Board Promulgates Applicable USP
Standards for Sterile Compounding
While MWDs Are Licensed Separately
With emergency rules effective January 31, 2014, all Tennessee-
licensed pharmacies and pharmacists are required to follow
the most current version of applicable United States Pharmacopeia
(USP) guidelines when compounding sterile products.
As revised, Rule 1140-01-.01 (39) states “. . . ‘USP standards’
means any applicable standard or standards published in the most
current version of United States Pharmacopeia National Formulary
[USP-NF] guidelines, to the extent that such guidelines do
not conflict with state law, rules, or Board Policy Statements
and as those guidelines may, from time to time, be amended. . .”
Currently, Board investigators are utilizing USP-NF General
Chapter <797>, Edition 2012, to reference and educate registrants
on the new guidelines.
Also, as stated in emergency rule, the Board has designed
an educational tool known as gap analysis, which will soon be
available for pharmacists’ review. According to Board Vice President
Nina Smothers, the analysis is designed to help pharmacy
employees in assessing their sterile compounding pharmacy
practice for strengths and weaknesses in regard to USP Chapter
<797> and other best practices. “We want the Gap Analysis to
be an open book test for the pharmacist,” Smothers said. Board
investigators plan to work from a modified form, built from questions
used in the gap analysis, to inspect for sterile compounding
regulation compliance.
The emergency rules, which also include fee increases for
all Board registrants, and other pertinent rule changes may be
viewed at http://state.tn.us/sos/rules_filings/01-17-14.pdf.
Fee increases are viewable on the Board website at http://
health.state.tn.us/boards/pharmacy/PDFs/FeeIncrease_
EffectiveJanuary31.pdf.
Modifier fees are added for pharmacies that are compounding
sterile products and manufacturers and wholesalers/distributors
(MWDs) that are manufacturing, wholesaling, or distributing
sterile products.
Also included in the emergency rules, the wholesaler/distributor
is now being licensed separately from the manufacturer.
In the next six months, final rules are to be promulgated by the
Board, as the emergency rules will become replaced at that time.
quoted from here
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