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
Keep in mind we don't have information or findings regarding GMP and related sterility lapses for hospital pharmacy environments-the 483 findings and warning letters issued by FDA are without a comparator on the hospital side. I'm not sure if we even have USP 797 standard-based inspection findings for hospitals. That said, this looks like a gold-standard program for patient-specific compounding with short expiry dating for products made from FDA-approved sterile starting materials (traditional IV admixture). If entities like this start compounding from API with uncertain qualifications for specific uses based on hypothesis, I would want FDA to take a look.
For example, a suspension for injection made from a chemical API that does not provide warranty for end use, for which particle distribution is not ascertained, for which a sterile manufacturing process (compounding recipe) is used as the basis for formulation but has never been validated and itself does not provide warranty…intended for a hypothetical use based on limited testing and no formal vetting by regulatory authorities--more complicated than typically acknowledged.
2 comments:
Keep in mind we don't have information or findings regarding GMP and related sterility lapses for hospital pharmacy environments-the 483 findings and warning letters issued by FDA are without a comparator on the hospital side. I'm not sure if we even have USP 797 standard-based inspection findings for hospitals.
That said, this looks like a gold-standard program for patient-specific compounding with short expiry dating for products made from FDA-approved sterile starting materials (traditional IV admixture). If entities like this start compounding from API with uncertain qualifications for specific uses based on hypothesis, I would want FDA to take a look.
For example, a suspension for injection made from a chemical API that does not provide warranty for end use, for which particle distribution is not ascertained, for which a sterile manufacturing process (compounding recipe) is used as the basis for formulation but has never been validated and itself does not provide warranty…intended for a hypothetical use based on limited testing and no formal vetting by regulatory authorities--more complicated than typically acknowledged.
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