In: Nursing
You are a pharmacist. You recently purchased a gross of an
antibiotic from a secondary pharmaceutical wholesaler. A patient
last week came in and said the pill tasted funny, and never
dissolved. Concerned, you had the pill tested and found it was
compressed drywall powder coated in highway paint.
What is going on here? Is this a big or common problem? Does the
FDA handle these matters or does some other agency?
There are many shady ingredients that consumers buy from drug sellers that have found in counterfeit medications. the paint contains heavy metals for pigment and hydrocarbons that are poison for the body. compressed drywall powder like salt are chemicals used to mimic the real thing that harms the body and become poison. it is a big issue when it becomes toxic for the body it causes nerve damage and other body system dysfunction. FDA considers the drug safety, performance, quality, authenticity of any medication. product quality causes issues during manufacturing and storage. FDA contact with concern for a quality product that needs investigation. FDA does not test drugs, the center will evaluate the drug manufacturer full data, by analyzing the data CDER reviewers assess the benefit for the drugs and risk relation if the drug is approved. Center for Drug Evaluation and Research(CDER) decides through fast evaluation usually by the manufacturer whether it is safe and it can be used. once the drug gets approved by CDER the drug will be on the market for production and distribution. FDA considers the drug's overall safety.it considers a new drug to be safe through a clinical trials. safety information about relayed toxicity should be reported after a disclose report,investigator should be notified.investigational new drug safety reports invetigated with inforamtion to protect the patients.