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. “Ante-area” means an ISO
Class 8 or better 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) reduces the need for the heating, ventilating, and
air-conditioning (HVAC) control system to respond to large disturbances.
C. “Aseptic
technique” means proper manipulation of preparations to maintain sterility.
D. “Batch” means more than one unit of a
compounded preparation that is intended to have uniform character and quality
within specified limits, prepared in a single process, and completed during the
same and limited time period.
E. “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.
F. “Biological safety cabinet” (BSC) means a ventilated
cabinet that provides ISO Class 5 environment for CSP’s, provides personnel,
preparation, and environmental protection having an open front with inward
airflow for personnel protection, downward high-efficiency particulate air
(HEPA)-filtered laminar airflow for preparation protection, and HEPA-filtered
exhausted air for environmental protection.
G. “Buffer area” means an area where the primary engineering
control (PEC) is physically located.
Activities that occur in this area include the staging of components and
supplies used when compounding CSP’s.
H. “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.
I. “Cleanroom” means a room in which the concentration of airborne particles is
controlled to meet a specified airborne particulate cleanliness class. Microorganisms in the environment are
monitored so that a microbial level for air, surface, and personnel gear are
not exceeded for a specified cleanliness class.
J. “Closed system vial-transfer device” means a vial-transfer system that allows no venting or exposure of
substances to the environment.
K. “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 body
cavities;
(6) ophthalmic drops and ointments; and
(7) tissue implants.
L. “Compounding aseptic containment
isolator” (CACI) means
an enclosed ISO Class 5 environment workspace for compounding of hazardous
sterile preparations, provides personnel protection with negative pressure and
appropriate ventilation and provides preparation protection by isolation from
the environment and high-efficiency particulate air (HEPA)-filtered laminar
airflow. Air exchange with the
surrounding environment should not occur unless the air is first passed through
a microbial retentive filter (HEPA minimum) system capable of containing
airborne concentrations of the physical size and state of the drug being
compounded. Where volatile hazardous
drugs are prepared, the exhaust air from the isolator should be appropriately
removed by properly designed building ventilation.
M. “Compounding aseptic isolator” (CAI) means an enclosed ISO
Class 5 environments for compounding pharmaceutical ingredients or
preparations. It is designed to maintain
an aseptic compounding environment within the isolator throughout the
compounding and material transfer processes.
Air exchange into the isolator from the surrounding environment should
not occur unless the air has first passed through a microbial retentive filter
(HEPA minimum).
N. “Critical
area” means an ISO Class 5 environment.
O. “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. Risk of microbial
particulate contamination of the critical site increases with the size of the
openings and exposure time.
P. “Direct compounding area” (DCA) means
a critical area within the ISO Class 5 primary engineering control (PEC) where
critical sites are exposed to unidirectional HEPA-filtered air, also known as
first air.
Q. “Disinfectant” means an agent that frees from
infection and destroys disease-causing pathogens or other harmful microorganisms,
but may not kill bacterial and fungal spores.
It refers to substances applied to inanimate agents, usually a chemical
agent, but sometimes a physical one.
R. “Hazardous drugs” means drugs classified as hazardous if
studies in animals or humans indicate exposures to them have a potential for
causing cancer, development or reproductive toxicity or harm to organs.
(Reference current NIOSH publications).
S. “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.
T. “Immediate use” means administration begins not later than
one hour following the start of the compounding procedure. For those events in
which delay in preparation would subject patient to additional risk and meeting
USP/NF <797> (Immediate-Use CSP
Provision) criteria.
U. “ISO 5” means air containing no more than 100 particles per cubic foot of air
of a size at least 0.5 micron or larger in diameter (3520 particles per cubic
meter).
V. “ISO 7” means air containing no more than 10,000 particles per cubic foot of
air of a size at least 0.5 micron or larger in diameter (352,000 particles per
cubic meter).
W. “ISO 8” means air containing
no more than 100,000 particles per cubic foot of air of a size at least 0.5
micron or larger in diameter (3,520,000 particles per cubic meter).
X. “Laminar airflow” means
a non-turbulent, non-mixing streamline flow of air in parallel layers.
Y. “Laminar
airflow workbench” (LAFW) means a ventilated cabinet for compounding of
sterile preparations. Provides
preparation protection with high-efficiency particulate air (HEPA) filtered
laminar airflow, ISO Class 5. Airflow
may be horizontal (back to front) or vertical (top to bottom) in direction.
Z. “Media-fill test” means a
test used to qualify aseptic technique of compounding personnel or processes
and to ensure that the processes used are able to produce sterile preparation
without microbial contamination. During
this test, a microbiological growth medium such as soybean-casein digest medium
is substituted for the actual drug product to simulate admixture
compounding. The issues to consider in
the development of a media-fill test are media-fill procedures, media selection,
fill volume, incubation, time, and temperature, inspection of filled units,
documentation, interpretation of results, and possible corrective actions
required.
AA. “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.
BB. “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.
CC. “Parenteral product” means any
preparation administered by injection through one or more layers of skin
tissue.
DD. “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.
EE. “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.
FF. “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.
GG. “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.
HH. “Preparation”
means a CSP that is a sterile drug or nutrient compounded in a
licensed pharmacy or other healthcare-related facility pursuant to the order of
a licensed prescriber; the article may or may not contain sterile products.
II. “Primary
engineering control” (PEC) means a device or room that provides an
ISO Class 5 environment for the exposure of critical sites when compounding
CSP’s. Such devices include, but may not
be limited to, laminar airflow workbenches (LAFW’s), biological safety cabinets
(BSC’s), compounding aseptic isolators (CAI’s), and compounding aseptic
containment isolators (CACI’s).
JJ. “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.
KK. “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.
LL. “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.
MM. “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.
NN. “Secondary
engineering control” means the ante area and buffer area or cleanroom in which
primary engineering controls are placed.
OO. “Segregated
compounding area” means a designated space, either a
demarcated area or room, that is restricted to preparing low-risk level CSP’s
with 12-hour or less BUD. Such area
shall contain a device that provides unidirectional airflow of ISO Class 5 air
quality for preparation of CSP’s and shall be void of activities and materials
that are extraneous to sterile compounding.
PP. “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.
QQ. “Standard
operating procedure” (SOP) means a written protocol detailing the required standards for
performance of tasks and operations within a facility.
RR. “Sterile”
means free from bacteria or other living microorganisms.
SS. “Sterilization by filtration” means passage of a fluid or solution
through a sterilizing grade membrane to produce a sterile effluent.
TT. “Sterilizing grade membranes” means membranes that are documented
to retain 100% 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 0.22 mm
or 0.2 mm porosity, depending on the
manufacturer’s practice.
UU. “Terminal
sterilization” means the application of a lethal process (e.g., steam under pressure or
autoclaving) 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.
VV. “Unidirectional
flow” means airflow moving in a single direction in
a robust and uniform manner and at sufficient speed to reproducibly sweep
particles away from the critical processing or testing area.
WW. “USP” means United States
pharmacopeia.
[16.19.36.7 NMAC - N, 06-28-14; A,
03-22-15]
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 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]
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 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.
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]
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
insure proper function and operation with documentation retained for three
years.
B. Primary 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) USP/NF or USP on Compounding: A Guide for
the Compounding Practitioner;
(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]
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.
B. Written policies and procedures must be submitted to the state board of pharmacy prior to the issuance of any license. These records 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]
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, 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) critical area contamination factors;
(3) environmental monitoring;
(4) facilities;
(5) equipment and supplies;
(6) sterile pharmaceutical calculations and terminology;
(7) sterile pharmaceutical compounding documentation;
(8) quality assurance procedures;
(9) proper gowning and gloving technique;
(10) the handling of cytotoxic and hazardous drugs; and
(11) general conduct in the controlled area.
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
glove fingertip and media fill tests.
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 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) annual testing of glove fingertip and media fill for low
and medium risk compounding;
(4) six-month testing of glove fingertip and media fill
testing for high risk compounding.
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 pharmacist-in-charge 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]
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) batch lot or
control number;
(c) final concentration(s),
and volume when appropriate, solution ingredient names and amounts;
(d) beyond use date,
and time when applicable;
(e) route of
administration when applicable;
(f) date of
preparation;
(g) facility
identifier; 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;
(h) when
appropriate, ancillary instructions such as storage instructions or cautionary
systems, including hazardous material warning labels and containment bags; and
(i) device
instructions when needed.
(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) route of
administration;
(e) directions for
use, including infusion rates, specific times scheduled, when appropriate and
applicable;
(f) 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;
(g) when
appropriate, ancillary instructions such as storage instructions or cautionary
systems, including hazardous material warning labels and containment bags; and
(h) device
instructions when needed;
(i) 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. If batch preparation of compounded sterile preparations
is being performed, a record must be maintained for each batch.
(1) A formulation record shall provide a
consistent source document (recipe) for CSP preparation and shall include the
following:
(a) name, strength,
dosage form, and final volume of the compounded preparation;
(b) all ingredients
and their quantities;
(c) equipment needed
to prepare the CSP, when appropriate, and mixing instructions;
(d) other
environmental controls, such as the duration of mixing and other factors
pertinent to consistent preparation of the CSP;
(e) beyond use
dating, the container for dispensing, storage requirements, and quality control
procedures; and
(f) information
need for proper labeling (e.g. sample label).
(2) The compounding record for each CSP
batch shall verify accurate compounding in accordance with the formulation
record and shall include:
(a) reference to the
formulation record for the CSP;
(b) name, strength,
volume, manufacturer, and manufacturer’s lot number for each component;
(c) name, strength,
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 support personnel (i.e., pharmacist intern or pharmacy
technician), the identifier of the pharmacist that completed the final check;
(f) date of
preparation;
(g) batch lot or
control number assigned;
(h) assigned beyond
use date, and time when appropriate;
(i) results of
applicable quality control procedures.
[16.19.36.15 NMAC - N, 09-07-14;
A, 03-22-15]
HISTORY OF 16.19.36
NMAC: [RESERVED]