ACPE-Approved Nonsterile Compounding Certificate for Pharmacists

Compounding medications requires specialized training and knowledge. Changing a medication formulation can affect its stability and effectiveness. Compounded medications provide important treatment options for patients with specific clinical needs not met by existing products. Risks, such as bacterial or fungal contamination and calculation errors leading to under- or over-dosing, are possible with compounding. For quality and safety, several pieces of legislation define the oversight of compounding. State boards of pharmacy and the Food and Drug Administration share oversight of compounding with several additional federal agencies. The United States Pharmacopeia (USP) publishes standards for compounding to ensure patient safety. USP Chapters 795 and 800 apply to the compounding of nonsterile preparations. Knowledge of these standards and adherence to them are crucial to minimizing common errors and improving patient safety.

Documentation is vital to the nonsterile compounding process. Proper documentation has implications for patient safety, legal compliance, and quality assurance. Meticulous record-keeping is crucial in promoting optimal outcomes. Pharmacy technicians involved in nonsterile compounding should be well-versed in managing various records, including Master Formulation Records (MFR) and Compounding Records (CR). With a firm grounding in standards and best practices related to documentation and record-keeping, compounding personnel will be better equipped to ensure quality and consistency in compounded preparations.

Pharmaceutical compounding involves preparing medications that are unique to the specific health needs of a patient. Pharmacy technicians who compound nonsterile medications should be well-versed in compounding standards and skilled in the techniques needed to prepare medications that are effective, safe, and of high quality. This continuing education program will review techniques related to compounding nonsterile preparations, including particle size reduction, weighing, and mixing. Additionally, techniques for preparing capsules, tablets, solutions, suspensions, suppositories, ointments, and lozenges will be described. The process of assigning beyond-use dates to CNSPs will also be discussed.

Developing compounding plans should be based on the practitioner-patient-pharmacist relationship. Dosage forms are the physical unit or form in which drugs or active pharmaceutical ingredients are prepared for delivery. Physical, mechanical, and chemical properties of formulation parameters, such as disintegration, dissolution, absorption, and shelf life, influence dosage form in compounding decisions. Pharmacy personnel ponder these factors and frequently prepare dosage forms to meet individual patients' needs or bridge supply chain problems or product shortages. Pharmacy teams providing compounded formulations are poised to provide dosage forms such as powders, capsules, tablets, lozenges, suppositories, solutions, ointments, and others to ensure active ingredients reach the intended treatment site. Important dosage form considerations include tips for compounding the preparations, patient counseling, and recalling examples of formulations. Increasing awareness of dosage forms and administration can advance competencies and confidence in shared decision-making, improve compounding discussions with prescribers, and optimize patient outcomes based on individualized dosage forms.

This course provides an overview of the facilities, equipment, and supplies necessary for non-sterile drug compounding practices. It is designed to equip pharmacy professionals with the knowledge and skills to adhere to the highest standards of compounding nonsterile formulations and safely handling hazardous drugs. Covering a broad spectrum of topics, from the basics of compounding facilities, equipment, and supplies to the intricacies of complying with state and federal regulations, this course is crucial for anyone involved in preparing medications for human and animal use. Participants will review the principles of good compounding practices and the specific guidelines outlined in USP Chapters 795 and 800. This course aims to ensure that compounders can produce medications of acceptable strength, quality, and purity while maintaining the safety of the compounder and the patient.

Flavoring medications has been described as both an art and a science. Compounding personnel should recognize that this process extends beyond simply adding flavoring or sweetening agents to a compounded preparation. Instead, flavoring involves understanding how to select and combine appropriate flavoring agent(s), namely one or more that complement the medication well, do not adversely affect the stability or compatibility of the formulation, and are preferable to the patient. The ability to appropriately flavor and sweeten medications is a crucial skill of pharmacy personnel that helps optimize patient adherence while ensuring the medication remains stable, safe, and effective. This continuing education activity will discuss various methods to flavor and sweeten medications, describe these processes for pediatric and veterinary preparations, and compare available sweetening agents.

A strong understanding of pharmaceutical calculations allows pharmacy technicians to prepare compounded nonsterile preparations accurately and safely. This course provides an overview of fundamental pharmaceutical calculations, including units of measurement, conversions, the ratio and proportion method, dimensional analysis, expressions of concentrations, density, and specific gravity. The alligation and aliquot method will be reviewed, as well as drug dosing and reconstitution calculations. Step-by-step example problems will be provided to aid the learner in understanding these concepts.

This course provides training in the methods and standards required for compounding nonsterile pharmaceutical products. Participants will learn about Quality Assurance (QA), which encompasses a series of programs to ensure that procedures used in compounding meet specific standards to prevent errors. These standards include rigorous training and evaluation of pharmacy personnel, monitoring and testing of compounding equipment, and assessment of compounded products and patient outcomes. The course also covers Quality Control (QC), which focuses on testing ingredients, devices, and final products to ensure they meet identity and purity standards to catch errors. Essential record keeping, which supports effective QA and QC practices by documenting each step of the compounding process, will also be a key component of the curriculum.