Current through April 3, 2024
(1)
Application for a license to operate as a pharmacy practice site, manufacturer,
outsourcing facility, oxygen supplier or wholesaler/distributor within the
state of Tennessee shall be submitted to the office of the board at least
thirty (30) days prior to the scheduled opening date. No pharmacy practice
site, manufacturer, outsourcing facility, oxygen supplier or
wholesaler/distributor may open within the state of Tennessee until a license
has been obtained; and such license will not be issued until an inspection by
an authorized representative of the board has been made.
(2) An application for an existing pharmacy
practice site, manufacturer, outsourcing facility, oxygen supplier or
wholesaler/distributor physically located within the state of Tennessee must be
filed when the pharmacy practice site, manufacturer, outsourcing facility,
oxygen supplier or wholesaler/distributor changes name, location or ownership.
(a) Transactions constituting a change of
ownership include, but are not limited to, the following:
1. A sole proprietor becomes a member of a
partnership or corporation, which succeeds him as the new operator;
2. A partnership dissolves;
3. One partnership is replaced by another
through the removal, addition or substitution of a partner;
4. Two (2) or more corporations merge and the
originally licensed corporation does not survive; and
5. Transfers between levels of
government.
(b)
Transactions which do not constitute a change of ownership include, but are not
limited to, the following:
1. Changes in the
membership of a corporate board of directors or board of trustees;
2. Two (2) or more corporations merge and the
originally licensed corporation survives; and
3. Corporate stock transfers or sales, even
when a controlling interest.
(3) No out-of-state pharmacy practice site,
manufacturer outsourcing facility, oxygen supplier or wholesaler/distributor
shall conduct business in the state of Tennessee until such pharmacy practice
site, manufacturer, outsourcing facility, oxygen supplier or
wholesaler/distributor obtains the required license from the board. In order to
obtain a license for a pharmacy practice site, manufacturer, outsourcing
facility, oxygen supplier or wholesaler/distributor physically located
out-of-state the following standards must be met.
(a) Pharmacy practice site.
1. Submit an application for a license, which
shall include the address of the pharmacy practice site, name of owner if a
sole proprietorship, names of partners if a partnership or names and titles of
all officers if a corporation and names of all pharmacists who practice at the
site, together with the appropriate application fee. The director shall be
notified in writing within thirty (30) days of any change in the information
contained on the original application for a license, including names of
pharmacists practicing at the site.
2. Comply with all statutorily authorized
directions and requests for information from the board.
3. Maintain at all times a current permit,
license or registration to conduct the pharmacy practice site in compliance
with the laws of the state in which the site is physically located.
4. Submit a copy of the most recent
inspection report resulting from an inspection conducted by the regulatory or
licensing agency of the state in which the pharmacy practice site is physically
located. Thereafter, the pharmacy practice site shall submit to the director a
copy of any subsequent inspection report conducted by the regulatory or
licensing agency of the state in which the site is physically located.
(i) An out-of-state pharmacy practice site
engaged in compounding must provide an inspection performed within the previous
twelve (12) months.
(ii) An
inspection completed by the United States Food and Drug Administration, or an
inspection performed by the National Association of Boards of Pharmacy in lieu
of an inspection by the regulatory or licensing agency of the state in which
the pharmacy practice site is physically located is acceptable.
5. Maintain records of
prescription orders dispensed to and/or of medication assessments provided to
persons residing in Tennessee.
6.
All records of prescription orders prepared and dispensed to persons residing
in Tennessee shall be readily retrievable from other records.
7. During regular hours of operation, but not
less than six (6) days per week nor for a minimum of forty (40) hours per week
provide access to a pharmacist by a toll-free telephone service. A toll-free
number shall be placed on the label affixed to the dispensing container for
each prescription dispensed to a person residing in Tennessee.
8. Designate a pharmacist in charge who shall
be responsible for compliance with the provisions in this section, and who
shall hold a current Tennessee pharmacist license.
9. All out-of-state pharmacy practice sites
shall comply with the requirements for patient counseling, patient profiling,
drug regimen review and pharmaceutical care as set forth at
1140-03-.01.
10. The Board may
require additional information before issuing or renewing a pharmacy license to
ensure compliance with applicable laws of this state and rules of the
Board.
(b) Manufacturer,
outsourcing facility, oxygen supplier or wholesaler/distributor.
1. Submit an application for a license, which
shall include the address of the manufacturer, outsourcing facility, oxygen
supplier or wholesaler/distributor, name of owner if a sole proprietorship,
names of partners if a partnership or names and titles of all officers if a
corporation, together with the appropriate application fee. The director shall
be notified in writing within thirty (30) days of any change in the information
contained on the original application for a license.
2. Submit a copy of the most recent
inspection report resulting from an inspection conducted by the regulatory or
licensing agency of the state in which the manufacturer, outsourcing facility,
oxygen supplier or wholesaler/distributor is physically located, or by the Food
& Drug Administration. Thereafter, the manufacturer, outsourcing facility,
oxygen supplier or wholesaler/distributor shall submit to the director a copy
of any subsequent inspection report conducted by the regulatory or licensing
agency of the state in which the manufacturer, outsourcing facility, oxygen
supplier or wholesaler/distributor is physically located, or by the
FDA.
3. Comply with the
requirements contained in Chapter 1140-09 of the rules of the Board of
Pharmacy.
(4)
Representatives of a manufacturer, outsourcing facility or
wholesaler/distributor conducting business in the state of Tennessee and who
possesses and distributes controlled substances shall obtain a controlled
substance registration from the Board of Pharmacy.
(5) Any entity licensed as or applying for
licensure as manufacturer or outsourcing facility conducting business in the
state of Tennessee and who manufactures, prepares, propagates, repackages, or
processes sterile drug products or biological products using aseptic processing
must register and possess a modifier as a sterile manufacturer with the Board
of Pharmacy in accordance with this chapter. This section shall not apply to
wholesalers/distributors of sterile products.
(6) It shall be unlawful for any person to
procure or attempt to procure a license or certificate of registration for such
person or for any other person by making any false representations.
(7) In determining whether to grant a license
under this rule, the board shall require from the applicant proof satisfactory
to the board that the:
(a) Applicant is of
good moral character, or, if the applicant is a partnership or corporation,
that the managing officers are of good moral character; and
(b) That the applicant is equipped as to
land, buildings and equipment necessary to conduct the business for which the
application has been submitted.
(8) Upon request, the Board may waive
selected portions of these requirements so long as any waiver granted is
consistent with the Board's authority under Tenn. Code Ann. Title 63, Chapters
1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.
Authority: T.C.A. §§
53-11-301,
53-11-302, 53-14-104, 53-14-107, 63-10-203, 63-10-204, 63-10-210, 63-10-216,
63-10-301, 63-10-308, 63-10-310, and
63-10-312.
