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
As stated, the AAO/OMIC appear to believe that the intent of USP 797 is to prevent infection. This is incorrect. Infection control is related but separate from quality control, and more specifically contamination control, which at the broad and granular impact safety AND effectiveness well beyond infection risk, for example, hypersensitivity reactions to antibody dimers/trimers or other contaminating particulate, or physical-chemical-biologic tissue incompatibilities.
The informed consent as described could simply advise patients of the off-label indication and not the risks associated with off-label preparation and off-label route of administration, resulting in federal quality attribute destruction.
1 comment:
As stated, the AAO/OMIC appear to believe that the intent of USP 797 is to prevent infection. This is incorrect. Infection control is related but separate from quality control, and more specifically contamination control, which at the broad and granular impact safety AND effectiveness well beyond infection risk, for example, hypersensitivity reactions to antibody dimers/trimers or other contaminating particulate, or physical-chemical-biologic tissue incompatibilities.
The informed consent as described could simply advise patients of the off-label indication and not the risks associated with off-label preparation and off-label route of administration, resulting in federal quality attribute destruction.
Post a Comment