David G. Miller6:29 p.m. EDT April 28, 2013
Source quoted from USAToday
Let state boards enforce national standards
STORY HIGHLIGHTS
When the tragic news of the deaths and sickness associated with products made at the New England Compounding Center came out last fall, the nation's attention appropriately focused on what went terribly wrong — and what steps to take to keep anything like it from ever happening again.
OUR VIEW: Time to fix 'broken' system
Pharmacists were more concerned than anyone because our profession is dedicated to one thing: the health of the patients we serve by compounding drugs upon request from authorized prescribers, such as doctors. NECC was essentially manufacturing drugs, not compounding.
The difficult matter that the public, the industry, policymakers and Congress are wrestling with is what regulations, laws or jurisdictions must be changed to make sure no NECCs happen again.
The International Academy of Compounding Pharmacists, representing 3,000 pharmacists nationwide, is studying the bill released by several senators Friday. We applaud the steps the Senate is taking to ensure that compounded medications are as safe as they can be.
But we believe aspects of the draft will need further discussion and refinement, and we intend to work with the committee on these. We plan to offer suggestions on improving standards to raise the quality of compounded medications.
Our group is also concerned that some provisions could reduce patient and physician access to customized medications, the very essential services that compounding pharmacists provide. We support nationwide standards enforced by each state's board of pharmacy, the entities that have traditionally regulated compounding pharmacies.
We also want to eliminate loopholes and don't believe that any group of pharmacies should be exempted from regulatory change, as this bill would do.
The states are responsible for licensing and oversight of medical providers, including compounding pharmacies, and the FDA is and should be responsible for pharmaceutical manufacturers. The terminology and some definitions in the proposed category of "compounding manufacturers" create confusion and blur authority of regulators. Our group will recommend improvements to make the proposed categories clearer.
Our members look forward to finding the right steps to ensure the safety of patients everywhere — steps that won't prevent compounding pharmacists from continuing to serve the public's vital health needs.
David G. Miller is CEO of the International Academy of Compounding Pharmacists.
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