Rules of the Tennessee Board of Pharmacy — Introduction

RULES OF THE TENNESSEE BOARD OF PHARMACY 665 MAINSTREAM DRIVE NASHVILLE, TN 37243 Chapter Title

1140-01 .........................................................................................................................Introductory Rules

1140-02 ...................................................................................Professional Conduct and Responsibilities

1140-03 ...................................................................................................................Standards of Practice

1140-04 .................................Institutional and Alternate or Alternative Infusion Pharmacy Practice Sites

1140-05 ....................................................................................................................Continuing Education

1140-06 .................................................................................................Nuclear Pharmacy Practice Sites

1140-07 ........................................................................Sterile Product Preparation in Pharmacy Practice

1140-08 ...............................................................................................................................Civil Penalties

1140-09 .............Manufacturers, Outsourcing Facilities, Oxygen Suppliers and Wholesalers/Distributors

1140-10 ........................................................................Rules of Procedure for Hearing Contested Cases

1140-11 .................................................................................Controlled Substance Monitoring Database

1140-12 ……………………………………………..…………………………………………………..Repealed

1140-13 …….....………………………………… Pharmacy Practice in Federally Qualified Health Centers

1140-14 ..................................................................................Long-Term Care Pharmacy Practice Sites

1140-15 ............................................................Prescribing and Dispensing of Hormonal Contraceptives

1140-16 .......................................................................................................Third Party Logistics Provider

1140-17 ……………………………………………..…………………………………………………..Repealed

ADMINISTRATIVE HISTORY Original chapter 1140-01 was certified on June 7, 1974, under Chapter 491 of the Public Acts of 1974 as Rules in effect when Chapter 491 became effective. The Administrative History following each rule gives the date on which the rule was certified, or the date on which the rule was filed and its effective date, if promulgated after March 11, 1974. The Administrative History following each rule also shows the dates of any amendments or repeals. Rules 1140-01-.04 and 1140-01-.31 filed June 7, 1974; effective July 7, 1974. Amendments to rules 1140-01-.02, 1140-01-.07, 1140-01-.10, 1140-01-.12 through 1140-01-.15, 1140- 01-.18, 1140-01-.20, 1140-01-.25, and 1140-01-.27 through 1140-01-.30 filed June 7, 1974; effective July 7, 1974. Amendment to rule 1140-01-.14(3) filed June 25, 1975; effective July 25, 1975. Amendment to rules 1140-01-.14(2), 1140-01-.18(1)(b), 1140-01-.29(2), 1140-01-.31(5), and 1140-01-.3 through 1140-01-.37 filed September 23, 1975; effective October 23, 1975. Repeal of rules 1140-01-.02(h) and 1140-01-.07(g) filed January 11, 1977; effective February 10, 1977. Amendment to rules 1140-01-.04(1), 1140-01-.14, 1140-01-.16, 1140-01-.19(6), and 1140-01-.28(1), (2), (4), (8), (9), (10) and (11)(b) filed January 11, 1977; effective February 10, 1977. Rules 1140-01-.28(13), 1140-01-.31(2) and (7), and 1140-01-.38 filed January 11, 1977; effective February 10, 1977. Amendments to rules 1140-01-.10, 1140-01-.24(1), 1140-01-.25, 1140-01-.30(1) and 1140-01-.31(5) filed December 15, 1977; effective January 16, 1978. Rule 1140-01-.39 filed December 15, 1977; effective January 16, 1978. Amendments to rules 1140-01-.28 and 1140-01-.31 filed April 27, 1978; effective July 14, 1978. Amendments to rule 1140-01-.10 filed September 26, 1978; effective December 29, 1978. Rules 1140-01-.40 and 1140-01-.41 filed September 26, 1978; effective December 29, 1978. Original chapter 1140-01 filed November 22, 1978; effective January 8, 1979. Amendments to rules 1140-01-.02, 1140-01-.07, and 1140-01-.31 filed April 11, 1979; effective July 30, 1979. Repeal of chapter 1140-01 and new rules 1140-01-01-.01 through 1140-01-01-.10 filed February 7, 1983; effective March 9, 1983. Original rules 1140-01-03-.01 through 1140-01-03-.24 and 1140-01-04-.01 through 1140-01-04-.21 filed February 7, 1983; effective March 9, 1983. Amendments to rules 1140-01-.03, 1140-01-.04 and 1140-04-.12 filed December 17, 1984; effective March 16, 1985. Amendment to rule 1140-01-.08 filed September 30, 1985; effective October 30, 1985. Amendment to rule 1140-03-.11 filed November 25, 1985; effective February 12, 1986. Amendment to rule 1140-01-.10 filed May 23, 1986; effective August 12, 1986. Amendment to 1140-01-.07 and original chapter 1140-06 filed January 26, 1987; effective April 29, 1987. Original chapter 1140-07-.01 through 1140-07-.07 filed October 1, 1987; effective November 15, 1987. Amendment to rule 1140-03-.16 filed October 1, 1987; effective November 15, 1987. Amendments to rule 1140-01-.10 filed October 1, 1987; effective January 27, 1988. Amendments to rule 1140-03-.24 filed January 19, 1988; effective March 4, 1988. Amendments to rules 1140-01-.02, 1140-01-.04 and 1140-01-.08 filed January 19, 1988; effective April 27, 1988. Amendment to rule 1140-01-.10 filed November 18, 1988; effective February 28, 1989. Amendment to rule 1140-01-.08 filed August 25, 1989; effective October 9, 1989. Original chapter 1140-08 and amendments to rules 1140-01-.06, 1140-03-.18, and 1140-03-.21 filed November 15, 1989; effective December 30, 1989. Amendment to rule 1140-01-.09 filed April 12, 1990; effective July 29, 1990. Amendment to rule 1140-01-.10 filed October 18, 1990; effective January 29, 1991. Amendment to rule 1140-01-.10 filed May 3, 1991; effective August 28, 1991. Original rule 1140-03-.25 filed August 2, 1991; effective September 16, 1991. Amendment to rules 1140-04-.12 and 1140-04-.13 filed August 30, 1991; effective November 27, 1991. Amendment to rules 1140-01-.03, 1140-01-.08, 1140-03-.06, 1140-03-.18 and original rule 1140-01-.11 filed October 30, 1991; effective December 14, 1991. Original chapter 1140-09 filed January 7, 1992; effective February 22, 1992. Amendments to rules 1140-03-.03, 1140-03-.06, 1140-03-.22, 1140-04-.05 and 1140-07-.04 filed November 16, 1992; effective January 8, 1993. Amendment to rule 1140-01-.10 filed December 22, 1992; effective March 31, 1993. Amendment to rule 1140-01-.10 filed June 25, 1993; effective September 28, 1993. Amendments to rules 1140-03-.04, 1140-03-.05, 1140-03-.18, 1140-03-.24, 1140-07-.01, 1140-07-.03,

1140-07-.04, 1140-07-.05, 1140-07-.06, and 1140-07-.07; original rules 1140-07-.08, 1140-07-.09, 1140- 07-.10; original chapter 1140-10 filed March 30, 1994; effective June 13, 1994. Amendment to rules 1140-01-.08, 1140-01-.09, and 1140-05-.02 through 1140-05-.05 filed November 17, 1993; effective March 30, 1995. Amendment to rule 1140-03-.25 filed January 30, 1995; effective May 31, 1995. Amendment to rule 1140-01-.10 filed October 19, 1996; effective February 28, 1996. Repeal of and new chapter 1140-01 through 1140-10 filed May 11, 1998; effective July 25, 1998. Amendment to rules 1140-01-.10, 1140-01-.14, 1140-02-.02, 1140-03-.04, 1140-03-.14, 1140-04-.09, and

1140-05-.02 filed August 19, 2002; effective November 2, 2002. Original chapter 1140-11 filed December 22, 2005; effective March 7, 2006. Public necessity rule filed 1140-12 filed February 16, 2007; expired July 31, 2007. Public necessity rules 1140-13-.01 through 1140-13-.08 filed November 25, 2008; effective through May 9, 2009. New rule 1140-03-.16 and amendments to rules 1140-01-.01, 1140-01-.05, 1140-01-.14, 1140-03-.15,

1140-05-.01, and 1140-06-.03 filed November 24, 2008; effective February 7, 2009. New rule 1140-13-.01 through 1140-13-.08 filed February 24, 2009; effective May 10, 2009. Amendments to rules 1140-01-.01, 1140-01-.09, and 1140-01-.14 and 1140-02-.01 and 1140-02-.02 filed December 23, 2009; effective March 23, 2010. Amendments to rules 1140-01-.03 and 1140-02-.02 filed January 4, 2012; effective April 3, 2012. Emergency rules 1140-11-.01, 1140-11-.02, 1140-11-.04, 1140-11-.05, and 1140-11-.06 filed January 4, 2013; effective through July 3, 2013. Repeal and new rules 1140-11-.01, 1140-11-.02, 1140-11-.04, 1140-11-.05, and 1140-11-.06 filed April 2, 2013; effective July 1, 2013. Emergency rules 1140-01-.01, 1140-01-.02, 1140-01-.08, 1140-01-.10, 1140-01-.11, 1140-01-.12, 1140- 01-.13, 1140-01-.14, and 1140-01-.15 filed January 31, 2014; effective through July 30, 2014. The rules expired effective July 31, 2014 and reverted to their previous statuses. Emergency rules 1140-07-.02, 1140-07-.03, 1140-07-.04, 1140-07-.05, 1140-07-.06, 1140-07-.07, 1140- 07-.08, and 1140-07-.09 filed January 31, 2014; effective through July 30, 2014. The rules expired effective July 31, 2014 and reverted to their previous statuses. Emergency rules 1140-09-.01, 1140-09-.02, 1140-09-.03, 1140-09-.04, 1140-09-.05, and 1140-09-.06 filed January 31, 2014; effective through July 30, 2014. The rules expired effective July 31, 2014 and reverted to their previous statuses. Amendments to rules 1140-11-.01 and 1140-11-.04 filed December 16, 2013; effective March 16, 2014. Amendments to rules 1140-01-.01, 1140-01-.02, 1140-01-.08, 1140-01-.10, 1140-01-.11, 1140-01-.13,

1140-01-.14, 1140-01-.15, and 1140-01-.16, and original rule 1140-01-.12 filed July 11, 2014; effective October 9, 2014. Amendments to rules 1140-07-.03, 1140-07-.04, 1140-07-.05, 1140-07-.06, 1140-07-.07, 1140-07-.08, and 1140-07-.09, and new rule 1140-07-.02 filed July 11, 2014; effective October 9, 2014. Amendments to rules 1140-09-.01, 1140-09-.02, 1140-09-.03, 1140-09-.04, and 1140-09-.05 and original rule 1140-09-.06 filed July 11, 2014; effective October 9, 2014. Amendment to rule 1140-11-.02 filed August 29, 2014; effective November 27, 2014. Amendments to rules 1140-01-.01, 1140-01-.03, 1140-01-.04, 1140-01-.05, 1140-01-.07, 1140-01-.08,

1140-01-.09, 1140-01-.10, 1140-01-.13, 1140-01-.15, 1140-01-.16, 1140-02-.01, 1140-02-.02, 1140-03- .01 through 1140-03-.04, 1140-03-.06, 1140-03-.08, 1140-03-.10, 1140-03-.11, 1140-03-.14 through

1140-03-.16, 1140-04-.02 through 1140-04-.12, 1140-04-.14 through 1140-04-.18, 1140-05-.02, 1140-05- .04, 1140-07-.02, 1140-07-.03, 1140-07-.04, 1140-08-.01, 1140-09-.01 through 1140-09-.03, 1140-09-.05,

1140-11-.01, 1140-11-.04, and 1140-13-.03 and new rules 1140-03-.17, 1140-11-.03, 1140-11-.08, and

1140-14-.01 through 1140-14-.14 filed November 22, 2016; effective February 20, 2017. Original rules 1140-15-.01 through 1140-15-.09 filed April 19, 2018; effective July 18, 2018. Original rules 1140-17-.01 through 1140-17-.12 filed May 31, 2018; effective August 29, 2018. Amendments to rules 1140-01-.01 and 1140-01-.10 and original rules 1140-16-.01 through 1140-16-.07 filed September 12, 2018; effective December 11, 2018. Amendments to rules 1140-11-.01 and 1140-11-.02, repeal of rules 1140-11-.05 through 1140-11-.07, and subsequent renumbering of rule 1140-11-.08 filed October 28, 2021; effective January 26, 2022. New rule 1140-09-.07 filed February 1, 2022; effective May 2, 2022. Amendments to rules 1140-01-.08, 1140-01-.09, 1140-02-.02, and 1140-07-.01 through 1140-07-.10 filed December 15, 2023; effective March 14, 2024. Amendments to rules 1140-07-.01 through 1140-07-.10 expired pursuant to Chapter 827, § 1 of the 2024 Public Acts, effective May 1, 2024, and the rules reverted to their previous statuses. Amendments to rules 1140-01-.10, 1140-03-.06, and 1140-03-.17 and new rule 1140-03-.18 filed December 15, 2023; effective March 14, 2024. Repeal of rules 1140-12-.01 through 1140-12-.09, 1140-13-.04, 1140-13-.05, and 1140-17-.01 through

1140-17-.12 filed June 5, 2024; effective September 3, 2024. Amendments to rules 1140-01-.07 and 1140-02-.02 filed July 18, 2025; effective October 16, 2025.