The Drug Quality and Security Act Essay

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Introduction: Since 2001, compounded drugs have caused more than 1,000 illnesses, and 87 deaths in the United States (cite 1). All of these unfortunate incidents were caused by errors during the manufacturing of compounded drugs, and in most cases, because of contamination. On the 25th of September 2013, the Drug Quality and Security Act, also known as H.R. 3204, was introduced, and three days later, was passed by the House of Representatives. On the 18th of November, this Act cleared the Senate. On the 27th of September, 2013, President Barack Obama signed the Drug Quality and Security Act into law (cite 2).
Background: Compounded drugs are drugs that are mixed by a licensed pharmacist, in a licensed pharmacy (cite 4). Compounding …show more content…

The difficulty with tracking and controlling drugs comes from the current laws. States have power over pharmacies, however, the FDA has power over the manufacturers of drugs. The new law, the Drug Quality and Security Act, also known as the track and trace system requires that all manufactures add serial numbers and electronic codes to their packages, so that they can be tracked as they move from the manufacturer to the pharmacist, and any steps in between. Now, large compounding pharmacies must register with the FDA, while smaller pharmacies can continue to operate under state laws and requirements. A major flaw found in the law was that the law does not require any company to register with the FDA, which forces the individual doctors and hospitals to make decisions of whether or not to purchase from FDA-registered companies or not (cite source). Point of View: In my opinion, the new law does provide a more specific regulation that will help control the manufacturing and distribution of compounded drugs. I do believe that the United States Food and Drug Administration should have more power to control and regulate the distribution of drugs, as well as have more power to inspect companies to insure product safety.
Conclusion: Because of past incidents where tainted drugs have compromised the safety

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