Discussion Concerning Nasal Sprays and Whether They Should be
Compounded in a Sterile Environment (Tab 30)
Ms. Fisher presented information on recommendations concerning whether or not nasal sprays should be compounded in a sterile environment. She explained that comments were received from
Gigi Davidson, BSPh. DICVP, Chair, USP Compounding Expert Committee, and Audra L. Conwell, CAE, Executive Director/CEO of
the Alliance of Independent Pharmacist of Texas, and noted that the comments received from both Ms. Davidson and Ms. Conwell stated that the Federal Drug Administration and the USP 797 guidelines do not require nasal sprays be compounded as sterile preparations.
Ms. Fisher also presented a report from Loyd V. Allen, Jr., Ph.D., FACA, FAPhA, in which he asserted that nasal sprays should be compounded as sterile preparations.
Ms. Fisher explained that to date TSBP has taken a conservative approach and required nasal sprays be prepared in a sterile environment.
President Waggener recognized John Boliver, PCCA, who presented oral remarks to the Board.
Following discussion the motion was made by Ms. Yoakum that the Board not consider nasal sprays a sterile product and not require nasal sprays be compounded in a sterile environment. The motion was seconded by Mr. Abeldt and passed 7-0-1, with Ms. Stine abstaining.
quoted from November 3, 2015 minutes
Ms. Fisher presented information on recommendations concerning whether or not nasal sprays should be compounded in a sterile environment. She explained that comments were received from
Gigi Davidson, BSPh. DICVP, Chair, USP Compounding Expert Committee, and Audra L. Conwell, CAE, Executive Director/CEO of
the Alliance of Independent Pharmacist of Texas, and noted that the comments received from both Ms. Davidson and Ms. Conwell stated that the Federal Drug Administration and the USP 797 guidelines do not require nasal sprays be compounded as sterile preparations.
Ms. Fisher also presented a report from Loyd V. Allen, Jr., Ph.D., FACA, FAPhA, in which he asserted that nasal sprays should be compounded as sterile preparations.
Ms. Fisher explained that to date TSBP has taken a conservative approach and required nasal sprays be prepared in a sterile environment.
President Waggener recognized John Boliver, PCCA, who presented oral remarks to the Board.
Following discussion the motion was made by Ms. Yoakum that the Board not consider nasal sprays a sterile product and not require nasal sprays be compounded in a sterile environment. The motion was seconded by Mr. Abeldt and passed 7-0-1, with Ms. Stine abstaining.
quoted from November 3, 2015 minutes
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