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, December 18, 2014
FACT of the Day December 18, 2014 The FDA Has Conducted 175 inspections of compounding facilities during the past two years. "Our findings uncovered a variety of problems with sterile drug production practices at these facilities. As a result of these inspections, numerous firms stopped making sterile drugs and many recalled drug products that had been made under substandard conditions. In some cases, we worked with state officials to revoke or suspend pharmacy licenses. We also issued warning letters to firms that were producing drugs under inadequate conditions, notifying them of violations of the law and the need to take steps to correct the violations and prevent their recurrence," FDA Commissioner Margaret A. Hamburg
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NECC also acted like a manufacturer by advertising specific products as safe and effective for use in populations (not to meet the specific need of an individual patient who required a tailored medication). If pharmacists knowingly make drugs under substandard conditions, they are endangering the lives of patients. But, if pharmacists are unaware of the risks they may be building into products, i.e. the types of risks that are identified during drug development, and in environments where federal surveillance and oversight is required, and through mandated reporting and signal detection, shouldn't the fact that they are at a disadvantage for even knowing and understanding risks be disclosed? Pharmacists do or should know that the chemicals they buy may have disclaimers on their certificates of analysis (purity results listed may not be guaranteed by sellers) and they do know that there are disclaimers on many of the formulas published or purchased for compounding, disclosing that safety and efficacy are undetermined, and they do know that non-sterile ingredients have a great degree of uncertainty regarding their ability to be cleared of harmful viable and non-viable organisms, and that forcing liquids through fine filters may create shear force stress that does not destroy filter integrity but that changes the shape of bacteria allowing for passage into purportedly sterile products. They also are likely to know whether or not the products they market carry product liability insurance. Still, the marketing momentum continues, without disclosures to purchasers or prescribers. These information asymmetries may continue to be exploited for financial gains.
And if the SC ruling confirmed a right to advertise specific compounded products, with that right must come certain responsibilities?
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