Critical Regulatory Issue in Health Care Paper

Topics: Pharmaceutical drug, Pharmacology, Pharmacy Pages: 3 (735 words) Published: November 25, 2013
Critical Regulatory Issue in Health Care
Febuary 19, 2013
Ann Nevers

Critical Regulatory Issue in Health Care
Pharmacists are vital to the health care industry because it provides medicine. Over time the responsibilities and duties of pharmacists have shifted drastically. The Food and Drug Administration is an agency that monitors and ensures safety of medicines Americans will use. Pharmaceuticals are the most regulated products in the country. The laws pertaining to the shifting roles and increased responsibilities in pharmaceuticals have emerged. The two legislative acts the fuel the power of the FDA is followed significant tragedies. Pharmacists provide care in case of emergencies and now are held responsible for malpractice, face ethical challenges to dispensing pharmaceuticals and consultations for patients. The purpose of the paper is to find an article that or current legal case that involves a critical regulatory issue in health care.

Many drugs that Americans consume are not approved by the FDA. Some medicines are beyond the scope of the FDA regulatory authority or some are approved to be used in other ways. Often some problems occur after the product has been approved by the FDA (Hooper, 2008). A manufacturer of the popular cholesterol reducing drug recalled 40 batches after finding out that it may contain small particles of glass. The glass particles were similar to the size of a grain of sand. If ingested it could be dangerous. There were no true adverse effects related to the recall are very low which means there are no injuries reported The pharmaceutical company Ranbaxy is recalling bottles of 10, 20, and 40 milligram tablets atorvastatin calcium, the generic version of Lipitor. The FDA granted the company approval of the manufacture of drug in New Jersey in 2011. Ranbaxy has been under the radar since 2006 for submitting false data to FDA and barred the company from manufacturing drugs in the...

Cited: Hooper, C. (2013). "Pharmaceuticals: Economics and Regulation.” The Concise Encyclopedia of Economics. Liberty Fund, Retrieved from
Walton, J. (2012). "Generic Cholesterol Medication Recalled." Chattenooga Publishing Company, Retrieved from
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