21CFR201.26

05-08

翻譯：李光義

[Code of Federal Regulations]

美國聯邦法規

[Title 21, Volume 4]

21片，4卷

[Revised as of April 1, 2017]

2017.04.01修訂

[CITE: 21CFR201.26]

引證：21CFR201.26

TITLE 21--FOOD AND DRUGS

21篇-食品與藥品

CHAPTER I--FOOD AND DRUG ADMINISTRATION

第一章-食品與藥品管理

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 A--General Labeling Provisions

A 子部分—一般標籤規定

Sec. 201.26 Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.

201.26小節國家戰略儲備持有的人用藥品的標籤要求的豁免情況及替代方案

(a) The appropriate FDA Center Director may grant an exception or alternative to any provision listed in paragraph (f) of this section and not explicitly required by statute, for specified lots, batches, or other units of a human drug product, if the Center Director determines that compliance with such labeling requirement could adversely affect the safety, effectiveness, or availability of such product that is or will be included in the Strategic National Stockpile.

(a) 如果中心主任確定，遵守此類標籤要求可能會對已納入或將納入戰略性國家儲備的此類產品的安全性，有效性或可用性產生不利影響，FDA中心主任可以為本小節（f）段中列出的任何規定提供豁免或替代方案，並且法規不會對特定批次或其他單位的人用藥物產品提出明確要求。

(b)(1)(i) A Strategic National Stockpile official or any entity that manufactures (including labeling, packing, relabeling, or repackaging), distributes, or stores a human drug product that is or will be included in the Strategic National Stockpile may submit, with written concurrence from a Strategic National Stockpile official, a written request for an exception or alternative described in paragraph (a) of this section to the Center Director.

(b)(1)(i) 國家戰略儲備官員或任何製造（包括貼簽，包裝，重新貼標籤或重新包裝），分銷或儲存已納入或將納入戰略性國家儲備的人用藥物產品的實體，可以在戰略國家儲備官員的書面同意下向本中心主任提供本小節（a）段所述的豁免或替代方案的書面申請。

(ii) The Center Director may grant an exception or alternative described in paragraph (a) of this section on his or her own initiative.

(ii) 中心主任可自行提出本小節第（a）段所述的豁免或替代方案。

(2) A written request for an exception or alternative described in paragraph (a) of this section must:

(2)本小節(a)段所述的豁免或替代方案的書面申請必須：

(i) Identify the specified lots, batches, or other units of the human drug product that would be subject to the exception or alternative;

(i) 明確將受到豁免或替代的人類藥物產品的指定批次或其他單位;

(ii) Identify the labeling provision(s) listed in paragraph (f) of this section that are the subject of the exception or alternative request;

(ii) 明確本小節（f）段落中列出的標籤規定必須服從於豁免或替代申請；

(iii) Explain why compliance with such labeling provision(s) could adversely affect the safety, effectiveness, or availability of the specified lots, batches, or other units of a human drug product that are or will be held in the Strategic National Stockpile;

(iii) 解釋符合此類標籤要求可能會對已納入或將納入戰略性國家儲備的特定批次或其他單位的人用醫藥產品的安全性，有效性或可用性產生不利影響的理由；

(iv) Describe any proposed safeguards or conditions that will be implemented so that the labeling of the product includes appropriate information necessary for the safe and effective use of the product, given the anticipated circumstances of use of the product;

(iv) 描述將要實施的任何建議的保障措施或條件，以使在產品使用的預期情況下產品標籤包含安全有效使用產品所需的適當信息;

(v) Provide a draft of the proposed labeling of the specified lots, batches, or other units of the human drug product subject to the exception or alternative; and

(v)提供豁免或替代方案下的特定批次或其他單位的人用醫藥產品的建議的標籤草案；以及

(vi) Provide any other information requested by the Center Director in support of the request.

(vi)向中心主任提供支持該請求的任何其他信息；

(c)中心主任必須基於本小節對所有的請求作出書面的回復。

(d) A grant of an exception or alternative under this section will include any safeguards or conditions deemed appropriate by the Center Director so that the labeling of product subject to the exception or alternative includes the information necessary for the safe and effective use of the product, given the anticipated circumstances of use.

(d)基於本小節授予的豁免或替代方案將會包括中心主任認為合適的保障措施或條件，以便於在產品預期使用的情況下，豁免或替代方案下的產品標籤包括安全和有效使用該產品的必要信息。

(e) If you are a sponsor receiving a grant of a request for an exception or alternative to the labeling requirements under this section:

(e)如果您是獲得本小節標籤要求豁免或替代方案請求批准的贊助商：

(1) You need not submit a supplement under 314.70(a) through (c) or 601.12(f)(1) through (f)(2) of this chapter; however,

(1)您不必根據本節314.70(a)~ (c) 或601.12(f)(1) ~(f)(2)的要求提交補充材料；但是

(2) You must report any grant of a request for an exception or alternative under this section as part of your annual report under 314.70(d) or 601.12(f)(3) of this chapter.

(2)您必須根據本節314.70(d)或601.12(f)(3)的要求在你的年度報告中報告任何基於本小節豁免或替代方案申請的批准。

(f) The Center Director may grant an exception or alternative under this section to the following provisions of this chapter, to the extent that the requirements in these provisions are not explicitly required by statute:

(f) 中心主任可根據本小節的規定，對本章下列規定給予豁免或替代方案，只要法規對這些規定沒有明確的要求：

(1) 201.1(h)(1) through (h)(2), (h)(5) through (h)(6), and (i);

(1) 201.1(h)(1) ~ (h)(2), (h)(5) ~ (h)(6), 以及 (i);

(2) 201.10(a), (d)(2), (f), (g)(1), and (h)(1);

(2) 201.10(a), (d)(2), (f), (g)(1), 以及(h)(1);

(3) 201.17;

(4) 201.18;

(5) 201.19;

(6) 201.20;

(7) 201.21;

(8) 201.22;

(9) 201.24; and

(9) 201.24; 以及

(10) 312.6.

[72 FR 73599, Dec. 28, 2007]

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。