FDA 2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry
标准简介
2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。标准截图
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标准文档类型为2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry[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
2016 Medical Gas Container-Closure Rule Questions and Answers 1
Guidance for Industry (Small Entity Compliance Guide) 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 help small businesses better understand and comply with recently issued regulations on current good manufacturing practice (CGMP) and labeling for medical gases. On November 18, 2016 (81 FR 81685), FDA published a final rule “Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements” (Container-
Closure Rule or final rule). The final rule amends certain CGMP regulations regarding medical gases to increase the likelihood that the contents of medical gas containers are accurately identified on labeling and by container coloring and to reduce the likelihood of the wrong gas being connected to a supply system by requiring gas-specific outlet connections. The final rule also revises an existing labeling regulation (21 CFR 201.161) that exempts listed medical gases from certain otherwise-applicable labeling requirements under specified conditions (including meeting the applicable medical gas labeling and container closure requirements and including certain warning statement(s)). FDA has prepared this guidance in accordance with section 212 of the Small Business 2
Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28) to assist small entities in complying with the Container-Closure Rule. 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 Office of Regulatory Policy in cooperation with the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. 2
5 U.S.C. 601 (note).
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