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Order of the Ministry of Health
(No.53)
The Measures for the Administration of Prescriptions, which were deliberated and adopted at the executive meeting of the Ministry of Health on November 27th, 2006, are hereby promulgated and shall come into force as of May 1st, 2007.
Minister Gao Qiang
February 14th, 2007
Measures for the Administration of Prescriptions
| | 卫生部令
（第53号）
《处方管理办法》已于2006年11月27日经卫生部部务会议讨论通过，现予发布，自2007年5月1日起施行。
部长 高强
二〇〇七年二月十四日
处方管理办法
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Chapter I General Rules
| | 第一章 总则
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Article 1 For the purpose of regulating the administration of prescriptions, improve the quality of prescriptions, promoting the rational use of drugs and safeguarding medical safety, these Measures are formulated in accordance with the Law on Medical Practitioners, the Pharmaceutical Administration Law, Regulation on the Administration of Medical Institutions, the Regulation on the Administration of Narcotics and Psychotropic Drugs and other relevant laws and regulations.
| | 第一条 为规范处方管理，提高处方质量，促进合理用药，保障医疗安全，根据《执业医师法》、《药品管理法》、《医疗机构管理条例》、《麻醉药品和精神药品管理条例》等有关法律、法规，制定本办法。
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Article 2 The term “prescription” as mentioned in these Measures refers to the medical documents which are issued by certified medical practitioners or assistant medical practitioners (hereinafter referred to as medical practitioners), examined, dispensed and checked by the specialized technical personnel of pharmacy who have acquired the qualification for holding the professional and technical post of pharmacy, and are taken as the credentials of the patients' use of drugs. Prescriptions include the doctor's advice on drug use for the inpatient areas of medical institutions.
These Measures apply to the medical institutions and their personnel that are related to the issuance, dispensing and safekeeping of prescriptions.
| | 第二条 本办法所称处方，是指由注册的执业医师和执业助理医师（以下简称医师）在诊疗活动中为患者开具的、由取得药学专业技术职务任职资格的药学专业技术人员（以下简称药师）审核、调配、核对，并作为患者用药凭证的医疗文书。处方包括医疗机构病区用药医嘱单。
本办法适用于与处方开具、调剂、保管相关的医疗机构及其人员。
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Article 3 The Ministry of Health shall be responsible for the supervision and administration of the issuance, dispensing, safekeeping of prescriptions and other relevant work of the whole nation.
An administrative department of health at or above the county level shall be responsible for the issuance, dispensing, safekeeping of prescriptions and other relevant work conducted within its region of administration.
| | 第三条 卫生部负责全国处方开具、调剂、保管相关工作的监督管理。
县级以上地方卫生行政部门负责本行政区域内处方开具、调剂、保管相关工作的监督管理。
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Article 4 When issuing or dispensing prescriptions, medical practitioners or pharmacists shall follow the principles of safety, effectiveness and economy.
Prescription drugs shall be sold, dispensed and used upon the strength of the prescriptions issued by medical practitioners.
| | 第四条 医师开具处方和药师调剂处方应当遵循安全、有效、经济的原则。
处方药应当凭医师处方销售、调剂和使用。
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Chapter II General Rules on Prescription Administration
| | 第二章 处方管理的一般规定
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Article 5 Prescription standards (Annex 1) shall be uniformly formulated by the Ministry of Health, prescription format shall be uniformly formulated by the administrative departments of health of the provinces, autonomous regions, and municipalities directly under the Central Government (hereinafter referred to as provincial administrative departments of health), and prescriptions shall be printed by medical institutions in accordance with the prescribed standards and format.
| | 第五条 处方标准（附件1）由卫生部统一规定，处方格式由省、自治区、直辖市卫生行政部门（以下简称省级卫生行政部门）统一制定，处方由医疗机构按照规定的标准和格式印制。
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Article 6 The writing of a prescription shall satisfy the following requirements:
| | 第六条 处方书写应当符合下列规则：
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(1) The patient's general situation and clinic diagnosis shall be clearly and completely filled in and be consistent with those recorded in the case records;
| | （一）患者一般情况、临床诊断填写清晰、完整，并与病历记载相一致。
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(2) One prescription shall be for the use of drugs of only one patient;
| | （二）每张处方限于一名患者的用药。
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(3) The handwriting shall be legible and may not be amended; in the case of any amendment, it is necessary to sign at the amended place and indicate the date of amendment;
| | （三）字迹清楚，不得涂改；如需修改，应当在修改处签名并注明修改日期。
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(4) Standard Chinese names of drugs shall be used, and standard English names of drugs may be used in case there are no corresponding Chinese names. No medical institution, medical practitioner or pharmacist may make up any abbreviated drug name without authorization or use any code name. The drug name, dose, specification and use direction shall be indicated in an accurate and standard way. The use directions may be written in standard Chinese, English, Latin or abbreviated style, but no such ambiguous words as “follow the doctor's advice” or “use by yourself” may be used.
| | （四）药品名称应当使用规范的中文名称书写，没有中文名称的可以使用规范的英文名称书写；医疗机构或者医师、药师不得自行编制药品缩写名称或者使用代号；书写药品名称、剂量、规格、用法、用量要准确规范，药品用法可用规范的中文、英文、拉丁文或者缩写体书写，但不得使用“遵医嘱”、“自用”等含糊不清字句。
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(5) The age of patient shall be the exact age, as for a newborn, its age shall be the days or months of its birth, and its weight shall be indicated where necessary.
| | （五）患者年龄应当填写实足年龄，新生儿、婴幼儿写日、月龄，必要时要注明体重。
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(6) Western medicines and prepared Chinese medicines may be prescribed in a same prescription or in two different prescriptions, and traditional Chinese herbal slices shall be prescribed in a separate prescription.
| | （六）西药和中成药可以分别开具处方，也可以开具一张处方，中药饮片应当单独开具处方。
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(7) When prescribing western medicines and prepared Chinese medicines, each medicine shall be indicated as a separate paragraph, and one prescription shall at most include five medicines.
| | （七）开具西药、中成药处方，每一种药品应当另起一行，每张处方不得超过5种药品。
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(8) A prescription of traditional Chinese herbal slices shall be written by the order of “monarch, minister, assistant and guide”, namely, “principal drugs, supplementary drugs, adjuvant drugs and guiding drugs”; such special requirements as dispensing and decoction shall be bracketed at the right top of a drug, such as bagged with cloth, decocted first, cooked then, etc.; any special requirement on the producing area and processing of a drug shall be indicated before the name of the drug;
| | （八）中药饮片处方的书写，一般应当按照“君、臣、佐、使”的顺序排列；调剂、煎煮的特殊要求注明在药品右上方，并加括号，如布包、先煎、后下等；对饮片的产地、炮制有特殊要求的，应当在药品名称之前写明。
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(9) The use directions and quantity of a drug shall be the general directions and quantity as described in the instructions of the drug, in case it is necessary to overdose a drug for a certain special circumstance, the corresponding reason shall be indicated and the prescription shall be signed again;
| | （九）药品用法用量应当按照药品说明书规定的常规用法用量使用，特殊情况需要超剂量使用时，应当注明原因并再次签名。
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(10) Except for special circumstances, clinical diagnosis shall be indicated;
| | （十）除特殊情况外，应当注明临床诊断。
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(11) A slash shall be marked at the blank space of a prescription to finish the prescription;
| | （十一）开具处方后的空白处划一斜线以示处方完毕。
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(12) The signature style and personal seal of the medical practitioner issuing the prescription shall be identical with those filed with the pharmacy department of the medical institution where he works for future reference, and may not be changed at will; in the case of any change, new samples shall be registered and filed for record.
| | （十二）处方医师的签名式样和专用签章应当与院内药学部门留样备查的式样相一致，不得任意改动，否则应当重新登记留样备案。
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Article 7 The dosage and quantity of a drug shall be written in Arabic numerals. The dosage shall be written with statutory dosage units: g, mg, μg and ng as for weight; L and ml as for capacity; international unit (IU), unit (U); and g as for traditional Chinese herbal slices.
The unit of tablets, pills, capsules and granules shall be slice, pellet, piece and bag, respectively; the unit of liquor shall be bottle; the unit of ointment and cream shall be tube or box; the unit of injection shall be bottle, and the content shall also be indicated. The unit of traditional Chinese herbal slices shall be dose.
| | 第七条 药品剂量与数量用阿拉伯数字书写。剂量应当使用法定剂量单位：重量以克（g）、毫克（mg）、微克（μg）、纳克（ng）为单位；容量以升（L）、毫升（ml）为单位；国际单位（IU）、单位（U）；中药饮片以克（g）为单位。
片剂、丸剂、胶囊剂、颗粒剂分别以片、丸、粒、袋为单位；溶液剂以支、瓶为单位；软膏及乳膏剂以支、盒为单位；注射剂以支、瓶为单位，应当注明含量；中药饮片以剂为单位。 |
Chapter III Acquisition of Prescription Right
| | 第三章 处方权的获得
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Article 8 A certified medical practitioner shall obtain the corresponding prescription right at the practice place.
A prescription issued by an assistant medical practitioner at a medical institution shall not become effective until it is signed by a medical practitioner of the practice place or affixed with his personal seal.
| | 第八条 经注册的执业医师在执业地点取得相应的处方权。
经注册的执业助理医师在医疗机构开具的处方，应当经所在执业地点执业医师签名或加盖专用签章后方有效。
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Article 9 A certified assistant medical practitioner who engages in the general practice activities at a medical institution of a village, autonomous township of ethnic minorities or town may acquire corresponding prescription right at the certified practice place.
| | 第九条 经注册的执业助理医师在乡、民族乡、镇、村的医疗机构独立从事一般的执业活动，可以在注册的执业地点取得相应的处方权。
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Article 10 A medical practitioner may issue prescriptions after he files the sample of his signature or personal seal with the certified medical institution.
| | 第十条 医师应当在注册的医疗机构签名留样或者专用签章备案后，方可开具处方。
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Article 11 A medical institution shall train its medical practitioners and pharmacists in terms of the use and standardized management of narcotics and psychotropic substances. Upon examination, a qualified medical practitioner may acquire the prescription right of narcotics and the psychotropic drugs of category I, and a qualified pharmacist may acquire the qualification for dispensing narcotics and the psychotropic drugs of category I.
Only after acquiring the prescription right of narcotics and the psychotropic drugs of category I may a medical practitioner prescribe narcotics and the psychotropic drugs of category I at the medical institution he works, but he may not prescribe any such drug for himself. And only after acquiring the qualification for dispensing narcotics and the psychotropic drugs of category I may a medical practitioner dispense narcotics and the psychotropic drugs of category I at the medical institution he works.
| | 第十一条 医疗机构应当按照有关规定，对本机构执业医师和药师进行麻醉药品和精神药品使用知识和规范化管理的培训。执业医师经考核合格后取得麻醉药品和第一类精神药品的处方权，药师经考核合格后取得麻醉药品和第一类精神药品调剂资格。
医师取得麻醉药品和第一类精神药品处方权后，方可在本机构开具麻醉药品和第一类精神药品处方，但不得为自己开具该类药品处方。药师取得麻醉药品和第一类精神药品调剂资格后，方可在本机构调剂麻醉药品和第一类精神药品。
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Article 12 A prescription issued by a personnel of probation period at a medical institution shall not become effective until it is examined and signed by a medical practitioner with prescription right of this medical institution or affixed with his personal seal.
| | 第十二条 试用期人员开具处方，应当经所在医疗机构有处方权的执业医师审核、并签名或加盖专用签章后方有效。
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Article 13 The prescription right of a medical practitioner engaged in advanced studies shall be granted by the medical institution accepting him after confirming his competence for such professional work on the basis of the actual situation.
| | 第十三条 进修医师由接收进修的医疗机构对其胜任本专业工作的实际情况进行认定后授予相应的处方权。
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Chapter IV Issue of Prescriptions
| | 第四章 处方的开具
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Article 14 A medical practitioner shall issue prescriptions in light of the need of medical treatment, disease prevention or health protection and in accordance with diagnosis and treatment norms, and the indications, pharmacological actions, dosage, use directions, contraindications, adverse reactions and precautions as prescribed in drug instructions.
The prescription of the poisonous substances or radiopharmaceuticals for medical use shall strictly abide by the relevant laws, rules and regulations.
| | 第十四条 医师应当根据医疗、预防、保健需要，按照诊疗规范、药品说明书中的药品适应证、药理作用、用法、用量、禁忌、不良反应和注意事项等开具处方。
开具医疗用毒性药品、放射性药品的处方应当严格遵守有关法律、法规和规章的规定。
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Article 15 A medical institution shall make drug formularies in light of its nature, functions and tasks.
| | 第十五条 医疗机构应当根据本机构性质、功能、任务，制定药品处方集。
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Article 16 A medical institution shall procure drugs according to the generic names of the drugs as approved and published by the drug supervisory and administrative department, and can only procure at most 2 varieties of injection drugs and 2 varieties of orally taken drugs that are under a same generic name, and 1~2 compound preparations whose prescribed compositions are similar, with the exception of the drugs of any other form, dosage or specification used for special diagnosis and treatment purposes.
| | 第十六条 医疗机构应当按照经药品监督管理部门批准并公布的药品通用名称购进药品。同一通用名称药品的品种，注射剂型和口服剂型各不得超过2种，处方组成类同的复方制剂1～2种。因特殊诊疗需要使用其他剂型和剂量规格药品的情况除外。
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Article 17 When issuing prescriptions, a medical practitioner shall use the generic names of drugs, patent names of new bioactive compounds and names of compound preparation drugs as approved and published by the drug supervisory and administrative department.
A medical practitioner shall, when prescribing the preparations prepared by the medical institution he works, use the drug names approved by the provincial administrative department of health or drug supervisory and administrative department.
A medical practitioner may use the habitual names of drugs published by the Ministry of Health when issuing prescriptions.
| | 第十七条 医师开具处方应当使用经药品监督管理部门批准并公布的药品通用名称、新活性化合物的专利药品名称和复方制剂药品名称。
医师开具院内制剂处方时应当使用经省级卫生行政部门审核、药品监督管理部门批准的名称。
医师可以使用由卫生部公布的药品习惯名称开具处方。
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Article 18 A prescription shall be good for the date of issue only. Where it is necessary to extend the valid period under a certain special circumstance, the medical practitioner issuing the prescription shall indicate the valid period, which shall be no more than 3 days.
| | 第十八条 处方开具当日有效。特殊情况下需延长有效期的，由开具处方的医师注明有效期限，但有效期最长不得超过3天。
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Article 19 A prescription may provide drugs available for no more than 7 days, and no more than 3 days as for a prescription of emergency treatment; in the case of some chronic diseases, senile diseases or a special circumstance, the available period may be prolonged to a proper extent, provided that the medical practitioner shall indicate the corresponding reasons.
．．．．．． | | 第十九条 处方一般不得超过7日用量；急诊处方一般不得超过3日用量；对于某些慢性病、老年病或特殊情况，处方用量可适当延长，但医师应当注明理由。
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