Part A - Standards
- Introduction
- Risk Management
- Quality Management
- Personnel & Training
- Premises & Equipment
- Documentation
- Preparation
- Formulation & Stability
- Quality Control
- Complaints, Product Recalls & Adverse Events
- Procurement & Quality Assessment of Extemporaneously Prepared Medicines
- Audit & Monitoring
Part B - Extemporaneous Preparation Formulary
- Introduction
- Formulary of Extemporaneous Preparations:
- Acetazolamide oral liquid
- Allopurinol oral liquid
- Amiodarone hydrochloride oral liquid
- L-Arginine hydrochloride oral liquid
- Azathioprine oral liquid
- Bendroflumethiazide oral liquid
- Captopril oral liquid
- Clobazam oral liquid
- Clonazepam oral liquid
- Clonidine hydrochloride oral liquid
- Clozpine oral liquid
- Co-careldopa oral liquid (levodopa and carbidopa)
- Co-enzyme Q10 oral liquid
- Dexamethasone oral liquid and dexamethasone sodium phosphate oral liquid
- Diazoxide oral liquid
- Dinoprostone (prostaglandin E2) oral liquid
- Ergocalciferol oral liquid
- Ethambutol hydrochloride oral liquid
- Gabapentin oral liquid
- Gliclazide oral liquid
- Hydrocortisone oral liquid
- Indometacin (indomethacin) oral liquid
- Isosorbide mononitrate oral liquid
- Joulie's solution (oral phosphate supplement)
- Knox mouthwash
- Levothyroxine sodium oral liquid
- Lorazepam oral liquid
- Magnesium glycerophosphate oral liquid
- Menadiol sodium phosphate oral liquid
- Metformin hydrochloride oral liquid
- Midazolam hydrochloride oral liquid
- Morphine sulfate oral liquid
- Omeprazole oral liquid
- Phenobarbital and phenobarbital sodium oral liquid
- Phenoxybenzamine hydrochloride oral liquid
- Potassium acid phosphate oral liquid
- Primidone oral liquid
- Pyrazinamide oral liquid
- Pyridoxine hydrochloride (vitamin B6) oral liquid
- Quinine sulfate oral liquid
- Sildenafil citrate oral liquid
- Sodium bicarbonate oral liquid
- Sodium chloride oral liquid
- Sodium phenylbutyrate oral liquid
- St Mark's solution
- Tacrolimus oral mouthwash
- Tacrolimus oral suspension
- Thiamine hydrochloride oral liquid
- Tranexamic acid oral mouthwash
- Vancomycin hydrochloride oral liquid
- Warfarin sodium oral liquid
Appendices- Change control request form
- Deviation reporting form
- Example raw material specification
- Example worksheet
- Technical agreement for commissioning of extemporaneous product preparation service
- Audit tool for extemporaneous preparation
- Suspending agents