ASHP Statement on HELP Committee Proposed Pharmaceutical Compounding Bill April 30th, 2013 John Buck

The American Society of Health-System Pharmacists (ASHP) is encouraged by the provisions included in draft legislation released by the Senate Committee on Health, Education, Labor, and Pensions (HELP) to address regulatory gaps in the oversight of compounding outsourcers.

“Based on a preliminary assessment, ASHP is pleased with the direction the Senate is heading on this very important legislation that includes key provisions we have advocated for over the past six months,” said ASHP CEO Paul W. Abramowitz, PharmD, FASHP. “We are particularly pleased that the committee recognizes the role of the states in overseeing traditional compounding, including that which occurs in hospitals and health systems, while creating a new definition of a “compounding manufacturer” that would be overseen by the Food and Drug Administration (FDA).”

The Society has been actively engaged with HELP Committee staff as they have developed legislative language and has sought to distinguish patient-care driven hospital and health-system compounding from commercial compounding provided by compounding outsourcers.

The draft legislation establishes a boundary between traditional pharmacy compounding and defines a new entity, “compounding manufacturer,” which compounds preparations without or in advance of a prescription and engages in interstate commerce. It also preserves the states’ primary role in regulating traditional pharmacies.

ASHP will thoroughly review the discussion draft and submit comments to the Committee by its May 3 deadline.

Source: ASHP

Question of the Day: 4/30/2013 Doesn't Congress Needs to Listen to the Experts in the Field--the Ones Who Deal with the Real World of Compounding?

In reading articles recently posted, it is apparent that there is still much misunderstanding about compounding, compounding pharmacies and the state of the law.  If as some commentators say, "the FDA dropped the ball"  then why is there a need for new federal legislation giving them authority over some compounders if in fact they had authority over all compounders or at least the group recently inspected by them?  If the FDA did not drop the ball  and thus did not have authority to regulate, then isn't it true the states dropped the ball and that there may be a need for additonal federal legislaton of some kind?

Doesn't it make sense for Congress to get more input from the people who actually deal with compounding everyday?  Why not call leading pharmcist in compounding and knowledgeable marketing directors that deal with the realities of compounding to testify before them and get their input in how the federal legislation should be drafted?

Health Canada Reviews Compounding Regulations Following Drug Scare

After reports of more than 1,000 patients receiving diluted chemotherapy treatments, Health Canada has implemented an interim solution to cover gray areas in the oversight of small compounding facilities, allowing admixing to continue under strict direction.

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International Regulatory Compliance Blog--Compounding Laboratories & Pharmacies – How Safe Are Your Products?

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Will Senate fix compounding pharmacy oversight this time?

The first time most people heard of a “compounding pharmacy” was last fall, when people started dying after getting routine shots produced by one such operation in the Boston area. By early this month, the death toll stood at 53, or 50 more than the marathon bombings.

Among the dead was Douglas Wingate, 47, a Virginia account executive whose only complaint was a pinched nerve in his shoulder. He got a steroid shot and became a victim of a meningitis outbreak tied to tainted injections made by the New England Compounding Center.

More than 700 people in 20 states have been sickened, and many are still suffering.

In the aftermath of this public health disaster, Republicans and Democrats in Congress are debating two questions: Has the Food and Drug Administration failed to use its existing authority to oversee compounders such as NECC? Or does the FDA need broader powers?

The answers are yes, and yes. The FDA repeatedly dropped the ball. And the agency’s authority does need to be clarified and expanded.

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