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Healthcare-reform legislation aims to change regulation of the compounding pharmacy profession

3/25/2010

Would limit access to custom-compounded medicines in human and animal health.

 
 
(Washington DC, March 25, 2010) Language included in the physician’s “sunshine” provisions of the recent healthcare insurance reform bill (H.R.4872) includes the practice of pharmacy compounding under the definition of “manufacturing” and could subject the practice to an entirely new regulatory administration. This could have a direct impact on what compounders must do to comply with the law and could limit patients’ access to compounded medication.

Last summer the compounding pharmacy profession’s professional group, the International Academy of Compounding Pharmacists, successfully lobbied the House of Representatives to change language in the draft legislation that would define compounding pharmacists as manufacturers. Unfortunately, in the legislation as signed into law this week, the language reverted back to the original, problematic language.

We urge you to contact your federal legislators (both House and Senate Representatives) and ask them to correct this language by asking that they exclude the practice of compounding from the definition of manufacturing.

Millions of Americans have unique health care needs that off-the-shelf prescription medications cannot meet. For them, personalized medication solutions—mixed safely by trained, licensed pharmacists—are the only option to achieve the desired health care outcome.

The Food and Drug Administration, the U.S. Supreme Court, Congress and virtually every major association of health care professionals and patient advocates recognize the value of compounding as an integral component of contemporary pharmacy practice. These pharmacists work with physicians, nurse practitioners and veterinarians to create customized medication solutions for patients and animals whose health care needs are not met by manufactured medications.

Click here to take action!



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