PTCE: The Basics of Order Entry and Processing

KNOWLEDGE DOMAIN 4.0 - Knowledge Area 4.1: Procedures to compound non-sterile products (e.g., ointments, mixtures, liquids, emulsions, suppositories, enemas)
- Knowledge Area 4.2: Formulas, calculations, ratios, proportions, alligations, conversions, Sig codes (e.g., b.i.d., t.i.d., Roman numerals), abbreviations, medical terminology, and symbols for days supply, quantity, dose, concentration, dilutions
- Knowledge Area 4.3: Equipment/supplies required for drug administration (e.g., package size, unit dose, diabetic supplies, spacers, oral and injectable syringes)
- Knowledge Area 4.4: Lot numbers, expiration dates, and National Drug Code (NDC) numbers
- Knowledge Area 4.5: Procedures for identifying and returning dispensable, non-dispensable, and expired medications and supplies (e.g., credit return, return to stock, reverse distribution)

Skills You Need To Know:
- Define the term compounding, describe common situations in which compounding is required, and identify examples of non-sterile compounding.
- Identify the steps that are necessary in the compounding process.
- Understand the techniques by which solutions, suspensions, ointments, creams, powders, suppositories, and capsules are prepared.
- Understand the intake process, including prescription interpretation and data entry.
- Calculate doses that are required in order to process prescriptions, including days supply, quantity, dose, volume, etc.
- Perform pharmacy calculations.
- Learn commonly used formulas that are needed to fill prescriptions.
- Interpret commonly used abbreviations.
- Learn commonly used medical terminology.
- Be familiar with the equipment/supplies that are needed for drug administration.
- Understand the procedures that are used to identify medications that are returned to the pharmacy for credit, that are to be returned to stock, or that are using reverse distribution.

Manufacturers supply dosage forms to meet the needs of a majority of their patients. Sometimes a dosage form is unavailable, not currently on the market for that drug, or not carried by the pharmacy. In these cases, the pharmacist uses his or her chemistry background and knowledge of medications in order to make a special preparation. This process of mixing and preparing drug components to meet a patient’s needs is called extemporaneous compounding.
Technicians may be called upon to assist the pharmacist with these preparations. Compounded preparations can be made to adjust a dose, flavor a medication, reformulate the drug to remove an ingredient that a patient is allergic to (such as gluten), or even change a dosage form to one that is more suitable for the patient (e.g., changing from a tablet to a suspension).

Compounding vs. Manufacturing
Compounding is the formulation of an individual compound that is made specifically to meet a patient’s needs. It is not commercially available, and it is not available to be resold by the patient or the prescriber. Manufacturing involves batch compounding of FDA-approved compounds that are then sold to pharmacies or health care practitioners.
Extemporaneous compounding can be broken down into two categories: sterile compounding and non-sterile compounding. Sterile compounding is used for intravenous solutions, parenteral nutrition, and ophthalmic formulations. Non-sterile compounding is used for tablets, capsules, creams, ointments, suspensions, suppositories, transdermal applications, and troches.
The United States Pharmacopeial Convention is the leading authority in setting standards for product safety and purity. This nonprofit organization publishes a compendium called the USP-NF (National Formulary) with standards for chemical substances, compounded products, dosage forms, medical supplies, and dietary supplements. USP <795> (Chapter 795) describes compounding practices and procedures that are used for non-sterile preparations. USP <797> (Chapter 797) provides specific procedures and methods that are used for compounding sterile preparations.

Non-Sterile Compounding
Non-sterile compounding refers to any oral, transdermal, vaginal, or rectal medicinal preparations formulated using strict quality control standards. The use of high-grade pharmaceutical ingredients, along with training of personnel, safeguards against calculation errors, and documentation, certifies the preparation’s stability and consistency. USP <795>, the first set of enforceable standards that guide non-sterile compounding preparations, provides both guidelines and procedures for compounding with the intent of protecting both the patient and the preparer. These standards include:
- Ensuring pharmaceutical ingredient purity and potency
- Maintaining accuracy when mixing compounds in order to make customized medications
- Providing proper documentation on compounding procedures
- Maintaining and supplying acceptable packing, storing, and labeling
- Keeping all surfaces and equipment clean
- Using purified water when mixing compounds or when cleaning surfaces and equipment

Compounds may be prepared for specialty practices, including dermatology, home care, hormone replacement therapy, hospices, men’s health, pediatrics, podiatry, veterinary medicine, and women’s health. Pharmacy technicians may be required to obtain special certification and training to work in a designated compounding pharmacy. The Professional Compounding Centers of America (PCCA) offer certification and training for compounding professionals.
Non-sterile compounding can be divided into three distinct categories.

Table: Non-Sterile Compounding Categories

A proper environment with adequate space designated for compounding is required. The compounding facility should have an abundant supply of both clean hot and cold water. This supply should include purified water for washing equipment and supplies, as well as for compounding prescriptions that require the addition of water. Controlled lighting and temperature are necessary to avoid contamination and decomposition. The designated area should also be free of dust and contain an eye wash station.

Product Inventory
All bulk products are typically stored in tight, light-resistant containers at room temperature. Expiration dates, sources of ingredients, and NDC numbers are commonly checked to ensure accuracy and purity. Safety data sheets (SDS) for all non-sterile compounding procedures should be kept in the designated compounding area. Schedule II controlled substances should be locked in a designated area that is accessible to the pharmacist. Beyond-use dating (BUD) is used for compounded products and indicates the time by which mixed preparations should be used to avoid physical and chemical degradation of the excipient, microbial contamination, proliferation, and an impact on the integrity of the container-closure system. Beyond-use dating is initiated at the time of compounding. As stated in Chapter 6, non-aqueous solutions have a BUD of no later than 6 months or a BUD equal to the earliest expiration date of any active pharmaceutical ingredient (API). Oral solutions that contain water have a BUD of no later than 14 days post reconstitution. Topical solutions and semisolid formulations that contain water have a BUD of no later than 30 days.

Equipment and Supplies
Compounding equipment may vary based on the pharmacy practice specialty. Pharmacy technicians need to be familiar with this equipment (its uses and maintenance).
- MORTAR AND PESTLE: These can be used to compound liquid or solid preparations.

○ Glass, with its smooth surface, is ideal for suspensions, oily agents, and chemotherapeutic agents.
○ Porcelain and Wedgwood provide a coarse-grained surface that is ideal for triturating.
- SPATULA: These instruments are made of stainless steel, hard rubber, or plastic and are used to prepare ointments and creams, loosen material from the surface of a mortar and pestle, and transfer ingredients.
- OINTMENT SLAB: This is a compounding slab made of ground glass. As an alternative, disposable non-absorbent parchment paper may also be used.

- WEIGHING PAPERS AND CUPS: These are disposable plastic or paper containers that are used to weigh powder or solid substances. The weight of the container must be tared out prior to weighing the substance. A tare weight is the weight of the empty container.
- GRADUATED CYLINDER: This is a cylindrical piece of laboratory glassware that is made of glass or polypropylene and is used to measure the volume of a liquid. Capacities range from 10 mL to 1,000 mL. The amount measured should be no less than 20% of the cylinder’s capacity.
○ Liquid measurements are observed at eye level by verifying the volume at the bottom of a meniscus, which is the curved surface that appears due to surface tension. Refer to the Figure below.




Reading a meniscus

- PIPETTE: This is a long, thin, calibrated, narrow glass tube that is used to measure and transfer small volumes of liquid.
- CLASS III PRESCRIPTION BALANCE: This is a two-pan balance system that is used to determine the weight of the material that is being compounded. It is required to have a Class III prescription balance present in all pharmacies.

○ The balance must be calibrated; this process involves using a known weight and properly assessing the scale for accuracy.
○ This device can measure compounds that range in weight from 120 mg to 120 g.
○ This device has a sensitivity read of 6 mg, meaning that 6 mg of a substance will move the pointer of the balance one division off equilibrium.
○ The weights are cylindrical in shape, are often made of brass or polished metal, and range from 1–5 grams, with fractional weights ranging from 10–500 mg.




Class III prescription balance and brass weights

When weighing ingredients using the Class III prescription balance, the following steps should be used:
1. Lock the balance by turning the arrest knob.
2. Verify that the internal weights are set to zero.
3. Level the balance (left to right) by adjusting the leveling screw feet.
4. Place a weigh boat or weighing paper onto each pan.
5. Unlock the balance, and observe the indicator arrow. If the arrow does not rest at the center of the index, then it will be necessary to re-level the balance left to right.
6. Lock the balance, and place the weights onto the right pan. Place the material that is to be weighed onto the left pan using forceps or tweezers.
7. Release the balance, and note the shift on the pointer. If the pointer shifts to the right, there is not enough of the substance and more should be added. If the pointer shifts to the left, there is too much of the substance and some should be removed.
8. Arrest the balance each time before a substance is removed or added in Step 7 (if needed).
9. Write down the final measurement with the top down, and check your work.
10. Return the weights and supplies, clean the balance, close the lid, and verify that the balance is locked.

- REFRIGERATOR AND FREEZER: These devices are used to store supplies.
○ Temperatures should be checked and logged in accordance with the law and pharmacy standards.
○ Refrigerator temperatures range from 2°C to 8°C (36°F to 46°F).
○ Freezer temperatures range from −20°C to −10°C (−4°F to 14°F).
- ELECTRONIC BALANCE: This is a single-pan balance that is used to determine the weight of substances used in compounded prescriptions. This system provides a digital reading and has a sensitivity of 0.1 mg.
- FORCEPS: This is an instrument that is used to grasp or hold small objects. It may also be used to transfer weights.
- MOLDS AND PRESSES: These are reusable trays that are used to prepare rectal and vaginal suppositories, oral rapid-dissolving tablets, troches, and lollipops.
- STIR ROD: This is a glass rod that is usually the thickness of a drinking straw and is used to mix liquids.
- FUNNEL: This is a tube that is made of glass, plastic, rubber, or stainless steel and is wide at the top and narrow at the bottom. It is used to transfer liquids or powders into small openings.
- BEAKER: This is a cylindrical container with a flat bottom that is used to store, mix, or heat liquids.

Containers for Packaging
Compounded products are stored in a variety of packages that range from amber-colored vials or bottles, to ointment jars, and to capsule and suppository boxes or containers. The selection is dependent upon the type of compound that is being prepared. Liquids are housed in amber-colored bottles while ointments and creams are placed into jars. The Topi-CLICK, a type of specialized topical packaging system, is a topical metered-dosing dispenser that provides consistent automated dosing
throughout the patient’s treatment. The Topi-CLICK system can house 1–3 months’ worth of medication, and this system is primarily used for the delivery of topical creams.

Techniques Used to Prepare Prescriptions
The preparation of non-sterile prescriptions is customized according to industry and legal standards to maintain potency and purity. Compounding pharmacists will ensure that the final preparation is pure and accurate, properly labeled, and stored. The following are techniques used to produce compounded preparations:
- TRITURATION reduces the particle size of an ingredient by grinding it into a powder (e.g., by using a mortar and pestle).
- SPATULATION uses a spatula to mix ingredients in a plastic bag, on ointment paper, or via another medium.
- LEVIGATION grinds a powder by incorporating a liquid.
- PULVERIZATION is the process of reducing particle size in a solid by using a substance in which the particle is soluble (e.g., camphor, alcohol).
- GEOMETRIC DILUTION is a technique used when mixing different quantities of two or more ingredients to achieve a homogeneous mixture.

○ First, the smaller-quantity ingredient is mixed with an equal part of diluent (base) until the ingredient is incorporated in the diluent.
○ The diluent is continually added in small amounts until all of it has been incorporated and a homogeneous mixture has been formed.
- SIFTING is a process that is used to blend or combine powders by using a wire mesh sieve.
- BLENDING is a general term that is used to describe the act of combining two substances.
- TUMBLING is a process that is used to mix powders in a bag or container and “tumble” or rotate the container to mix the ingredients thoroughly.
- COMMINUTION is the act of reducing a substance to fine particles.

Non-Sterile Compounding Process
Many different prescriptions can be made using non-sterile techniques. The pharmacist will evaluate the appropriateness of the order and determine product selection. Ingredient selection should be based on National Formulary (NF) or USP guidelines and should meet safety and purity standards.

Table: Compounded Preparations
Common made compounds.

Compounded preparations may include one, two, or multiple ingredients. Active ingredients produce a pharmacological response or change. Inactive ingredients are needed to fill prescriptions but do not produce a pharmacological response.

Table: Commonly Used Inactive Ingredients