Newsletter - October 1, 2015
FDA to Destroy Illegal Drugs Drugs Arriving in the US by Mail
Internet pharmacies, mostly located outside of the US borders, are often used by consumers to import drugs into the country illegally. Most of such shipments, which arrive primarily by international mail, are mislabeled as other innocuous things such as dietary supplements, food and cosmetics. And often they are caught at the US customs. Every year the US customs catches about 15000 such mails mostly containing small amounts of drugs for individual users. However, once caught by customs, under the law so far, the shipments were sent back to the country of origin and most of the times these shipments were sent right back. Read More..
USP Revises Compounding Pharmacy Rule to Address Sterile Drugs
Since the fungal meningitis outbreak of 2012 linked to contaminated injectable drugs prepared a Massachusetts compounding pharmacy, multiple laws have been passed to regulated compounding pharmacies primarily requiring cGMP compliance and registration with FDA. However, the processes used for compounding are still described in USP monographs. This week, USP announced a much anticipated update to Monograph 797, Pharmaceutical Compounding—Sterile Preparationswhich closes the loop on all sterile compounding practices. Read More..
Is FDA's Expedited Approval Programs Leading to Bad Drugs
Two articles in the British Medical Journal this week raise questions about the utility of FDA’s expedited approval programs such as breakthrough therapies and fast-track designations. The articles challenge if in its efforts to approve drugs fast, FDA is being lax in its safety and effectiveness analysis prior to approval. It is obvious from the review that FDA’s safety reviews were quite good in that no drugs were withdrawn from the market for safety reasons. However, the effectiveness of several drugs approved by FDA under the expedited programs was questionable many times. Also, some programs were overused in the opinion of the authors. Read More..
FDA to Destroy Illegal Drugs Drugs Arriving in the US by Mail
Internet pharmacies, mostly located outside of the US borders, are often used by consumers to import drugs into the country illegally. Most of such shipments, which arrive primarily by international mail, are mislabeled as other innocuous things such as dietary supplements, food and cosmetics. And often they are caught at the US customs. Every year the US customs catches about 15000 such mails mostly containing small amounts of drugs for individual users. However, once caught by customs, under the law so far, the shipments were sent back to the country of origin and most of the times these shipments were sent right back. Read More..
USP Revises Compounding Pharmacy Rule to Address Sterile Drugs
Since the fungal meningitis outbreak of 2012 linked to contaminated injectable drugs prepared a Massachusetts compounding pharmacy, multiple laws have been passed to regulated compounding pharmacies primarily requiring cGMP compliance and registration with FDA. However, the processes used for compounding are still described in USP monographs. This week, USP announced a much anticipated update to Monograph 797, Pharmaceutical Compounding—Sterile Preparationswhich closes the loop on all sterile compounding practices. Read More..
Is FDA's Expedited Approval Programs Leading to Bad Drugs
Two articles in the British Medical Journal this week raise questions about the utility of FDA’s expedited approval programs such as breakthrough therapies and fast-track designations. The articles challenge if in its efforts to approve drugs fast, FDA is being lax in its safety and effectiveness analysis prior to approval. It is obvious from the review that FDA’s safety reviews were quite good in that no drugs were withdrawn from the market for safety reasons. However, the effectiveness of several drugs approved by FDA under the expedited programs was questionable many times. Also, some programs were overused in the opinion of the authors. Read More..
