On the recordSeptember 6, 2017
It is frustrating and egregious that this amendment is actually necessary, but it is. The FDA has, thus far, blatantly ignored congressional direction to respect the statutory difference between distributing and dispensing of compound medications. As a dentist and healthcare provider for more than 25 years, I can tell you from my professional experience how harmful this overreaching guidance from the FDA would be to patients. As a dentist, I often use specialty compounded medications to deliver the customized care my patients deserved. I relied on the expertise of my pharmacist colleagues to ensure that medications were available to patients as appropriate. As a Congressman, I support this amendment to ensure FDA follows congressional intent. As a doctor, I support this amendment because it means better care for patients. Mr. Chairman, I thank the gentleman from Georgia, and I urge my colleagues to support this amendment--and that is doctor's orders. Ms. DeLAURO. Mr. Chairman, why are we afraid of safety standards? The safety concerns with this amendment are also exacerbated by the fact that many States do not exercise appropriate oversight over compounding pharmacies. A recent study revealed that nearly half of all States surveyed do not track the number of pharmacies that perform the sterile compounding in their State. They make proactive State oversight impossible. Do we really want to allow these facilities to go unchecked?…
Source
govinfo.gov




