irishspirit
3rd March 2011, 13:50
The drug products on this list were obtained from the Drug Registration and Listing
System (DRLS) in December 2010. For more DRLS Information (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/default.htm)1.
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register and list all of their commercially marketed drug products with the FDA (21 U.S.C. § 360 and 21 CFR 207). Many drug firms do not update their drug listing information with FDA as required by law; consequently, the information in DRLS is both over- and under-inclusive. Therefore, the list above of unapproved prescription cough/cold/allergy drug products may include drugs that are no longer being marketed and/or may not include prescription cough/cold/allergy drug products that are currently being marketed if the drug firm has not listed or updated their information with DRLS. Any unapproved prescription oral cough/cold/allergy drugs that are not on this list are not entitled to any grace period and are subject to immediate enforcement action.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm245106.htm
Guy's look at the list, it is huge.
System (DRLS) in December 2010. For more DRLS Information (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/default.htm)1.
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register and list all of their commercially marketed drug products with the FDA (21 U.S.C. § 360 and 21 CFR 207). Many drug firms do not update their drug listing information with FDA as required by law; consequently, the information in DRLS is both over- and under-inclusive. Therefore, the list above of unapproved prescription cough/cold/allergy drug products may include drugs that are no longer being marketed and/or may not include prescription cough/cold/allergy drug products that are currently being marketed if the drug firm has not listed or updated their information with DRLS. Any unapproved prescription oral cough/cold/allergy drugs that are not on this list are not entitled to any grace period and are subject to immediate enforcement action.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm245106.htm
Guy's look at the list, it is huge.