21CRF201.10

05-25

21CRF201.10

來自專欄藥品註冊管理

翻譯：李光義

[Code of Federal Regulations]

美國聯邦法規

[Title 21, Volume 4]

21篇．第4卷

[Revised as of April 1, 2017]

2017.4.1 修改版

[CITE: 21CFR201.10]

引證：21CRF201.10

TITLE 21--FOOD AND DRUGS

21篇-食品與藥品

CHAPTER I--FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER C--DRUGS: GENERAL

第I節—衛生和人類服務部食品藥品監督管理局C分節—藥物：通則

PART 201 -- LABELING 201部分-標籤

Subpart A--General Labeling Provisions

A 子部分—一般標籤規定

Sec. 201.10 Drugs; statement of ingredients.

201.10小節藥品；成分說明

(a) The ingredient information required by section 502(e) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any intervening written, printed, or graphic matter, except the proprietary names of ingredients, which may be included with the listing of established names, and such statements that are specifically required for certain ingredients by the act or regulations in this chapter.

聯邦食品藥品和化妝品法案502（e）小節要求的成分信息需同時在標籤上體現出來，沒有任何介於書面的，印刷的或圖形之間的問題，但成分的專有名稱除外，這些專有名稱可能包括在既定名稱以及本節法規或法案對某些成分特別要求的陳述中。

(b) The term ingredient applies to any substance in the drug, whether added to the formulation as a single substance or in admixture with other substances.

術語「成分」一詞適用於藥品中的任何物質，無論是作為單一物質添加到配方中，還是與其他物質混合使用。

某一藥品的標籤可能由於以下原因（其他原因）而產生誤導：

(1) The order in which the names of the ingredients present in the drug appear in the labeling, or the relative prominence otherwise given such names.

藥品中所含成分的名稱出現在標籤中的順序，或相對突出的位置

(2) Failure to reveal the proportion of, or other fact with respect to, an ingredient present in such drug, when such proportion or other fact is material in the light of the representation that such ingredient is present in such drug.

當成分比例或其他成分存在於此類藥物中的表示而具有實質意義，未能透露相關比例或其他存在於這種藥物中的成分，

(3) The employment of a fanciful proprietary name for a drug or ingredient in such a manner as to imply that the drug or ingredient has some unique effectiveness or composition when, in fact, the drug or ingredient is a common substance, the limitations of which are readily recognized when the drug or ingredient is listed by its established name.

當某一藥品或成分使用一個特殊的專有名稱時，這樣一種方式是為了暗示該葯或成分具有某種獨特的有效性或成分，實際上該葯或成分是一種普通的物質，當藥品或成分按照其既定名稱列出時，能夠輕易地認識到這種方式的局限性。

(4) The featuring in the labeling of inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation.

惰性或非活性成分標籤方面的特色，在某種程度上創造了一種印象，即其價值超過其在製劑中真正功能性作用

(5) Designation of a drug or ingredient by a proprietary name that, because of similarity in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredient.

由於拼寫或發音的相似性，通過專有名稱確定某一藥品或成分，可能與其他不同藥品或成分的專有名稱或既定名稱混淆。

(d)(1) If the drug is in tablet or capsule form or other unit dosage form, any statement of the quantity of an ingredient contained therein shall express the quantity of such ingredient in each such unit. If the drug is not in unit dosage form, any statement of the quantity of an ingredient contained therein shall express the amount of such ingredient in a specified unit of weight or measure of the drug, or the percentage of such ingredient in such drug. Such statements shall be in terms that are informative to licensed practitioners, in the case of a prescription drug, and to the layman, in the case of a nonprescription drug.

如果藥物是片劑或膠囊或其他劑型，則該成分在每個此類單元中的數量。如果藥物不是單位劑型，則其中某一成分任何關於數量的陳述都應該描述該成分在指定的重量或量度的藥物單位中的數量，或這種成分在該藥物中的百分比。對於執業醫師來說，處方葯中這些陳述應該是能夠提供信息的，對非專業人員來說，非處方葯中這些陳述應該是能夠提供信息。

(2) A statement of the percentage of an ingredient in a drug shall, if the term percent is used without qualification, mean percent weight-in-weight, if the ingredient and the drug are both solids, or if the ingredient is a liquid and the drug is a solid; percent weight in volume at 68 deg. F. (20 deg. C.), if the ingredient is a solid and the drug is a liquid; and percent volume in volume at 68 deg. F. (20 deg. C.), if both the ingredient and the drug are liquids, except that alcohol shall be stated in terms of percent volume of absolute alcohol at 60 deg. F. (15.56 deg. C.).

如果術語「百分比」沒有限定使用，成分和藥物都是固體，或者成分是液體且藥物是固體，某一成分在藥物中的百分比，則表示重量百分比；如果成分是固體且藥物是液體，百分比指在68℉（20℃）的體積/重量百分比；如果成分和藥物都是液體，百分比指在68℉（20℃）的體積/體積百分比，除了乙醇應該用60℉（15.56℃）下無水乙醇的體積百分比表示。

(e) A derivative or preparation of a substance named in section 502(e) of the act is an article derived or prepared from such substance by any method, including actual or theoretical chemical action.

本法案第502（e）小節命名的某一物質的衍生物或製備物是以任何方法（包括實際或理論化學作用）從該物質衍生或製備的。

(f) If an ingredient is a derivative or preparation of a substance specifically named in section 502(e) of the act and the established name of such ingredient does not indicate that it is a derivative or preparation of the parent substance named in section 502(e) of the act, the labeling shall, in conjunction with the listing of the established name of such ingredient, declare that such article is a derivative or preparation of such parent substance.

如果某種成分是本法案第502（e）小節中具體命名的物質的衍生物或製備物，並且該成分的既定名稱並不預示該成分是本法案502（e）中命名的母體物質的衍生物或製備物，該標籤應連同該成分的既定名稱的列表一起聲明該成分是該母體物質的衍生物或製備物。

(g)(1) If the label or labeling of a prescription drug bears a proprietary name or designation for the drug or any ingredient thereof, the established name, if such there be, corresponding to such proprietary name or designation shall accompany such proprietary name or designation each time it is featured on the label or in the labeling for the drug; but, except as provided in this subparagraph, the established name need not be used with the proprietary name or designation in the running text of the label or labeling. On any label or page of labeling in which the proprietary name or designation is not featured but is used in the running text, the established name shall be used at least once in the running text in association with such proprietary name or designation and in the same type size used in such running text: Provided, however, That if the proprietary name or designation is used in the running text in larger size type, the established name shall be used at least once in association with, and in type at least half as large as the type used for, the most prominent presentation of the proprietary name or designation in such running text. If any labeling includes a column with running text containing detailed information as to composition, prescribing, side effects, or contraindications and the proprietary name or designation is used in such column but is not featured above or below the column, the established name shall be used at least once in such column of running text in association with such proprietary name or designation and in the same type size used in such column of running text: Provided, however, That if the proprietary name or designation is used in such column of running text in larger size type, the established name shall be used at least once in association with, and in type at least half as large as the type used for, the most prominent presentation of the proprietary name or designation in such column of running text. Where the established name is required to accompany or to be used in association with the proprietary name or designation, the established name shall be placed in direct conjunction with the proprietary name or designation, and the relationship between the proprietary name or designation and the established name shall be made clear by use of a phrase such as "brand of" preceding the established name, by brackets surrounding the established name, or by other suitable means.

如果處方葯的標籤或標籤貼有該藥物或其任何成分的專有名稱或為其指定名稱，為了和專有名稱或指定名稱保持一致，每次標籤或藥品標籤上標明該專有名稱或指定名稱時，應該使用既定名稱（如果存在）；但除本款規定者外，既定名稱不得與專有名稱或指定名稱在標籤或標籤的正文中一起使用。在任何專有名稱或指定名稱沒有突出顯示但用於運行文本的標籤或頁面上，應在運行文本中至少使用一次既定名稱，以與該專有名稱或指定名稱相關聯，並在此類運行文本中使用與Provided, however相同類型大小的字體：如果專有名稱或指定名稱在運行文本中使用較大字體類型，為了最大程度突出顯示專有名稱和指定名稱，應以相同字體一般大小的形式至少使用一次既定名稱。如果任何標籤中包含一個正在運行的文本欄，其中包含有關組成，處方，副作用或禁忌症的詳細信息，並且專有名稱或指定名稱用於該欄中，但不在該欄的上方或下方出現，則該正在運行的文本欄至少使用一次既定名稱以與專有名稱或指定名稱相關聯，並在此類正在運行的文本欄使用與Provided, however相同的字體大小。如果專有名稱或指定名稱在此類正在運行的文本欄中使用更大的字體，為了最大程度在正在運行的文本欄中突出顯示專有名稱和指定名稱，應以相同字體一般大小的形式至少使用一次既定名稱。如果要求既定名稱與專有名稱或指定名稱一起使用或與專有名稱或名稱結合使用，則既定名稱應與專有名稱或指定名稱直接相連，以及專有名稱或指定名稱與既定名稱之間的關係應在既定名稱前通過使用一個諸如的「brand of」的短語，將既定名稱放入括弧里或通過其他合適的方式來表達清楚。

(2) The established name shall be printed in letters that are at least half as large as the letters comprising the proprietary name or designation with which it is joined, and the established name shall have a prominence commensurate with the prominence with which such proprietary name or designation appears, taking into account all pertinent factors, including typography, layout, contrast, and other printing features.

(2) 既定名稱的字母應以至少為組成專有名稱或與其相連的指定名稱的字母一半大小印刷，且考慮到所有相關因素，包括版式，版面，對比度和其他列印功能，既定名稱應具有與該專有名稱或指定名稱相稱的顯著性。

(h)(1) In the case of a prescription drug containing two or more active ingredients, if the label bears a proprietary name or designation for such mixture and there is no established name corresponding to such proprietary name or designation, the quantitative ingredient information required on the label by section 502(e) of the act shall be placed in direct conjunction with the most prominent display of the proprietary name or designation. The prominence of the quantitative ingredient information shall bear a reasonable relationship to the prominence of the proprietary name.

(h)(1) 對於含有兩種或兩種以上活性成分的處方葯，如果標籤上貼有此類混合物的專有名稱或指定名稱，並且沒有與該專有名稱或指定名稱相對應的既定名稱，則本法案502（e）小節要求標籤上所需的定量成分信息應放在與專有名稱或指定名稱的最顯著的直接相關的位置上。定量成分信息的突出性應與專有名稱的顯著性相關聯。

(2) If the drug is packaged in a container too small to bear the quantitative ingredient information on the main display panel, the quantitative ingredient information required by section 502(e) of the act may appear elsewhere on the label, even though the proprietary name or designation appears on the main display panel of the label; but side- or back-panel placement shall in this case be so arranged and printed as to provide size and prominence of display reasonably related to the size and prominence of the front-panel display.

(2) 如果藥物被包裝在一個太小的容器中而不能在主顯示面板上顯示定量成分信息，即使專有名稱或指定名稱出現在標籤的主顯示面板上，本法案第502（e）小節要求的定量成分信息可能出現在標籤的其他位置; 但是在這種情況下，側面或後面板的位置應該如此布置和列印，

以提供與前面板明顯相關的尺寸和顯著性。

(i) A drug packaged in a container too small or otherwise unable to accommodate a label with sufficient space to bear the information required for compliance with section 502(e)(1) (A)(ii) and (B) of the act shall be exempt from compliance with those clauses: Provided, That:

(i) 某一藥品包裝在一個太小的容器中以至於不能容納印有符合本法案502(e)(1) (A)(ii)和(B)要求的信息的標籤，則免於遵守以下的這些條款：

(1) The label bears: 標籤印有：

(i) The proprietary name of the drug; 藥物的專有名稱；

(ii) The established name, if such there be, of the drug; 既定名稱，如果該葯有的話；

(iii) An identifying lot or control number; and 一個識別的批號或控制號；以及

(iv) The name of the manufacturer, packer, or distributor of the drug; and

藥品生產商、包裝商或分銷商的名稱；以及

(2) All the information required to appear on the label by the act and the regulations in this chapter appears on the carton or other outer container or wrapper if such carton, outer container, or wrapper has sufficient space to bear such information, or such complete label information appears on a leaflet with the package.

(2) 如果此類紙箱，外部容器或包裝紙有足夠的空間來承載此類信息，或者此類完整標籤信息出現在紙箱或其他外部容器或包裝紙上，則本節中的要求和規定出現在標籤上的所有信息需要出現在紙箱、外部容器或包裝紙上。

[40 FR 13998, Mar. 27, 1975, as amended at 67 FR 4906, Feb. 1, 2002]

原文來源於：國際藥品註冊網&廣州佳鑫醫藥科技有限公司

本譯文著作權歸作者所有，非經作者或國際藥品註冊網授權，不得轉載。