FDA CPG Sec. 608.200 Prescription Use of Certain Injectable Animal Drugs
标准简介
CPG Sec. 608.200 Prescription Use of Certain Injectable Animal Drugs[附网盘链接]由Food&Drug Administration于当前发布，适用于U.S。标准截图
![CPG Sec. 608.200 Prescription Use of Certain Injectable Animal Drugs[附网盘链接]](/img/20210914103654mkpbf.jpg)
标准文档说明
标准文档类型为CPG Sec. 608.200 Prescription Use of Certain Injectable Animal Drugs[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
Sec. 608.200 Prescription Use of Certain Injectable Animal Drugs Compliance Policy Guide Guidance for FDA Staff This compliance policy guide represents the current thinking of the Food and Drug Administration (FDA) 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 the approach satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this compliance policy guide as listed on the title page. I. Introduction The purpose of this compliance policy guide (CPG) is to provide guidance for FDA staff on prescription legend requirements for certain injectable animal drugs. In general, FDA’s guidance documents, including this CPG, do not establish legally enforceable responsibilities. Instead, they describe the Agency’s current thinking on various topics and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. Background Section 503(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and title 21, Code of Federal Regulations § 201.105 (21 CFR 201.105), set forth the conditions for prescription legend requirements for animal drugs. These include such factors as the toxicity or other potentiality for harmful effect, or the method of use which necessitates the supervision of a licensed veterinarian for safe use. Adequate directions for safe use of such drugs by laypersons cannot be written. Section 503(f)(4) of the FD&C Act recites the veterinary legend caution statement: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.” Other terms such as “for veterinary use only” and “for sale to graduate veterinarians” are not the prescription legend. There are some animal injectable drugs which cannot be safely used except under the supervision of a licensed veterinarian. These include the following: a. All drugs labeled for intravenous (IV) administration in dogs, cats, and other small animals; b. All drugs labeled for intra-articular, intrathecal, epidural, paravertebral, subconjunctival, and retrobulbar administration in all species;
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