Chapter IV

Control over Pharmaceuticals in Medical Institutions

Article 22 A medical institution shall be staffed with legally qualified pharmaceutical professionals. No one who is not a pharmaceutical professional may directly engage in technical work in pharmacy.

Article 23 To dispense pharmaceutical preparations, a medical institution shall be subject to examination and permission by the administrative department for health of the people’s government of the province, autonomous region or municipality directly under the Central Government, and upon approval by the drug regulatory department of the said people’s government, a Pharmaceutical Preparation Certificate for Medical Institution shall be issued to it by the said drug regulatory department. No one may dispense pharmaceutical preparations without the certificate.

The valid term shall be indicated in the certificate. For renewal of the certificate upon expiration, reexamination is required.

Article 24 To dispense pharmaceutical preparations, the medical institution shall possess the facilities, management system, testing instruments and hygienic conditions for ensuring their quality.

Article 25 The pharmaceutical preparations to be dispensed by the medical institutions shall be ones that are to meet the clinic need of the institution but are not available on the market and shall be subject to approval in advance by the local drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government. The quality of the dispensed pharmaceutical preparations shall be subject to test according to regulations; those passing the testing may be used within the institution on the basis of the physician’s prescription. In special cases, the pharmaceutical preparations dispensed by a medical institution may be used by other designated medical institutions, upon approval by the drug regulatory department under the State Council or by the drug regulatory department of the people’s government of a province, autonomous region or municipality directly under the Central Government.

No pharmaceutical preparations dispensed by medical institutions may be marketed.

Article 26 For purchasing drugs, medical institutions shall establish and apply an examination and acceptance system, and check the certificate of drug quality, labels and other marks; no drugs that do not meet the specified requirements may be purchased or used.

Article 27 Prescriptions dispensed by pharmacists of medical institutions shall be checked, and on drugs listed in the prescriptions may be changed or substituted without authorization. The pharmacists shall refuse to dispense incompatible or over-dose prescriptions; when necessary, they may do the dispensing only after corrections or re-signing is made by the prescribing physician.

Article 28 A medical institution shall establish and apply a system for drug storage, and take necessary measures to ensure drug quality, such as cold storage, protection against freeze and humidity and avoidance of insects and rodents.