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山东省药品使用质量管理规范
发布时间: 作者: 平台管理
<span id="t" > <p><style type="text/css"> <!-- /* Font Definitions */ @font-face {font-family:宋体; panose-1:2 1 6 0 3 1 1 1 1 1; mso-font-alt:SimSun; mso-font-charset:134; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:3 135135232 16 0 262145 0;} @font-face {font-family:"\@宋体"; panose-1:2 1 6 0 3 1 1 1 1 1; mso-font-charset:134; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:3 135135232 16 0 262145 0;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-parent:""; margin:0cm; margin-bottom:.0001pt; text-align:justify; text-justify:inter-ideograph; mso-pagination:none; font-size:10.5pt; mso-bidi-font-size:12.0pt; font-family:"Times New Roman"; mso-fareast-font-family:宋体; mso-font-kerning:1.0pt;} p {mso-margin-top-alt:auto; margin-right:0cm; mso-margin-bottom-alt:auto; margin-left:0cm; mso-pagination:widow-orphan; font-size:12.0pt; font-family:宋体; mso-bidi-font-family:宋体;} /* Page Definitions */ @page {mso-page-border-surround-header:no; mso-page-border-surround-footer:no;} @page Section1 {size:595.3pt 841.9pt; margin:72.0pt 90.0pt 72.0pt 90.0pt; mso-header-margin:42.55pt; mso-footer-margin:49.6pt; mso-paper-source:0; layout-grid:15.6pt;} div.Section1 {page:Section1;} --></style><style type="text/css"> /* Style Definitions */ table.MsoNormalTable {mso-style-name:普通表格; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin:0cm; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman"; mso-ansi-language:#0400; mso-fareast-language:#0400; mso-bidi-language:#0400;}</style></p> <div class="Section1" style="layout-grid: 15.6pt none"> <p class="MsoNormal" align="center" style="text-indent: 30px; line-height: 1.5; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第一章<span lang="EN-US" style="font-family: "> </span>总 则<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第一条 为了规范我省药品使用质量管理，保障人体用药安全、有效，根据《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》和《山东省药品使用条例》等法律法规的规定，制定本规范。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第二条 本规范适用于本省行政区域内下列用药人药品购进、储存、调配环节的质量管理：<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（一）<span lang="EN-US" style="font-family: "> </span>医疗机构；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（二）<span lang="EN-US" style="font-family: "> </span>计划生育技术服务机构；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（三）<span lang="EN-US" style="font-family: "> </span>疾病预防控制机构、戒毒机构等。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第三条 用药人应当对所使用药品的质量负责，依据本规范建立包括组织机构、职责制度、过程管理和设施设备等方面的质量管理体系，并保证有效运行。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="center" style="text-indent: 30px; line-height: 1.5; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第二章<span lang="EN-US" style="font-family: "> </span>机构与人员<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第四条 医疗机构内药事部门及人员设置应符合《医疗机构药事管理暂行规定》的相关要求。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第五条<span lang="EN-US" style="font-family: "> </span>根据有关规定，不需设置药事部门的医疗机构和其他用药人应当设专人负责本单位的药品质量管理工作，并明确相应的岗位职责。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第六条<span lang="EN-US" style="font-family: "> </span>药事部门负责人应当符合下列条件：<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px"> （一）三级医疗机构药事部门负责人应当具有药学专业高级技术职称或者取得执业药师资格。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px"> （二）二级医疗机构药事部门负责人应当具有药学专业中级以上（含中级）技术职称或者取得执业药师资格。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px"> （三）一级医疗机构和计划生育技术服务机构药事部门负责人应当具有药师以上（含药师）技术职称或者取得执业药师资格。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第七条 用药人直接从事药品质量管理、购进、验收、养护、保管、调配工作的人员应当接受药事法律、法规及专业知识培训。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">用药人应当建立人员培训档案。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第八条 从事药品质量管理、调配、验收、养护、保管等直接接触药品的工作人员，每年应当进行健康查体，并建立健康档案。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">健康查体由当地药品监督管理部门指定二级以上医疗机构或者疾病预防控制机构承担。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">患有精神病、传染病和皮肤病等可能污染药品的人员，不得从事直接接触药品的工作。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="center" style="text-indent: 30px; line-height: 1.5; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第三章 药品购进与验收<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第九条 用药人购进药品应当以保证质量为前提，从具有合法资格的药品生产、药品批发企业采购药品。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第十条 用药人购进药品时，必须严格审核供货单位、购进药品及销售人员的资质，建立供货单位档案，索取以下资料：<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（一）加盖供货单位原印章的《药品生产许可证》或《药品经营许可证》及营业执照的复印件；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（二）加盖供货单位原印章的所销售药品的批准证明文件复印件；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（三）加盖供货单位原印章和企业法定代表人印章（或者签名）的授权书复印件。授权书应当载明授权销售药品的品种、地域、期限、销售人员的身份证号码；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（四）药品销售人员的身份证复印件；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（五）供货单位开具的标明供货单位名称、药品名称、生产厂商、批号、数量、价格等内容的销售凭证。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">购进进口药品时，除应向供货单位索取上述资料外，还应当索取加盖供货单位原印章的《进口药品通关单》复印件。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第十一条 用药人购进药品，必须建立并执行进货检查验收制度，验收人员要逐批验明药品的包装、规格、标签、说明书、合格证明和其他标识；不符合规定要求的，不得购进。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第十二条 用药人应当建立真实、完整的药品购进验收记录，做到票、帐、物相符。药品购进验收记录应包括药品的通用名称、规格、批号、有效期、生产厂商、批准文号、供货单位、购进数量、购进日期、验收结论及验收人签名等内容。购进验收记录保存至超过药品有效期<span lang="EN-US" style="font-family: ">1</span>年，但不得少于<span lang="EN-US" style="font-family: ">3</span>年。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第十三条 购进麻醉药品、精神药品、医疗用毒性药品、放射性药品等特殊管理的药品，应当从具有相应资格的药品生产或经营企业购进。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第十四条 用药人购进需要保持冷链运输条件的疫苗等药品，应当检查运输条件是否符合要求并作好记录；对不符合运输条件要求的，应当拒绝接收。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><font style="font-family: 宋体"><font style="font-size: 14px"><span lang="EN-US" style="color: black; line-height: 150%; font-family: ; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"> </span><span style="color: black; line-height: 150%; font-family: ; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第四章<span lang="EN-US" style="font-family: "> </span>药品储存与养护<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></span></font></font></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第十五条 用药人储存药品应当设置与诊疗范围和用药规模相适应的、与诊疗区和治疗区分开的药房、药库。药房、药库的内墙壁、顶棚和地面应光洁、平整，门窗应严密。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">一级以上医疗机构、县级以上计划生育技术服务机构和县级以上疾病预防控制机构应当设置药库；乡级计划生育技术服务机构应当设置药房。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第十六条<span lang="EN-US" style="font-family: "> </span>药库应当根据药品的质量要求，在相应的常温（温度为<span lang="EN-US" style="font-family: ">0</span>—<span lang="EN-US" style="font-family: ">30</span>℃）、阴凉（温度不高于<span lang="EN-US" style="font-family: ">20</span>℃）、冷藏（温度为<span lang="EN-US" style="font-family: ">2</span>—<span lang="EN-US" style="font-family: ">10</span>℃）条件下储存，相对湿度保持在<span lang="EN-US" style="font-family: ">45</span>—<span lang="EN-US" style="font-family: ">75%</span>之间。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">对储存有特殊要求的药品应当按照药品说明书或包装上标注的条件及有关规定储存。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第十七条<span lang="EN-US" style="font-family: "> </span>药库应当配备以下设施设备：<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（一）保持药品与地面之间有一定距离的设施；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（二）避光、通风设备；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（三）监测和调控温、湿度设备；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（四）符合安全用电要求的照明设施；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（五）防尘、防潮、防污染、防虫、防鼠以及防火等设施。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第十八条<span lang="EN-US" style="font-family: "> </span>药库内应当划分合格药品区、待验药品区、不合格药品区等专用场所；各区实行色标管理，合格药品区为绿色，待验药品区为黄色，不合格药品区为红色。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第十九条 库存药品与地面、墙、顶之间应有相应的间距或隔离措施。药品与墙、屋顶（梁）的间距不小于<span lang="EN-US" style="font-family: ">30</span>厘米，与地面间距不小于<span lang="EN-US" style="font-family: ">10</span>厘米。药品垛堆之间应有一定距离。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第二十条<span lang="EN-US" style="font-family: "> </span>库存药品应按照药品属性分类存放。药品与非药品分开存放；中药饮片分库存放；化学药品、中成药分类存放；易串味药品单独密闭存放；易燃、易爆、强腐蚀性等危险性药品必须设专库存放，并有必要的安全措施。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第二十一条<span lang="EN-US" style="font-family: "> </span>药品养护人员应当做好药库温湿度的监测和管理。每天定时对药库温湿度进行记录。温湿度超出规定范围的，应及时调控并予以记录。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第二十二条<span lang="EN-US" style="font-family: "> </span>药房应当配备药品陈列货架（柜）。不合格药品应当单独存放，并有明确标识；需避光储存的药品应当有防护措施；冷藏药品应当在相应的温度条件下存放。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第二十三条<span lang="EN-US" style="font-family: "> </span>陈列药品应根据品种规格剂型或药理作用分类摆放，药品与医疗器械、内服药与外用药、性质互相影响、易串味药品、拆零药品应当分开摆放。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第二十四条 对库存药品和陈列药品应当定期进行检查和养护并做好记录，库存药品每季度养护一次，陈列药品每月养护一次，重点品种每半月养护一次。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">对影响药品质量的隐患应当及时排除；对过期、污染或变质等不合格产品，应当按照有关规定及时予以处理。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第二十五条<span lang="EN-US" style="font-family: "> </span>麻醉药品、一类精神药品、医疗用毒性药品、放射性药品应当设专库或专柜存放，做到双人保管，专帐记录，帐物相符。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="center" style="text-indent: 30px; line-height: 1.5; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第五章 药品的调配<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第二十六条 用药人调配的药品应当与诊疗范围相适应。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第二十七条 用药人调配药品时，必须凭注册的执业医师、执业助理医师或者乡村医生开具的处方或医嘱进行，非经医师开具处方不得调配药品。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第二十八条 药品发放应当遵循“先产先出”、 “近效期先出”和按批号发放的原则。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第二十九条 用药人调配、拆零药品，应当根据临床需要设立独立的调配、拆零场所或者专用操作台。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">调配、拆零场所应定期清洁消毒，保持工作环境卫生整洁。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">调配、拆零使用的容器和工具应定期清洗、消毒，防止污染药品。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">药品拆零时不得裸手直接接触药品。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第三十条 直接接触拆零药品的包装材料（容器）应当清洁卫生，并在包装材料上标明药品通用名称、规格、用法、用量、有效期、批号、医疗机构名称、拆零日期等内容。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">拆零药品不得混批包装。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第三十一条<span lang="EN-US" style="font-family: "> </span>药品拆零应当做好详细记录。拆零记录至少应当保存一年，原包装应当保存至拆零药品用完为止。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第三十二条 中药饮片的调配和质量管理，执行《医院中药饮片管理规范》的有关规定。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第三十三条 用药人在完成处方调配后，必须按照有关规定妥善保存处方。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="center" style="text-indent: 30px; line-height: 1.5; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第六章 制度与管理<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第三十四条 用药人应当根据药品使用的实际情况，建立健全并执行保证药品质量的管理制度。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">质量管理制度主要内容包括：<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（一）各级药品质量管理岗位职责；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（二）药品购进、验收、储存、养护、出库等环节的管理；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（三）首次供货企业合法资质审核的管理；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（四）调配和审核处方的管理；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（五）药品效期的管理；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（六）特殊药品的管理；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（七）不合格药品和退货药品的管理；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（八）与药品质量有关设施设备（如温度调控设备、冰箱、冷柜、去湿机、温湿度计等）使用的管理；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（九）有关记录和凭证的管理；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（十）药品不良反应监测的管理；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（十一）人员健康查体的管理；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（十二）药品拆零的管理；<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（十三）人员培训的管理等。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第三十五条 用药人应当对保证药品质量的管理制度实施情况定期检查和考核，并做好记录。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第三十六条 用药人在使用药品过程中发现假劣药品，必须停止使用，并及时向所在地药品监督管理部门和卫生行政部门报告，不得擅自处理。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第三十七条 用药人应当执行药品不良反应监测报告制度，依法履行药品不良反应监测报告义务，确定机构或人员负责本单位药品不良反应信息的收集、报告工作。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="center" style="text-indent: 30px; line-height: 1.5; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第七章 附 则<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第三十八条 本规范涉及用语的含义如下：<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><font style="font-family: 宋体"><font style="font-size: 14px"><span lang="EN-US" style="color: black; line-height: 150%; font-family: ; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">(</span><span style="color: black; line-height: 150%; font-family: ; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">一<span lang="EN-US" style="font-family: ">)</span>医疗机构，是指按照《医疗机构管理条例》批准登记的从事疾病诊断、治疗活动的机构，包括医院、社区卫生服务中心（站）、妇幼保健院、卫生院、疗养院、门诊部、诊所、卫生室（所）、急救中心（站）、专科疾病防治院（所、站）以及护理院（站）等。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></span></font></font></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（二）计划生育技术服务机构，是指按照《计划生育技术服务管理条例》的规定，由设区的市级以上地方人民政府计划生育行政部门批准并发给《计划生育技术服务机构执业许可证》，从事计划生育技术服务的机构。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（三）药事部门，是指医疗机构内部设置，并在其负责人领导下负责本单位药品质量管理、药品购进、保管、调配、调剂使用等药事管理工作的部门。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（四）药学专业技术人员，是指按照《卫生技术人员职务试行条例》规定，取得药学专业技术职务任职资格人员，包括主任药师、副主任药师、主管药师、药师、药士。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">（五）拆零药品，是指拆掉药品最小包装即失去该药品的名称、功能主治或适应症、用法、用量和有效期等标识，需要再包装的药品。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第三十九条 疫苗的质量管理按照国务院《疫苗流通和预防接种管理条例》有关规定执行。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第四十条 医疗机构制剂配制的质量管理，按照国家食品药品监督管理局《医疗机构制剂配制质量管理规范》执行。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" align="left" style="text-indent: 30px; line-height: 1.5; mso-pagination: widow-orphan"><span style="font-size: 11.5pt; color: black; line-height: 150%; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-family: 宋体"><font style="font-size: 14px">第四十一条 本规范由省药品监督管理部门负责解释。<span lang="EN-US" style="font-family: "> <o:p style="text-indent: 30px; line-height: 1.5; font-family: "></o:p></span></font></font></span></p> <p class="MsoNormal" style="text-indent: 30px; line-height: 1.5"><span style="font-size: 11.5pt; color: black; font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><font style="font-size: 14px; font-family: 宋体">第四十二条 本规范自<span lang="EN-US" style="font-family: ">2007</span>年<span lang="EN-US" style="font-family: ">10</span>月<span lang="EN-US" style="font-family: ">1</span>日起施行。</font></span></p> </div></span>
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