In the July 2, 2014, Federal Register, FDA issued a proposed rule to amend its regulations by expanding the number of drug products that may not be compounded under exemptions to the FDCA. FDA noted these revisions are necessary because, since FDA published the original list as a final rule in 1999, some products have been withdrawn or removed from the market because they were found to be unsafe or not effective. The proposed rule would add 25 drug products to the list and modify the description of one drug product already on the list. In the same notice, FDA withdrew a related January 4, 2000, proposed rule. Comments are due September 2, 2014.
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