CHILE

On May 3, the Ministry of Health opened a public consultation to submit the “Regulations for the elaboration of cytostatic preparations in pharmacy prescriptions” bill for the consideration of interested parties. This document is based on the “Regulations applicable to the preparation of pharmaceutical preparations in pharmacy prescriptions” and comments on its contents may be submitted for one month, by e-mail to [email protected]. Once the consultation has been completed and the final document has been published, the technical standard will enter into force six months after its publication in the Official Gazette.

Among the highlights of the proposal are the provisions related to the physical plant, equipment, drugs and materials, and the necessary personnel; the specifications regarding the protective elements to be used; the processing stages (pharmaceutical evaluation of the prescription; preparation; labeling; automation; and quality control); and the pharmaceutical evaluation of the prescription as a form of validation from the point of view of the feasibility of its preparation, with related aspects such as the stability and physical-chemical compatibility of the components and quantities prescribed.

It should be noted that cytostatic preparations include antineoplastic, immunomodulatory and immunosuppressive drugs as well as antiviral drugs and monoclonal antibodies for oncological use. Likewise, the health authority requires that the opinions be sent with reference to the text of the bill, indicating the associated paragraph, proposed modification and rationale, among other things.

On the other hand, the Ministry of Health published a decree to incorporate a new annex on “Good Manufacturing Practices for Radiopharmaceutical Products” to the current regulation on “Good Manufacturing Practices (GMP) for the Pharmaceutical Products Industry” and to the measure that “Approves the Regulation of the National System for the Control of Pharmaceutical Products for Human Use”. The same portfolio also approved the document containing the rights and obligations of the users of the health system. These provisions are already in force.