Posted: 27 Oct 2016 06:54 PM PDT
By James E. Valentine & Karla L. Palmer –
We reported earlier this month that the Food and Drug Administration (FDA) amended its regulations to update the list of drugs that may not used in compounding under the exceptions set forth in sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). This list reflects those drugs that have been withdrawn or removed from the market because the drugs or components of such drugs have been found to be unsafe or not effective. See 21 C.F.R. § 216.24. FDA is at it again with another proposed rule that would further amend this list.
In alignment with the votes of the June 2015 Pharmacy Compounding Advisory Committee (see meeting transcript here), the proposed rulemaking would add the following three drugs to the current list of 83 drugs:
Comments on the proposed rule can be submitted until January 3, 2017 here.
Hace 4 horas