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Stat News: Proposed Federal Legislation Could Heighten Controversy Over Compounding Pharmacies

Wednesday, April 20, 2016   (0 Comments)
Posted by: Dagmar Anderson
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In an April 19th Stat News article by Ed Silverman, it's reported that the House Appropriations Committee has introduced language that would alter a key requirement for pharmacists to make and dispense compounded medicines, which are generally customized for specific patient needs. And the language runs counter to a draft guidance that the US Food and Drug Administration released just last week that would govern compounding practices. 

 

"Specifically, the amendment would allow pharmacists to compound medicines without needing prescriptions for individual patients. This has been a contentious issue in the wake of the 2012 outbreak of fungal meningitis that was tied to a compounding pharmacy and led to 64 deaths. The episode underscored confusion between federal and state oversight of compounders."

  

IACP Makes Clear to Stat News that FDA Continues to Ignore Congressional Intent

 

Article Excerpt

 

"A spokeswoman for the International Academy of Compounding Pharmacists sent us a statement from John Voliva, an executive vice president at the trade group: “The FDA continues to ignore clear congressional intent where the states have clearly indicated pathways in which pharmacies can participate in office-use compounding. The 2017 appropriations bill reinforces this intent.”

The trade group also criticized the agency over its draft guidance, arguing the FDA issued contradictory views on traditional compounders. The group maintained the agency’s draft guidance would allow hospital pharmacies to dispense larger batches of compounded medicines. “FDA’s draft guidance on anticipatory compounding is confusing at best and may ignore the clear language of bill when it comes to defining this practice,” the IACP spokeswoman wrote.

 

Please click here to read the entire Stat News article.


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