FDA Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry

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Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry[附网盘链接]是于不久前发布的FDA标准，适用于United States。

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Child-Resistant Packaging Statements in Drug Product Labeling 1

Guidance for Industry This guidance represents 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 office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance is intended to assist applicants, manufacturers, packagers, and distributors (collectively referred to as firms) who choose to include child-resistant packaging (CRP) 2

statements in their drug product labeling. The guidance discusses what information should be included to support CRP statements in labeling for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications. In addition to recommendations for labeling of prescription drug products, this guidance also includes recommendations for labeling both for nonprescription drug 3

products approved under an NDA or ANDA and those that are marketed under the Over-the-

4

Counter (OTC) Drug Review. This guidance is intended to help ensure that such labeling is 5

clear, useful, informative, and, to the extent possible, consistent in content and format. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic 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. 1

This guidance has been prepared by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2

References to drugs and biological products include drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C) and biological products licensed under section 351 of the Public Health Service Act (PHSA) that are drugs. For the purposes of this guidance, drug product or drug will be used to refer to human prescription drug and biological products that are regulated as drugs. 3

For the purposes of this guidance, the term nonprescription drug products refers to over-the-counter (OTC) drug products. 4

See 21 CFR 330-358. 5

This guidance is intended to apply to FDA-regulated drug products that bear CRP statements, regardless of whether CRP is required for such products under 16 CFR 1700. For example, bulk packages of prescription drugs that are shipped to pharmacies for repackaging by a pharmacist are not required to utilize CRP, but a firm may nevertheless choose to use CRP (and a CRP statement) for such drugs. 16 CFR 1701.1. 1

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