WHO TRS 996, 2016 Annex 2

WHO TRS (Technical Report Series) 996, 2016 Annex 2

FIP–WHO technical guidelines: Points to consider in the provision by health-care professionals of children specific preparations that are not available as authorized products-Annex 2

WHO TRS (Technical Report Series) 996, 2016 Annex 2

Click on the titles below for complete guidelines


1. Introduction and scope 

1.1 Background 

1.2 Purpose 

1.3 Target audience and health-care settings 

2. Glossary 

3. Alternatives to compounding 

3.1 Sourcing of a commercially-available (marketed) or manufactured product if available 

3.2 Dose rounding 

3.3 Therapeutic alternatives

3.4 Manipulation of dosage forms 

3.4.1 Tablet splitting 

3.4.2 Tablet/capsule dispersion for oral administration 

3.4.3 Crushing tablets/opening capsules and mixing powder with food or drink 

3.4.4 Giving the injectable form by the oral route 

3.4.5 Splitting suppositories 

3.4.6 Rectal administration 

3.4.7 General advice when changing the route of administration

4. Compounding 

4.1 Good manufacturing practices aspects 

4.2 Some potential problems 

4.2.1 Oral liquids 

4.2.2 Microbial contamination 

4.3 Basic considerations 

5. Information, availability and access 

5.1 Standards of practice and guidelines 

5.2 Formularies and compendia 

5.3 Source and supply 

5.4 Networks and information services 


Appendix 1  Examples of therapeutic alternatives to extemporaneous formulations 

1. Introduction and scope

1.1 Background

Pediatric patients should have access to authorized, age-appropriate preparations of medicines that can be administered safely and effectively. Nothing in this document should detract from this objective. However, it is recognized that such preparations are not always available and in such cases a safe and effective alternative must be sought.

WHO TRS (Technical Report Series) 996, 2016 Annex 2

Post a Comment