Legal Analysis on Behavior for Large Quantity Compounding of the Preparations in Advance in Medical Institutions
Medicine for the treatment of disease should be preparations with specific pharmaceutical form and dosage. Production of medicine is based on non-specific patients with the same disease, but prescription fulfill and compounding are under instructions from medical and pharmaceutical professionals. Productions of preparation should follow the regulations in Good Manufacture Practice (GMP). Medicines must have the consistent contents, the reproducibility of therapeutic effects and validation for manufacturing processes in order to ensure the quality and protect the safety and efficacy. The legislator would determinate the violators as counterfeit drugs. Pharmaceutical forms and dosage of medicine for patients with the same disease should be judged by their constitution. Prescription compounding for a specific patient should not be applied to other patients. Large quantity compounding in advance could not ensure the safety and efficiency, and it is also beyond the responsibility of the professionals. Therefore, it should be a production behavior if compounding new pharmaceutical forms and new products in advance exceeds the range of compounding under the regulations.