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		at 6:23 PM
	"...GMP requirements" above should read "...GMP requirement exemptions" on The New Federal Compounding Law by Mike Corrado Remove content | Delete | Spam	Anonymous	at 5:56 PM
	Under 503A, compounded drugs that meet stipulated conditions are exempt from 3 provisions of the FFDCA, and, they may still be held to other provisions for which they are not exempt. Guidance available here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377052.pdf If you read most recent FDA warning letters, making drugs under unsanitary conditions can result in adulteration charges, wether or not conditions are being met for new drug, labeling, and GMP requirements. Bird feathers fungus and filth should not make their way into FDA-approved or compounded pharmaceuticals, regardless of whether or not they are intended for sterile administration. on The New Federal Compounding Law by Mike Corrado Remove content | Delete | Spam	Anonymous	at 5:54 PM
	Non-sterile compounds are covered under the original 503A, which was substantially weakened by the Supreme Court ruling but which may have been corrected under DQSA, with clarifications regarding false and misleading claims. But I agree--non-sterile compounds can be just as dangerous, and are currently heavily marketed through sophisticated programs. Check out this patent for "compounded transdermal pain management," including 30-40% by weight of ketamine, intended for mixture with other potent and potentially toxic substances, including clonidine, and local anesthetics implicated in previous compounded drug deaths and for which FDA has taken prior enforcement actions: https://www.google.com/patents/US20130085171?dq=ininventor:%22Charles+D.+HODGE%22&hl=en&sa=X&ei=SkkCVKXEA43BggSp7IHACw&ved=0CFAQ6AEwBw on Second Question of the Day August 30, 2014 Did Congress make a huge mistake by not including nonsterile compounded medications in the DQSA because they may pose just as big a risk as sterile compounded medications?