Thursday, March 6, 2014

Tennessee Board of Pharmacy Promulgates Applicable USP Standars for Sterile Compounding While MWDs are Licensed Separately

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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