Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,927
6819-7008 p. ; 28 cm.View a full description of this periodical.
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in-process and final checks, and affixes his or her initials to the
appropriate quality control records.
(4) Special education, training, and evaluation require-
ments for pharmacy personnel compounding or responsible for the
direct supervision of pharmacy personnel compounding sterile prepa-
rations.
(A) General.
(i) All pharmacy personnel preparing sterile prepa-
rations shall receive didactic and experiential training and competency
evaluation through demonstration, testing (written and practical) as
outlined by the pharmacist-in-charge and described in the policy and
procedure or training manual. Such training shall include instruction
and experience in the following areas:
(I) aseptic technique;
(II) critical area contamination factors;
(III) environmental monitoring;
(IV) structure and engineering controls related to
facilities;
(V) equipment and supplies;
(VI) sterile preparation calculations and termi-
nology;
(VII) sterile preparation compounding documen-
tation;
(VIII) quality assurance procedures;
(IX) aseptic preparation procedures including
proper gowning and gloving technique;
(X) handling of cytotoxic and hazardous drugs,
if applicable; and
(XI) general conduct in the controlled area.
(ii) The aseptic technique of each person compound-
ing or responsible for the direct supervision of personnel compound-
ing sterile preparations shall be observed and evaluated as satisfactory
through written and practical tests, and media-fill challenge testing, and
such evaluation documented.
(iii) Although media-fill tests may be incorporated
into the experiential portion of a training program, media-fill tests must
be conducted at each pharmacy where an individual compounds sterile
preparations. No preparation intended for patient use shall be com-
pounded by an individual until the on-site media-fill tests test indicates
that the individual can competently perform aseptic procedures, ex-
cept that a pharmacist may temporarily compound sterile preparations
and supervise pharmacy technicians compounding sterile preparations
without media-fill tests provided the pharmacist:
(I) has completed a recognized course in an ac-
credited college of pharmacy or a course sponsored by an ACPE ac-
credited provider which provides 20 hours of instruction and experi-
ence in the areas listed in this subparagraph; and
(II) completes the on-site media-fill tests within
seven days of commencing work at the pharmacy.
(iv) Media-fill tests procedures for assessing the
preparation of specific types of sterile preparations shall be represen-
tative of all types of manipulations, products, risk levels, and batch
sizes that personnel preparing that type of sterile preparation are likely
to encounter.(v) The pharmacist-in-charge shall ensure continu-
ing competency of pharmacy personnel through in-service education,
training, and media-fill tests to supplement initial training. Personnel
competency shall be evaluated:
(I) during orientation and training prior to the
regular performance of those tasks;
(II) whenever the quality assurance program
yields an unacceptable result;
(III) whenever unacceptable techniques are ob-
served; and
(IV) at least on an annual basis for low- and
medium-risk level compounding, and every six months for high-risk
level compounding.
(B) Pharmacists.
(i) All pharmacists who compound sterile prepara-
tions for administration to patients or supervise pharmacy technicians
and pharmacy technician trainees compounding sterile preparations
shall:
(I) complete through a single course, a minimum
of 20 hours of instruction and experience in the areas listed in subpara-
graph (A) of this paragraph. Such training may be obtained through:
(-a-) completion of a structured on-the-job di-
dactic and experiential training program at this pharmacy which pro-
vides 20 hours of instruction and experience in the areas listed in para-
graph (1) of this subsection. Such training may not be transferred to
another pharmacy unless the pharmacies are under common ownership
and control and use a common training program; or
(-b-) completion of a recognized course in an
accredited college of pharmacy or a course sponsored by an ACPE ac-
credited provider which provides 20 hours of instruction and experi-
ence in the areas listed in subparagraph (A) of this paragraph.
(II) possess knowledge about:
(-a-) aseptic processing;
(-b-) quality control and quality assurance as
related to environmental, component, and finished preparation release
checks and tests;properties of drugs;
tem selection; and(-c-) chemical, pharmaceutical, and clinical
(-d-) container, equipment, and closure sys-(-e-) sterilization techniques.
(ii) The required experiential portion of the training
programs specified in this subparagraph must be supervised by an indi-
vidual who has already completed training as specified in subparagraph
(B) or (C) of this paragraph.
(C) Pharmacy technicians and pharmacy technician
trainees. In addition to specific qualifications for registration, all phar-
macy technicians and pharmacy technician trainees who compound
sterile preparations for administration to patients shall:
(i) have initial training obtained either through com-
pletion of:
(I) a single course, a minimum of 40 hours of in-
struction and experience in the areas listed in subparagraph (A) of this
paragraph. Such training may be obtained through:
(-a-) completion of a structured on-the-job di-
dactic and experiential training program at this pharmacy which pro-
vides 40 hours of instruction and experience in the areas listed in sub-
paragraph (A) of this paragraph. Such training may not be transferredADOPTED RULES August 31, 2012 37 TexReg 6927
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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/m1/108/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.