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79R4456 YDB-F
By: Van de Putte S.B. No. 492
A BILL TO BE ENTITLED
AN ACT
relating to drug compounding by a pharmacy for a practitioner's
office use and to distribution of compounded and repackaged drugs
to pharmacies under common ownership.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 551.003(9), Occupations Code, is amended
to read as follows:
(9) "Compounding" means the preparation, mixing,
assembling, packaging, or labeling of a drug or device:
(A) as the result of a practitioner's
prescription drug order based on the
practitioner-patient-pharmacist relationship in the course of
professional practice;
(B) for administration to a patient by a
practitioner as the result of a [or the] practitioner's initiative
based on the practitioner-patient-pharmacist relationship in the
course of professional practice;
(C) [(B)] in anticipation of a prescription drug
order based on a routine, regularly observed prescribing pattern;
or
(D) [(C)] for or as an incident to research,
teaching, or chemical analysis and not for selling or dispensing,
except as allowed under Section 562.155.
SECTION 2. Subchapter D, Chapter 562, Occupations Code, is
amended to read as follows:
SUBCHAPTER D. COMPOUNDED AND REPACKAGED DRUGS [ADVERTISING OR
PROMOTING BY PHARMACIST OR PHARMACY]
Sec. 562.151. DEFINITIONS. In this subchapter:
(1) "Office use" means the provision and
administration of a compounded drug to a patient by a practitioner
in the practitioner's office or by the practitioner in a health care
facility or treatment setting, including a hospital, ambulatory
surgical center, or pharmacy.
(2) "Reasonable quantity" with reference to drug
compounding means an amount of a drug that:
(A) does not exceed the amount a practitioner
anticipates may be used in the practitioner's office before the
expiration date of the drug;
(B) is reasonable considering the intended use of
the compounded drug and the nature of the practitioner's practice;
and
(C) for any practitioner and all practitioners as
a whole, is not greater than an amount the pharmacy is capable of
compounding in compliance with pharmaceutical standards for
identity, strength, quality, and purity of the compounded drug that
are consistent with United States Pharmacopoeia guidelines and
accreditation practices.
Sec. 562.152. COMPOUNDING FOR OFFICE USE. A pharmacy may
dispense and deliver a reasonable quantity of a compounded drug to a
practitioner for office use by the practitioner in accordance with
this chapter.
Sec. 562.153. REQUIREMENTS FOR OFFICE USE COMPOUNDING. To
dispense and deliver a compounded drug under Section 562.152, a
pharmacy must:
(1) verify the source of the raw materials to be used
in a compounded drug;
(2) 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);
(3) enter into a written agreement with a practitioner
for the practitioner's office use of a compounded drug;
(4) comply with all applicable competency and
accrediting standards as determined by the board; and
(5) comply with the procedures established by the
board.
Sec. 562.154. WRITTEN AGREEMENT. An agreement required by
Section 562.153(3) must:
(1) address acceptable standards of practice for a
compounding pharmacy and a practitioner that enter into an
agreement under this section;
(2) require the practitioner to include on a patient's
chart the lot number and expiration date of a compounded drug
administered by the practitioner to a patient under this
subchapter;
(3) include the name and address of each party to the
agreement and the location of the compounding pharmacy and
practitioner's office;
(4) describe the scope of services to be performed by
the pharmacy and practitioner, including a statement of the process
for:
(A) the practitioner to administer a compounded
drug;
(B) the practitioner administering a compounded
drug to counsel patients;
(C) a patient to report an adverse reaction or
submit a complaint;
(D) the pharmacy to recall batches of compounded
drugs; and
(E) the pharmacy to access a patient's name and
medical information if necessary;
(5) include a description of the procedure for a
practitioner to request a compounded drug, which must include a
written statement of the product's commercial unavailability; and
(6) include indemnity and liability clauses.
Sec. 562.155. DISTRIBUTION OF COMPOUNDED AND REPACKAGED
PRODUCTS TO CERTAIN PHARMACIES. (a) A Class A pharmacy licensed
under Chapter 560 is not required to register or be licensed under
Chapter 431, Health and Safety Code, to distribute compounded and
prepackaged pharmaceutical products to a Class C pharmacy licensed
under Chapter 560.
(b) A Class C pharmacy licensed under Chapter 560 is not
required to register or be licensed under Chapter 431, Health and
Safety Code, to distribute compounded and repackaged
pharmaceutical products to other Class C pharmacies licensed under
Chapter 560 and under common ownership.
Sec. 562.156. COMPOUNDING SERVICE AND COMPOUNDED DRUG
PRODUCTS. A compounding pharmacist or pharmacy may advertise or
promote:
(1) nonsterile prescription compounding services
provided by the pharmacist or pharmacy; and
(2) specific compounded drug products that the
pharmacy or pharmacist dispenses or delivers.
SECTION 3. Section 431.002(23), Health and Safety Code, is
amended to read as follows:
(23) "Manufacture" means:
(A) the process of combining or purifying food or
packaging food for sale to a person at wholesale or retail, and
includes repackaging, labeling, or relabeling of any food;
(B) the process of preparing, propagating,
compounding, processing, packaging, repackaging, labeling,
testing, or quality control of a drug or drug product, but does not
include compounding that is done within the practice of pharmacy
and pursuant to a prescription drug order or initiative from a
practitioner for a patient or repackaging that is done in
accordance with Section 562.155, Occupations Code;
(C) the process of preparing, fabricating,
assembling, processing, packing, repacking, labeling, or
relabeling a device; or
(D) the making of any cosmetic product by
chemical, physical, biological, or other procedures, including
manipulation, sampling, testing, or control procedures applied to
the product.
SECTION 4. Section 431.2021(a), Health and Safety Code, is
amended to read as follows:
(a) A person who engages in wholesale distribution of
prescription drugs in this state for use in humans is exempt from
this subchapter if the person is exempt under:
(1) the Prescription Drug Marketing Act of 1987, as
amended (21 U.S.C. Section 353(c)(3)(B));
(2) the regulations adopted by the secretary to
administer and enforce that Act; [or]
(3) the interpretations of that Act set out in the
compliance policy manual of the United States Food and Drug
Administration; or
(4) Section 562.155, Occupations Code.
SECTION 5. This Act takes effect September 1, 2005.