Tennessee New Statute Regarding Office Use

Statute Amended Regarding Compounding
As stated in Public Chapter 266, TCA 63-10-204(4), the definition
of “compounding” includes the following new language:
(D) For use in a licensed prescribing practitioner’s office for
administration to the prescribing practitioner’s patient or
patients when the product is not commercially available
upon receipt of an order from the prescriber;
(E) For use in a health care facility for administration to
a patient or patients receiving treatment or services
provided by the facility when the product is not commercially
available upon receipt of an order from an
authorized licensed medical practitioner of the facility;
(F) For use by emergency medical services for administration
to a patient or patients receiving services from them
under authorized medical control when the product is
not commercially available upon receipt of an order
from a licensed prescriber authorized to provide medical
control; or
(G) For use by a licensed veterinarian for administration
to their non-human patient or patients or for dispensing
to non-human patients in the course of the practice
of veterinary medicine upon receipt of an order from
a veterinarian when the product is not commercially
available.
In TCA 63-10-204(12), the definition of “dispense” now reads
as follows:
. . . “Dispense” means preparing, packaging, compounding
or labeling for delivery and actual delivery of a prescription
drug, nonprescription drug or device in the course of
professional practice to a patient or the patient’s agent, to
include a licensed health care practitioner or a health
care facility providing services or treatment to the patient
or patients, by or pursuant to the lawful order of a
prescriber . . .
TCA 63-10-216 adds this section as follows:
(a) Prior to initial licensure in this state as a compounding
pharmacy, a pharmacy located outside of this state

must have an inspection by the regulatory or licensing
agency of the state in which the pharmacy practice site
is physically located. Out-of-state pharmacy practice
sites must provide a copy of the most recent inspection
by the regulatory or licensing agency of the state in
which the pharmacy practice site is physically located,
which must have been within the previous twelve (12)
months. Prior to renewal of its license in this state, an
out-of-state pharmacy practice site must provide the
most recent inspection by the regulatory or licensing
agency of the state in which the pharmacy practice site
is physically located or equivalent regulatory entity,
and which must have been within the previous twelve
(12) months. The board of pharmacy shall have the
right to require additional information before issuing or
renewing a pharmacy license to insure compliance with
applicable laws of this state and any rules and policies
of the board.
(b) Any compounding pharmacy having an active Tennessee
license shall notify the board within fourteen (14)
business days of receipt of any order or decision by a
regulatory agency, other than the Tennessee board of
pharmacy, imposing any disciplinary action, including
any warning, on the pharmacy.
(c) Any pharmacies engaged in sterile compounding must
comply with relevant United States Pharmacopeia (USP)
guidelines as adopted by the board by rule or policy.
(d) Any pharmacies engaging in sterile compounding, except
hospital pharmacies compounding for inpatients of
a hospital, shall report on a quarterly basis to the board
the quantity of sterile compounded products dispensed
in a defined time period in accordance with policies
adopted by the board; provided, however, the executive
director of the board may request this information from
a hospital pharmacy for cause and the hospital pharmacy
shall be required to respond in a timely manner as defined
by the executive director of the board.
The Board plans to discuss rules and policies for additional clarification
to the statute in the near future.
In regard to federal compounding regulations, be advised to
continually monitor United States Code 21 353. The current
regulation may be found at the following Web link: www
.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
PharmacyCompounding/ucm155666.htm.

Quoted from Tennessee Board of Pharmacy June 2013 Newsletter