It is important to note that BUDs and expiration dates are not the same. Beyond use dating applies the same expiration dating principles, but adds the consideration of sterility. Each category differs in the potential for microbial contamination during the compounding of the admixture. By following this guideline, compounding personnel ensure consistent compounding practices. The guideline also serves as quick reference of stability information for appropriate assignment of beyond use dating. These guidelines are established and maintained at individual practicing locations with varying levels of detail and accuracy. Most often, the guidelines are generic; stability is granted for a particular medication in a particular diluent, without appropriate references for specific concentrations. In an effort to improve sterile compounding across a multihospital system, we developed the following beyond use dating guidelines eAppendix to improve consistency and patient safety while meeting regulatory concerns.
Stability of Drug
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.
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.
Beyond-use dates for compounded preparations are usually assigned based on When assigning a beyond-use date, pharmacists should consult and apply.
In our latest question and answer, the pharmacist discusses the difference between ‘expiration date’ and ‘beyond use’ date as well as what they mean. I was prescribed Doxycycline hyclate on Sept 19, and never took them. Can I still take them or are they expired? Medications are required to be labeled by the manufacturer with two key pieces of information on the packaging:. The above quote is referring to required and standard qualities like safety, potency and purity of a drug.
When a pharmacy dispenses you a medication, it must be labeled with an expiration date or a beyond use date. Per the FDA, the beyond use date is defined as:. The beyond use date that is listed depends on the product being dispensed and takes into account how long a drug is stable after being dispensed.
A beyond use date BUD is the date after which a compounded preparation shall not be used. The BUD is determined from the date the preparation is compounded. This date should be based on drug-specific, scientifically valid studies when possible.
pharmacist in this particular near-miss situation almost dispensed a compounded preparation intended to be used past the acceptable beyond-use date. This.
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Using a Pharmacy Glove Box for Compounding Sterile Preparations
To support compounding of products that are sterile and chemically stable, beyond use dating of admixtures must include a thorough evaluation of appropriate resources. In most instances, resources provide documentation of a specific compounded admixture, at a specific concentration and storage parameters, that does not coincide with current operations or patient-specific requirements. To meet the operational demands of a pharmacy, institutions employ a referenced guideline approach to guide decision making for safe sterile admixing.
Regarding sterile compounding, pharmacists should pay particularly close In the absence of sterility testing, what beyond use dates (BUDs) must be used?
The chapter was to have become official on December 1, , but USP-NF announced on September 23, , that appeals were pending on provisions of the chapter regarding beyond-use dating, use of alternative technologies proven equivalent to those described in the chapter, and applicability of the chapter to veterinary practitioners. This notice and content of this program will be updated as events occur.
Compounding has been a fundamental aspect of providing medicines to patients for centuries. Physicians, chemists, and pharmacists manipulated naturally derived products including those of plant, mineral, and animal origin into medicines. They did this through mixing, grinding, filtering, percolating, heating, and distilling, which led to preparations of vinegars, extracts, infusions, elixirs, syrups, tinctures, ointments, and pills. Today, compounding has made a resurgence because of many drug shortages in recent years; the need for customized drug formulations as a result of allergies; special dosage forms for pediatric patients, geriatric patients, and special needs populations; and the movement toward specialty and personalized medicines.
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A As used in this chapter of the Administrative Code: 1 “Compounding”, except as provided in paragraph A of rule of the Administrative Code, means the preparation, mixing, assembling, packaging, and labeling of one or more drugs. Compounding includes the combining, admixing, mixing, diluting, reconstituting, or otherwise altering of a drug or bulk drug substance,.
An in-state pharmacy does not include a nuclear pharmacy as defined in rule of the Administrative Code.
Beyond-Use Date Standards in General Chapters and a coalition of compounding pharmacies and professional associations.
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.
Three concepts that create a lot of confusion: stability, beyond-use date, expiration
In sterile health care organizations, patients receive compounded sterile preparations CSPs that are stored for extended periods before use. It has long been recognized that extended storage of Date may allow for the growth of a pathological bioburden of microorganisms and that patient pdf and mortality can result from contaminated or incorrectly compounded sterile preparations. These guidelines are intended to help compounding personnel prepare CSPs of high quality and reduce the potential for harm to patients and consequences for compounding personnel.
Pharmacy supports the incorporation of compounding regu- lations into state beyond-use dating for sterile preparations compounded in a segregated.
RAA is managed by Somnia. Q: As a practicing consultant pharmacist to ambulatory surgery centers, I am often asked about the beyond use dating of medications drawn into syringes. Since most ASCs do not have an isolator or glove box for this procedure, I advocate following USP , and consider those pre-drawn syringes an immediate-use compounded sterile preparation, and suggest a one-hour beyond use dating. Is this too stringent?
Does USP apply in these situations if they are not IV admixtures but are, for example, injectable local anesthetics which are not given intravenously? Clifford Gevirtz: Yes, I think you the consulting pharmacist are going a bit far in your interpretation. To quote from the USP guideline www. However, if the expiration date of the vial is sooner than 28 days, then it expires on that date.