Current through Register Vol. 49, No. 2, February 2024
07-02-0001
-STANDARDS FOR COMPOUNDING AND DISPENSING STERILE PRODUCTS
The purpose of this regulation is to provide standards in the conduct,
practices, and operations of a pharmacy preparing and dispensing products
requiring sterility, such as injectables, ophthalmics, and inhalants.
Except for those products where stability prohibits advanced
compounding, all products dispensed by the pharmacy shall be in a form ready
for administration, except in health care facilities where medications may be
provided as demanded by policies and procedures.
Pharmacies and pharmacists dispensing sterile products shall comply
with all applicable federal, state, and local law and regulation concerning
pharmacy and also these additional rules:
I. Guidelines for preparation of sterile
products will be based on the distinction of sterile products as either low
risk or high risk products.
A. Low risk
sterile products are those products which meet the following characteristics:
a. The finished product is compounded with
commercially available, sterile equipment (e.g. syringes, vials,
needles.)
b. Preparation involves
basic aseptic manipulations promptly executed (completion of product occurs
without interruption.)
c. Closed
system transfers are used in which the container closure system remains
essentially intact throughout the process, compromised only by penetration of a
needle or other device used to withdraw the product. (Ampuls will be considered
closed systems.)
d. Individual
products prepared upon receipt of a patient prescription order.
e. Quantities of 48 hours or less and
expiration times of 72 hours or less.
B. High risk sterile products are those
products which meet any of the following characteristics:
a. Compounding involves preparation over a
prolonged period of time; or
b.
Products used are non-sterile; or
c. Batch preparation of large quantities are
performed in anticipation of prescription orders; or
d. Epidurals and intrathecals prepared using
non sterile products; or
e.
Preparation of parenteral nutrition solutions with expiration dates greater
than 48 hours; or
f. quantities of
more than 48 hours and/or expiration times of more than 72 hours, antibiotics
and injectables with preservatives (ie: benzyl alcohol, methylparabens) would
be exempted and considered as low risk steril products.
C. Pharmacies and pharmacists preparing low
risk sterile products shall adhere to all of this regulation except section
X,
which applies when high risk sterile products are prepared.
II. Pharmacist Requirements:
Any pharmacist in charge who performs or supervises the preparation or
sterilization of sterile medications shall:
A. Have available written policies and
procedures for all steps in the compounding of sterile preparations. In
addition, said policies and procedures shall address personnel education and
training and evaluation, storage and handling, clothing, personal hygiene, hand
washing, aseptic technique, quality assurance, expiration dating, and other
procedures as needed.
B. Certify
that all participating pharmacists and pharmacy technicians have completed a
Board approved training and testing program in sterile product preparation.
Documentation of training and testing shall be available for review, by
February 30, 2002.
C. Develop
policies and procedures to annually test and review the techniques of
participating pharmacists and pharmacy technicians to assure adherence to
aseptic procedures.
III.
Pharmacy Technician Requirements
Pharmacy Technicians participating in the preparation of sterile
products shall have completed a Board approved pharmacist supervised training
and testing program in sterile product preparation. Documentation of training
and testing shall be available.
IV. Work Area and Equipment:
Any pharmacy dispensing sterile parenteral solutions shall meet or
exceed the following requirements:
A.
A separate controlled limited access area (also called a buffer area or buffer
room) for compounding sterile solutions, which shall be of adequate space for
compounding, labeling, dispensing, and sterile preparation of the medication.
This area shall have controlled temperature and humidity. Cleanliness of the
area is of critical importance. Drugs and other materials, taken into the
limited access area, shall be removed from cardboard and other particle
generating materials before being taken into the area.
B. The controlled limited access area shall
have a certified and inspected class 100 environment. Such an environment
exists inside a certified laminar airflow hood (clean room, biological safety
cabinet or other barrier isolator meeting class 100 requirements) used for the
preparation of all sterile products. The Class 100 environment device or area
is to be inspected and certified yearly. Barrier isolator workstations are
closed systems and are not as sensitive to their external environment as
laminar airflow equipment. It is recommended to place them in a limited access
area with cleaning and sanitizing in the surrounding area on a routine
basis.
C. Hazardous drugs shall be
prepared within a certified Class 11 Type A (exhaust may be discharged to the
outdoors) or Class 11 Type B (exhaust may be discharged to the outdoors)
laminar flow biological safety cabinet. The Class 11, Type B can be obtained
with a bag in-bag out filter to protect the personnel servicing the cabinet and
facilitate disposal. When preparing cytotoxic agents, gowns and gloves shall be
worn. All new construction, and those undergoing renovation requiring the
moving of existing hoods used in the preparation of cytotoxic drugs, shall
exhaust the hood to the outdoors, unless the Board of Pharmacy grants an
exception. The cabinet of choice is a Class 11, Type B. For the purpose of this
regulation, hazardous drugs shall be defined as agents that exhibit
characteristics of genotoxicity, carcinogenicity, teratogenicity, or evidence
of serious organ or other toxicity at low doses.
D. The area shall be designed to avoid
excessive traffic and airflow disturbances.
E. The area shall be ventilated in a manner
not interfering with laminar flow hood conditions.
F. Daily procedures must be established for
cleaning the compounding area.
V. Storage:
All Pharmacies preparing and dispensing sterile products must
provide:
A. Adequate controlled room
temperature storage space for all raw materials.
B. Adequate storage space for all equipment.
All drugs and supplies shall be stocked on shelving above the floor.
C. Adequate refrigerator storage space for
compounded solutions, with routinely documented temperatures. Temperature
ranges required are 36-46F or 2-8C.
D. Adequate freezer storage space if finished
products are to be frozen (e.g. reconstituted antibiotics.) There shall be a
procedure to routinely document temperatures.
VI. Labeling:
In addition to regular labeling requirements, the label shall include:
A. Parenteral products shall have the
rate of infusion when applicable.
B. Expiration date (Policies and Procedures
shall address label change procedures as required by physician
orders.)
C. Storage requirements or
special conditions.
D. Name of
ingredients and amounts contained in each dispensing unit.
E. All products dispensed to outpatients, and
removed from the site of preparation for administration different than the site
of preparation, shall have label information as required by state
law.
VII. Shipping:
A. Policies and procedures shall assure
product stability during delivery.
B. Pharmacy must assure ability to deliver
products within an appropriate time frame.
VIII. Home Patient Care Services:
The pharmacist in charge of the pharmacy dispensing sterile parenteral
solutions shall provide the following or assure that they are provided prior to
providing medications.
A. The
pharmacist must assure that the patient is properly trained if
self-administering.
B. In
situations where a pharmacy or pharmacist employs a nurse to administer
medications, the pharmacist in charge must:
1.
Employ a Registered Nurse.
2.
Assure that proper records are maintained in compliance with laws and
regulations.
3. Make these records
available to inspectors from appropriate agencies.
C. 24-hour service shall be assured by the
pharmacy.
D. Pharmacists shall
recommend and monitor clinical laboratory data as requested.
E. Side effects and potential drug
interactions should be documented and reported to the physician.
F. Patient histories and therapy plans should
be maintained.
IX.
Destruction of Cytotoxic Drugs:
Any pharmacy providing cytotoxic drugs shall establish procedures
assuring the return and proper destruction of any unused radioactive or
cytotoxic drugs or other hazardous material (destruction containers for
needles).
In every instance, the pharmacist in charge shall monitor the delivery,
storage, and administration records of medications dispensed from his/her
pharmacy.
X. When preparing
high risk sterile products, the above procedures, in addition to the following,
shall be met:
A. Compound all medications in a
separate controlled limited access area with a positive air flow room inspected
and certified as meeting class 10,000 requirements (class 10,000 as defined by
Federal Standard 209E). It is recommended that all pharmacies have an anteroom
designed to be separate from the buffer room. The anteroom should be available
for the decontamination of supplies and equipment, and donning of protective
apparel. A sink should be available in the anteroom area so that personnel can
scrub prior to entering the buffer room.
B. Use total aseptic techniques, including
gowning, mask, and hair net. Scrubs may be worn instead of gowning if not worn
or covered outside of the controlled limited access area.
C. Provide a system for tracking each
compounded product including:
1. Personnel
involved in each stage of compounding;
2. Raw materials used including quantities,
manufacturer, lot number, and expiration date;
3. Labeling.
4. Compounding records shall be kept for 2
years.
D. Establishment
of procedures for sterilization of all products prepared with any non-sterile
ingredients by filtration with 0.22 micron or other means appropriate for the
product components.
E.
Establishment of procedures for monitoring microbial growth. All sterile
products compounded using non-sterile ingredients and prepared in large batch
quantities in which no patient specific prescription exists shall have end
product sterility testing required. Any positive sterility test results shall
prompt an investigation of aseptic technique, environmental control, and other
sterility assurance controls to identify and correct problems as much as
possible.
F. Establishment of
procedures for yearly testing the techniques of pharmacists using simulated
aseptic procedures and documentation thereof Any construction requirements as
required by this regulation (ie: separate controlled limited access area and
certification of class 10,000) must be complied with by January, 2004)
Adopted: 6/85 (Amended 8/2001)