21 CFR 201.56 处方药和生物制品标签的内容和格式要求
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[Code of Federal Regulations] [Title 21, Volume 4] [Revised as of April 1, 2017] [CITE: 21CFR201.56]
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
(3) For products for which an NDA, BLA, or efficacy supplement has been approved anytime from June 30, 2004, up to and including June 29, 2005, a supplement with proposed conforming labeling must be submitted no later than June 30, 2010.
21 条——食品和药品 第一章——食品药品监管局
卫生及公共服务部 C 节 药物：通则 第 201 部分——标签（瓶签和说明书）
B 部分——处方药和/或胰岛素的标签要求
Sec. 201.56 Requirements on content and format of labeling for human prescription drug and biological products.
（3）标签必须根据可能来自人体经验的数据。如果 没有足够的证据证明安全或缺乏有效的证据，就不可能 提出任何有关药物使用的暗示性的声明或建议。结论基 于动物数据，但必须在人体内安全有效地使用该药物， 必须将其确定为与人体数据一起列入标签的适当部分。
(b) Categories of prescription drugs subject to the labeling content and format requirements in 201.56(d) and 201.57.
(5) For products for which an NDA, BLA, or efficacy supplement has been approved anytime from June 30, 2002, up to and including June 29, 2003, a supplement with proposed conforming labeling must be submitted no later
（1）对于 NDA、BLA 或临床补充申请在 2006 年 6 月 30 日或之后提交批准的产品，提出的一致性标签必须作 为申请的一部分提交。
（2）对于 NDA、BLA 或临床补充申请在 2006 年 6 月 30 日待批准的产品，或已从 2005 年 6 月 30 日起批准的 产品，包括 2006 年 6 月 30 日在内，不迟于 2009 年 6 月 30 日提交补充建议标签。
(1) The labeling must contain a summary of the essential scientific information needed for the safe and effective use of the drug.
(2) The labeling must be informative and accurate and neither promotional in tone nor false or misleading in any particular. In accordance with 314.70 and 601.12 of this chapter, the labeling must be updated when new information becomes available that causes the labeling to become inaccurate, false, or misleading.
(1) For products for which an NDA, BLA, or efficacy supplement is submitted for approval on or after June 30, 2006, proposed conforming labeling must be submitted as part of the application.
(i) Prescription drug products for which a new drug application (NDA), biologics license application (BLA), or efficacy supplement was approved by the Food and Drug Administration (FDA) between June 30, 2001 and June 30, 2006;
(2) For products for which an NDA, BLA, or efficacy supplement is pending on June 30, 2006, or thatFra Baidu bibliotekhas been approved any time from June 30, 2005, up to and including June 30, 2006, a supplement with proposed conforming labeling must be submitted no later than June 30, 2009.
(1) The following categories of prescription drug products are subject to the labeling requirements in paragraph (d) of this section and 201.57 in accordance with the implementation schedule in paragraph (c) of this section:
(ii) Prescription drug products for which an NDA, BLA, or efficacy supplement is pending on June 30, 2006; or
(iii) Prescription drug products for which an NDA, BLA, or efficacy supplement is submitted anytime on or after June 30, 2006.
（3）对于 NDA、BLA 或临床补充申请的产品，从 2004 年 6 月 30 日起，直至 2005 年 6 月 29 日，均已批准，建 议的合格标签必须在 2010 年 6 月 30 日之前提交。
（b）201.56（d）和 201.57 规定的标签内容和格式要求 的处方药类别。
（1）根据本节第（c）段的实施时间表，以下类别 的处方药产品符合本节（d）段和 201.57 条的标签要求：
（i）在 2001 年 6 月 30 日至 2006 年 6 月 30 日 期间由 FDA 批准的新药申请（NDA）、生物制品许可证申 请（BLA）或功效补充的处方药产品；
(2) Prescription drug products not described in paragraph (b)(1) of this section are subject to the labeling requirements in paragraph (e) of this section and 201.80. (c) Schedule for implementing the labeling content and format requirements in 201.56(d) and 201.57. For products described in paragraph (b)(1) of this section, labeling conforming to the requirements in paragraph (d) of this section and 201.57 must be submitted according to the following schedule:
(4) For products for which an NDA, BLA, or efficacy supplement has been approved anytime from June 30, 2003, up to and including June 29, 2004, a supplement with proposed conforming labeling must be submitted no later than June 30, 2011.
(3) The labeling must be based whenever possible on data derived from human experience. No implied claims or suggestions of drug use may be made if there is inadequate evidence of safety or a lack of substantial evidence of effectiveness. Conclusions based on animal data but necessary for safe and effective use of the drug in humans must be identified as such and included with human data in the appropriate section of the labeling.
201.56 人用处方药和生物制品标签的内容和格式要求。
(a) General requirements. Prescription drug labeling described in 201.100(d) must meet the following general requirements:
SUBCHAPTER C--DRUGS: GENERAL
PART 201 -- LABELING
Subpart B--Labeling Requirements for Prescription Drugs and/or Insulin
〔联邦条例守则〕 〔标题 21，第 4 卷〕 [截至 2017 年 4 月 1 日修订] [引用：21CFR201.56]
（A）一般要求。201.100（d）所述处方药标识必须符合 以下一般要求：
（1）标签必须包含安全有效使用该药物所需的基本 科学信息的摘要。
（2）标签必须是翔实的和准确的，既不夸大，也非 虚假信息或具误导性。根据本章的 314.70 和 601.12，为 避免标签信息变得不准确、错误或误导，当出现新信息 时，标签必须被更新。
（ii）NDA、BLA 或临床补充申请在 2006 年 6 月 30 日待批准的处方药产品；或
（iii）在 2006 年 6 月 30 日或以后任何时候提 交 NDA、BLA 或功效补充的处方药产品。
（2）本节第（b）（1）款中未说明的处方药产品， 在本节（e）段和（201.80）段中有标注要求。
（c）在 201.56（d）和 201.57 中实施标签内容和格式要 求的时间表。对于本节第（b）（1）款所述的产品，符合 本节（201.57）款（d）项要求的标签必须按照以下时间 表提交：
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
(3) For products for which an NDA, BLA, or efficacy supplement has been approved anytime from June 30, 2004, up to and including June 29, 2005, a supplement with proposed conforming labeling must be submitted no later than June 30, 2010.
21 条——食品和药品 第一章——食品药品监管局
卫生及公共服务部 C 节 药物：通则 第 201 部分——标签（瓶签和说明书）
B 部分——处方药和/或胰岛素的标签要求
Sec. 201.56 Requirements on content and format of labeling for human prescription drug and biological products.
（3）标签必须根据可能来自人体经验的数据。如果 没有足够的证据证明安全或缺乏有效的证据，就不可能 提出任何有关药物使用的暗示性的声明或建议。结论基 于动物数据，但必须在人体内安全有效地使用该药物， 必须将其确定为与人体数据一起列入标签的适当部分。
(b) Categories of prescription drugs subject to the labeling content and format requirements in 201.56(d) and 201.57.
(5) For products for which an NDA, BLA, or efficacy supplement has been approved anytime from June 30, 2002, up to and including June 29, 2003, a supplement with proposed conforming labeling must be submitted no later
（1）对于 NDA、BLA 或临床补充申请在 2006 年 6 月 30 日或之后提交批准的产品，提出的一致性标签必须作 为申请的一部分提交。
（2）对于 NDA、BLA 或临床补充申请在 2006 年 6 月 30 日待批准的产品，或已从 2005 年 6 月 30 日起批准的 产品，包括 2006 年 6 月 30 日在内，不迟于 2009 年 6 月 30 日提交补充建议标签。
(1) The labeling must contain a summary of the essential scientific information needed for the safe and effective use of the drug.
(2) The labeling must be informative and accurate and neither promotional in tone nor false or misleading in any particular. In accordance with 314.70 and 601.12 of this chapter, the labeling must be updated when new information becomes available that causes the labeling to become inaccurate, false, or misleading.
(1) For products for which an NDA, BLA, or efficacy supplement is submitted for approval on or after June 30, 2006, proposed conforming labeling must be submitted as part of the application.
(i) Prescription drug products for which a new drug application (NDA), biologics license application (BLA), or efficacy supplement was approved by the Food and Drug Administration (FDA) between June 30, 2001 and June 30, 2006;
(2) For products for which an NDA, BLA, or efficacy supplement is pending on June 30, 2006, or thatFra Baidu bibliotekhas been approved any time from June 30, 2005, up to and including June 30, 2006, a supplement with proposed conforming labeling must be submitted no later than June 30, 2009.
(1) The following categories of prescription drug products are subject to the labeling requirements in paragraph (d) of this section and 201.57 in accordance with the implementation schedule in paragraph (c) of this section:
(ii) Prescription drug products for which an NDA, BLA, or efficacy supplement is pending on June 30, 2006; or
(iii) Prescription drug products for which an NDA, BLA, or efficacy supplement is submitted anytime on or after June 30, 2006.
（3）对于 NDA、BLA 或临床补充申请的产品，从 2004 年 6 月 30 日起，直至 2005 年 6 月 29 日，均已批准，建 议的合格标签必须在 2010 年 6 月 30 日之前提交。
（b）201.56（d）和 201.57 规定的标签内容和格式要求 的处方药类别。
（1）根据本节第（c）段的实施时间表，以下类别 的处方药产品符合本节（d）段和 201.57 条的标签要求：
（i）在 2001 年 6 月 30 日至 2006 年 6 月 30 日 期间由 FDA 批准的新药申请（NDA）、生物制品许可证申 请（BLA）或功效补充的处方药产品；
(2) Prescription drug products not described in paragraph (b)(1) of this section are subject to the labeling requirements in paragraph (e) of this section and 201.80. (c) Schedule for implementing the labeling content and format requirements in 201.56(d) and 201.57. For products described in paragraph (b)(1) of this section, labeling conforming to the requirements in paragraph (d) of this section and 201.57 must be submitted according to the following schedule:
(4) For products for which an NDA, BLA, or efficacy supplement has been approved anytime from June 30, 2003, up to and including June 29, 2004, a supplement with proposed conforming labeling must be submitted no later than June 30, 2011.
(3) The labeling must be based whenever possible on data derived from human experience. No implied claims or suggestions of drug use may be made if there is inadequate evidence of safety or a lack of substantial evidence of effectiveness. Conclusions based on animal data but necessary for safe and effective use of the drug in humans must be identified as such and included with human data in the appropriate section of the labeling.
201.56 人用处方药和生物制品标签的内容和格式要求。
(a) General requirements. Prescription drug labeling described in 201.100(d) must meet the following general requirements:
SUBCHAPTER C--DRUGS: GENERAL
PART 201 -- LABELING
Subpart B--Labeling Requirements for Prescription Drugs and/or Insulin
〔联邦条例守则〕 〔标题 21，第 4 卷〕 [截至 2017 年 4 月 1 日修订] [引用：21CFR201.56]
（A）一般要求。201.100（d）所述处方药标识必须符合 以下一般要求：
（1）标签必须包含安全有效使用该药物所需的基本 科学信息的摘要。
（2）标签必须是翔实的和准确的，既不夸大，也非 虚假信息或具误导性。根据本章的 314.70 和 601.12，为 避免标签信息变得不准确、错误或误导，当出现新信息 时，标签必须被更新。
（ii）NDA、BLA 或临床补充申请在 2006 年 6 月 30 日待批准的处方药产品；或
（iii）在 2006 年 6 月 30 日或以后任何时候提 交 NDA、BLA 或功效补充的处方药产品。
（2）本节第（b）（1）款中未说明的处方药产品， 在本节（e）段和（201.80）段中有标注要求。
（c）在 201.56（d）和 201.57 中实施标签内容和格式要 求的时间表。对于本节第（b）（1）款所述的产品，符合 本节（201.57）款（d）项要求的标签必须按照以下时间 表提交：