By Douglas B. Farquhar –
Well, that certainly didn’t take long.
FDA has clearly been eager to initiate its new, clarified powers over compounding pharmacies. President Obama only signed the new act (the Drug Quality and Security Act) the day before Thanksgiving, and this morning we find that FDA has already issued three draft guidances on human drug compounding. One restates prohibitions contained in earlier guidances from FDA. Another tells pharmaceutical compounders how they can register as “outsourcing facilities,” the new “voluntary” category for certain compounding pharmacies that ship compounded drugs across state lines. The third tells outsourcing facilities how they should report the drugs they compound. Links to the new guidances are included below.
Many of the provisions of the new Act, which was summarized in an earlier blog post, depend on issuance of regulations by FDA, and many of those regulations require input from an advisory committee that was disbanded years ago and hasn’t been reborn yet. As a result, there had been some speculation that the impact of the new Act would be somewhat delayed.
continue to read here
Well, that certainly didn’t take long.
FDA has clearly been eager to initiate its new, clarified powers over compounding pharmacies. President Obama only signed the new act (the Drug Quality and Security Act) the day before Thanksgiving, and this morning we find that FDA has already issued three draft guidances on human drug compounding. One restates prohibitions contained in earlier guidances from FDA. Another tells pharmaceutical compounders how they can register as “outsourcing facilities,” the new “voluntary” category for certain compounding pharmacies that ship compounded drugs across state lines. The third tells outsourcing facilities how they should report the drugs they compound. Links to the new guidances are included below.
Many of the provisions of the new Act, which was summarized in an earlier blog post, depend on issuance of regulations by FDA, and many of those regulations require input from an advisory committee that was disbanded years ago and hasn’t been reborn yet. As a result, there had been some speculation that the impact of the new Act would be somewhat delayed.
continue to read here
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