TITLE 16 OCCUPATIONAL
AND PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 36 COMPOUNDED
STERILE PREPARATIONS
16.19.36.1 ISSUING AGENCY: Regulation and Licensing Department - Board of Pharmacy.
[16.19.36.1 NMAC - N, 06-28-14]
16.19.36.2 SCOPE: All facilities as defined in Paragraph (1),
(2), (5) through (11) and (15) of Subsection B of 61-11-14 NMSA 1978, and all
persons or entities that own or operate, or are employed by a facility for the
purpose of providing pharmaceutical compounded sterile preparations or
services.
[16.19.36.2 NMAC - N, 06-28-14; A, 03-22-15]
16.19.36.3 STATUTORY AUTHORITY: Paragraph
(6) of Subsection A of Section 61-11-6 NMSA 1978 authorizes the board of
pharmacy to provide for the licensing of all places where dangerous drugs are
stored, dispensed, distributed or administered and for the inspection of their
facilities and activities. Paragraph (7)
of Subsection A of 61-11-6 NMSA 1978 authorizes the board to enforce the
provisions of all laws of the state pertaining to the practice of pharmacy and
the manufacture, production, sale or distribution of drugs and their standards
of strength and purity.
[16.19.36.3 NMAC - N, 06-28-14]
16.19.36.4 DURATION: Permanent.
[16.19.36.4 NMAC - N, 06-28-14]
16.19.36.5 EFFECTIVE DATE: June 28, 2014, unless a different date is
cited at the end of a section.
[16.19.36.5 NMAC - N, 06-28-14]
16.19.36.6 OBJECTIVE: The objective of Part 36 of Chapter 19 is
to establish standards to ensure that the citizens of New Mexico receive
properly compounded contaminant-free sterile preparations properly compounded
in accordance with all applicable USP/NF General Chapters numbered below 1000.
[16.19.36.6 NMAC - N, 6-28-14; A, 03-22-15]
16.19.36.7 DEFINITIONS:
A. “Air
changes per hour” (ACPH) means the number of times a volume of
air equivalent to the room passes through the room each hour.
B. “Anteroom” means an ISO Class 8 or cleaner area where personnel hand hygiene and garbing procedures, staging of
components, order entry, CSP labeling, and other high-particulate generating
activities are performed. It is also a
transition area that:
(1) provides assurance
that pressure relationships are constantly maintained so that air flows from
clean to dirty areas; and
(2) contains a line
of demarcation which is a visible line on the floor that separates the clean
and dirty sides of the anteroom.
C. “Aseptic processing” A method by which separate, sterile components (e.g., drugs, containers, or closures) are brought together under conditions that maintain their sterility. The components can either be purchased as sterile or, when starting with nonsterile components, can be separately sterilized prior to combining (e.g., by membrane filtration or by autoclave).
D. “Aseptic technique” means proper
manipulation of preparations to maintain sterility.
E. “Batch”
More than one CSP prepared as described in the MFR in a single,
discrete process, and expected to have uniform character and quality, within
specified limits.
F. “Beyond-use
date” (BUD) means the date,
or as appropriate, date and time, after which a compounded preparation is not
to be used and is determined from the date and time the preparation is
compounded.
G. “Biological
safety cabinet” (BSC) A
ventilated cabinet that may be used for compounding. These cabinets are divided
into three general classes (Class I, Class II, and Class III). Class II BSCs
are further divided into types (Type A1, Type A2, Type B1, Type B2, and Type
C1).
H. “Biological safety cabinet (BSC),
Class II” A ventilated cabinet with an open front and inward and downward
unidirectional HEPA-filtered airflow and HEPA-filtered exhaust. A BSC used to
prepare a CSP must be capable of providing an ISO Class 5 or better environment
for preparation of the CSPs.
I. “Buffer room” An ISO Class 7 or cleaner
room with fixed walls and doors where PEC(s) that generate and maintain an ISO
Class 5 environment are physically located. The buffer room may only be
accessed through the anteroom or another buffer room.
J. “Category 1 CSP” A CSP that
is assigned a BUD of 12 h or less at controlled room temperature or 24 h or
less refrigerated that is compounded in accordance with all applicable
requirements for Category 1 CSPs in USP/NF <797>.
K. “Category 2 CSP” A CSP that
may be assigned a BUD of greater than 12 h at controlled room temperature or
greater than 24 h refrigerated that is compounded in accordance with all
applicable requirements for Category 2 CSPs in USP/NF <797>.
L. “Category 3 CSP” A CSP that
may be assigned a BUD exceeding the limits in for Category 2 CSPs and is
compounded in accordance with all applicable requirements for Category 3 CSPs
in USP/NF <797>.
M. “Certification” means independent third party documentation
declaring that the specific requirements of USP/NF <797> (USP General Chapters: <797>
Pharmaceutical Compounding-Sterile Preparations) have been met.
N. “Cleaning” The process of
removing substances (e.g., organic and inorganic material) from objects and
surfaces, normally accomplished by manually or mechanically using water with
detergents or enzymatic products.
O. “Cleaning agent” An agent,
usually containing a surfactant, used for the removal of substances (e.g.,
dirt, debris, microbes, and residual drugs or chemicals) from surfaces.
P. “Cleanroom suite” A
classified area that consists of both an anteroom and buffer room.
Q. “Closed system vial-transfer device” means a vial-transfer system that allows no
venting or exposure of substances to the environment.
R. “Component” Any ingredient
used in the compounding of a preparation, including any active ingredient,
added substance, or conventionally manufactured product.
S. “Compounded
sterile preparations” (CSP’s)
include, but are not limited, to the following dosage forms which must be
sterile when administered to patients:
(1) parenteral
preparations;
(2) aqueous
bronchial and nasal inhalations;
(3) baths
and soaks for live organs and tissues;
(4) injections
(e.g. colloidal dispersions, emulsions,
solutions, suspensions);
(5) irrigations for wounds and
internal body cavities;
(6) ophthalmic
drops and ointments; and
(7) implants.
T. “Compounding
aseptic containment isolator”
(CACI) A type of RABS that uses HEPA filtration to provide
an ISO Class 5 unidirectional air environment designed for the compounding of
sterile HDs.
U. “Compounding
aseptic isolator” (CAI) A
type of RABS that uses HEPA filtration to provide an ISO Class 5 unidirectional
air environment designed for compounding of sterile non-HDs.
V. “Compounding record” (CR)
Documents the compounding of each CSP.
W. “Container closure system”
Packaging components that together contain and protect the dosage form. This
includes primary packaging components and secondary packaging components, if
the latter are intended to provide additional protection.
X. “Containment ventilated
enclosure” (CVE) A non-ISO classified full or partial enclosure that uses
ventilation principles to capture, contain, and remove airborne contaminants
through HEPA filtration and prevent their release into the work environment.
Y. “Critical area” means an ISO Class five
environment.
Z. “Critical site” means a location that includes any component or fluid
pathway surfaces (e.g., vial septa, injection ports, beakers) or openings
(e.g., opened ampules, needle hubs) exposed and at risk of direct contact with
air (e.g., ambient room or HEPA filtered), moisture (e.g., oral and mucosal
secretions), or touch contamination.
AA. “Designated person” Individual
assigned to be responsible and accountable for the performance and operation of
the facility and personnel as related to the preparation of CSPs. For pharmacies the designated person must be
the pharmacist-in-charge. For clinic
facilities the designated person must be the consultant pharmacist.
BB. “Direct compounding area” (DCA) means
a critical area within the ISO Class five primary engineering control (PEC)
where critical sites are exposed to unidirectional HEPA-filtered air, also
known as first air.
CC. “Disinfectant” A chemical
or physical agent used on inanimate surfaces and objects to destroy fungi,
viruses, and bacteria. Sporicidal
disinfectants are considered a special class of disinfectants that also are
effective against bacterial and fungal spores.
DD. “Dynamic airflow smoke pattern test”
A PEC test in which a visible source of smoke, which is neutrally buoyant, is
used to observe air patterns within the unidirectional space (i.e., the DCA)
under dynamic operating conditions (see the entry for Dynamic operating
conditions). This test is not appropriate for ISO Class 7 or ISO Class 8
cleanrooms that do not have unidirectional airflow (see the entry for Visual
smoke study).
EE. “Dynamic operating conditions”
Conditions in the compounding area in which operating personnel are present and
simulating or performing compounding.
The conditions should reflect the largest number of personnel and
highest complexity of compounding expected during routine operations as
determined by the designated person(s).
FF. “Garb” Items such as gloves,
garments (e.g., gowns), shoe covers, head and facial hair covers, masks, and
other items designed to reduce particle-shedding from personnel and minimize
the risk of contamination of CSP(s).
GG. “Hazardous drug” (HD) Any drug identified
by at least one of the following six criteria: carcinogenicity, teratogenicity
or developmental toxicity, reproductive toxicity in humans, organ toxicity at
low dose in humans or animals, genotoxicity, or new drugs that mimic existing
HDs in structure or toxicity. (Reference current NIOSH publications).
HH. “High-efficiency particulate air
(HEPA) filtration” Being, using, or containing a filter designed to remove
ninety-nine and ninety-seven one-hundredths percent of airborne particles
measuring zero and three-micron or greater in diameter passing through it.
II. “Home care” means health care provided in the patient’s
home (not a hospital or skilled nursing facility) by either licensed health
professionals or trained caregivers. May
include hospice care.
JJ. “Integrated vertical laminar flow
zone” (IVLFZ) A designated ISO Class 5 area serving as the PEC within an
ISO Class 7 or cleaner buffer room. In the IVLFZ, unidirectional airflow is
created by placing HEPA filters over the entire surface of the worktables and
by effective placement of air returns.
KK. “ISO class” An air-quality
classification from the International Organization for Standardization.
LL. “Laminar airflow” means a non-turbulent, non-mixing
streamline flow of air in parallel layers.
MM. “Laminar airflow system” (LAFS) A
device or zone within a buffer room that provides an ISO Class 5 or better air
quality environment for sterile compounding. The system provides a
unidirectional HEPA filtered airflow.
NN. “Laminar airflow workbench” (LAFW) A
device that is a type of LAFS that provides an ISO Class 5 or better air
quality environment for sterile compounding. The device provides a
unidirectional HEPA-filtered airflow.
OO. “Line of demarcation” A visible
line on the floor that separates the clean and dirty sides of the anteroom.
PP. “Master formulation record”
(MFR) A detailed record of procedures that describes how the CSP is to be
prepared.
QQ. “Media-fill
test” A simulation used to qualify processes and personnel engaged
in sterile compounding to ensure that the processes and personnel are able to prepare CSPs without contamination.
RR. “Multiple-dose container” means a multiple-unit container for articles
or preparations intended for parenteral administration only and usually
containing antimicrobial preservatives.
Once opened or entered, a multiple dose container with antimicrobial
preservative has a BUD of 28 days unless otherwise specified by the
manufacturer.
SS. “Negative pressure room” means a
room that is at a lower pressure than the adjacent spaces and therefore, the
net flow of air is into the room.
TT. “One-step disinfectant cleaner”
A product with an EPA-registered (or equivalent) claim that it can clean and
disinfect a nonporous surface in the presence of light to moderate organic
soiling without a separate cleaning step.
UU. “Parenteral
product” means any preparation administered by injection through one or
more layers of skin tissue.
VV. “Pass-through chamber” An
enclosure with sealed doors on both sides that should be interlocked. The
pass-through chamber is positioned between two spaces for the purpose of
minimizing particulate transfer while moving materials from one space to
another.
WW. “Personal protective equipment” (PPE) means
items such as gloves,
gowns, respirators, goggles, face shields, and others that protect individual
workers from hazardous physical or chemical exposures.
XX. “Pharmacy bulk packages” means a container of a sterile preparation
for parenteral use that contains many single doses. Contents are intended for use in a pharmacy
admixture program and are restricted to use in a suitable ISO Class 5
environment.
YY. “Plan of care” means an individualized care plan for
each patient receiving parenteral products in a home setting to include the
following:
(1) description of actual
or potential drug therapy problems and their proposed solutions;
(2) a description of
desired outcomes of drug therapy provided;
(3) a proposal for patient
education and counseling; and
(4) a plan specifying
proactive objective and subjective monitoring (e.g. vital signs, laboratory
test, physical findings, patient response, toxicity, adverse reactions, and
noncompliance) and the frequency with which monitoring is to occur.
ZZ. “Positive
pressure room” means a
room that is at a higher pressure than the adjacent spaces and, therefore, the
net airflow is out of the
room.
AAA. “Primary
engineering control” (PEC) A device or zone that provides
an ISO Class five air quality environment for sterile compounding.
BBB. “Process
validation” means
documented evidence providing a high degree of assurance that a specific
process will consistently produce a preparation meeting its predetermined
specifications and quality attributes.
CCC. “Product”
means a commercially
manufactured drug or nutrient that has been evaluated for safety and efficacy
by the FDA. Products are accompanied by
full prescribing information, which is commonly known as the FDA-approved
manufacturer’s labeling or product package insert.
DDD. “Quality
assurance” means a program for
the systematic monitoring and evaluation of the various aspects of a service or
facility to ensure that standards of quality are being met.
EEE. “Quality
control” means a system for
verifying and maintaining a desired level of quality in a preparations or
process, as by planning, continued inspection, and corrective action as
required.
FFF. “Reconstitution”
The process of adding a diluent to a conventionally manufactured product to
prepare a sterile solution or suspension.
GGG. “Repackaging”
The act of removing a sterile product or preparation from its original primary
container and placing it into another primary container, usually of smaller
size without further manipulation.
HHH. “Restricted-access
barrier system” (RABS) An enclosure that provides HEPA-filtered ISO Class five
unidirectional air that allows for the ingress and/or egress of materials
through defined openings that have been designed and validated to preclude the
transfer of contamination, and that generally are not to be opened during
operations. Examples of RABS include CAIs and CACIs.
III. “Secondary
engineering control” The area where the PEC is placed (e.g., a
cleanroom suite or an SCA). It incorporates specific design and operational
parameters required to minimize the risk of contamination within the
compounding area.
JJJ. “Segregated
compounding area” A designated space, area, or room that is not
required to be classified and is defined with a visible perimeter. The SCA must
contain a PEC and is suitable for preparation of Category 1 CSPs only.
KKK. “Single-dose container” means a single-dose, or a single-unit,
container for articles or preparations intended for parenteral administration
only. It is intended for a single
use. Examples of single-dose containers
include prefilled syringes, cartridges, fusion-sealed containers, and
closure-sealed containers when so labeled.
LLL. “Sporicidal disinfectant” A
chemical or physical agent that destroys bacterial and fungal spores when used
in sufficient concentration for a specified contact time. It is expected to
kill all vegetative microorganisms.
MMM. “Stability”
The extent to which a product or preparation retains physical and chemical
properties and characteristics within specified limits throughout its
expiration or BUD.
NNN. “Standard
operating procedure” (SOP) means a written protocol
detailing the required standards for performance of tasks and
operations within a facility.
OOO. “Sterile Compounding” The process of
combining, admixing, diluting, pooling, reconstituting, repackaging, or
otherwise altering a drug product or bulk drug substance to create a sterile
preparation.
PPP. “Sterility” The absence of viable
microorganisms.
QQQ. “Sterilization
by filtration” means
passage of a fluid or solution through a sterilizing grade membrane to produce
a sterile effluent.
RRR. “Sterilizing
grade filter”
means filter membranes that are documented
to retain one hundred percent of a culture of 107 microorganisms of
a strain of Brevundimonas (Pseudomonas) diminuta
per square centimeter of membrane surface under a pressure of not less than
30 psi. Such filter membranes are nominally at zero and twenty-two mm or zero
and two mm pore size.
SSS. “Terminal
sterilization” means the application of a lethal process (e.g., steam, dry heat, irradiation) to sealed containers for the purpose
of achieving a predetermined sterility assurance level of usually less than 10−6,
or a probability of less than one in one million of a non-sterile unit.
UUU. “Unidirectional
airflow” Air within a PEC
moving in a single direction in a uniform manner and at sufficient velocity to
sweep particles away from the DCA.
VVV. “USP”
means United States
pharmacopeia.
WWW. “Visual smoke study” A test, used in
ISO Class 7 and ISO Class 8 rooms that do not have unidirectional airflow, in
which a visible source of smoke, which is neutrally buoyant, is used to verify
an absence of stagnant airflow. This test does not need to be performed under
dynamic operating conditions and is not appropriate for PECs (see the entry for
Dynamic airflow smoke pattern test).
XXX. “Workflow management system” Technology
comprised of hardware and/or software that allows for automation to assist in
the verification of components of, and preparation of, CSPs and to document
components and processes.
[16.19.36.7 NMAC - N, 06-28-14; A, 03-22-15; A, 8/13/2024]
16.19.36.8 PHARMACIST IN CHARGE:
A. All facilities compounding sterile
preparations must designate a pharmacist in charge of operations who is
licensed as a pharmacist in the state of residence of the facility.
B. The
pharmacist-in-charge (or consultant
pharmacist, for in-state clinics)
is responsible for:
(1) the development, implementation and
continuing review and maintenance of written policies, procedures and SOP’s
which comply with USP/NF standards;
(2) providing a pharmacist
who is available for 24 hour seven-day-a-week services;
(3) establishing a system to
ensure that the CSP’s prepared by compounding personnel are administered by
licensed personnel or properly trained and instructed patients;
(4) establishing a system to ensure that CSP’s
prepared by compounding personnel are prepared in compliance with USP/NF
<797> (USP General Chapters: <797>
Pharmaceutical Compounding-Sterile Preparations) standards;
(5) ensuring facility
personnel comply with written policies, procedures, and SOP’s; and
(6) developing an appropriate
and individualized plan of care in collaboration with patient or caregiver and
other healthcare providers for each patient receiving parenteral preparations
in a home setting.
[16.19.36.8 NMAC - N, 06-28-14; A, 8/13/2024]
16.19.36.9 FACILITIES:
A. The room or area in which compounded sterile
preparations (CSP’s) are prepared:
(1) must be physically
designed and environmentally controlled to meet standards of compliance as
required by USP/NF <797> (USP
General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations);
(2) must be periodically
monitored, evaluated, tested, and certified by environmental sampling testing (includes
both viable and nonviable particle sampling) as required by USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile
Preparations) with documentation retained for three years;
(3) must have a minimum of
100 square feet dedicated to compounding sterile preparations;
(a) the minimum size of a retail pharmacy must be 240 square feet; a
retail pharmacy with preparation of sterile products capabilities must have 340
square feet with 100 square feet exclusive to compounding sterile preparations;
(b) the
stand alone CSP facility must have a minimum of 240 square feet with 100 square
feet exclusive to compounding sterile preparations; and
(4) must be clean,
lighted, and at an average of 80-150 foot candles; and
(5) must minimize particle generating activities; and
(6) must have a sink of sufficient size for compounding personnel to adequately wash hands and forearms up to the elbows with soap and water.
B. Addition of a compounding sterile preparations area in existing pharmacies will require submission of plans for remodeling to the board office for approval and inspection prior to licensure.
C. A
new CSP facility must comply with 16.19.6.8 NMAC through 16.19.6.11 NMAC of the
regulations.
[16.19.36.9 NMAC - N, 06-28-14; A, 8/13/2024]
16.19.36.10 EQUIPMENT: Each facility compounding sterile preparations shall have sufficient
equipment for the safe and appropriate storage, compounding, packaging, labeling,
dispensing and preparation of compounded sterile preparations drugs and
parenteral preparations appropriate to the scope of pharmaceutical services
provided and as specified in USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile
Preparations).
A. All
equipment shall be cleaned, maintained, monitored, calibrated, tested, and
certified as appropriate to ensure proper function and operation with
documentation retained for three years.
B. Primary and secondary engineering controls used to provide an aseptic environment shall be
tested in the course of normal operation by an
independent qualified contractor and certified as meeting the requirements
presented in USP/NF <797> (USP
General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations) at
least every six months and when relocated, certification records will be
maintained for three years.
C. A
library of current references (hard copy or electronic) shall be available
including:
(1) All USP/NF chapters applicable to the
facility’s sterile compounding practice;
(2) New Mexico pharmacy laws, rules and
regulations;
(3) specialty references
(stability and incompatibility references, sterilization and preservation
references, pediatric dosing, and drug monograph references) as appropriate for
the scope of services provided.
D. Automated
compounding devices shall:
(1) have accuracy verified
on a routine basis at least every 30 days per manufacturer's specifications;
(2) be observed every 30
days by the operator during the mixing process to ensure the device is working
properly;
(3) have data entry
verified by a pharmacist prior to compounding or have accurate final documentation of compounded preparations to
allow for verification of ingredients by a pharmacist prior to dispensing; and
(4) have accuracy of
delivery of the end product verified according to
written policies and procedures.
[16.19.36.10 NMAC - N, 06-28-14; A, 8/13/2024]
16.19.36.11 DOCUMENTATION REQUIRED:
A. Written
policies, procedures
and SOPs consistent with USP/NF
<797> (General Chapter
<797> Pharmaceutical Compounding-Sterile Preparations) standards as
well
as those required below, must be
established, implemented, followed by facility personnel, and available for inspection and review by authorized agents of the board of pharmacy. All personnel who perform or oversee
sterile compounding must be trained in these policies, procedures and SOPs.
B. Written policies and procedures must be submitted to the state board of pharmacy prior to the issuance of any license. These policies and procedures must include but are not limited to:
(1) cleaning, disinfection, evaluation, validation, testing, certification, and maintenance of the sterile compounding area;
(2) personnel qualifications, training, assessment and performance validation;
(3) operation, maintenance, validation, testing, and certification of facility and equipment;
(4) SOP's for compounding, storing, handling, and dispensing of all components used and all compounded sterile preparations;
(5) SOP's for proper disposal of physical, chemical, and infectious waste;
(6) quality control guidelines and standards;
(7) quality assurance guidelines and standards;
(8) SOP's for determination of stability, incompatibilities, and drug interactions;
(9) error
prevention and incident reporting policies and procedure as per 16.19.25 NMAC.
C. All records required by this part shall be kept by the facility for at least three years and shall be readily available for inspection by the board or boards’ agent.
[16.19.36.11 NMAC - N, 06-28-14; A, 03-22-15; A, 8/13/2024]
16.19.36.12 RECORD KEEPING AND PATIENT PROFILE: The compounded sterile preparations facility is required to maintain patient's records which include but are not limited to the following.
A. Prescription records or provider orders including the original prescription or original provider order, refill authorization, alterations in the original prescription or original provider order, and interruptions in therapy due to hospitalization.
B. Patient's history including pertinent information regarding allergy or adverse drug reactions experienced by the patient.
C. Patients receiving parenteral preparations in a home setting are contacted at a frequency appropriate to the complexity of the patient’s health problems and drug therapy as documented on patient specific
plan of care and with each new prescription, change in therapy or condition.
D. Documentation
that the patient receiving parenteral preparations in a home setting
or the agent has received a written copy of the plan of care and training in
the safe administration of the medication.
[16.19.36.12 NMAC - N, 06-28-14]
16.19.36.13 REQUIREMENTS FOR TRAINING: All personnel, including pharmacists, pharmacists who supervise
compounding personnel (including
designated persons),
pharmacists interns and pharmacy technicians , shall have completed didactic
and experiential training with competency evaluation through demonstration and
testing (written or practical) as required by USP/NF <797> (USP General Chapters: <797>
Pharmaceutical Compounding-Sterile Preparations)and as outlined by the
pharmacist-in-charge and described in the site policy and procedures or
training manual, prior to compounding sterile preparations.
A. Instructional
topics shall include:
(1) aseptic technique;
(2) achieving
and/or maintaining sterility (and apyrogenicity if
compounding with nonsterile components);
(3) principles of high-efficiency
particulate air (HEPA)-filtered unidirectional airflow within the ISO Class five
area
(4) environmental
monitoring;
(5) proper use of
PECs;
(6) equipment and
supplies;
(7) sterile pharmaceutical
calculations, measuring, mixing, and terminology;
(8) documentation
of the compounding process (MFR and CR);
(9) quality assurance
procedures;
(10) hand hygiene
(11) proper
gowning and gloving technique;
(12) the
handling of cytotoxic and hazardous drugs (if
applicable);
(13) principles of movement of materials and personnel within the compounding area; and
(14) cleaning and disinfection.
B. Training
shall be obtained through completion of a site-specific, structured on-the-job didactic
and experiential training program (not transferable to another practice site).
C. Pharmacy
technicians shall complete 100 hours of documented experiential training in
compounded sterile preparations in accordance with Section 61-11-11.1 of the
Pharmacy Act NMSA 1978 prior to compounding sterile preparations. Documentation of experiential training as
defined in Subsection A of this section is transferrable to another practice
site.
D. Experiential
training shall include those areas of training as outlined in USP <797> (USP General Chapters: <797>
Pharmaceutical Compounding-Sterile Preparations) with appropriate
observational assessment and testing of performance as outlined in USP
<797> (USP General Chapters:
<797> Pharmaceutical Compounding-Sterile Preparations) including garbing
competency and aseptic manipulation competency evaluations.
E. All
personnel, including pharmacists compounding sterile hazardous drugs,
pharmacists supervising compounding personnel, pharmacy interns compounding
sterile hazardous drugs, and pharmacy technicians compounding sterile hazardous
drugs, shall have completed didactic and experiential training with competency
evaluation through demonstration and written or practical testing as required
by USP/NF <800> (USP General Chapters: <800> Hazardous
Drugs – Handling in Healthcare Settings) in addition to training in sterile non-hazardous preparations as
listed above. Training will be conducted
as outlined by the pharmacist-in-charge and described in the site policy and
procedures or training manual and shall be completed prior to compounding
sterile hazardous preparations.
F. Frequency
of training and assessment shall be conducted as required by USP <797> (USP General Chapters: <797>
Pharmaceutical Compounding-Sterile Preparations) to assure continuing
competency and include:
(1) initial training
before compounding sterile preparations;
(2) annual refresher
training and assessment in didactic topics;
(3) garbing
competency and aseptic manipulation competency evaluations every 6 months for
personnel compounding Category 1 and Category 2 CSPs;
(4) garbing
competency and aseptic manipulation competency evaluations every 3 months for
personnel compounding Category 3 CSPs.
(5) Personnel who have direct oversight
of compounding personnel (including designated persons) must complete garbing
competency and aseptic manipulation competency evaluations annually (unless a
more frequent requirement applies).
G. Documentation
of training: Written documentation of
initial and in-service training, the results of written or practical testing,
and process validation of compounding, personnel shall be retained for three
years and
contain the following information:
(1) name of person receiving the training
or completing the testing or process validation;
(2) date(s) of the
training, testing, or process validation;
(3) general description of
the topics covered in the training or testing or of the process validated;
(4) name of person supervising the
training, testing, or process validation;
(5) signature of the
person receiving the training or completing the testing or process validation and the designated person or other pharmacist employed by the
pharmacy and designated by the pharmacist-in-charge as responsible for
training, testing, or process validation of personnel.
[16.19.36.13 NMAC - N, 06-28-14; A, 03-22-15; A, 8/13/2024]
16.19.36.14 PATIENT OR CAREGIVER TRAINING FOR USE
OF COMPOUNDED STERILE PREPARATIONS IN A HOME SETTING:
A. The
pharmacist shall maintain documentation that the patient has received training
consistent with Subsection F of 16.19.4.16 NMAC.
B. The
facility shall provide a 24-hour toll free telephone number for use by patients
of the pharmacy.
C. There
shall be a documented, ongoing quality assurance program that monitors patient
care and pharmaceutical care outcomes, including the following:
(1) routine
performance of prospective drug use review and patient monitoring functions by
a pharmacist;
(2) patient
monitoring plans that include written outcome measures and systems for routine
patient assessment;
(3) documentation
of patient training.
[16.19.36.14 NMAC - N, 6-28-14]
16.19.36.15 QUALITY ASSURANCE OF COMPOUNDED
STERILE PREPARATIONS:
A. There shall be a documented, ongoing
performance improvement control program that monitors personnel performance,
equipment, and facilities:
(1) all
aspects of sterile product preparation, storage, and distribution, including
details such as the choice of cleaning materials and disinfectants and
monitoring of equipment accuracy shall be addressed in policy and procedures;
(2) if
non-sterile to sterile bulk compounding of more than 25 units of compounded
sterile preparations is performed using non-sterile chemicals, containers, or
devices, and the results of appropriate end product
testing must be documented prior to the release of the product from quarantine;
the test must include appropriate tests for particulate matter and pyrogens;
(3) there
shall be documentation of quality assurance audits at regular, planned
intervals, including infection control and sterile technique audits; a plan for
corrective action of problems identified by quality assurance audits shall be
developed which includes procedures for documentation of identified problems
and action taken; a periodic evaluation as stated in the policy and procedures
of the effectiveness of the quality assurance activities shall be completed and
documented;
(4) the
batch label of each sterile compounded product shall contain:
(a) drug
product name(s), diluent names(s), and amount(s) of each;
(b) assigned
internal identification number (e.g., barcode, prescription, order, or lot
number);
(c) final
concentration(s), and volume when appropriate, solution ingredient names and
amounts;
(d) beyond
use date, and time when applicable;
(e) dosage form
(f) route
of administration when applicable;
(g) date
of preparation;
(h) name
or initials of person preparing the product and, if prepared by supportive
personnel, the name or identifying initials and the name or initials of the
pharmacist that completed the final check;
(i) when appropriate, ancillary
instructions such as storage instructions or cautionary systems, including
hazardous material warning labels and containment bags;
(j) device instructions when needed;
(k) if it is a single-dose container, a statement stating such;
(l) if it is a multiple-dose container, a statement stating such; and
(m) compounding facility name and contact information if the CSP is to be sent outside of the facility or healthcare system in which it was compounded.
(5) the
patient specific label of a CSP shall contain:
(a) patient
name;
(b) solution,
ingredient names, amounts;
(c) beyond
use date, and time when applicable;
(d) dosage form;
(e) route
of administration;
(f) directions
for use, including infusion rates, specific times scheduled, when appropriate
and applicable;
(g) identifier
of person preparing the product and, if prepared by supportive personnel (i.e.,
pharmacist intern or pharmacy technician), the identifier of the pharmacist
that completed the final check;
(h) when
appropriate, ancillary instructions such as storage instructions or cautionary
systems, including hazardous material warning labels and containment bags;
(i) device instructions when needed;
(j) assigned internal identification
number (e.g., barcode, prescription, order, or lot number);
(k) if it is a single-dose container, a
statement stating such;
(l) if it is a multiple-dose container,
a statement stating such; and
(m) if
dispensed for other than inpatient use, the label shall include all other
required information.
B. There shall be a mechanism for tracking
and retrieving products which have been recalled. The following records must be maintained for CSPs.
(1) A
master formulation record (MFR) shall be created for all CSPs prepared from nonsterile
ingredients(s) and CSP batch preparations and shall include the following:
(a) name,
strength, dosage form, and final volume of the compounded preparation;
(b) all ingredients and their quantities; if applicable, relevant characteristics of components (e.g., particle size, salt form, purity grade, solubility)
(c) complete
instructions for preparing the CSP, including equipment, supplies, a
description of the compounding steps, and any special precautions;
(d) other
information as needed to describe the compounding process and ensure
repeatability (e.g., adjusting pH and tonicity; sterilization method, such as
steam, dry heat, irradiation, or filter);
(e) beyond
use dating and storage
requirements;
(f) information needed for proper labeling (e.g. sample label);
(g) type and size of container closure system(s);
(h) physical description of the final CSP;
(i) quality control (QC) procedures (e.g., pH testing, filter integrity testing); and
(j) reference source to support the stability of the CSP.
(2) A
compounding record (CR) must be created for all Category 1, Category 2, and
Category 3 CSPs. A CR must also be
created for immediate-use CSPs prepared for more than one patient. The CR must include at least the following
information:
(a) reference
to the MFR for the CSP (if applicable);
(b) name,
strength, weight or volume, manufacturer, manufacturer’s
lot number , and expiration date for each component;
(c) name,
strength, dosage form, and volume of the finished CSP;
(d) reconciliation
of actual yield with anticipated yield, and total number of CSP units produced;
(e) identifier
of person preparing the product and, if prepared by a pharmacist intern or pharmacy
technician, the identifier of the pharmacist that completed the final check;
(f) date
and time of preparation;
(g) assigned internal identification number (e.g. prescription,
order, or lot number);
(h) assigned
beyond use date, and time when appropriate and storage requirements;
(i) results of applicable quality control procedures; and
(j) calculations made to determine and verify quantities and/or concentrations of components, if applicable.
[16.19.36.15 NMAC - N, 09-07-14; A, 03-22-15; A, 8/13/2024]
HISTORY OF 16.19.36 NMAC:
[RESERVED]