Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Subscribe to:
Post Comments (Atom)
1 comment:
Safety issues are generally detected and mitigated during drug development, otherwise they would not meet the rigor of multidisciplinary review and approval by regulatory authorities prior to the granting market approval. Even with approval by authorities, some drugs will have unresolved safety signals or missing information that must be addressed in the post marketing setting, through the gathering of information, analysis and related decision-making.
There are numerous theoretical basic science, animal and clinical science safety signals related to any proposed multi-ingredient transdermal formulation intended for the far reaching indications for which the compounded creams are marketed-- from scar removal to the treatment of cardiovascular circulatory problems. There are also very serious safety signals related to prior compounded cream deaths.
The pervasively marketed, patent-holding compounded pain creams simply have not been investigated and vetted prior to marketing--they are experimental. But you would not know that from their promotion.
Post a Comment