Introduction to Non-Sterile Compounding 2024

Introduction to Non-Sterile Compounding Learning Objectives 1. Be familiar with reasons to compound or not compound 2. Recognize compounding regulations that apply to compounded nonsterile products 3. Define common terms related to compounding 4. Compare and contrast solutions and suspensions 5. Ide...

Introduction to Non-Sterile Compounding Learning Objectives 1. Be familiar with reasons to compound or not compound 2. Recognize compounding regulations that apply to compounded nonsterile products 3. Define common terms related to compounding 4. Compare and contrast solutions and suspensions 5. Identify the components of a non-sterile compounded formulation (active ingredient, inactive ingredient, wetting agent, base) and recognize common examples 6. Convert between common units (ex. Milligrams to grams, pounds to kilograms, milliliters to ounces) and solve calculations using these conversions 7. Understand percentage preparations and be able to use this when performing pharmacy calculations Definition Compounding is the combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling, or otherwise altering a drug or bulk drug substance to create a preparation that meets the unique needs of an individual patient Provides tailored therapy to patients (human or animal) who may not be able to use commercially available products due to dosing requirements, allergies, or rare diseases. Products are prepared in limited quantities as a result of a prescriber-patient-pharmacist relationship May also include preparations made for research purposes Shrewsbury RP. Applied Pharmaceutics in Contemporary Compounding. 4th ed. Englewood, CO. Morton Publishing, 2020. Allen LV. The Art, Science, and Technology of Pharmaceutical Compounding. 6th Edition. American Pharmacist Association, 2020. Reasons to Compound Remove allergens (excipients) Limited strength options Change dosage form (ex. patient cannot swallow or making a dosage form more appealing to a child) Conceal taste of a medication (flavoring) Unavailable products or combinations Change release of a medication Animals/veterinary pharmacy Drug discontinued or on backorder When Not to Compound Medication is commercially available Cost or monetary reasons is not a valid reason to compound Avoid compounding for food animal species (very rare situations) Compounding does not apply to: Splitting tablets Reconstituting conventionally manufactured products in accordance with the manufacturer’s instructions (ex. Antibiotic for suspension) Repackaging/prepacking conventionally manufactured products USP FAQs November 1, 2022. Accessed 4/10/23. Available at: file:///Users/000051444/Downloads/USP22_HQS_Compounding_795_FAQ_Document_V2a-2.pdf Kienle P. The Chapter Answer Book. 2nd Edition. Published 2023 by American Society Of Health-System Pharmacists, Bethesda ISBN-13: 978-1-58528-722-2, ISBN: 1-58528-722-9 Common Compounded Non-Sterile Preparations (CNSP) Topical (ointments, creams, lotions, gels, stick) Oral liquids (solutions, suspensions, emulsion) Tablets Capsules Troches Lollipops Suppositories Examples from Practice Oral hormone replacement therapy (HRT) Thyroid treatment Phenytoin gel (wound healing) Ginger lollipops (nausea) Omeprazole or Lansoprazole suspension (infants with GERD) Captopril oral solution (vet) Suppositories (hemorrhoids) Veterinary Compounding Veterinary Compounding Drugs compounded for use in animals Various dosage forms including oral, topical, parental, transdermal Must consider patient size, anatomy, physiology, safety, sensitivity, as well as safety of personnel administering doses. Often larger volumes and sometimes multiple injection sites. Best to avoid compounding for food animal Safety Includes the safety of you, your team, and your patients Dust, contact residue, volatiles: “It’s what you can’t see” Personal protective equipment (PPE) Cleaning procedures important Proper handwashing Working inside a hood Workflow (formulation, list of supplies, etc - have a plan) Standard Operating Procedures (SOPs) Compounding Software Quality control Equipment Equipment Mortar and pestle (mixing and grinding materials, reducing particle size) Graduated cylinders (measure liquids) Balance (weigh solids) Spatulas (mixing materials) Ointment slab (to work on) Hot plate (heating and mixing) Magnetic stir bar and glass rod (for stirring) Thermometers Equipment Reminders Measuring liquids: Select the appropriate size Find the meniscus: Equipment Reminders Weighing solids: Use rubber spatulas: Equipment Reminders Measuring temperature: Incorrect Method: Compounding Regulations State Board of Pharmacy* Compounding is primarily regulated by state boards of pharmacy USP Standards Sets standards for compounding which states may choose to enforce Minimum requirements FDA: Drug Quality and Security Act (DQSA) Compounded drugs are not FDA approved DQSA was created in 2013 to give the FDA more authority to regulate and monitor compounding Helps to regulate raw materials used in compounding Category 503A and 503B Pharmacies Iowa Board of Pharmacy Compounding Regulations United States Pharmacopeia (USP) Convention issues national standards that apply to compounding USP General Chapter : applies to compounded sterile preparations. USP General Chapter : applies to compounded nonsterile products USP General Chapter : establishes practice and quality standards of hazardous drugs to minimize the exposure to hazardous drugs within health care settings * USP officially updated November 1, 2023 The Art, Science, and Technology of Pharmaceutical Compounding, 6th Edition 2020. https://doi-org.cowles-proxy.drake.edu/10.21019/9781582123578.ch21 Compounding Regulations USP General Chapter Major Updates: Personnel Training: All personnel involved must undergo initial training, demonstrate competency, and have a documented refresher training every 12 months Core competencies of training: hand hygiene, garbing, cleaning and sanitizing, handling and transporting components and CNSPs, measuring and mixing, proper use of equipment, documentation More specifics on cleaning and sanitizing Beyond Use Dates: Significant changes Introduce concept of water activity (aw) Water - impacts microbial growth and degradation mechanisms Revisions became official on November 1, 2023 Revised General Chapter Published is USP-NF: Available at https://www.uspnf.com/notices/795-pub-announcement-20221101 Personal Hygiene and Garbing for Non-Sterile Compounding Required: Gloves and handwashing Remove any personal jewelry, watch, etc. Wash hands and forearms up to the elbows with soap and water for at least 30 seconds (minimum) Rinse from fingertips to elbows Dry hands and forearms to the elbows completely with disposable towels or wipes Allow hand and forearms to dry thoroughly before donning gloves Personal Hygiene and Garbing for Non-Sterile Compounding Recommended Garb Shoe, head, and facial hair covers Masks and gowns Eye protection Garbing requirements and frequency of changing should be outlined in SOP Protect personnel from chemical exposure and prevent contamination of preparations https://go.usp.org/USP_GC_795_FAQs Beyond Use Date (BUD) Beyond use dates are the date after which a compounded preparation must not be used Determined from the date/time the preparation is compounded Different than an expiration dates (established by manufacturer based on stability testing) Identifies the time by which a preparation, once compounded, is at increased risk for: Physical or chemical degradation Microbial contamination and proliferation Impact on integrity due to the container closure system USP Compounding Standards and Beyond Use Dates. Accessed 4/10/23. Available at: https://go.usp.org/USP_GC_795_FAQs Beyond Use Dates (BUD): Non-Sterile Compounding Updated Beyond Use Dates based on Revised Non-Sterile Compounded Formulation BUD Storage Non-preserved aqueous dosage forms 14 days Refrigerator Preserved aqueous dosage forms 35 days Controlled room temperature or refrigerator Oral liquids (non-aqueous) 90 days Controlled room temperature or refrigerator Other non-aqueous dosage forms 180 days Controlled room temperature or refrigerator *Aqueous is defined as: aw > 0.6 and Non-Aqueous is defined as: aw < 0.6 * aw = water activity (ie. the available water to support microbial growth or hydrolytic reactions). * Guidance on water activity can be found: 1. USP Table 3 (gives a determined water activity for some common preparations). 2. United States Pharmacopeial Convention. General chapter