Safe Drug Compounding Act of 2007

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Safe Drug Compounding Act of 2007 is legislation sponsored by liberal Democratic Senator Ted Kennedy (Mass.) to extend the authority of the federal government and the FDA into domains traditionally regulated by the states. Specifically, this bill would confer on the FDA new and full authority to regulate compounding pharmacies. Republican Senators Pat Roberts (K.S.) and Richard Burr (N.C.) are listed as co-sponsors.

According to an estimate provided by an FDA official in testimony to Congress, in 2003 there were 30 million prescriptions for compounded products.[1] This legislation would affect every one of these prescriptions by requiring:

-- federally mandated disclosures;

-- federally mandated disclaimers in advertising;

-- restrictions on conditions for which physicians may prescribe compounded drugs; and

-- limits on how much product can be sold by one compounding pharmacy.

Constitutional issues raised by this proposed legislation include federalism (states' rights), the practice of medicine and free speech (the mandatory disclaimers).

References

  1. http://www.fda.gov/ola/2003/pharmacycompound1023.html
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