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FDA Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry Draft Revised Draft

蒋千琴 3/11/2022 浏览 227 FDA U.S

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Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry Draft Revised Draft[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于U.S。

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Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry Draft Revised Draft[附网盘链接]
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标准部分原文

Draft — Not for Implementation 1 Drug Products Labeled as Homeopathic 1

2 Guidance for FDA Staff and Industry 3 4 5 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 6 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 7 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 8 applicable statutes and regulations. To discuss an alternative approach, contact the FDA office 9 responsible for this guidance as listed on the title page. 10 11 12 13 I. INTRODUCTION 14 15 This draft guidance describes how we intend to prioritize enforcement and regulatory actions for 2

16 homeopathic drug products marketed in the United States without the required FDA approval. 17 As discussed below, FDA has developed a risk-based approach under which the Agency intends 18 to prioritize enforcement and regulatory actions involving certain categories of such products 19 that potentially pose a higher risk to public health. 20 21 The Agency anticipates that many homeopathic drug products will fall outside the categories of 22 drug products that FDA intends to prioritize for enforcement and regulatory action as described 23 in section III below. 24 25 For the purposes of this draft guidance, we define a “homeopathic drug product” as a drug 26 product that is labeled as “homeopathic,” and is labeled as containing only active ingredients and 27 dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of 3

28 the United States (HPUS). 29 30 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 31 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 32 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 33 the word should in Agency guidances means that something is suggested or recommended, but 34 not required. 35 36 II. BACKGROUND 37 38 Homeopathy is an alternative medical practice that has a historical basis in theory and practice 39 first systematized in the late 1700s. Homeopathy is generally based on two main principles: (1) 1

This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. 2

For the purposes of this guidance, all references to drugs and drug products refer to human drugs, including drugs that are biological products, regulated by CDER or CBER. 3

A product that conforms to the HPUS dilution standards may still fall under the enforcement priorities described in section III below. 1

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