FDMA reauthorized the 1992 Prescription Drug User Fee Act, sunset the separate regulation of antibiotics (making them subject to approval under FDCA Section 505), and provided a special role for USP standards to assist FDA in ensuring the quality of compounded drugs. In addition, PET radiopharmaceutical manufacturers became exempt (until December 12, 2011, per FDA regulations issued December 10, 2009) from submitting new drug applications for each compounded PET product and were instead directed to the monograph and compounding standard in the USP.
Published Oct 7, 2010
