Current through April 3, 2024
(1) To the extent
that a medical order contains an order for the compounding, dispensing or
administration of a prescription drug or device or related material, the
medical order shall be treated as a prescription order. Written medical and
prescription orders must be signed by the prescriber. Verbal medical and
prescription orders must be immediately reduced to writing (by hand or other
means), dated, and initialed by the authorized individual accepting the medical
and prescription orders.
(2) Each
medical and prescription order when dispensed shall be serially numbered, filed
numerically and maintained so as to be readily retrievable at the pharmacy
practice site for at least two (2) years from the date the medical and
prescription order was last dispensed. Institutional pharmacies shall not be
required to serially number medical and prescription orders dispensed for
administration to inpatients of that institution.
(3) A pharmacist upon initial dispensing of a
medical or prescription order shall record on that medical or prescription
order: the date such medical or prescription order was dispensed, the
pharmacist's initials, and the amount of any product dispensed. If the
pharmacist merely initials and dates a medical or prescription order the
pharmacist shall be deemed to have dispensed the full face amount of the
medical or prescription order.
(4)
A pharmacist upon refilling a medical or prescription order shall enter on the
back of that medical or prescription order: the date such medical or
prescription order was refilled, the pharmacist's initials, and the amount of
any product dispensed on such refill. If the pharmacist merely initials and
dates the back of the medical or prescription order the pharmacist shall be
deemed to have dispensed a refill for the full face amount of the medical or
prescription order. As an alternative to recording refill information on the
back of medical and prescription orders, an automated data processing system
may be used for the storage and retrieval of refill information for medical and
prescription orders, subject to the following conditions:
(a) Any such computerized system must provide
on-line retrieval (via CRT display or hard-copy printout) of the original
medical or prescription order information and the complete refill history of
all medical and prescription orders which are currently authorized for
refilling. This shall include all the information contained in and required to
be entered on each such medical or prescription order. This data must include
at least the medical or prescription order serial number; date of issuance of
the medical or prescription order; patient's name (and address on controlled
substance medical and prescription orders); prescriber's name (and address and
DEA registration number on controlled substance medical and prescription
orders); product name, strength, dosage form, and quantity prescribed;
directions for use, and labeling instructions; refill instructions; and the
date of dispensing, quantity dispensed, and identity (name, initials, or
identification code) of the dispensing pharmacist for the original dispensing
and each refill.
(b) Each
individual pharmacist using a computerized system in the refilling of a medical
or prescription order shall certify that the information entered into the
computer for such a refill is correct by verifying, dating, and signing a
hard-copy printout of each day's medical or prescription order refill data, or
in lieu of such a printout, by signing a statement in a book or file each day
attesting that the refill information entered that day has been reviewed by the
pharmacist and is correct as shown. Such documentation shall be separately
maintained at the pharmacy practice site for at least two (2) years from the
date of the last dispensing.
(c)
Any such computerized system shall have the capability of producing a hard-copy
printout of any medical or prescription order refill data which the pharmacy
practice site is responsible for maintaining under the laws and/or regulations
of this state and/or the federal government. (This would, for example, furnish
a medical or prescription order-by-medical or prescription order,
refill-by-refill audit trail for any specified strength and dosage form of any
prescription drug and device, by either brand or generic name or both.) Such a
printout must include: the medical or prescription order serial number;
patient's name (and address on controlled substance medical and prescription
orders); name of prescriber; name, strength, and dosage form of the product;
and the date of each refill, quantity dispensed on each refill, and the name or
identification code of the dispensing pharmacist. Controlled substance data
contained on such a printout must be separated, asterisked, or in some other
manner visually identifiable apart from other items appearing on the printout.
Any computerized system employed by a pharmacy practice site must, upon the
request of an authorized representative of the board, send or provide such a
printout to the pharmacy practice site within forty eight (48) hours excluding
weekends (Saturdays and Sundays) and legal holidays.
(d) In the event that a pharmacy practice
site which utilizes such a computerized system experiences system down-time,
the pharmacy practice site must have a written or readily retrievable auxiliary
policy and procedure which will be used for documentation of refills of all
medical and prescription orders. This auxiliary procedure must ensure that each
refill is authorized, and that all appropriate data is retained for on-line
data entry as soon as the computer system is available for use again.
(e) Each pharmacy practice site and
pharmacist using such a computerized system must comply with the provisions of
paragraphs one (1) and two (2) of this rule. In addition, the requirements of
paragraph three (3) of this rule shall apply, unless this initial dispensing
data is included on the printout required by subparagraph four (4)(b) of this
rule, and is identified as pertaining to the initial dispensing.
(5) A pharmacist may dispense an
appropriately authorized refill of a medical or prescription order by referral
to a patient profile (medication record) instead of the original medical or
prescription order on file at that pharmacy practice site, subject to the
following conditions:
(a) The patient profile
must contain all the information contained in and required to be entered on the
original medical or prescription order, including the complete refill history
of that medical or prescription order. This data includes the medical or
prescription order serial number; date of issuance of the medical or
prescription order; name of patient; name of the prescriber; product name;
strength; dosage form, and quantity prescribed; directions for use, and
labeling instructions; refill instructions; and the date of dispensing,
quantity dispensed, and initials of the dispensing pharmacist for the original
dispensing and each refill. Dispensing data must be identified as to whether it
pertains to the original dispensing or to a refill.
(b) Controlled substance data contained on
the patient profile must be asterisked, redlined, or in some other manner
visually identifiable apart from other items appearing on the
profile.
(c) The patient profile
system must contain a complete and accurate record of the refill history of all
medical and prescription orders dispensed at the pharmacy practice site. (This
record will constitute compliance with the provisions of paragraph four (4) of
this rule.)
(d) Each such profile
must be maintained so as to be readily retrievable at the pharmacy practice
site for at least two (2) years from the date of the last dispensing recorded
on the profile.
(e) A pharmacist
dispensing a medical or prescription order by referral to a patient profile in
so doing certifies as to the accuracy and validity of the information contained
on the patient profile.
(f) Each
pharmacy practice site and pharmacist using such a patient profile system must
comply with the provisions of paragraphs one (1) and two (2) of this rule. In
addition, the requirements of paragraph three (3) of this rule shall obtain,
unless the patient profile system contains a record of this initial dispensing
information for all medical and prescription orders dispensed at the pharmacy
practice site.
(6) No
pharmacist, or pharmacy intern or pharmacy technician under the supervision of
a pharmacist, shall compound or dispense any medical or prescription order
except upon the following conditions:
(a) All
medical and prescription orders shall be compounded and dispensed in strict
conformity with any directions of the prescriber. Nothing in this rule shall
prohibit a pharmacist from substituting a therapeutically equivalent
prescription drug or device or related material containing the same active
ingredient or ingredients, dosage form and strength;
(b) No medical or prescription order shall be
refilled if it contains a statement over the signature of the prescriber that
it is not to be refilled, and a medical or prescription order shall not be
refilled unless so authorized by the prescriber;
(c) If any medical or prescription order
contains a statement that it may be refilled a specified number of times within
or during any particular period, such order shall be refilled in strict
conformity with such statement; and
(d) If a prescription contains a statement
that during any particular time it may be refilled at will, the order shall be
refilled in strict conformity to dosage directions, with the exception that it
may not be refilled after the expiration of the time specified or one (1) year
from the date the order was originally issued or dispensed, whichever comes
first.
(e) At a rate, based on the
actual number of medical and prescription orders compounded and dispensed per
hour or per day, that does not pose a danger to the public health, safety or
welfare.
(7) Copies of
Medical and Prescription Orders.
(a) Copies of
medical and prescription orders issued directly to the patient by the pharmacy
practice site where the order was originally compounded and dispensed pursuant
to the receipt of the order shall bear on the face thereof, in letters red in
color and equal in size to those describing the prescription drug or device or
related material, the statement: "Copy for Information Only." Presentation of
an informational written copy or label of a dispensing container shall be for
information purposes only and have no legal status as a valid medical or
prescription order. The recipient pharmacist of such copy or label shall
contact the prescriber or transferor pharmacy practice site and obtain all
information required by this rule, which is the same as obtaining an original
medical or prescription order;
(b)
Medical and prescription orders shall be transferred between pharmacy practice
sites for the purpose of compounding and dispensing provided that the
transferee, upon receiving such order directly from the transferor, records the
following:
1. The name, address and original
medical or prescription order serial number at the pharmacy practice site from
which the order was transferred;
2.
The name of the transferor; and
3.
All information constituting a medical or prescription order including the
following:
(i) Date the order was originally
issued and dispensed;
(ii) Original
number of refills authorized on the original order;
(iii) Date of last dispensing; and
(iv) Number of valid refills
remaining.
(c) The transferee informs the patient that
the original medical or prescription order has been canceled at the pharmacy
practice site from which it was obtained.
(d) Computerized systems must satisfy all
information requirements.
(e) The
transfer of schedule III, IV, V, controlled substances are subject to the
conditions set forth in 21
C.F.R. 1306.25.
(8) It is permissible for any pharmacy
practice site, pharmacist, or pharmacy intern or pharmacy technician under the
supervision of a pharmacist, or any other place of business engaged in
compounding and dispensing prescription drugs and devices and related materials
for human consumption to receive from any patient or other person the return of
any portion of an order that has been taken from the premises of the pharmacy
practice site or other place of business, only if authorized:
(a) Pursuant to Tennessee Board of Pharmacy
rule 1140-04-.10; or
(b) For the purpose of collection for
disposal or destruction of any prescription drug; provided that participation
in the program shall be voluntary, and such collection and destruction shall be
conducted in accordance with the provisions of
21 CFR §
1317.
(9) Medical and prescription orders cannot be
accepted, solicited, collected or advertised at any location other than a
pharmacy practice site for which a license has been issued by the Board, and
such pharmacy practice site shall be actively engaged in compounding and
dispensing medical and prescription orders. An entity or other non-licensed
site which does not dispense drugs directly to patients may accept, solicit,
and collect prescriptions for the purpose of medication therapy management or
other consultative services related to drug therapy and patient care.
(10) Medical and prescription orders typed or
printed must be signed by the prescriber. Oral medical and prescription orders
shall be initialed by the authorized individual accepting the order.
Authority: T.C.A. §§
63-10-204,
63-10-304,
63-10-404(4), (11), (14), (19), (26), (29), (30),
and (34), 63-10-504(b)(1), 63-10-504(j),
63-10-504(b)(1) and (2), 63-10-204, 63-10-304, and 2015 Acts, Pub. Chap.
40.
