WORK INSTRUCTION
Title: Compounding of Non-Sterile Preparations
1.0 Policy
The Pharmacy Department of De La Salle University Medical Center is mainly
responsible for providing an adequate supply of drugs, medicines and other medical
supplies for in-patients and out-patients.
Effectivity of this procedure can be attained upon the implementation of the following
procedures:
1. Compounding of Non-Sterile Preparations may only be performed in the
Pharmacy in accordance with applicable standards.
2.
2.0 Responsible
2.1 Compounding can only be performed by a pharmacist in accordance with the
Pharmacy Law (Republic Act No. 10918)
2.2 Training – the Pharmacist must supervise all compounding activities and
ensure that supportive personnel are adequately trained to perform assigned
functions. Training programs should include instruction in the following areas:
2.2.1 Proper Use of Compounding Equipment
2.2.2 Pharmaceutical Techniques needed for preparing compounded
dosage forms
2.2.3 Properties of Dosage Forms to be compounded (see USP-NF)
2.2.4 Stability, Solubility, and related materials literatures.
2.2.5 Handling of nonhazardous and hazardous materials in the work
area as specified on Material Safety Data Sheets (MSDSs) and its
proper disposal
2.2.6 Use and interpretation of chemical and pharmaceutical symbols,
abbreviations in medication orders and in product formulation
directions.
2.2.7 Pharmaceutical calculations
Pharmacists should be competent-verified through observation, written tests,
or quality control testing of finished products.
2.3 Attire – Pharmacist should wear protective apparels such as, face mask,
hairnet, and gloves to avoid microbial contaminations.
ATTN: If personnel to perform and assist the compounding is sick or has any
signs of symptoms of cough, colds or any other illnesses, and/or bleeding, has
open lesions: DO NOT PROCEED TO COMPOUNDING. As it may cause cross-
contamination of the compounding preparations.
Scope – Compounding of Nonsterile Preparations that must comply with this chapter
include but are not limited to following dosage forms:
Solid Oral Dosage Form
Liquid Oral Dosage Form
3.0 Guidelines
3.1 Instruction
3.1.1 All medicines should be provided by the pharmacy otherwise, do
not compound.
3.1.2 Compounding fee – a compounding fee will be charged to the
patient for the added service performed by the Pharmacy.
3.1.3 Requisition slip – the nurse should request the medicine and its
quantity to be compounded together with the medication order prior
compounding.
3.2 Facilities and Equipment
3.2.1 Compounding Space – must be specifically designated for
nonsterile compounding. The designation must be compliant in the
DLSMHSI’s Standard Operation Procedures (SOP). The
compounding space must be well lit and must be maintained in a
clean, orderly, sanitary condition and in a good state of repair. The
space must provide for the orderly placement of equipment and
materials to prevent mix-ups among components, containers,
labels, in-process materials, and finished Compounding Non-Sterile
Preparations (CNSPs). The space should be designed, arranged,
and used in a way that minimizes cross contamination from non-
compounding areas which are sufficiently away from potential
interruptions, chemical contaminants and sources of dust and
particulate matter.
3.2.2 Water Sources - A source of hot and cold water and an easily
accessible sink must be available for compounding. The sink must
be emptied of all items unrelated to compounding and must be
cleaned if visibly soiled before being used to clean any equipment
used in nonsterile compounding.
3.2.3 Equipment – must be stored in a manner that minimizes the risk of
contamination. To reduce the potential exposure to personnel or
contamination of facility and the medication that will be
compounded, non-sterile compounding must be done in a closed-
system manner (e.g: ventilated area, room/space that is not
adjacent to air-condition, open window/s, electric fan, air-purifier,
etc.)
Equipment should be used are:
Mortar and pestles for crushing, pulverizing, grinding of
tablets
Weighing balance used for measuring specifically of solid
materials or any solid forms that will be added or reduced to
make the specified compounded preparations.
Beaker for transferring of liquid materials and/or mixing.
Graduated cylinder for measuring any liquid materials.
Compounding Glass Slab provide a hard surface for mixing
and blending compounding materials.
Spatula used for blending, transferring, dividing, and
handling compounded materials.
3.3 Preparation requirements
3.3.1 Verification of final compounded non-sterile preparations
3.3.2 Master Formulation Record
3.3.3 Ingredients used for non-sterile compounding — quality and
storage
3.3.4 Compounding record
3.3.5 Conduct of personnel in compounding areas
3.3.6 Labelling and packaging
3.3.7 Labelling policy
3.3.8 Label and supplementary label
3.3.9 Packaging process and procedure
3.3.10 Storage
3.3.11 Temperatures for different types of storage
3.3.12 Transport and delivery of compounded non-sterile preparations
3.3.13 Beyond-use date and dating methods
3.4 Cleaning and Sanitizing
Pharmacist and personnel to assist compounding should ALWAYS wash
hands prior compounding to avoid cross-contamination.
If compounding is not performed daily, cleaning and sanitizing must be
completed before initiating compounding. Cleaning and sanitizing must be
repeated when spills occur and when surfaces are visibly soiled.
Equipment should be cleaned and sanitized always to prevent contamination
and/or deterioration of medicines/drugs to be used in compounding non-
sterile preparations.
Reference/s:
American Society of Health-System Pharmacists. Compounding Nonsterile Products in
Pharmacies. Retrieved from:
https://www.ashp.org/-/media/assets/policy-guidelines/docs/technical-assistance-
bulletins/technical-assistance-bulletins-compounding-nonsterile-products-
pharmacies.ashx accessed on 10th June 10, 2022.
United States of Pharmacopoeia and National Formulary. Pharmaceutical
Compounding – Non-Sterile Preparations. Retrieved from:
file:///C:/Users/hisuser/Downloads/795_PHARMACEUTICAL_COMPOUNDING_NONS
TERILE_PREPARATIONS_POST_Revised_03%20(1).pdf accessed on 8th June 2022.
