Customized Medicines for Personalized Treatments - PODCAST Episode

Compounding and Specialty Pharmacy – Regulations, Innovations and Reputations

Compounding Pharmacists have a very challenging, and rewarding job, in their development of specialized medicines for individualized patient care. For many, there is satisfaction in working to solve the needs of patients through innovative partnership with patient and practitioner. Too often professionals in this space are mired by regulatory inconsistencies, special interest groups, lack of transparency and a tarnished reputation, all of which make this highly challenging job even more difficult. In this episode of Voices in Validation we speak with Eric Kastango and Kevin Hansen about some of the hurdles and opportunities in Compounding.

Links:

FDA Guidance - https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies

USP General Chapters for compounding establish procedures, methods and practices that are utilized by practitioners to help ensure the quality of compounded preparations.

There are several essential compounding General Chapters:

<795> Pharmaceutical Compounding—Nonsterile Preparations
<797> Pharmaceutical Compounding—Sterile Preparations
<800> Hazardous Drugs—Handling in Healthcare Settings
<825> Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging
<1160> Pharmaceutical Calculations in Pharmacy Practice
<1163> Quality Assurance in Pharmaceutical Compounding