Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,937
6819-7008 p. ; 28 cm.View a full description of this periodical.
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(i) verify the source of the raw materials to be used
in a compounded drug;
(ii) comply with applicable United States Pharma-
copoeia guidelines, including the testing requirements, and the Health
Insurance Portability and Accountability Act of 1996 (Pub. L. No.
104-191);
(iii) enter into a written agreement with a practi-
tioner for the practitioner's office use of a compounded preparation;
(iv) comply with all applicable competency and ac-
crediting standards as determined by the board; and
(v) comply with the provisions of this subsection.
(2) Written Agreement. A pharmacy that provides sterile
compounded preparations to practitioners for office use or to another
pharmacy shall enter into a written agreement with the practitioner or
pharmacy. The written agreement shall:
(A) address acceptable standards of practice for a com-
pounding pharmacy and a practitioner and receiving pharmacy that en-
ter into the agreement including a statement that the compounded drugs
may only be administered to the patient and may not be dispensed to
the patient or sold to any other person or entity except as authorized by
563.054 of the Act;
(B) require the practitioner or receiving pharmacy to in-
clude on a patient's chart, medication order or medication administra-
tion record the lot number and beyond-use date of a compounded prepa-
ration administered to a patient;
(C) describe the scope of services to be performed by
the pharmacy and practitioner or receiving pharmacy, including a state-
ment of the process for:
(i) a patient to report an adverse reaction or submit
a complaint; and
(ii) the pharmacy to recall batches of compounded
preparations.
(3) Recordkeeping.
(A) Maintenance of Records.
(i) Records of orders and distribution of sterile com-
pounded preparations to a practitioner for office use or to a Class C
pharmacy for administration to a patient shall:
(I) be kept by the pharmacy and be available, for
at least two years from the date of the record, for inspecting and copying
by the board or its representative and to other authorized local, state,
or federal law enforcement agencies;
(II) maintained separately from the records of
products dispensed pursuant to a prescription or medication order; and
(III) supplied by the pharmacy within 72 hours,
if requested by an authorized agent of the Texas State Board of Phar-
macy or its representative. If the pharmacy maintains the records in an
electronic format, the requested records must be provided in an elec-
tronic format. Failure to provide the records set out in this subsection,
either on site or within 72 hours for whatever reason, constitutes prima
facie evidence of failure to keep and maintain records.
(ii) Records may be maintained in an alternative
data retention system, such as a data processing system or direct
imaging system provided the data processing system is capable of
producing a hard copy of the record upon the request of the board,
its representative, or other authorized local, state, or federal law
enforcement or regulatory agencies.(B) Orders. The pharmacy shall maintain a record of all
sterile compounded preparations ordered by a practitioner for office use
or by a Class C pharmacy for administration to a patient. The record
shall include the following information:
(i) date of the order;
(ii) name, address, and phone number of the practi-
tioner who ordered the preparation and if applicable, the name, address
and phone number of the Class C Pharmacy ordering the preparation;
and
(iii) name, strength, and quantity of the preparation
ordered.
(C) Distributions. The pharmacy shall maintain a
record of all sterile compounded preparations distributed pursuant to
an order to a practitioner for office use or by a Class C pharmacy for
administration to a patient. The record shall include the following
information:
(i) date the preparation was compounded;
(ii) date the preparation was distributed;
(iii) name, strength and quantity in each container of
the preparation;
(iv) pharmacy's lot number;
(v) quantity of containers shipped; and
(vi) name, address, and phone number of the practi-
tioner or Class C Pharmacy to whom the preparation is distributed.
(D) Audit Trail.
(i) The pharmacy shall store the order and distribu-
tion records of preparations for all sterile compounded preparations or-
dered by and or distributed to a practitioner for office use or by a Class
C pharmacy for administration to a patient in such a manner as to be
able to provide a audit trail for all orders and distributions of any of the
following during a specified time period.
(I) any strength and dosage form of a preparation
(by either brand or generic name or both);
(II) any ingredient;
(III) any lot number;
(IV) any practitioner;
(V) any facility; and
(VI) any pharmacy, if applicable.
(ii) The audit trail shall contain the following infor-
mation:
(I) date of order and date of the distribution;
(II) practitioner's name, address, and name of the
Class C pharmacy, if applicable;
(III) name, strength and quantity of the prepara-
tion in each container of the preparation;
(IV) name and quantity of each active ingredient;
(V) quantity of containers distributed; and
(VI) pharmacy's lot number;
(4) Labeling. The pharmacy shall affix a label to the prepa-
ration containing the following information:ADOPTED RULES August 31, 2012 37 TexReg 6937
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Texas. Secretary of State. Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012, periodical, August 31, 2012; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth253227/m1/118/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.