Prior to 2012, compounding pharmacies were not required by law to follow current good manufacturing practices. Then, in October 2012 there was an outbreak of fungal meningitis reported. The Center for Disease Control traced the outbreak to fungal contamination in an injectable corticosteroid that was compounded by New England Compounding Center. Doses from the lots found to be contaminated had been shipped to 75 medical facilities in 23 states, and doses had been administered to about 14,000 patients.
Following this tragedy, the Drug Quality and Security Act was enacted, a bill that would modify the Federal Food, Drug, and Cosmetic Act and give more authority to regulate and monitor the manufacturing of compounded medication.
For this assignment, research the Drug Quality and Security Act, which was signed into law by President Obama in November 2013.
Answer key question such as:
- What are some of the changes that were a result of this Act being signed that effect the compounding industry
- Do you believe this tragedy would have been prevented had this bill already been in place? How?
- How could it prevent an outbreak like that which occurred in 2012 from happening again?
- What drawbacks do you see if any and in what ways could this law be improved?
Conduct online research, and then write a 2-page paper, remembering to answer the above listed questions. Be sure to also include your references. You will be scored on your grammar and organization as well, so be sure and spend time revising before submitting.