This document provides a checklist for drug formulation requests for extemporaneous, galenical, or sterile preparations. The checklist includes sections for verifying that the request form is completed with all necessary information, approved by the appropriate heads of department and deputy directors, and includes relevant references as hard or soft copies. Completed checklists along with approved request forms should be sent to the Pharmacy Practice and Development Division of the Ministry of Health in Petaling Jaya, Selangor, Malaysia.
This document provides a checklist for drug formulation requests for extemporaneous, galenical, or sterile preparations. The checklist includes sections for verifying that the request form is completed with all necessary information, approved by the appropriate heads of department and deputy directors, and includes relevant references as hard or soft copies. Completed checklists along with approved request forms should be sent to the Pharmacy Practice and Development Division of the Ministry of Health in Petaling Jaya, Selangor, Malaysia.
This document provides a checklist for drug formulation requests for extemporaneous, galenical, or sterile preparations. The checklist includes sections for verifying that the request form is completed with all necessary information, approved by the appropriate heads of department and deputy directors, and includes relevant references as hard or soft copies. Completed checklists along with approved request forms should be sent to the Pharmacy Practice and Development Division of the Ministry of Health in Petaling Jaya, Selangor, Malaysia.
EXTEMPORANEOUS/GALENICAL/STERILE PREPARATION PHARMACY PRACTICE & DEVELOPMENT DIVISION, MINISTRY OF HEALTH
CHECKLIST:
No. Document Yes No
A. Request Form – Drug Formulation Request Form: Extemporaneous/ Galenical/ Sterile Preparation 1. NEW FORMULATION request 2. UPDATE/ AMENDMENT existing formulation (eg : shelf-life, references etc) 2. COMPLETE all the necessary information required (Section A- F) 3. Checked & approved by HEAD OF DEPARTMENT 4. Checked & approved by STATE/ INSTITUTE DEPUTY DIRECTOR PHARMACEUTICAL SERVICES DIVISION (PSD)* B. References 1. Attachment of the references (HARDCOPY/ SOFTCOPY) *Through appropriate committees at the state level
Completed checklist must be attached together with the approved request form and send to:
PHARMACY PRACTICE & DEVELOPMENT DIVISION, MINISTRY OF HEALTH MALAYSIA
(Pharmaceutical Care Branch) LOT 36, JALAN PROFESOR DIRAJA UNGKU AZIZ 46200, PETALING JAYA, SELANGOR 03-7841 3200/3320 (Attn : Inpatient Pharmacy Section)
Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Translated by Office of Safety I, Pharmaceuticals and Medical Devices Agency