21CFR201.70

來自專欄藥品註冊管理

[Code of Federal Regulations]

美國聯邦法規

[Title 21, Volume 4]

21篇，4卷

[Revised as of April 1, 2017]

2017.04.01修訂

[CITE: 21CFR201.70]

引證：21CFR201.70

TITLE 21--FOOD AND DRUGS

21篇-食品和藥品

CHAPTER I--FOOD AND DRUG ADMINISTRATION

第一章—食品與藥品管理

衛生與公共服務

SUBCHAPTER C--DRUGS: GENERAL

C分節—藥品：通則

PART 201 -- LABELING 201部分—標籤

Subpart C--Labeling Requirements for Over-the-Counter Drugs

C分節—非處方葯（OTC）的標籤要求

Sec. 201.70 Calcium labeling. 201.70 小節 含鈣產品-標籤

(a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the calcium content per dosage unit (e.g., tablet, teaspoonful) if the calcium content of a single maximum recommended dose of the product (which may be one or more dosage units) is 20 milligrams or more. OTC drug products intended for oral ingestion include gum and lozenge dosage forms, but do not include dentifrices, mouthwashes, or mouth rinses.

(a) 如果用於口服的非處方藥物（OTC）的單位最大推薦劑量（其可以是一種或更多劑量單位）的鈣含量為20毫克或更多，則該產品的標籤應標明每個劑量單位（例如，每片，一茶匙）的鈣含量。用於口服的非處方藥包括咀嚼片和含片，但不包括膏劑，漱口劑。

(b) The calcium content shall be expressed in milligrams or grams per dosage unit and shall include the total amount of calcium regardless of the source, i.e., from both active and inactive ingredients. If the dosage unit contains less than 1 gram of calcium, milligrams should be used. The calcium content per dosage unit shall be rounded-off to the nearest 5 milligrams (or nearest tenth of a gram if over 1 gram). The calcium content per dosage unit shall follow the heading "Other information" as stated in 201.66(c)(7).

(b) 鈣含量應以每個劑量單位毫克或克表示，並應標明鈣的總量，而且應不論其來源均要計算在內（來自活性成分和非活性成分）。如果劑量單位鈣含量小於1克，則應使用毫克表示。每個劑量單位的鈣含量數值應四捨五入到最接近的5毫克（如果超過1克，則為最接近的十分之一克）。每個劑量單位的鈣含量應按照201.66(c)(7)中標題為「其他信息」的所述。

(c) The labeling of OTC drug products intended for oral ingestion shall contain the following statement under the heading "Warning" (or "Warnings" if it appears with additional warning statements) if the amount of calcium present in the labeled maximum daily dose of the product is more than 3.2 grams: "Ask a doctor before use if you have [in bold type] [bullet] 1 kidney stones [bullet] a calcium-restricted diet". The warnings in 201.64(c), 201.70(c), 201.71(c), and 201.72(c) may be combined, if applicable, provided the ingredients are listed in alphabetical order, e.g., a calcium or sodium restricted diet.

(c) 如果產品最大日劑量標籤中的鈣含量為超過3.2克，用於口服的OTC藥品的標籤應在標籤「警告」（或「警告」，如果出現附加警告聲明）下涉及以下聲明：「使用前請諮詢醫生，如果你有[以粗體顯示] [著重號] 腎結石[著重號]限制鈣攝入的飲食」。如果適用的話，201.64(c), 201.70(c), 201.71(c)和201.72(c)中的警告可以合併，按字母順序列出產品輔料成分，例如限制鈣或鈉攝入的成分。

(d) Any product subject to this paragraph that is not labeled as required by this paragraph and that is initially introduced or initially delivered for introduction into interstate commerce after the following dates is misbranded under sections 201(n) and 502(a) and (f) of the Federal Food, Drug, and Cosmetic Act.

適用於本款條例的產品，卻未按本款要求加貼標籤的，以及在以下日期根據聯邦食品、藥品和化妝品法第201(N)和502(A)和(F)節被錯誤地貼上標籤後，初次推出或初次銷售用於州際貿易。

(1) As of the date of approval of the application for any single entity and combination products subject to drug marketing applications approved on or after April 23, 2004.

用於任何單一實體和組合產品的申請截至批准日期適用於2004年4月23日或之後批准的藥物上市申請。

(2) September 24, 2005, for all OTC drug products subject to any OTC drug monograph, not yet the subject of any OTC drug monograph, or subject to drug marketing applications approved before April 23, 2004.

2005年9月24日，所有符合專論的OTC產品，不僅僅是專論里的OTC產品，或者是2004年4月3日之前獲批的上市申請。

1See 201.66(b)(4) of this chapter for definition of bullet symbol.

關於【著重號】的定義參考本節201.66(b)(4)

[69 FR 13733, Mar. 24, 2004]

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。