17 I. INTRODUCTION 18 19 This guidance is intended to assist applicants in writing the DRUG ABUSE AND 20 DEPENDENCE section of labeling, as described in the regulations for the content and format of 2 3

, 21 labeling for human prescription drug and biological products (21 CFR 201.57(c)(10)). This 22 guidance applies to: 23 4

24 • Prescription drugs controlled under the Controlled Substances Act (CSA) 25 26 • Prescription drugs not controlled under the CSA for which there is important information 27 to convey to health care providers related to abuse and dependence 28 29 This guidance discusses and provides recommendations on the following: 30 31 • The general principles to consider when drafting the DRUG ABUSE AND 32 DEPENDENCE section of the labeling 33 1

This guidance has been prepared by the Office of Medical Policy in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2

This guidance applies to drugs, including biological drug products. For the purposes of this guidance, drug product or drug will be used to refer to human prescription drug and biological products that are regulated as drugs. 3

See the final rule “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” (71 FR 3922, January 24, 2006) and additional labeling guidances at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084159.htm. 4

The complete list of all scheduled substances can be found at 21 CFR part 1308, which is updated following publication in the Federal Register of a drug scheduling action by the Drug Enforcement Administration (DEA).

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