Be Prepared: Best Practices for Compounding Medications in Nonsterile Environments
By its nature, the word “sterile” in health care brings to mind cleanliness, proper procedures, safety and trustworthiness. Conversely, use of “nonsterile” to describe anything in a health care setting can be off-putting. When it comes to pharmacies compounding medications in nonsterile environments, however, these preparations are just as crucial to patient care as anything prepared in environments categorized as sterile.
For compounding pharmacies and pharmacists, it is vital to understand what constitutes compounding medications in a nonsterile environment and how to keep those preparations compliant with federal and state regulations.
The difference between sterile and nonsterile preparations comes down to how the medication will be administered. If it is an injection, infusion or will be applied opthalmically, the preparation is considered to be sterile. The nonsterile category includes solutions, suspensions, ointments, creams, powders, suppositories, capsules and tablets—all items that compounding pharmacies create for health care providers in order to ensure the most efficient and most custom patient care.1
United States Pharmacopoeia (USP) further breaks down nonsterile preparations into sub-categories of simple, moderate and complex preparations. Simple compounded medications are simply liquid versions of medications typically administered as tablets or capsules. Moderate preparations require some calculation of dosage or used to indicate a preparation without available stability data, while the complex tag is reserved for preparations that require special training, equipment or facilities. Pharmacists and operators should take note that even simple processes like reconstituting antibiotic suspensions are considered compounding and are covered by USP rules on compounding medications in a nonsterile environment.2
USP is the leading authority on conventions for compounding medications in a nonsterile environment. Guidelines in USP <795> govern nonsterile preparations the same way USP <797> governs sterile preparations. In many states, USP conventions carry the force of law, and in states where they do not, the conventions are still considered the operating standard of practice for all compounding pharmacies.3
Preparing Your Pharmacy and Pharmacists for Compounding Medications in Nonsterile Environments
One of the most important sections of USP <795> is titled “Responsibilities of the Compounder.” Like any pharmacological process, compounding medications in a nonsterile environment is fraught with opportunities for mistakes, which can have far-reaching consequences for patients, providers and compounding pharmacies. The section lays out ten tenets of compounding for all pharmacists and pharmacy operators, including:
- Compounding personnel be appropriately trained and capable of performing the compounding duties;
- The ingredients to be used in the compound medication were purchased from reliable sources and properly stored, a crucial element of compounding that reinforces the importance of having the right supplier relationships;
- All equipment is properly cleaned, maintained and used;
- and that only authorized personnel are allowed in areas where compounding occurs.
The chapter also takes care to clearly lay out requirements for each drug preparation, detailing exactly how each dose should be measured and documented. The preparation criteria specifies, among other guidelines, that:
- Doses must be previously evaluated for chemical and physical properties, what dosage form (topical, capsule, etc.);
- All ingredients have been inspected to make sure they are the correct ingredient, and for purity and quality;
- The workspace is clean and all equipment has been inspected for cleanliness and functionality;
- and that only one preparation may be worked on in each pharmacist’s workspace at a time.
The guidelines go on to repeatedly belie the perceptions that arise from “nonsterile” environments—the chapter is very clear that compounding facilities and compounding equipment need to be rigorously prepared and inspected at all opportunities. USP <795> also heavily emphasizes proper handling and storage, and correctly calculating and labeling compounded medication with beyond-use-dates (BUD). Specifically, the convention states that BUDs should be assigned “conservatively,” in order to ensure that patients will not be taking the compounded medication anywhere close to actual expiration dates. Since compounded medications are designed for swift administration after preparation, proper storage can be the difference between effective medication and unusable doses.4
Considering the complexity of maintaining all aspects of a compounding pharmacy to federal and state standards, operators should implement thorough quality assurance programs to make sure that all of these processes are being followed, documented and checked often.
When it comes to compounding medications in a nonsterile environment, operators should be intimately versed in USP <795> and all applicable federal and state regulations governing compounding pharmacies. The USP conventions exist to ensure the highest-quality medications and the best possible patient care, allowing providers to give patients the medications needed for their individual situation, which is what compounding medications is all about. Operators can set themselves up for success and ensure the best patient treatment by thoroughly preparing their sterile and nonsterile environments.
Pharmaceutica North America is the premier provider of high-quality active pharmaceutical ingredients and custom compounding kits for both sterile and nonsterile compounded preparations. To learn more about how our ingredients and kits can assist your pharmacy with creating compounded medications for patients and providers, please contact us today.
- “Frequently Asked Questions About Pharmaceutical Compounding,” Nov. 19, 2012, http://www.pharmacist.com/frequently-asked-questions-about-pharmaceutical-compounding ↩
- “What is Nonsterile Drug Compounding?” http://pharmacy.about.com/od/Specialty/a/What-Is-Nonsterile-Drug-Compounding.htm ↩
- “ASHP Technical Assistance Bulletin on Compounding Nonsterile Products in Pharmacies,” April 27, 1994, http://www.ashp.org/doclibrary/bestpractices/preptabnonsterile.aspx ↩
- “<795> Pharmaceutical Compounding–Nonsterile Preparations,” Jan. 1, 2014, http://www.usp.org/sites/default/files/usp_pdf/EN/gc795.pdf; “What Does USP <795> Mean to You?” April 18, 2013, http://www.pharmacytimes.com/publications/issue/2013/april2013/what-does-usp-795-mean-to-you ↩