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
Monday, September 29, 2014
Very Important Comment and Questions from Reader regarding compounded vs. counterfeit drugs
This is a really important question. While the public health outcomes of counterfeit, substandard or falsified medications are generally the same (patient exposure to potentially unsafe or ineffective drugs), the motives behind the business models and tolerance for introducing risk of harm to patients (and manufacturing personnel) may be very different. If the penalties are similar and severe across all fronts, patients/workers will have highest level of protection. If it is easier and as profitable to make a substandard or falsified drug and not risk harsh penalties, why bother making the drugs look original at all? Call them "customized" for that particular market space.
Also worrisome--what should define a counterfeit API, and how should they be (globally) authenticated for certain necessary uses, without risking growth of substandard/counterfeit/falsified marketplace?