| (A) Initial formula validation. Prior to routine compounding
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-sterile
preparations shall be inspected for accuracy of correct identities
and amounts of ingredients, packaging, labeling, and expected physical
appearance before the non-sterile preparations are dispensed.
(10) Quality Control.
(A) The pharmacy shall follow established quality control
procedures to monitor the quality of compounded drug preparations
for uniformity and consistency such as capsule weight variations,
adequacy of mixing, clarity, or pH of solutions. When developing these
procedures, pharmacy personnel shall consider the provisions of Chapter
795, concerning Pharmacy Compounding Non-Sterile Preparations, Chapter
1075, concerning Good Compounding Practices, and Chapter 1160, concerning
Pharmaceutical Calculations in Prescription Compounding contained
in the current USP/NF. Such procedures shall be documented and be
available for inspection.
(B) Compounding procedures that are routinely performed,
including batch compounding, shall be completed and verified according
to written procedures. The act of verification of a compounding procedure
involves checking to ensure that calculations, weighing and measuring,
order of mixing, and compounding techniques were appropriate and accurately
performed.
(C) Unless otherwise indicated or appropriate, compounded
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 agencies;
and
(B) supplied by the pharmacy within 72 hours, if requested
by an authorized agent of the Texas State Board of Pharmacy. 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 prescription
drug or medication orders. Compounding records for all compounded
preparations shall be maintained by the pharmacy electronically 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 materials,
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 pharmacy
technician or pharmacy technician trainee performing the compounding;
(iv) signature or initials of the pharmacist responsible
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 prepared;
(vii) a reference to the location of the following
documentation which may be maintained with other records, such as
quality control records:
(I) the criteria used to determine the beyond-use date;
and
(II) documentation of performance of quality control
procedures. Documentation of the performance of quality control procedures
is not required if the compounding process is done pursuant to a patient
specific order and involves the mixing of two or more commercially
available oral liquids or commercially available preparations when
the final product is intended for external use.
(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 prepared
and 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;
(VII) storage requirements;
(VIII) a reference to the location of the following
documentation which may be maintained with other records, such as
quality control records:
(-a-) the criteria used to determine the beyond-use
date; and
(-b-) documentation of performance of quality control
procedures.
(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 and expiration date of each component;
(III) component manufacturer/distributor or suitable
identifying number;
(IV) container specifications;
(V) unique lot or control number assigned to batch;
(VI) beyond use date of batch-prepared preparations;
(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 pharmacy is not required to register
or be licensed under Chapter 431, Health and Safety Code, to distribute
non-sterile compounded preparations to a Class C pharmacy.
(C) A Class C pharmacy is not required to register
or be licensed under Chapter 431, Health and Safety Code, to distribute
non-sterile compounded preparations that the Class C pharmacy has
compounded for other Class C pharmacies under common ownership.
(D) To dispense and deliver a compounded preparation
under this subsection, a pharmacy must:
(i) verify the source of the raw materials to be used
in a compounded drug;
(ii) comply with applicable United States Pharmacopoeia
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 practitioner
for the practitioner's office use of a compounded preparation;
(iv) comply with all applicable competency and accrediting
standards as determined by the board; and
(v) comply with the provisions of this subsection.
(2) Written Agreement. A pharmacy that provides non-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:
Cont'd... |
