22 Tex. Admin. Code § 291.131 - Pharmacies Compounding Non-Sterile Preparations
(a) Purpose. Pharmacies compounding
non-sterile preparations, prepackaging pharmaceutical products, and
distributing those products shall comply with all requirements for their
specific license classification and this section. The purpose of this section
is to provide standards for the:
(1)
compounding of non-sterile preparations pursuant to a prescription or
medication order for a patient from a practitioner in Class A (Community),
Class C (Institutional), and Class E (Non-resident) pharmacies;
(2) compounding, dispensing, and delivery of
a reasonable quantity of a compounded non-sterile preparation in a Class A
(Community), Class C (Institutional), and Class E (Non-resident) pharmacy to a
practitioner's office for office use by the practitioner;
(3) compounding and distribution of
compounded non-sterile preparations by a Class A (Community) pharmacy for a
Class C (Institutional) pharmacy; and
(4) compounding of non-sterile preparations
by a Class C (Institutional) pharmacy and the distribution of the compounded
preparations to other Class C (Institutional) pharmacies under common
ownership.
(b)
Definitions. In addition to the definitions for specific license
classifications, the following words and terms, when used in this section,
shall have the following meanings, unless the context clearly indicates
otherwise.
(1) Active pharmaceutical
ingredient--Any substance intended to be used in the compounding of a
preparation, thereby becoming the active ingredient in that preparation and
furnishing pharmacological activity or other direct effect in the diagnosis,
cure, mitigation, treatment, or prevention of disease in humans or animals or
affecting the structure and function of the body.
(2) Beyond-use date--The date or time after
which the compounded non-sterile preparation shall not be stored or transported
or begin to be administered to a patient. The beyond-use date is determined
from the date or time when the preparation was compounded.
(3) Cleaning--The process of removing soil
(e.g., organic and inorganic material) from objects and surfaces, normally
accomplished by manually or mechanically using water with detergents or
enzymatic products.
(4)
Component--Any ingredient intended for use in the compounding of a drug
preparation, including those that may not appear in such preparation.
(5) Compounding--The preparation, mixing,
assembling, packaging, or labeling of a drug or device:
(A) as the result of a practitioner's
prescription drug or medication 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 practitioner's initiative based
on the practitioner-patient-pharmacist relationship in the course of
professional practice;
(C) in
anticipation of prescription drug or medication orders based on routine,
regularly observed prescribing patterns; or
(D) for or as an incident to research,
teaching, or chemical analysis and not for sale or dispensing, except as
allowed under §562.154 or Chapter 563 of the Occupations Code.
(6) Containment primary
engineering control--A ventilated device designed and operated to minimize
worker and environmental exposures to airborne contaminants through the full or
partial enclosure of a potential contaminant source, the use of airflow capture
velocities to trap and remove airborne contaminants near their point of
generation, the use of air pressure relationships that define the direction of
airflow into the cabinet, and the use of high-efficiency particulate air (HEPA)
filtration on all potentially contaminated exhaust streams. Examples of
containment primary engineering control include containment ventilated
enclosures, biological safety cabinets, and compounding aseptic containment
isolators.
(7) Controlled room
temperature--The temperature maintained thermostatically that encompasses the
usual and customary working environment of 20 - 25 degrees C (68 - 77 degrees
F).
(8) Designated person(s)--One
or more individuals assigned by the pharmacist-in-charge or the
pharmacist-in-charge's designee to be responsible and accountable for the
performance and operation of the facility and personnel as related to the
preparation of compounded non-sterile preparations.
(9) Hot water--The temperature of water from
the pharmacy's sink maintained at a minimum of 41 degrees C (105 degrees
F).
(10) Reasonable quantity--An
amount of a compounded drug that:
(A) does not
exceed the amount a practitioner anticipates may be used in the practitioner's
office or facility before the beyond use 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.
(11)
Refrigerator--A cold place in which the temperature is controlled between 2 - 8
degrees C (36 - 46 degrees F).
(12)
Sanitizing--A process for reducing on inanimate surfaces the number of all
forms of microbial life including fungi, viruses, and bacteria using an
appropriate agent.
(13)
SOPs--Standard operating procedures.
(14) USP/NF--The current edition of the
United States Pharmacopeia/National Formulary.
(15) Water activity--A measure of the
fraction of total water that is unbound and freely available to participate in
chemical, biochemical, or physiochemical reactions or provide an environment
that can support microbial growth.
(c) Personnel. All personnel who compound or
have direct oversight of compounding non-sterile preparations shall be
initially trained and qualified by demonstrating knowledge and competency in
the areas outlined in paragraph (5)(C) of this subsection.
(1) Pharmacist-in-charge. In addition to the
responsibilities for the specific class of pharmacy, the pharmacist-in-charge
shall have the responsibility for, at a minimum, the following concerning
non-sterile compounding:
(A) determining that
all personnel involved in non-sterile compounding possess the education,
training, and proficiency necessary to properly and safely perform compounding
duties undertaken or supervised;
(B) determining that all personnel involved
in non-sterile compounding obtain continuing education appropriate for the type
of compounding done by the personnel;
(C) assuring that the equipment used in
compounding is properly maintained;
(D) maintaining an appropriate environment in
areas where non-sterile compounding occurs; and
(E) assuring that effective quality control
procedures are developed and followed.
(2) Designated person(s). The
pharmacist-in-charge or the pharmacist-in-charge's designee shall designate one
or more individuals to be responsible and accountable for the performance and
operation of the facility and personnel for the preparation of compounded
non-sterile preparations. The designated person(s) shall be identified in the
facility's SOPs. If the compounding facility has only one person responsible
for all compounding in the facility, then that person is the designated
person.
(3) Pharmacists. Special
requirements for non-sterile compounding.
(A)
All pharmacists engaged in compounding shall:
(i) possess the education, training, and
proficiency necessary to properly and safely perform compounding duties
undertaken or supervised; and
(ii)
obtain continuing education appropriate for the type of compounding undertaken
or supervised by the pharmacist.
(B) A pharmacist shall inspect and approve
all components, including consideration of all physical and chemical properties
of the components, drug product containers, closures, labeling, and any other
materials involved in the compounding process.
(C) A pharmacist shall review all compounding
records for accuracy and conduct in-process and final checks to ensure that
errors have not occurred in the compounding process.
(D) A pharmacist is responsible for the
proper maintenance, cleanliness, and use of all equipment used in the
compounding process.
(4)
Pharmacy technicians and pharmacy technician trainees. All pharmacy technicians
and pharmacy technician trainees engaged in non-sterile compounding shall:
(A) possess the education, training, and
proficiency necessary to properly and safely perform compounding duties
undertaken;
(B) obtain continuing
education appropriate for the type of compounding done by the pharmacy
technician or pharmacy technician trainee; and
(C) perform compounding duties under the
direct supervision of and responsible to a pharmacist.
(5) Training.
(A) All training activities shall be
documented and covered by appropriate SOPs as outlined in subsection (d)(8)(A)
of this section.
(B) All personnel
involved in non-sterile compounding shall be well trained and must participate
in continuing relevant training programs.
(C) Training shall include instruction,
experience, and demonstrated proficiency in the following areas:
(i) hand hygiene;
(ii) garbing;
(iii) cleaning and sanitizing;
(iv) handling and transporting components and
compounded non-sterile preparations;
(v) measuring and mixing;
(vi) proper use of equipment and devices
selected to compound non-sterile preparations; and
(vii) documentation of the compounding
process (e.g., Master Formulation Records and Compounding Records).
(d)
Operational Standards.
(1) General
requirements.
(A) Non-sterile drug
preparations may be compounded in licensed pharmacies:
(i) upon presentation of a practitioner's
prescription drug or medication order based on a valid
pharmacist/patient/prescriber relationship;
(ii) in anticipation of future prescription
drug or medication orders based on routine, regularly observed prescribing
patterns; or
(iii) in reasonable
quantities for office use by a practitioner and for use by a
veterinarian.
(B)
Non-sterile compounding in anticipation of future prescription drug or
medication orders must be based upon a history of receiving valid prescriptions
issued within an established pharmacist/patient/prescriber relationship,
provided that in the pharmacist's professional judgment the quantity prepared
is stable for the anticipated shelf time.
(i)
The pharmacist's professional judgment shall be based on the criteria used to
determine a beyond-use date outlined in paragraph (5)(C) of this
subsection.
(ii) Documentation of
the criteria used to determine the stability for the anticipated shelf time
must be maintained and be available for inspection.
(iii) Any preparation compounded in
anticipation of future prescription drug or medication orders shall be labeled.
Such label shall contain:
(I) name and
strength of the compounded preparation or list of the active ingredients and
strengths;
(II) facility's lot
number;
(III) beyond-use date as
determined by the pharmacist using appropriate documented criteria as outlined
in paragraph (5)(C) of this subsection; and
(IV) quantity or amount in the
container.
(C)
Commercially available products may be compounded for dispensing to individual
patients provided the following conditions are met:
(i) the commercial product is not reasonably
available from normal distribution channels in a timely manner to meet
patient's needs;
(ii) the pharmacy
maintains documentation that the product is not reasonably available due to a
drug shortage or unavailability from the manufacturer; and
(iii) the prescribing practitioner has
requested that the drug be compounded as described in subparagraph (D) of this
paragraph.
(D) A pharmacy
may not compound preparations that are essentially copies of commercially
available products (e.g., the preparation is dispensed in a strength that is
only slightly different from a commercially available product) unless the
prescribing practitioner specifically orders the strength or dosage form and
specifies why the patient needs the particular strength or dosage form of the
preparation. The prescribing practitioner shall provide documentation of a
patient specific medical need and the preparation produces a clinically
significant therapeutic response (e.g., the physician requests an alternate
product due to hypersensitivity to excipients or preservative in the
FDA-approved product, or the physician requests an effective alternate dosage
form) or if the drug product is not commercially available. The unavailability
of such drug product must be documented prior to compounding. The methodology
for documenting unavailability includes maintaining a copy of the wholesaler's
notification showing back-ordered, discontinued, or out-of-stock items. This
documentation must be available in hard-copy or electronic format for
inspection by the board.
(E) A
pharmacy may enter into an agreement to compound and dispense
prescription/medication orders for another pharmacy provided the pharmacy
complies with the provisions of §
291.125 of this title (relating to
Centralized Prescription Dispensing).
(F) Compounding pharmacies/pharmacists may
advertise and promote the fact that they provide non-sterile prescription
compounding services, which may include specific drug products and classes of
drugs.
(G) A pharmacy may not
compound veterinary preparations for use in food producing animals except in
accordance with federal guidelines.
(H) A pharmacist may add flavoring to a
prescription at the request of a patient, the patient's agent, or the
prescriber. The pharmacist shall label the flavored prescription with a
beyond-use-date that shall be no longer than fourteen days if stored in a
refrigerator unless otherwise documented. Documentation of beyond-use-dates
longer than fourteen days shall be maintained by the pharmacy electronically or
manually and made available to agents of the board on request. A pharmacist may
not add flavoring to an over-the-counter product at the request of a patient or
patient's agent unless the pharmacist obtains a prescription for the
over-the-counter product from the patient's practitioner.
(2) Library. In addition to the library
requirements of the pharmacy's specific license classification, a pharmacy
shall maintain a current copy, in hard-copy or electronic format, of Chapter
795 of the USP/NF concerning Pharmacy Compounding Non-Sterile
Preparations.
(3) Environment.
(A) Pharmacies engaging in compounding shall
have a designated and adequate area for the safe and orderly compounding of
non-sterile preparations, including the placement of equipment and
materials.
(B) Only personnel
authorized by the responsible pharmacist shall be in the immediate vicinity of
a drug compounding operation.
(C) A
sink with hot and cold running water, exclusive of rest room facilities, shall
be accessible to the compounding areas and be maintained in a sanitary
condition. Supplies necessary for adequate washing shall be accessible in the
immediate area of the sink and include:
(i)
soap or detergent; and
(ii)
air-driers or single-use towels.
(D) Appropriate measures shall be used to
prevent cross-contamination between compounding non-sterile preparations,
including dedication of equipment for such operations or the meticulous
cleaning of contaminated equipment prior to its use for the preparation of
subsequent compounds.
(E) Cleaning
and sanitizing of surfaces in the non-sterile compounding area(s) shall occur
on a regular basis as defined in appropriate SOPs as outlined in paragraph
(8)(A) of this subsection.
(4) Equipment and Supplies.
(A) If the pharmacy engages in compounding
non-sterile preparations that require weighing a component of the preparation,
the pharmacy shall have a Class A prescription balance, or analytical balance
and weights which shall be calibrated and have the accuracy of the balance
verified by the pharmacy at least every 12 months as specified in the
pharmacy's SOPs. The pharmacy shall document the calibration and
verification.
(B) The pharmacy
shall have equipment and utensils necessary for the proper compounding of
prescription drug or medication orders. Such equipment and utensils used in the
compounding process shall be:
(i) of
appropriate design and capacity, and be operated within designed operational
limits;
(ii) of suitable
composition so that surfaces that contact components, in-process material, or
drug products shall not be reactive, additive, or absorptive so as to alter the
safety, identity, strength, quality, or purity of the drug product beyond the
desired result;
(iii) cleaned and
sanitized immediately prior to and after each use; and
(iv) routinely inspected, calibrated (if
necessary), or checked to ensure proper performance.
(C) Weighing, measuring, or otherwise
manipulating components that could generate airborne chemical particles (e.g.,
active pharmaceutical ingredients, added substances, and conventionally
manufactured products) shall be evaluated to determine if these activities must
be performed in a containment primary engineering control to reduce the
potential exposure to personnel or contamination of the facility or compounded
non-sterile preparations. The process evaluation shall be carried out in
accordance with the facility's SOPs, and the assessment shall be
documented.
(D) If a containment
ventilated enclosure or biological safety cabinet is used, it shall be
certified at least every 12 months or according to manufacturer
specifications.
(5)
Labeling. In addition to the labeling requirements of the pharmacy's specific
license classification, the label dispensed or distributed pursuant to a
prescription drug or medication order shall contain the following.
(A) The generic name(s) or the official
name(s) of the principal active ingredient(s) of the compounded
preparation.
(B) A statement that
the preparation has been compounded by the pharmacy. (An auxiliary label may be
used on the container to meet this requirement).
(C) A beyond-use date after which the
compounded preparation should not be used. The beyond-use date shall be
determined as outlined in Chapter 795 of the USP/NF concerning Pharmacy
Compounding Non-Sterile Preparations including the following:
(i) The pharmacist shall consider:
(I) physical and chemical properties of
active ingredients;
(II) use of
preservatives and/or stabilizing agents;
(III) dosage form;
(IV) storage containers and conditions;
and
(V) scientific, laboratory, or
reference data from a peer reviewed source and retained in the pharmacy. The
reference data should follow the same preparation instructions for combining
components and packaged in a container with similar properties.
(ii) In the absence of stability
information applicable for a specific drug or preparation, the following
maximum beyond-use dates are to be used when the compounded preparation is
packaged in tight, light-resistant containers.
(I) Aqueous dosage forms. An aqueous
preparation is one that has a water activity equal to or greater than 0.6
(e.g., emulsions, gels, creams, solutions, sprays, or suspensions).
(-a-) Nonpreserved aqueous dosage forms: Not
later than 14 days when stored in a refrigerator.
(-b-) Preserved aqueous dosage forms: Not
later than 35 days when stored at controlled room temperature or in a
refrigerator.
(II)
Nonaqueous dosage forms. A nonaqueous dosage form is one that has a water
activity less than 0.6.
(-a-) Nonaqueous oral
liquids: Not later than 90 days when stored at controlled room temperature or
in a refrigerator.
(-b-) Other
nonaqueous dosage forms: Not later than 180 days when stored at controlled room
temperature or refrigerator. Other nonaqueous dosage forms that have a water
activity of less than 0.6 (e.g., capsules, tablets, granules, powders,
nonaqueous topicals, suppositories, and troches or lozenges).
(iii) Compounded
non-sterile preparations requiring shorter beyond-use dates. The beyond-use
dates in subclauses (I) and (II) of clause (ii) are the beyond-use dates for
compounded nonsterile preparations in the absence of specific stability
information. However, the designated person(s) shall still perform due
diligence to determine if there is existing stability data that would require a
shorter beyond-use date.
(I) The beyond-use
date of the compounded non-sterile preparation shall not exceed the shortest
remaining expiration date of any of the commercially available starting
components.
(II) For compounded
non-sterile preparations prepared from one or more compounded components, the
beyond-use date generally shall not exceed the shortest beyond-use date of any
of the individual compounded components. However, there may be acceptable
instances when the beyond-use date of the final compounded non-sterile
preparation exceeds the beyond-use date assigned to compounded components
(e.g., pH-altering solutions). If the assigned beyond-use date of the final
compounded non-sterile preparation exceeds the beyond-use date of the
compounded components, the physical, chemical, and microbiological quality of
the final compounded non-sterile preparation shall not be negatively
impacted.
(iv) Extending
beyond-use dates for compounded non-sterile preparations. Beyond-use date
limits may be exceeded when supported by valid scientific stability information
for the specific compounded preparation.
(I)
Compounded non-sterile preparations with a USP/NF monograph. When compounding
from a USP/NF compounded preparation monograph for the compounded non-sterile
preparation, the beyond-use date shall not exceed the beyond-use date specified
in the monograph.
(II) Compounded
non-sterile preparations with stability information. If there is a stability
study using a stability-indicating analytical method for the active
pharmaceutical ingredient(s), compounded non-sterile preparation formulation,
and material of composition of the container closure that will be used, then
the beyond-use date indicated by the study may be used in lieu of the
beyond-use date specified in subclauses (I) and (II) of clause (ii) for aqueous
and nonaqueous dosage forms, up to a maximum of 180 days.
(III) If the beyond-use date of the
compounded non-sterile preparation is extended beyond the beyond-use date
specified in subclauses (I) and (II) of clause (ii), an aqueous compounded
non-sterile preparation must pass antimicrobial effectiveness testing.
(-a-) The designated person(s) may rely on
antimicrobial effectiveness testing that is conducted, or contracted for, once
for each formulation in the particular container closure system, including
materials of composition or the container closure system, in which it will be
packaged.
(-b-) Alternatively, the
designated person(s) may rely on antimicrobial effectiveness testing results
provided by an FDA-registered facility or published in peer-reviewed literature
as long as the compounded non-sterile preparation formulation, including any
preservative, and container closure materials of composition are the same as
those tested, unless a bracketing study is performed.
(-c-) When a bracketing study is performed,
antimicrobial effectiveness testing may be performed on a low concentration and
on a high concentration of the active ingredient in the formulation to
establish preservative effectiveness across various strengths of the same
formulation (e.g., bracketing). The concentration of all other ingredients,
including preservatives, must fall within the bracketed range.
(6)
Written drug information. Written information about the compounded preparation
or its major active ingredient(s) shall be given to the patient at the time of
dispensing. A statement which indicates that the preparation was compounded by
the pharmacy must be included in this written information. If there is no
written information available, the patient should be advised that the drug has
been compounded and how to contact a pharmacist, and if appropriate the
prescriber, concerning the drug.
(7) Drugs, components, and materials used in
non-sterile compounding.
(A) Drugs used in
non-sterile compounding shall be USP/NF grade substances manufactured in an
FDA-registered facility.
(B) If
USP/NF grade substances are not available, or when food, cosmetics, or other
substances are or must be used, the substance shall be of a chemical grade in
one of the following categories:
(i)
Chemically Pure (CP);
(ii)
Analytical Reagent (AR); or
(iii)
American Chemical Society (ACS); or
(iv) Food Chemical Codex; or
(C) If a drug, component, or
material is not purchased from an FDA-registered facility, the pharmacist shall
establish purity and stability by obtaining a Certificate of Analysis from the
supplier and the pharmacist shall compare the monograph of drugs in a similar
class to the Certificate of Analysis.
(D) A manufactured drug product may be a
source of active ingredient. Only manufactured drugs from containers labeled
with a batch control number and a future expiration date are acceptable as a
potential source of active ingredients. When compounding with manufactured drug
products, the pharmacist must consider all ingredients present in the drug
product relative to the intended use of the compounded preparation.
(E) All components shall be stored in
properly labeled containers in a clean, dry area, under proper
temperatures.
(F) Drug product
containers and closures shall not be reactive, additive, or absorptive so as to
alter the safety, identity, strength, quality, or purity of the compounded drug
product beyond the desired result.
(G) Components, drug product containers, and
closures shall be rotated so that the oldest stock is used first.
(H) Container closure systems shall provide
adequate protection against foreseeable external factors in storage and use
that can cause deterioration or contamination of the compounded drug
product.
(I) A pharmacy may not
compound a preparation that contains ingredients appearing on a federal Food
and Drug Administration list of drug products withdrawn or removed from the
market for safety reasons.
(8) Compounding process.
(A) All significant procedures performed in
the compounding area shall be covered by written SOPs designed to ensure
accountability, accuracy, quality, safety, and uniformity in the compounding
process. At a minimum, SOPs shall be developed for:
(i) the facility;
(ii) equipment;
(iii) personnel;
(iv) preparation evaluation;
(v) quality assurance;
(vi) preparation recall;
(vii) packaging;
(viii) storage of compounded
preparations;
(ix) hand hygiene and
garbing; and
(x) cleaning and
sanitizing.
(B) Any
compounded preparation with an official monograph in the USP/NF shall be
compounded, labeled, and packaged in conformity with the USP/NF monograph for
the drug.
(C) Any person with a
communicable illness or open lesion that may adversely affect the safety or
quality of a drug product being compounded shall report these conditions to the
designated person(s). The designated person(s) shall determine whether the
person must be excluded from compounding areas until the person's conditions
have resolved.
(D) Personnel
engaged in the compounding of drug preparations shall perform proper hand
hygiene prior to engaging in compounding activities. Proper hand hygiene shall
be defined in appropriate SOPs as outlined in subparagraph (A) of this
paragraph and appropriate for prevention of preparation and facility
contamination.
(E) Garbing
requirements and the frequency of changing garb shall be determined by the
pharmacy and documented in appropriate SOPs as outlined in subparagraph (A) of
this paragraph. The garbing requirements under the pharmacy's SOPs must be
appropriate for the type of compounding performed. Gloves shall be worn for the
prevention of preparation and facility contamination.
(F) At each step of the compounding process,
the pharmacist shall ensure that components used in compounding are accurately
weighed, measured, or subdivided as appropriate to conform to the formula being
prepared.
(9) Quality
Assurance.
(A) Initial formula validation.
Prior to routine compounding of a non-sterile preparation, a pharmacy shall
conduct an evaluation that shows that the pharmacy is capable of compounding a
product that contains the stated amount of active ingredient(s).
(B) Finished preparation checks. The
prescription drug and medication orders, written compounding procedure,
preparation records, and expended materials used to make compounded non-sterile
preparations shall be inspected for accuracy of correct identities and amounts
of ingredients, packaging, labeling, and expected physical appearance and
properties before the non-sterile preparations are dispensed.
(10) Quality Control.
(A) The pharmacy shall follow established
quality control procedures to monitor the quality of compounded drug
preparations for uniformity and consistency such as capsule weight variations,
adequacy of mixing, clarity, or pH of solutions. When developing these
procedures, pharmacy personnel shall consider the provisions of Chapter 795,
concerning Pharmacy Compounding Non-Sterile Preparations, Chapter 1075,
concerning Good Compounding Practices, and Chapter 1160, concerning
Pharmaceutical Calculations in Prescription Compounding contained in the
current USP/NF. Such procedures shall be documented and be available for
inspection.
(B) Compounding
procedures that are routinely performed, including batch compounding, shall be
completed and verified according to written procedures. The act of verification
of a compounding procedure involves checking to ensure that calculations,
weighing and measuring, order of mixing, and compounding techniques were
appropriate and accurately performed.
(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.
(C) 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.
(2) Master Formulation Record and
Compounding Record.
(A) Master Formulation
Record. A master formulation record shall be developed and approved by a
pharmacist for all compounded preparations. Once approved, a duplicate of the
master formulation record shall be used as the compound record each time the
compound is prepared and on which all documentation for that compound occurs.
The master formulation record shall contain at a minimum:
(i) the formula;
(ii) the components;
(iii) the compounding directions;
(iv) evaluation and testing
requirements;
(v) specific
equipment used during preparation;
(vi) storage requirements;
(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, including, but not limited to, expected physical appearance
of the final product.
(B) Compounding Record. The record for each
preparation shall document the following:
(i)
identity of all components and their corresponding amounts, concentrations, or
volumes;
(ii) lot number and
expiration date of each component;
(iii) component manufacturer/distributor or
suitable identifying number;
(iv)
container specifications;
(v)
unique lot or control number;
(vi)
beyond use date;
(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.
(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 non-sterile compounded preparations
ordered by a practitioner for office use or by a Class C 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 Class C pharmacy ordering the preparation;
and
(iii) name, strength, and
quantity of the preparation ordered.
(C) Distributions. The pharmacy shall
maintain a record of all non-sterile compounded preparations distributed
pursuant to an order to a practitioner for office use or by a Class C 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 Class C pharmacy to whom the preparation is
distributed.
(D) Audit
Trail.
(i) The pharmacy shall store the order
and distribution records of preparations for all non-sterile compounded
preparations ordered by and or distributed to a practitioner for office use or
by a Class C pharmacy 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 Class C 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 non-sterile preparations 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 non-sterile preparation compounded by the pharmacy upon
identification of a potential or confirmed harm to a patient.
(3) In the event of a recall, the
pharmacist-in-charge shall ensure that:
(A)
each practitioner, facility, and/or pharmacy to which the preparation was
distributed is notified, in writing, of the recall;
(B) each patient to whom the preparation was
dispensed is notified, in writing, of the recall;
(C) if the preparation is prepared as a
batch, the board is notified of the recall, in writing;
(D) if the preparation is distributed for
office use, the Texas Department of State Health Services, Drugs and Medical
Devices Group, is notified of the recall, in writing;
(E) the preparation is quarantined;
and
(F) the pharmacy keeps a
written record of the recall including all actions taken to notify all parties
and steps taken to ensure corrective measures.
(4) If a pharmacy fails to initiate a recall,
the board may require a pharmacy to initiate a recall if there is potential for
or confirmed harm to a patient.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.