Thursday, May 29, 2014

FDA directed to meet with stakeholders on compounding drug legislation

The Senate Appropriations Committee directed FDA officials on Friday to meet with doctors, patients and pharmacists regarding implementation of a bill that affects compounded human drugs, following a request from Sen. Lamar Alexander (R-Tenn.).
The Compounding Quality Act, which was signed into law in November, removed provisions of the Federal Food, Drug and Cosmetic Act (FDCA) that the U.S. Supreme Court ruled unconstitutional in 2002.
Compounded drugs refer to prescription medications that are personalized by pharmacists to meet the exact dosage and strength requirements of individual patients.
“The purpose of the compounding law is to end confusion and improve communication so we can help prevent another tragic meningitis outbreak,” Alexander, the ranking member of the Senate Health, Education, Labor and Pensions Committee, said. “If FDA isn’t sitting down with doctors, patients and pharmacists and communicating how it is implementing the law, then I will stay on FDA until it does.”
The Compounding Quality Act removed provisions of the FDCA related to compounded drugs that required compliance with current good manufacturing practices, labels that include adequate directions for use and FDA approval prior to marketing, according to the FDA.
Alexander led the call for the FDA to meet with stakeholders regarding implementation of the Compounding Quality Act after hearing concerns from doctors, patients and pharmacists.
The Senate Appropriations Committee said it was concerned that the FDA began to implement the Compounding Quality Act by issuing guidance and appointing members to the Pharmacy Compounding Advisory Committee without meeting with stakeholders first.
FDA was directed by the committee to meet with stakeholders to ensure ongoing access to safe compounded drugs.

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