| (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; 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 or 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:
(A) address acceptable standards of practice for a
compounding pharmacy and a practitioner and receiving pharmacy that
enter into the agreement including a statement that the compounded
preparations 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) state that the practitioner or receiving pharmacy
should include on a separate log or in a patient's chart, medication
order, or medication administration record, the lot number and beyond-use
date of a compounded preparation administered to a patient; and
(C) describe the scope of services to be performed
by the pharmacy and practitioner or receiving pharmacy, including
a statement 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 non-sterile
compounded 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 Pharmacy
or its representative. 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 subsection,
either on site or within 72 hours for whatever reason, constitutes
prima facie evidence of failure to keep and maintain records.
Cont'd... |
