This week, Congress is expected to firm up FDA authority over compounding pharmacies like the one tied to last year's fatal outbreak of fungal meningitis. It will also give it stepped-up authority over those compounders that see enough market advantage that they volunteer to be regulated and pay a $15,000-a-year fee for the privilege.
"The question is, why would anybody ask for that? The answer is that 90% of hospitals outsource some of their compounding, and we hope that they will elect to buy from those facilities that operate under FDA oversight and those higher standards," explained Allan Coukell, a drug-policy expert at the Pew Charitable Trusts, which supports the legislation. "I think some will do it."
Read more: Legislation defines when FDA can take action against compounders - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/legislation-defines-when-fda-can-take-action-against-compounders/2013-10-01#ixzz2gVoyzD4d
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