Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,936
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age and use and shall require testing to determine the correct amount to
weigh for accurate content of active chemical moieties in compounded
sterile preparations.
(e) Records.
(1) Maintenance of records. Every record required under
this section must be:
(A) kept by the provider pharmacy and be available, for
at least two years for inspecting and copying by the board or its rep-
resentative and to other authorized local, state, or federal law enforce-
ment agencies; and
(B) supplied by the provider pharmacy within 72 hours,
if requested by an authorized agent of the Texas State Board of Phar-
macy. If the pharmacy maintains the records in an electronic format,
the requested records must be provided in an electronic format. Failure
to provide the records set out in this section, either on site or within 72
hours, constitutes prima facie evidence of failure to keep and maintain
records in violation of the Act.
(2) Compounding records.
(A) Compounding pursuant to patient specific prescrip-
tion drug orders. Compounding records for all compounded pharma-
ceuticals shall be maintained by the pharmacy electronically or manu-
ally as part of the prescription drug or medication order, formula record,
formula book, or compounding log and shall include:
(i) the date of preparation;
(ii) a complete formula, including methodology and
necessary equipment which includes the brand name(s) of the raw ma-
terials, or if no brand name, the generic name(s) or official name and
name(s) of the manufacturer(s) or distributor of the raw materials and
the quantities of each;
(iii) signature or initials of the pharmacist or phar-
macy technician or pharmacy technician trainee performing the com-
pounding;
(iv) signature or initials of the pharmacist respon-
sible for supervising pharmacy technicians or pharmacy technician
trainees and conducting in-process and finals checks of compounded
pharmaceuticals if pharmacy technicians or pharmacy technician
trainees perform the compounding function;
(v) the quantity in units of finished products or
amount of raw materials;
(vi) the container used and the number of units pre-
pared; and
(vii) a reference to the location of the following doc-
umentation which may be maintained with other records, such as qual-
ity control records:date; and
control procedures.(I) the criteria used to determine the beyond-use
(II) documentation of performance of quality(B) Compounding records when batch compounding or
compounding in anticipation of future prescription drug or medication
orders.
(i) Master work sheet. A master work sheet shall be
developed and approved by a pharmacist for preparations prepared in
batch. Once approved, a duplicate of the master work sheet shall be
used as the preparation work sheet from which each batch is preparedand on which all documentation for that batch occurs. The master work
sheet shall contain at a minimum:
(I) the formula;
(II) the components;
(III) the compounding directions;
(IV) a sample label;
(V) evaluation and testing requirements;
(VI) specific equipment used during preparation;
and
(VII) storage requirements.
(ii) Preparation work sheet. The preparation work
sheet for each batch of preparations shall document the following:
(I) identity of all solutions and ingredients and
their corresponding amounts, concentrations, or volumes;
(II) lot number for each component;
(III) component manufacturer/distributor or suit-
able identifying number;cassette);
batch;(IV) container specifications (e.g., syringe, pump
(V) unique lot or control number assigned to(VI) expiration date of batch-prepared prepara-
tions;
(VII) date of preparation;
(VIII) name, initials, or electronic signature of
the person(s) involved in the preparation;
(IX) name, initials, or electronic signature of the
responsible pharmacist;
(X) finished preparation evaluation and testing
specifications, if applicable; and
(XI) comparison of actual yield to anticipated or
theoretical yield, when appropriate.
(f) Office Use Compounding and Distribution of Compounded
Preparations to Class C Pharmacies or Veterinarians in Accordance
with 563.054 of the Act.
(1) General.
(A) A pharmacy may dispense and deliver a reasonable
quantity of a compounded preparation to a practitioner for office use
by the practitioner in accordance with this subsection.
(B) A Class A (Community) pharmacy is not required
to register or be licensed under Chapter 431, Health and Safety Code, to
distribute sterile compounded preparations to a Class C (Institutional)
pharmacy.
(C) A Class C (Institutional) pharmacy is not required
to register or be licensed under Chapter 431, Health and Safety Code, to
distribute sterile compounded preparations that the Class C pharmacy
has compounded for other Class C pharmacies under common owner-
ship.
(D) To dispense and deliver a compounded preparation
under this subsection, a pharmacy must:37 TexReg 6936 August 31, 2012 Texas Register
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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/m1/117/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.