| (VI) expiration 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 Sterile
Compounded Preparations
(1) General.
(A) A pharmacy may compound, dispense, deliver, and
distribute a compounded sterile preparation as specified in Subchapter
D, Texas Pharmacy Act Chapter 562.
(B) A Class A-S pharmacy is not required to register
or be licensed under Chapter 431, Health and Safety Code, to distribute
sterile compounded preparations to a Class C or Class C-S pharmacy.
(C) A Class C-S pharmacy is not required to register
or be licensed under Chapter 431, Health and Safety Code, to distribute
sterile compounded preparations that the Class C-S pharmacy has compounded
for other Class C or Class C-S pharmacies under common ownership.
(D) To compound 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.
(E) This subsection does not apply to Class B pharmacies
compounding sterile radiopharmaceuticals that are furnished for departmental
or physicians' use if such authorized users maintain a Texas radioactive
materials license.
(2) Written Agreement. A pharmacy that provides 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
drugs may only be administered to the patient and may not be dispensed
to the patient or sold to any other person or entity except to a veterinarian
as authorized by §563.054 of the Act;
(B) require the practitioner or receiving pharmacy
to include on 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 sterile compounded
preparations to a practitioner for office use or to an 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;
(II) be maintained separately from the records of preparations
dispensed pursuant to a prescription or medication order; and
(III) be 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.
(ii) Records may be maintained in an alternative data
retention system, such as a data processing system or direct imaging
system provided the data processing system is capable of producing
a hard copy of the record upon the request of the board, its representative,
or other authorized local, state, or federal law enforcement or regulatory
agencies.
(B) Orders. The pharmacy shall maintain a record of
all sterile compounded preparations ordered by a practitioner for
office use or by an institutional pharmacy for administration to a
patient. The record shall include the following information:
(i) date of the order;
(ii) name, address, and phone number of the practitioner
who ordered the preparation and if applicable, the name, address and
phone number of the institutional pharmacy ordering the preparation;
and
(iii) name, strength, and quantity of the preparation
ordered.
(C) Distributions. The pharmacy shall maintain a record
of all sterile compounded preparations distributed pursuant to an
order to a practitioner for office use or by an institutional pharmacy
for administration to a patient. The record shall include the following
information:
(i) date the preparation was compounded;
(ii) date the preparation was distributed;
(iii) name, strength and quantity in each container
of the preparation;
(iv) pharmacy's lot number;
(v) quantity of containers shipped; and
(vi) name, address, and phone number of the practitioner
or institutional pharmacy to whom the preparation is distributed.
(D) Audit Trail.
(i) The pharmacy shall store the order and distribution
records of preparations for all sterile compounded preparations ordered
by and or distributed to a practitioner for office use or by a pharmacy
licensed to compound sterile preparations for administration to a
patient in such a manner as to be able to provide an audit trail for
all orders and distributions of any of the following during a specified
time period:
(I) any strength and dosage form of a preparation (by
either brand or generic name or both);
(II) any ingredient;
(III) any lot number;
(IV) any practitioner;
(V) any facility; and
(VI) any pharmacy, if applicable.
(ii) The audit trail shall contain the following information:
(I) date of order and date of the distribution;
(II) practitioner's name, address, and name of the
institutional pharmacy, if applicable;
(III) name, strength and quantity of the preparation
in each container of the preparation;
(IV) name and quantity of each active ingredient;
(V) quantity of containers distributed; and
(VI) pharmacy's lot number.
(4) Labeling. The pharmacy shall affix a label to the
preparation containing the following information:
(A) name, address, and phone number of the compounding
pharmacy;
(B) the statement: "For Institutional or Office Use
Only--Not for Resale"; or if the preparation is distributed to a veterinarian
the statement: "Compounded Preparation";
(C) name and strength of the preparation or list of
the active ingredients and strengths;
(D) pharmacy's lot number;
(E) beyond-use date as determined by the pharmacist
using appropriate documented criteria;
(F) quantity or amount in the container;
(G) appropriate ancillary instructions, such as storage
instructions or cautionary statements, including hazardous drug warning
labels where appropriate; and
(H) device-specific instructions, where appropriate.
(g) Recall Procedures.
(1) The pharmacy shall have written procedures for
the recall of any compounded sterile preparation provided to a patient,
to a practitioner for office use, or a pharmacy for administration.
Written procedures shall include, but not be limited to the requirements
as specified in paragraph (3) of this subsection.
(2) The pharmacy shall immediately initiate a recall
of any sterile preparation compounded by the pharmacy upon identification
of a potential or confirmed harm to a patient.
Cont'd... |
