Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,922
6819-7008 p. ; 28 cm.View a full description of this periodical.
Extracted Text
The following text was automatically extracted from the image on this page using optical character recognition software:
(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 suit-
able identifying number;
(IV) container specifications;
(V) unique lot or control number assigned to
batch;
(VI) beyond use 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 non-sterile compounded preparations to a Class C (Insti-
tutional) pharmacy.
(C) A Class C (Institutional) 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 phar-
macy 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 Pharma-
copoeia 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 practi-
tioner for the practitioner's office use of a compounded preparation;
(iv) comply with all applicable competency and ac-
crediting 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 practi-
tioner or pharmacy. The written agreement shall:
(A) address acceptable standards of practice for a com-
pounding 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) require the practitioner or receiving pharmacy to in-
clude on a patient's chart, medication order, or medication adminis-
tration 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 state-
ment 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 (Institutional) 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;37 TexReg 6922 August 31, 2012 Texas Register
Upcoming Pages
Here’s what’s next.
Search Inside
This issue can be searched. Note: Results may vary based on the legibility of text within the document.
Tools / Downloads
Get a copy of this page or view the extracted text.
Citing and Sharing
Basic information for referencing this web page. We also provide extended guidance on usage rights, references, copying or embedding.
Reference the current page of this Periodical.
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/m1/103/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.