Compounding is an integral part of pharmacy practice and is essential to the provision of health care. The purpose of this chapter and applicable monographs on formulation is to help define what constitutes good compounding practices and to provide general information to enhance the compounder’s ability in the compounding facility to extemporaneously compound preparations that are of acceptable strength, quality, and purity. The pharmacist’s responsibilities in compounding drug preparations are to dispense the finished preparation in accordance with a prescription or a prescriber’s order or intent and to dispense those preparations in compliance with the requirements established by the Boards of Pharmacy and other regulatory agencies. Compounders must be familiar with statutes and regulations that govern compounding because these requirements vary from state to state. The compounder is responsible for compounding preparations of acceptable strength, quality, and purity with appropriate packaging and labeling in accordance with good compounding practices see Good Compounding Practices , official standards, and relevant scientific data and information. Compounders engaging in compounding should have to continually expand their compounding knowledge by participating in seminars, studying appropriate literature, and consulting colleagues. The compounder is responsible for ensuring that the quality is built into the compounded preparations of products, with key factors including at least the following general principles. See also Good Compounding Practices Personnel are capable and qualified to perform their assigned duties.
A beyond-use date is a date placed on a prescription by a pharmacy for compounded medications they prepare, noting when that prescription should no longer be used. This date is determined by the pharmacy when they prepare a compound prescription based on different factors, including:. The beyond-use date is different than an expiration date of a drug.
This includes moving a medication to a different container, which is the normal practice for pharmacies dispensing prescriptions.
Beyond-use dating for repackaged oral liquids can be a challenge. Although the USP has guidelines for assigning BUDs, it can often depend.
Unit-dose Packaging. Linda F. The unit-dose packaged medication system has been available since the s; however, it has become a standard of practice for health-systems in the U. Patients are charged for only the medications that they actually receive and not charged for an entire bulk bottle. Each dose can be barcoded to allow for new technologies, such as patient bedside scanning and electronic chart documentation.
Unit-dose packaging is often not very profitable for the drug manufacturers, and hundreds of common drugs are not commercially available in unit-dose packaging. Fortunately, there are several options available for unit-dose packaging drugs from bulk bottles: automated, semi-automated, manual, and outsourcing.
FDA Draft Guidance on Expiration Dating of Unit-Dose repackaged Solid Oral Dosage Forms
Beyond use dating for oral liquids Footnote a procedure for extension of compounded nonsterile components manufactured nonsterile preparations. For the beyond. Currently usp definition, added sterile compounded products must include mixing, or less depending on ingredients. C-Pecs used.
Examples include Captopril Oral Solution, and Indomethacin Topical Gel, and Liquids. Lozenges. Sprays. Creams. Powders. ES. Pastes. Labeling, Labeling, Expiration Date and Beyond-Use Date) based on the nature.
A parent who is considering giving expired acetaminophen to a febrile, crying child at 3 a. Since , drug products have been required to have an expiration date. The expiration date does not imply that just after the stated date, the drug is no longer viable, chemically stable or dangerous to use. The expiration date is the date that the manufacturer guarantees full potency and safety of the drug when it is stored in the original sealed container under proper conditions.
The manufacturer is permitted to determine from stability testing what expiration date to label a drug product. Most commonly, expiration dates are 1 to 5 years past manufacture. When a drug product is dispensed from a pharmacy, the vial or bottle label specific for the patient will commonly list an expiration date of 1 year from the date of dispensing, even if the original drug product bottle is stamped with an expiration date of more than 1 year.
This 1-year date is referred to as the beyond-use date.
Don’t Guess Any Longer! Read the Guide on Ex-Date for Unit Dose Repackaged Products
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Stability of extemporaneous oral liquid aprepitant formulation. extemporaneous oral liquid formulations of oseltamivir using commercially available capsules.
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Azurity currently offers a comprehensive product portfolio that serves multiple therapeutic areas, with more on the way! A growing portfolio of products designed to fulfill unmet needs of both pediatric and elderly patients. A family of prescription compounding kits designed as an alternative to conventional dosage forms. September 25, — Azurity Pharmaceuticals, a specialty pharmaceutical company that makes safe, high-quality treatments for patients requiring customized formulations for their care, announced today that Katerzia amlodipine Oral Suspension, September 11, – This September two companies met and became one, Azurity Pharmaceuticals is the beginning of that new family.
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Furosemide 10 mg/mL Oral Suspension
A: USP considers adding flavoring to a conventionally manufactured product to fall within the scope of compounding, because there are known instances when flavoring components have destabilized a product. If a flavoring component is added to a manufactured product that does not contain a preservative e. If a flavoring component is added to a manufactured product that contains a preservative e.
Beyond Use Dating (BUD). – Does the pharmacy compound oral preparations (tablets, capsules, liquids, lozenges, etc.)?
Acetazolamide : Allen LV Jr. Stability of acetazolamide, allopurinol, azathioprine, clonazepam, and flucytosine in extemporaneously compounded oral liquids. Am J Health-Syst Pharm. Stability of Adderall in extemporaneously compounded oral liquids. Allopurinol : Allen LV Jr. Alprazolam : Allen LV Jr. Stability of alprazolam, chloroquine phosphate, cisapride, enalapril maleate, and hydralazine hydrochloride in extemporaneously compounded oral liquids.
Stability of aminophylline in extemporaneously-prepared oral suspensions. J Inform Pharmacother.
Compounding FAQ for veterinarians
Compounding is an integral part of pharmacy practice and is essential to the provision of health care. Compounders must be familiar with statutes and regulations that govern compounding because these requirements vary from state to state. The compounder is responsible for compounding preparations of acceptable strength, quality, and purity with appropriate packaging and labeling in accordance with good compounding practices see Good Compounding Practices , official standards, and relevant scientific data and information.
The exact one hour “beyond use date” (see below). A drug or biological Does the nurse remain with the patient until oral medication is taken?
Beyond use dates are different from expiration dates. Expiration dates are required on commercially manufactured products and are determined after extensive study of the product’s stability. Most expiration dates are given in years for commercial products. Beyond use dates are used for compounded preparations and are generally in days or months. The major problem for pharmacists is that the stability of compounded formulations often is not known. Also, Many instabilities cannot be detected without the use of analytic equipment.
This is in contrast to incompatibilities that can be visually observed. It is not possible to use a manufacturer’s expiration date and extrapolate or estimate a beyond use date for a compounded formulation. The compounded formulation probably will not be identical to the manufactured product; it may have a different drug concentration, use different diluents, be a different fill volume, and be packaged in a different container type.
When an official monograph isn’t present, a systematic approach to assigning the date can be as follows:. Step 1. Beyond use dates should be in accordance with the manufacturer’s approved labeling. This means that the product was formulated according to the manufacturer’s directions, or that the formulation contains the same concentration of drug, in the same diluent, in the same packaging, for the same intended period of use, and so on.
3 Current good manufacturing process and current good cumpounding practices
Amancio Henrique Damasceno flag Denunciar. Courtesy of Elan Corporation, plc. Medical devices also are subject to the reporting of adverse events, to recall, and to termination of approval.
Beyond-Use Dating – the expiration date of compounded preparations based on Oral syringes are more accurate when measuring thick, viscous liquids.
Consequently, compounding fills therapeutic gaps. Pharmacist competence in providing pharmaceutical care and compounds for animal patients is critical because they are the only health care providers expected by society and permitted by law to provide pharmaceutical care for all species—humans and nonhumans. Almost two-thirds of US households have pets. Pharmacists are also well positioned to collaborate with veterinarians to provide high quality compounded formulations that are safe and have optimal compositions to deliver the intended therapeutic effect.
This activity is intended to provide pharmacists and pharmacy technicians with:. Perhaps one of the most critical elements for compounded preparations is to interpret prescription abbreviations and instructions correctly. Veterinary medical education evolved independently from human health care education, and classically trained pharmacists and pharmacy technicians often find abbreviations used on veterinary prescriptions unrecognizable.
Prescription review for nonhuman patients requires a novel dimension of due diligence.