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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
| | 衛生部令
（第53號）
《處方管理辦法》已于2006年11月27日經衛生部部務會議討論通過，現予發布，自2007年5月1日起施行。
部長 高強
二??七年二月十四日
處方管理辦法
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Chapter I General Rules
| | 第一章 總則
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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.
| | 第一條 為規範處方管理，提高處方質量，促進合理用藥，保障醫療安全，根據《執業醫師法》、《藥品管理法》、《醫療機構管理條例》、《麻醉藥品和精神藥品管理條例》等有關法律、法規，制定本辦法。
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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.
| | 第二條 本辦法所稱處方，是指由注冊的執業醫師和執業助理醫師（以下簡稱醫師）在診療活動中為患者開具的、由取得藥學專業技術職務任職資格的藥學專業技術人員（以下簡稱藥師）審核、調配、核對，並作為患者用藥憑證的醫療文書。處方包括醫療機構病區用藥醫囑單。
本辦法適用于與處方開具、調劑、保管相關的醫療機構及其人員。
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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.
| | 第三條 衛生部負責全國處方開具、調劑、保管相關工作的監督管理。
縣級以上地方衛生行政部門負責本行政區域內處方開具、調劑、保管相關工作的監督管理。
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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.
| | 第四條 醫師開具處方和藥師調劑處方應當遵循安全、有效、經濟的原則。
處方藥應當憑醫師處方銷售、調劑和使用。
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Chapter II General Rules on Prescription Administration
| | 第二章 處方管理的一般規定
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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.
| | 第五條 處方標准（附件1）由衛生部統一規定，處方格式由省、自治區、直轄市衛生行政部門（以下簡稱省級衛生行政部門）統一制定，處方由醫療機構按照規定的標准和格式印制。
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Article 6 The writing of a prescription shall satisfy the following requirements:
| | 第六條 處方書寫應當符合下列規則：
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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）患者一般情況、臨床診斷填寫清晰、完整，並與病曆記載相一致。
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(2) One prescription shall be for the use of drugs of only one patient;
| | （二）每張處方限于一名患者的用藥。
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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）字跡清楚，不得塗改；如需修改，應當在修改處簽名並注明修改日期。
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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）藥品名稱應當使用規範的中文名稱書寫，沒有中文名稱的可以使用規範的英文名稱書寫；醫療機構或者醫師、藥師不得自行編制藥品縮寫名稱或者使用代號；書寫藥品名稱、劑量、規格、用法、用量要准確規範，藥品用法可用規範的中文、英文、拉丁文或者縮寫體書寫，但不得使用“遵醫囑”、“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）患者年齡應當填寫實足年齡，新生兒、嬰幼兒寫日、月齡，必要時要注明體重。
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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）西藥和中成藥可以分別開具處方，也可以開具一張處方，中藥飲片應當單獨開具處方。
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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）開具西藥、中成藥處方，每一種藥品應當另起一行，每張處方不得超過5種藥品。
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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）中藥飲片處方的書寫，一般應當按照“君、臣、佐、使”的順序排列；調劑、煎煮的特殊要求注明在藥品右上方，並加括號，如布包、先煎、後下等；對飲片的產地、炮制有特殊要求的，應當在藥品名稱之前寫明。
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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）藥品用法用量應當按照藥品說明書規定的常規用法用量使用，特殊情況需要超劑量使用時，應當注明原因並再次簽名。
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(10) Except for special circumstances, clinical diagnosis shall be indicated;
| | （十）除特殊情況外，應當注明臨床診斷。
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(11) A slash shall be marked at the blank space of a prescription to finish the prescription;
| | （十一）開具處方後的空白處劃一斜線以示處方完畢。
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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）處方醫師的簽名式樣和專用簽章應當與院內藥學部門留樣備查的式樣相一致，不得任意改動，否則應當重新登記留樣備案。
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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, 米g 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.
| | 第七條 藥品劑量與數量用阿拉伯數字書寫。劑量應當使用法定劑量單位：重量以克（g）、毫克（mgㄘ﹜峚親ㄗ米g）、納克（ng）為單位；容量以升（L）、毫升（ml）為單位；國際單位（IU）、單位（U）；中藥飲片以克（g）為單位。
片劑、丸劑、膠囊劑、顆粒劑分別以片、丸、粒、袋為單位；溶液劑以支、瓶為單位；軟膏及乳膏劑以支、盒為單位；注射劑以支、瓶為單位，應當注明含量；中藥飲片以劑為單位。 |
Chapter III Acquisition of Prescription Right
| | 第三章 處方權的獲得
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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.
| | 第八條 經注冊的執業醫師在執業地點取得相應的處方權。
經注冊的執業助理醫師在醫療機構開具的處方，應當經所在執業地點執業醫師簽名或加蓋專用簽章後方有效。
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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.
| | 第九條 經注冊的執業助理醫師在鄉、民族鄉、鎮、村的醫療機構獨立從事一般的執業活動，可以在注冊的執業地點取得相應的處方權。
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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.
| | 第十條 醫師應當在注冊的醫療機構簽名留樣或者專用簽章備案後，方可開具處方。
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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.
| | 第十一條 醫療機構應當按照有關規定，對本機構執業醫師和藥師進行麻醉藥品和精神藥品使用知識和規範化管理的培訓。執業醫師經考核合格後取得麻醉藥品和第一類精神藥品的處方權，藥師經考核合格後取得麻醉藥品和第一類精神藥品調劑資格。
醫師取得麻醉藥品和第一類精神藥品處方權後，方可在本機構開具麻醉藥品和第一類精神藥品處方，但不得為自己開具該類藥品處方。藥師取得麻醉藥品和第一類精神藥品調劑資格後，方可在本機構調劑麻醉藥品和第一類精神藥品。
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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.
| | 第十二條 試用期人員開具處方，應當經所在醫療機構有處方權的執業醫師審核、並簽名或加蓋專用簽章後方有效。
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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.
| | 第十三條 進修醫師由接收進修的醫療機構對其勝任本專業工作的實際情況進行認定後授予相應的處方權。
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Chapter IV Issue of Prescriptions
| | 第四章 處方的開具
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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.
| | 第十四條 醫師應當根據醫療、預防、保健需要，按照診療規範、藥品說明書中的藥品適應證、藥理作用、用法、用量、禁忌、不良反應和注意事項等開具處方。
開具醫療用毒性藥品、放射性藥品的處方應當嚴格遵守有關法律、法規和規章的規定。
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Article 15 A medical institution shall make drug formularies in light of its nature, functions and tasks.
| | 第十五條 醫療機構應當根據本機構性質、功能、任務，制定藥品處方集。
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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.
| | 第十六條 醫療機構應當按照經藥品監督管理部門批准並公布的藥品通用名稱購進藥品。同一通用名稱藥品的品種，注射劑型和口服劑型各不得超過2種，處方組成類同的複方制劑1∼2種。因特殊診療需要使用其他劑型和劑量規格藥品的情況除外。
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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.
| | 第十七條 醫師開具處方應當使用經藥品監督管理部門批准並公布的藥品通用名稱、新活性化合物的專利藥品名稱和複方制劑藥品名稱。
醫師開具院內制劑處方時應當使用經省級衛生行政部門審核、藥品監督管理部門批准的名稱。
醫師可以使用由衛生部公布的藥品習慣名稱開具處方。
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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.
| | 第十八條 處方開具當日有效。特殊情況下需延長有效期的，由開具處方的醫師注明有效期限，但有效期最長不得超過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.
．．．．．． | | 第十九條 處方一般不得超過7日用量；急診處方一般不得超過3日用量；對于某些慢性病、老年病或特殊情況，處方用量可適當延長，但醫師應當注明理由。
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