S.B. No. 492
AN ACT
relating to inspection of and drug compounding by a pharmacy and to
distribution of compounded and prepackaged drugs to pharmacies
under common ownership.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subdivision (9), Section 551.003, 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 562.154 or Chapter 563.
SECTION 2. Section 556.051, Occupations Code, is amended to
read as follows:
Sec. 556.051. AUTHORIZATION TO ENTER AND INSPECT. The
board or a representative of the board may enter and inspect a
facility relative to the following:
(1) drug storage and security;
(2) equipment;
(3) components used in compounding, finished and
unfinished products, containers, and labeling of any item;
(4) sanitary conditions; or
(5) [(4)] records, reports, or other documents
required to be kept or made under this subtitle, Chapter 481 or 483,
Health and Safety Code, or the Comprehensive Drug Abuse Prevention
and Control Act of 1970 (21 U.S.C. Section 801 et seq.) or rules
adopted under one of those laws.
SECTION 3. Section 556.053, Occupations Code, is amended to
read as follows:
Sec. 556.053. EXTENT OF INSPECTION. Except as otherwise
provided in an inspection warrant, the person authorized to
represent the board may:
(1) inspect and copy documents, including records or
reports, required to be kept or made under this subtitle, Chapter
481 or 483, Health and Safety Code, or the Comprehensive Drug Abuse
Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.)
or rules adopted under one of those laws;
(2) inspect, within reasonable limits and in a
reasonable manner, a facility's storage, equipment, security,
prescription drugs or devices, components used in compounding,
finished and unfinished products, or records; or
(3) perform an inventory of any stock of prescription
drugs or devices, components used in compounding, or finished and
unfinished products in a facility and obtain samples of those
substances.
SECTION 4. Subchapter D, Chapter 562, Occupations Code, is
amended to read as follows:
SUBCHAPTER D. COMPOUNDED AND PREPACKAGED 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 in accordance with Chapter 563.
(2) "Prepackaging" means the act of repackaging and
relabeling quantities of drug products from a manufacturer's
original container into unit dose packaging or a multiple dose
container for distribution within a facility licensed as a Class C
pharmacy or to other pharmacies under common ownership for
distribution within those facilities. The term as defined does not
prohibit the prepackaging of drug products for use within other
pharmacy classes.
(3) "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) comply with all applicable competency and
accrediting standards as determined by the board; and
(4) comply with board rules, including rules regarding
the reporting of adverse events by practitioners and recall
procedures for compounded products.
Sec. 562.154. DISTRIBUTION OF COMPOUNDED AND PREPACKAGED
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
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 prepackaged
pharmaceutical products that the Class C pharmacy has compounded or
prepackaged to other Class C pharmacies licensed under Chapter 560
and under common ownership.
Sec. 562.155. 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 5. Subdivision (23), Section 431.002, 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 prepackaging that is done in
accordance with Section 562.154, 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 6. Subsection (a), Section 431.2021, 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 562.154, Occupations Code.
SECTION 7. This Act takes effect September 1, 2005.
______________________________ ______________________________
President of the Senate Speaker of the House
I hereby certify that S.B. No. 492 passed the Senate on
April 7, 2005, by the following vote: Yeas 31, Nays 0.
______________________________
Secretary of the Senate
I hereby certify that S.B. No. 492 passed the House on
April 28, 2005, by a non-record vote.
______________________________
Chief Clerk of the House
Approved:
______________________________
Date
______________________________
Governor