Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,921
6819-7008 p. ; 28 cm.View a full description of this periodical.
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(I) A pharmacy may not compound a preparation that
contains ingredients appearing on a federal Food and Drug Adminis-
tration list of drug products withdrawn or removed from the market for
safety reasons.
(8) Compounding process.
(A) All significant procedures performed in the com-
pounding area shall be covered by written SOPs designed to ensure
accountability, accuracy, quality, safety, and uniformity in the com-
pounding process. At a minimum, SOPs shall be developed for:
(i) the facility;
(ii) equipment;
(iii) personnel;
(iv) preparation evaluation;
(v) quality assurance;
(vi) preparation recall;
(vii) packaging; and
(viii) storage of compounded preparations.
(B) Any compounded preparation with an official
monograph in the USP/NF shall be compounded, labeled, and pack-
aged in conformity with the USP/NF monograph for the drug.
(C) Any person with an apparent illness or open lesion
that may adversely affect the safety or quality of a drug product being
compounded shall be excluded from direct contact with components,
drug product containers, closures, any materials involved in the com-
pounding process, and drug products until the condition is corrected.
(D) Personnel engaged in the compounding of drug
preparations shall wear clean clothing appropriate to the operation
being performed. Protective apparel, such as coats/jackets, aprons,
hair nets, gowns, hand or arm coverings, or masks shall be worn
as necessary to protect personnel from chemical exposure and drug
preparations from contamination.
(E) At each step of the compounding process, the phar-
macist shall ensure that components used in compounding are accu-
rately weighed, measured, or subdivided as appropriate to conform to
the formula being prepared.
(9) Quality Assurance.
(A) Initial formula validation. Prior to routine com-
pounding of a non-sterile preparation, a pharmacy shall conduct an
evaluation that shows that the pharmacy is capable of compounding
a product that contains the stated amount of active ingredient(s).
(B) Finished preparation checks. The prescription drug
and medication orders, written compounding procedure, preparation
records, and expended materials used to make compounded non-ster-
ile preparations shall be inspected for accuracy of correct identities and
amounts of ingredients, packaging, labeling, and expected physical ap-
pearance before the non-sterile preparations are dispensed.
(10) Quality Control.
(A) The pharmacy shall follow established quality con-
trol procedures to monitor the quality of compounded drug preparations
for uniformity and consistency such as capsule weight variations, ad-
equacy of mixing, clarity, or pH of solutions. When developing these
procedures, pharmacy personnel shall consider the provisions of Chap-
ter 795, concerning Pharmacy Compounding Non-Sterile Preparations,
Chapter 1075, concerning Good Compounding Practices, and Chapter1160, concerning Pharmaceutical Calculations in Prescription Com-
pounding contained in the current USP/NF. Such procedures shall be
documented and be available for inspection.
(B) Compounding procedures that are routinely per-
formed, including batch compounding, shall be completed and verified
according to written procedures. The act of verification of a com-
pounding procedure involves checking to ensure that calculations,
weighing and measuring, order of mixing, and compounding tech-
niques were appropriate and accurately performed.
(C) Unless otherwise indicated or appropriate, com-
pounded preparations are to be prepared to ensure that each preparation
shall contain not less than 90.0 percent and not more than 110.0
percent of the theoretically calculated and labeled quantity of active
ingredient per unit weight or volume and not less than 90.0 percent
and not more than 110.0 percent of the theoretically calculated weight
or volume per unit of the preparation.
(e) Records.
(1) Maintenance of records. Every record required by this
section shall be:
(A) kept by the pharmacy and be available, for at least
two years for inspecting and copying by the board or its representative
and to other authorized local, state, or federal law enforcement agen-
cies; and
(B) supplied by the pharmacy within 72 hours, if re-
quested by an authorized agent of the Texas State Board of Pharmacy.
If the pharmacy maintains the records in an electronic format, the re-
quested 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 or medication orders. Compounding records for all com-
pounded preparations shall be maintained by the pharmacy electron-
ically or manually 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) and name(s) of the
manufacturer(s) 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 final checks of compounded
preparations if pharmacy technicians or pharmacy technician trainees
perform the compounding function;
(v) the quantity in units of finished preparations or
amount of raw materials;
(vi) the container used and the number of units pre-
pared;
(vii) a reference to the location of the following doc-
umentation which may be maintained with other records, such as qual-
ity control records:ADOPTED RULES August 31, 2012 37 TexReg 6921
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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/m1/102/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.