Support Drug Regulation Acts

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Recommended: Drug standard and legislation

S.959—Pharmaceutical Compounding Quality, Security and Accountability Act, was introduced into the U.S Senate May 15, 2013 by Thomas Harkin, Democratic senator of Iowa, along with the support of five cosponsors. The bill, if it’d passed would have amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the regulation of compounded drugs. It would have allowed the Federal Government to oversee drug compounders’ operations to ensure drug quality and safety. Most recently, the bill was referred to the Senate Health, Education, Labor, and Pensions Committee but never made it to the floor for a vote. Supporters of S.959 were both Republicans and Democrats. This bill was a bipartisan effort. There was opposition to this bill from the International Academy of Compounding Pharmacists, who argued that the bill would not serve as a safeguard for Americans and cause unnecessary regulation. I support the passing of this bill. Regulation of compounded drugs is in the best interest to the public’s health and welfare. This would’ve stopped contaminated drugs from entering the market as well as lessening the amount of counterfeit drugs on the market.
The Federal Food, Drug and Cosmetic Act (FFDCA) was in the process of being amended with S.959. This bill would have amended FFDCA to include the regulation of drug compounding manufacturers’ operations to ensure drug quality and safety. S.959’s creation came about after an outbreak of fungal meningitis in September 2012 caused by a contaminated shipment of steroids, distributed by a drug compounding manufacturer named New England Compounding Center (NECC) which caused serious illnesses and death (Szabo, 2013), the Center for Disease Control (CDC) reported “as of Oct. 1, there were 750 ...

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...DC: CRS.

Editoral Board (2012). Bringing compounding pharmacies under federal regulation. The Washington Post.
IACP. (2013, July 30). IACP Message Points: Why the Current Draft of S. 959 is Still Unworkable. Retrieved from IACP : http://iacprx.org/displaycommon.cfm?an=1&subarticlenbr=670

James A. Morone, Rogan Kersh. (2013). Interest groups: them or us?, By The People (pp. 408-409). New York: Oxford University Press.
Martin, T. W. (2013, September 9 ). Dangers from compounding pharmacies persist. The wall street journal.
Morris, M. (2013, September 26). Bill would regulate large-scale compounding pharmacies. The Kansas Star.
The partnership for public service (2013, October 14). Rapid CDC response to meningitis outbreak from tainted steroid saved lives. The Washington Post
Szabo, L. (2013, August 11). FDA: New voluntary recall from compounding pharmacy. USA Today.

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