FDA CVM GFI #264 Standardized Medicated Feed Assay Limits
标准简介
CVM GFI #264 Standardized Medicated Feed Assay Limits[附网盘链接]是FDA于不久前发布的FDA标准，适用于United States。标准截图
![CVM GFI #264 Standardized Medicated Feed Assay Limits[附网盘链接]](/img/20210914103704e5g5g.jpg)
标准文档说明
标准文档类型为CVM GFI #264 Standardized Medicated Feed Assay Limits[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Draft — Not for Implementation Standardized Medicated Feed Assay Limits Draft Guidance for Industry This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. Introduction CVM establishes assay limits for drugs in medicated feeds (i.e., Type B and Type C medicated feeds) as part of the approval process for Type A medicated articles. The term “assay limits” refers to how much the measured amount of drug can deviate from the labeled amount of drug. The assay limits for Type B and Type C medicated feeds are specified as a range and published in 21 CFR §558.4(d). When a medicated feed assay value falls within this range using a validated method accepted by CVM, it indicates that the measured drug level in medicated feed is consistent with the labeled drug level. The assay limits are not intended to permit a feed manufacturer to add more or less than the labeled amount of drug to the medicated feed. Assay limits are used pre-approval to ensure that medicated feeds in Target Animal Safety (TAS), Effectiveness (EFF), Chemistry, Manufacturing, and Controls (CMC), Bioequivalence (BE), and Human Food Safety (HFS) residue chemistry studies contain the appropriate amount of drug, and post-approval for compliance and customer service purposes. This guidance recommends a standardized set of assay limits for medicated feeds. Standardized medicated feed assay limits allow predictability in the review process as sponsors can determine early in the drug development process what assay limits they should expect to meet for medicated feeds used in TAS, EFF, CMC, and HFS residue chemistry studies. The implementation of standardized medicated feed assay limits does not lower or otherwise change the current standards for safety and effectiveness and does not change the expectation regarding medicated feed assay methods, medicated feed assay method validation, and method transfer studies (see Guidance for Industry (GFI) #135, “Validation of Analytical Procedures for Type C 1
Medicated Feeds,” GFI #136, “Protocols for the Conduct of Method Transfer Studies for Type 2
C Medicated Feed Assay Methods,” and GFI #137, “Analytical Methods Description for Type 3
C Medicated Feeds” ). CVM will not require any additional medicated feed studies beyond those already required in the CMC technical section due to the implementation of standardized 1
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-135-validation-analytical-
procedures-type-c-medicated-feeds 2
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-136-protocols-conduct-
method-transfer-studies-type-c-medicated-feed-assay-methods 3
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-137-analytical-methods-
description-type-c-medicated-feeds
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