Current through Register Vol. 6, March 22, 2024
(1) Policies and
procedures must be prepared for the compounding, dispensing, delivery,
administration, storage, and use of sterile pharmaceutical products. The
policiesmust include a quality assurance program for monitoring personnel
qualifications and training in sterile technique, product storage, stability
standards, and infection control. Policies and procedures mustbe current and
available for inspection by a designee of the Board of Pharmacy.
(2) An institutional pharmacy compounding
sterile products must have an isolated area designed to avoid unnecessary
traffic and airflow disturbances.
(3) An institutional pharmacy compounding
sterile products must utilize an appropriate aseptic environmental control
device such as a laminar flow biological safety cabinet capable of maintaining
Class 100 conditions during normal activity, or have policies and procedures in
place limiting the pharmacy's scope of sterile product preparation.
(4) An institution preparing cytotoxic drugs
must have a vertical flow Class II biological safety cabinet. Cytotoxic drugs
must be prepared in a vertical flow Class II biological safety cabinet.
(a) Protective apparel including nonvinyl
gloves, gowns and masks must be available, and gloves must be worn at all
times.
(b) Appropriate containment
techniques must be used in addition to aseptic techniques required for sterile
product preparation.
(c) Prepared
doses of cytotoxic drugs must be clearly identified, labeled with proper
precautions, and dispensed in a manner to minimize risk of cytotoxic
spills.
(d) Disposal of cytotoxic
waste must comply with all applicable local, state, and federal laws.
(e) Written procedures for handling cytotoxic
spills must be included in the policies and procedures manual.
(5) All parenteral admixtures must
be labeled with date of preparation and expiration date clearly indicated,
patient name and room number, name and strength and/or amount of drug and base
solution, and any special handling or storage instructions.
(6) All aseptic environmental control devices
must be certified by an independent contractor for operational efficiency at
least every 12 months or when relocated, according to Federal Standard 209E.
Prefilters must be inspected periodically and replaced if needed.
(7) Inspection and replacement dates must be
documented and maintained for a period of at least two years.
(8) Documented records of ongoing quality
assurance programs, justification of expirationdates chosen, and employee
training records and technique audits must be available for inspection by the
Board of Pharmacy.
(9) The board
expects pharmacies/pharmacists engaged in compounding to have policies and
procedures to adhere to those guidelines that apply to their practice setting
and in all situations to comply with the spirit of United States Pharmacopeia
(USP) Chapter 795 "Compounding Nonsterile Preparations" and USP Chapter 797
"Pharmaceutical Compounding-Sterile Preparations."
(10) Immediate use compounds defined in ARM
24.174.301(21)
are prepared in an air quality environment that does not meet International
Organization of Standardization (ISO) Class 5 or better conditions. A preparer
of immediate use compounds is not required to wear gloves or gown if the
compounds are prepared using aseptic manipulation, only sterile ingredients,
products, components, and devices, and the following conditions are met:
(a) no more than three sterile ingredients,
products, components, and devices are used;
(b) only simple manipulation techniques are
employed;
(c) the preparer
completes the preparation without interruption and with no direct contact
contamination;
(d) the
administration must begin within one hour of preparation;
(e) if prepared by someone other than the
person who will administer the drug, labeling must include patient name, name
and quantity of ingredients, name of person who prepared it, and exact one hour
"beyond use date"; and
(f)
preparations do not involve the use of hazardous materials.
(11) Multi-dose vial defined in
ARM 24.174.301(29)
may be used until the expiration date noted on the vial. The beyond use date
(BUD) may be up to one month or the manufacturer's assigned BUD, whichever is
shorter from the time of initial entry, in accordance with the pharmacy
policies and procedures.
(12) A
same-day use product, defined in ARM
24.174.301(41),
that is prepared using aseptic manipulation in a controlled environment with
ISO 5 or better class air quality conditions, using only sterile ingredients,
products, components, and devices, may be classified as low- or medium-risk
provided that it meets all of the following conditions:
(a) only simple manipulation techniques
employed;
(b) the environment meets
or exceeds the following conditions:
(i) the
mixing cabinet is located in an area that restricts airflow to prevent drafts
and reduce particle counts;
(ii)
there is a partitioned area around the mixing cabinet to create a buffer zone,
which must be at least the width of the hood in front of the mixing cabinet;
and
(iii) the buffer zone must be
clearly identified to prevent cardboard or outer packing material intruding
into the buffer zone and to prevent any intrusion during the compounding
process.
(c) the
environment is cleaned daily;
(d)
batch preparation will not exceed eight CSPs;
(e) administration of the preparation must
begin within 24 hours of preparation; and
(f) the preparer must use gloves, shoe covers
or dedicated shoes, hair covers, gown, and a mask.
(13) The beyond use date (BUD), as defined in
ARM 24.174.301(2),
for a single-dose vial:
(a) shall be no
greater than one hour from the time of initial entry if accessed in an
environment of less than ISO 5; or
(b) may be up to 24 hours from the time of
initial entry if appropriately stored and accessed only in an environment equal
to or better than ISO 5.
(14) Low-risk and medium-risk level
compounded sterile preparation (CSP) is determined by the potential for
microbial contamination during preparation, and high-risk level CSP by the
potential for not being properly sterilized before administration to patients.
(a) Low-risk conditions:
(i) CSPs prepared using aseptic manipulation
with an air quality environment that is equal to or better than ISO Class 5,
using only sterile ingredients, products, components, and devices;
(ii) no more than three commercially
manufactured sterile products and entries into one container of sterile product
during preparation;
(iii)
manipulations limited to:
(A) aseptically
opening ampoules;
(B) penetrating
sterile stoppers on vials with sterile needles and syringes; and
(C) transferring sterile liquids in sterile
syringes to sterile administration devices, package containers of other sterile
products, and sterile containers for storage and dispensing.
(iv) in the absence of sterility
testing, preparations must be properly stored prior to administration as
follows:
(A) BUD less than or equal to 48
hours at controlled room temperature;
(B) BUD up to 14 days under refrigeration;
or
(C) BUD up to 45 days in solid
frozen state at minus 20 degrees centigrade.
(b) Medium-risk conditions:
(i) CSPs compounded aseptically under
low-risk conditions, but with the addition of one or more of the following
conditions:
(A) multiple individual or small
doses of sterile precuts are combined or pooled to prepare a CSP that will be
administered either to multiple patients or to one patient on multiple
occasions;
(B) the compounding
process includes complex aseptic manipulations other than single volume
transfer; or
(C) the compounding
process requires unusually long duration, such as that required to complete
dissolution or homogenous mixing.
(ii) In the absence of sterility testing,
preparations must be properly stored prior to administration as follows:
(A) BUD less than or equal to 30 hours at
controlled room temperature;
(B)
BUD up to nine days under refrigeration; or
(C) BUD up to 45 days in solid frozen state
at minus 20 degrees centigrade.
(c) High-risk conditions:
(i) CSPs compounded from nonsterile
ingredients including products manufactured for other routes of administration,
or a nonsterile device is employed before terminal sterilization;
(ii) exposure to an air quality environment
that does not meet ISO 5 or better conditions for more than one hour for any of
the following:
(A) sterile contents of
commercially manufactured products;
(B) CSPs that lack effective antimicrobial
preservatives; or
(C) sterile
surfaces of devices and containers for the preparation, transfer,
sterilization, and packaging of CSPs.
(iii) Prior to terminal sterilization:
(A) nonsterile procedures including weighing
and mixing occur in an air quality environment that does not meet ISO 7 or
better conditions;
(B) compounding
personnel are improperly gloved or garbed; or
(C) water containing preparations are stored
for more than six hours.
(iv) in the absence of sterility testing,
preparations must be properly stored prior to administration as follows:
(A) BUD less than or equal to 24 hours at
controlled room temperature;
(B)
BUD up to three days under refrigeration; or
(C) BUD up to 45 days in solid frozen state
at minus 20 degrees centigrade.
(v) all nonsterile devices must be rinsed
thoroughly with sterile, pyrogen-free water, then thoroughly drained or dried
immediately before use.
(vi)
terminal sterilization is required as follows:
(A) CSP solutions passed through a filter
with a nominal porosity not larger than 1.2 micron preceding or during filling
into their final containers to remove particulate matter; or
(B) sterilization of high-risk level CSPs by
filtration must be performed with a sterile 0.22 micron pore filter entirely
within an air quality environment better than or equal to ISO 5.
AUTH:
37-7-201,
MCA; IMP:
37-7-201,
37-7-307,
37-7-308,
MCA