Purpose


The Board proposes to open the rule for development to comprehensively review the rule for any necessary or needed changes of a technical or substantive nature or changes necessary to make the rule clearer, and for the specific purpose to review the impact, if any, to the rule due to the recently enacted federal Compounding Quality Act, which is Title I of the Drug Quality and Security Act. Pub. L. No. 113-54, 127 Stat. 587 [H.R. 3204] (Nov. 27 2013). And, to also determine if there are any necessary changes needed to subsection (3) in relation to the quantity of compounded drugs that may be compounded for purposes of Office Use Compounding.