Mamangun, Marianne Francesca D

3A

Laboratory Exercise No. 9: COMPOUNDING NON-STERILE PREPARATIONS

Compounding medications is an important responsibility of a pharmacist. In the pharmaceutical

field, compounding refers to creating a medication by adding, mixing, altering, or removing various
ingredients of a drug or drugs. There are two main types of compounding: sterile and non-sterile.

Sterile compounding involves creating a medication in an environment free from viruses, bacteria, or any
other potentially infectious microorganisms. This type of compounding is used for medications that will
be administered either through an IV, injection, or directly into the eyes. Administering medications
through these routes all have a very high risk of causing infection, so using sterile compounding techniques
will help to significantly reduce these risks.
Non-sterile compounding involves creating a medication in a clean environment but does not require the
environment to be completely free from all microorganisms. This type of compounding is used for
medications that will be taken orally, such as pills and liquids that are swallowed by the patient, or those
administered topically, such as ointments that are rubbed onto the skin. Compared to medications that
are injected into the body or put into the eyes, medications that are taken orally or topically have a much
lower risk of causing infection. On-sterile preparations include the production of solutions, suspensions,
ointments, creams, powders, suppositories, capsules, and tablets.

II. Procedures:
1. Based on the knowledge about Pharmaceutical Compounding of Non-Sterile Preparations, list
down the compounding facilities and describe their minimum standards/requirements.
- Compounding facilities must have adequate space for compounding different prescriptions.
This area will be used for the proper placement of different equipment and materials that will
be used in compounding. An orderly arrangement will surely help prevent any contaminations
in compounding. Areas used for sterile compounding is separated from non-sterile, this is to
ensure the sterility of the area.
- For the water usage, portable water or water from the faucet can be used for hand washing
and equipment washing. Purified water will be used in compounding nonsterile drug
preparations if the prescription indicates that water should be used, but the water should
meet the standards prescribed in the Environmental Protection Agency’s National Primark
Drinking Water Regulations. Purified water can also be used in rinsing equipment and other
utensils used in compounding. Water for pharmaceutical purposes is used in the preparation
of sterile drug preparations.
- The plumbing system in the compounding facility must be free from defects to prevent
contamination of any compound preparation. Hand washing facilities in the area must always
be present and working. Also, everything must be easily accessible for the pharmacists. The
facility should also have hot and cold water, soap or detergent, and an air-dried or single-use
towels. Area should always be maintained to prevent any discrepancy in the compounding
preparations.
- The compounding area must also be well-lighted. The heating, ventilation, temperature, and
humidity must always be controlled.
- All hazardous compounds or drugs must always be stored, prepared, and handles by
appropriate personnel. The disposal must comply to the federal and state regulations.
Reference: USP. <795> Pharmaceutical Compounding- Nonsterile Preparations, USP 41. Accessed from:
https://www.usp.org/sites/default/files/usp/document/our-work/compounding/usp-gc-795-proposed-
revision.pdf
2. Draw and describe the equipment and utensils needed for compounding of a drug preparation.
III. Questions
1. Enumerate and describe the three general categories of non-sterile compounding.
- The three general categories of non-sterile compounding are: (a) simple, (b) moderate, and
(c) complex.
a. Simple → this type of preparation has a USP compounding monograph or that it has
appeared in a peer-reviewed journal that contains quantities of components, the
compounding procedure and equipment, the stability data for formulation with
appropriate BUDs; or reconstituting or manipulating commercial products that may
require the addition of one or more ingredients as directed by the manufacturer.
Examples are captopril oral solution, indomethacin topical gel, and potassium bromide
oral solution for veterinary use.
b. Moderate → this type of preparation requires special calculations and procedures to
determine the quantities of components per preparation or per individual dosage units.
Examples include Morphine sulfate suppositories, diphenhydramine hydrochloride
troches.
c. Complex → this type of preparation requires personnel with special training. This also
requires a special environment, facility, equipment, and procedures to ensure
appropriate therapeutic outcomes. Examples include transdermal dosage forms,
modified-release preparation, and some inserts and suppositories for systemic effects.
Reference: USP. <795> Pharmaceutical Compounding- Nonsterile Preparations, USP 41. Accessed from:
https://www.usp.org/sites/default/files/usp/document/our-work/compounding/usp-gc-795-proposed-
revision.pdf

2. Discuss the general principles involved in compounding non-sterile preparations.

- Personnel must be trained and are capable of performing and are qualified to perform their
assigned duties.
- Compounded preparations must be purchased from reliable sources and stored according to
the manufacturer’s specifications or USP standards.
- Bulk component containers must be labeled with appropriate OSHA hazard communication
labels and MSDSs are available to compounding personnel
- All equipment must be cleaned and properly maintained
- The compounding environment must be appropriate for its intended use
- Only authorized personnel are allowed in the immediate vicinity
- Processes must be always carried our as intended or specified
- Compounding conditions and procedures must be prevented from errors
- All aspects of compounding must be documented
- Adequate procedures and records must exist for investigating and correcting failures or
problems in compounding, testing, or the preparation itself.
Reference: USP. <795> Pharmaceutical Compounding- Nonsterile Preparations, USP 41. Accessed from:
https://www.usp.org/sites/default/files/usp/document/our-work/compounding/usp-gc-795-proposed-
revision.pdf

3. Enumerate and describe the factors that influence drug stability.

- Common factors that affect the stability of a drug includes temperature, light, pH, oxidation,
and enzymatic degradation.
- Nature of the drug and its degradation mechanism
- Dosage form and its components
- Potential for microbial proliferation in the preparation
 - Container in which it is packaged
- Expected storage conditions
- Intended duration of therapy
Reference: USP. <795> Pharmaceutical Compounding- Nonsterile Preparations, USP 41. Accessed from:
https://www.usp.org/sites/default/files/usp/document/our-work/compounding/usp-gc-795-proposed-
revision.pdf