Thursday, August 29, 2013

While it is claimed that large-scale compounding pharmacies only make up 10% of the compounding market, they may supply much more (NY Times). The pharmacies inspected by the FDA are thought to be some of the largest outsourcers in the country. -

Prescription for Meningitis? Unsafe Pharmaceutical Practice Linked to Nationwide Death and Illness

Posted August 28, 2013 |

By: Tatum Brontë and Mark Zamora, Esq.

Last fall, the outbreak of fungal meningitis, which spanned across at least 20 states and took as many as 63 lives, was not an isolated event nor entirely unexpected. The outbreak joins the ranks of many other adverse events caused by the shady practices of drug manufacturing—practices the Food and Drug Administration has failed to gain authority over for nearly 15 years.

At the center? Lives lost and some injured for life. Traditional compounding is still a vital part of the drug industry today. What started as a way for local pharmacists to prepare tailor-made medicine made perfect sense; a liquid product for a mom to give her infant or a dose without an allergen (such as dye). Given their nature, compounding pharmacies fall under the state law and larger protective stipulations, including a 2002 protective ruling from the Supreme Court and the Food and Drug Administration Modernization Act of 1997 (FDAMA). For example, FDAMA exempts, under certain criteria, compounding pharmacies from registration and the obligation to permit access to records during an inspection.

In other words, compounding pharmacies are exempt from FDA oversight.

Where this gets ugly: Free from federal binds and offering drugs for cheaper prices (compare brand name Makena at $1,500 a dose to $25 offered by pharmacies), the demand for compounding pharmacy supply is growing. Now, with shipment across state lines and unregulated mass production, these “pharmacies” are comfortably in the grey area between state and federal jurisdiction. The risk? Lack of appropriate air filtration and insufficient microbial testing, among other risks of contamination—grounds for fungal meningitis and tainted medicine.

continue to read here

No comments: