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
Thursday, September 4, 2014
Breaking News: Compounding Pharmacist Arrested at Logan for Trying to Leave the Country
The FDA OCI affidavit in support of criminal complaint is an important read.
Because breaches in sterile facilities/processes have also been identified at other inspected pharmacies, entities sourcing sterile medications should carefully examine purchased drugs' labeling for "sterile" or "injectable" designations that would indicate the drug was produced and tested in a manner to render it sterile/pyrogen free. If not, is it possible that pharmacies selling products at high risk for contamination could potentially avoid charges like those outlined here even if their drugs are found to be contaminated? Could evidence reach the purchasing side, i.e., the customer intended to purchase a sterile/pyrogen free injectable but was supplied with something less than that? That might be a tougher argument--particularly if the purchaser did not detect the error on arrival, prior to administering it to patients (i.e. product had no sterile designation, and/or was not labeled for injection). If there is language to indicate the drug was made in a manner that would render it sterile (essentially a claim of sterility), would that be an indicator that there is or should be product liability insurance for the drug should something go wrong? I'm struggling with how the products can be sold in the first place, without product liability insurance. Sixteen other species of fungi detected in patients treated with the firm's methylprednisolone acetate.
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The FDA OCI affidavit in support of criminal complaint is an important read.
Because breaches in sterile facilities/processes have also been identified at other inspected pharmacies, entities sourcing sterile medications should carefully examine purchased drugs' labeling for "sterile" or "injectable" designations that would indicate the drug was produced and tested in a manner to render it sterile/pyrogen free. If not, is it possible that pharmacies selling products at high risk for contamination could potentially avoid charges like those outlined here even if their drugs are found to be contaminated? Could evidence reach the purchasing side, i.e., the customer intended to purchase a sterile/pyrogen free injectable but was supplied with something less than that? That might be a tougher argument--particularly if the purchaser did not detect the error on arrival, prior to administering it to patients (i.e. product had no sterile designation, and/or was not labeled for injection).
If there is language to indicate the drug was made in a manner that would render it sterile (essentially a claim of sterility), would that be an indicator that there is or should be product liability insurance for the drug should something go wrong? I'm struggling with how the products can be sold in the first place, without product liability insurance.
Sixteen other species of fungi detected in patients treated with the firm's methylprednisolone acetate.
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