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On March 2, 2011, the US Food and Drug Administration (FDA) ordered the systematic removal of ALL unapproved cough, cold, and allergy prescription medicines from the market.1
Over 500 products were affected by this action.2
The FDA intends to initiate enforcement action against any manufacturer producing any of the products included in this action on or after June 1, 2011 or
who ships any of the products included in this action on or after August 30, 2011.3
Generic drugs make up 77.8% of all prescriptions dispensed in the US.4
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Antibiotic Resistance – one of the world's most pressing public health problems5
The Center for Disease Control and Prevention observed its annual Get Smart About Antibiotics week during November 14-20, 2011.
Messages and resources for improving antibiotic use were promoted during this time in conjunction with the CDC's Get Smart for Healthcare campaign.6
For more information on antibiotic resistance and the Get Smart program, visit the Center for Disease Control and
Prevention website here.
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References
| 1. |
US Food and Drug Administration. FDA prompts removal of unapproved drugs from market. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245048.htm. Accessed December 15, 2011. |
| 2. |
US Food and Drug Administration. Unapproved prescription cough, cold, and allergy products. www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm245106.htm. Accessed December 15, 2011.
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| 3. |
Department of Health and Human Services. Federal Register Docket No. FDA-2011-N-0100. http://www.gpo.gov/fdsys/pkg/FR-2011-03-03/pdf/2011-4703.pdf. Accessed December 15, 2011.
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| 4. |
IMS National Sales Perspectives, Branded generics disaggregated, July 2011.
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| 5. |
Centers for Disease Control and Prevention. Get Smart: Know When Antibiotics Work, Antibiotic Resistance Questions & Answers. http://www.cdc.gov/getsmart/antibiotic-use/anitbiotic-resistance-faqs.html. Accessed December 15, 2011.
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| 6. |
Centers for Disease Control and Prevention. Get Smart: Know When Antibiotics Work, Overview & Past Events. http://www.cdc.gov/GetSmart/campaign-materials/week/overview.html. Accessed December 15, 2011.
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