Item 2259 – Further Update on
Pharmacy Compounding Matters
Item 2252 of the January 2013 Newsletter updated
North Carolina pharmacists on compounding regulation
matters arising as a result of the New England Compounding
Center tragedy. The Pharmacy Compounding
Working Group has proceeded with its charge to make a
report and recommendation to the Board on any needed
regulatory changes (whether statutory, rule-based,
training-based, or resource-based). That report and
recommendation is likely to be presented to the Board
this spring.
There continues to be discussion and debate at the
federal level about the need for amendments to the
federal Food, Drug, and Cosmetic Act to shift, clarify,
or both, the line between prescription drug compounding
(regulated at the state level by boards of pharmacy)
and prescription drug manufacturing (regulated at the
federal level by Food and Drug Administration (FDA)).
Board staff participated in an intergovernmental conference
hosted by FDA in late December 2012, where
multiple issues were discussed among federal and state
regulators. Indications are that federal legislation will
be introduced this spring. Board staff will update North
Carolina pharmacists on any developments.
Quoted from the North Carolina Board of Pharmacy April 2013 Newsletter