Nearly 9% of the questions on the PTCB Exam will concern compounding. You need to know the best practices and documentation for both sterile and non-sterile procedures that are outlined in this study guide. If you still have questions about anything here, please consult additional resources.
Product preparation in both sterile and nonsterile compounding requires the use of proper techniques to prevent contamination with bacteria or other potentially harmful substances. The main requirements for prevention of contamination differ for sterile and nonsterile compounding and are listed below. USP 797 and 795 outline the procedural requirements for sterile and nonsterile compounding, respectively.
Use appropriate hand washing technique.
Make use of personal protective equipment.
*Clean and disinfect sterile equipment. *
*Complete all product preparation and manipulation in the sterile environment. *
Use appropriate hand washing technique.
Use personal protective equipment.
Clean and disinfect sterile equipment.
Complete all product preparation and manipulation in the sterile environment.
Just like hazardous substances, pharmaceutical waste has specific handling and disposal criteria that is regulated by state law. For waste that is considered to be hazardous, you should follow the information outlined in the hazardous material section of this review guide. Pharmaceutical waste must be handled and disposed of in accordance with the Environmental Protection Agency (EPA) and must meet all state and federal standards. Characteristics that qualify medication waste as hazardous include corrosiveness, ignitability, reactivity, and toxicity and may include medications such as chemotherapy or immunological drugs.
When preparing medications that may cause hazardous waste, all materials must be stored and manipulated in a negative pressure room to protect the preparer. All waste must be labeled as “hazardous drug waste” and stored in appropriate areas in leak-proof containers. All needles or broken glass should be disposed of in a sharps container.
Appropriate documentation is very important for compounded medications and is listed as a requirement under USP 795 and 797. Pharmacies should keep records of all recipes used to make compounded products, as well as specific information for each individual product produced. All compounding records have the same retention requirements as other prescriptions according to state law. The requirements for each differ and are shown here:
Product compatibility and stability are extremely important for all compounded medications to maintain the integrity and safe use of the medication product. This includes using only compatible substances in a preparation and using the correct beyond-use dating to signify the product is still “good.” Just like for any other medication, the beyond-use date is the date when the medication product should not be used. Unlike other medications, however, compounds generally have a much shorter beyond-use date.
The length of stability varies for each specific compound and may be lengthened by using stabilizing agents in the preparation. Consult the product recipe for the specific compound you are preparing. If unknown, the following general rules apply to nonsterile compounds:
Capsules, tablets, other products not made with water—6 months maximum (unless one ingredient has an earlier beyond-use date)
Oral solution with a water base—14 days maximum
Topical solution, ointments, creams—30 days maximum
Sterile compounds have different requirements and generally have even shorter beyond-use dates than nonsterile compounds to ensure sterility of the product.
You should always check the physical product after making the compound to make sure it is stable and compatible. Signs of incompatibility include:
Formation of a precipitate
A color change from the original product
Separation of the ingredients
Note: Not all incompatibility is visible.
There are several pieces of equipment used during sterile compounding, all of which are used within a class 5 clean room as outlined in USP 797 and the International Organization for Standardization (ISO) environmental standards.
Laminar Flow Hood
The laminar flow hood creates an ultra clean environment for sterile compounding by using a High-Efficiency Particulate Air (HEPA) filter, which blows air downward and outward from the top and back of the hood, respectively. The air passes through an ultrafine filter before being blown across the workspace, which ensures it is particle-free and reduces the risk of product contamination. The hood needs to be cleaned prior to use and should be inspected on a regular basis to make sure it is working properly.
Vials—Glass containers with rubber stoppers that contain concentrated medication to be diluted or reconstituted and then diluted as part of a final medication product. Once the plastic lid is removed, vials should be swabbed with 70% isopropyl alcohol prior to any manipulation with a needle. Vials may be single- or multi-use containers. Ampules—Glass containers that can be used only once. Instead of having a rubber stopper for access to its contents, an ampule must be broken at the neck (the thinnest part of the ampule) to expose its contents. Because small glass particles may fall into the solution inside, the contents of an ampule must be withdrawn using a filter needle to prevent contamination. Once the solution is in the syringe, the needle must be changed before any further manipulation can occur.
Syringes—There are three distinct parts of a syringe: the plunger, barrel, and needle. The plunger is used to move medication through the barrel and out the tip through the needle. The internal aspect of the plunger is sterile and should not be touched during product manipulation. All needles should be discarded in the sharps container.
IV Bags— These are used for diluting and administering medications and come in multiple sizes with various diluents. Each bag contains two distinct ports: one for injecting medication and the other for administration to the patient. Before any manipulation during sterile compounding, the injection port needs to be sterilized with 70% isopropyl alcohol.
Because of the variety in the types of nonsterile compounding, the types of supplies needed will depend on the specific preparation. Several key pieces of equipment are common and will be discussed in more detail below. It is important to note that the list is not all-inclusive. For a more comprehensive list, refer to USP 795.
Mortar and Pestles— Mortars and pestles are used in mixing ingredients together to form various types of liquid-based mixtures. Different mortar and pestles are ideal for specific products. For example, glass is preferred when making suspensions, oil-based mixtures and porcelain is preferred for blending powders or making wet/dry emulsions.
Spatulas—Similar to use when baking, spatulas are used for combining or transferring ingredients and can also help to ensure components are evenly mixed together. Spatulas can be made out of multiple types of materials but are generally plastic or rubber in nature.
Graduated Cylinders—These are used to specifically measure liquids required during product preparation. Always measure from eye level.
Refrigerator and Freezer—All pharmacies are required to have both, and the temperature should be checked regularly and logged in accordance with state law.
Prescription Balance—All pharmacies are required to have a class A prescription balance that uses brass weights to measure ingredients down to 6 mg increments. The balance uses a counterweight system to determine the specific weight of solid ingredients. Because of the limited specificity, alloquats and geometric dilutions are often needed to measure small quantities. To eliminate this challenge, pharmacies may also use an electric balance, which is more specific and has a digital readout.
Product Molds—Capsules, suppositories, lollipops, gummies, troches, etc. all require molds to be prepared adequately in non-sterile compounding. Use the appropriate instructions for each type of mold to ensure the best possible products.