For Anyone Using Compounded Medications....

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.

Last summer we successfully lobbied the House of Representatives to change language grouping compounding pharmacists in the same category as manufacturers. Unfortunately, in the recently passed health care and budget reconciliation measure, H.R.4872, the language was changed and reverted back to the original language of “manufacturing” to include compounding by pharmacists. In other words, this language (included in the physician’s “sunshine” provisions of the bill) would include 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 patient access to compounded medication.

We urge you to contact your federal legislators (both House and Senate Representatives) and ask them to reverse their decision. Please insist that they exclude the practice of compounding from the definition of manufacturing.

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.

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