The conditions which a compounded sterile preparation CSP is stored under plays an important role in determining the beyond-use date BUD. A beyond-use date BUD is the date or time after which administration of a CSP shall not be initiated and is determined from the date or time the preparation is compounded 1. The BUDs described here are based on the risk of microbial contamination, and assume that the CSP components can remain chemically and physically stable. Storage in a refrigerator or freezer has shown to slow the growth of microorganisms allowing for longer BUDs for CSPs stored under colder temperatures versus controlled room temperature. Preparation characteristics also play a role in determining BUD. Those characteristics include method of achieving sterility, if sterility testing is performed, and if a preservative is added. Thorough preparation combined with enhanced storage conditions refrigeration and freezing can dramatically increase the time that the CSP can be stored before administration. The storage time of the CSP must not exceed the original BUD even if the storage conditions change, such as storing a CSP at room temperature and then storing it in the freezer. Some CSPs may be stored under various conditions before use. For example, a CSP may be frozen, thawed in a refrigerator, and then stored at room temperature before administration.
PH-06-07: Beyond-Use Dating and Labeling – University of Kentucky
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.
(USP) chapter , Pharmaceutical Compounding—Sterile. Preparations To help beyond-use dating for sterile preparations compounded in a segregated.
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.
Based on the type of drug, how fast it degrades, dosage, type of container, storage conditions, prescription length, the likelihood of contamination. Based on testing a drug in specific conditions related to storage containers, lighting, temperature, etc. The FDA says it’s dangerous to take medications after their expiration date because they may not be as effective, their chemical composition may have changed, or they may have deteriorated to a point where harmful bacteria could breed.
Particularly with antibiotics, it’s important to watch the expiration date because using an expired antibiotic means it may not be potent enough to completely treat your infection, leaving you at risk for a worse one. The bottom line is that it is best to not use expired medications because there is no guarantee that they will work the way they are supposed to and they may even make you worse. Medications need to be stored safely to help keep their chemical compositions intact and stop them from becoming breeding grounds for bacteria.
Stability of Drug
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Pharmacy Compounding Guidelines () state: The beyond-use time/date limit of any compounded reagent kit or radiopharmaceutical may be extended.
Note: certain features of this site have been disabled for the general public to prevent digital piracy. You agree not to use any web crawler, scraper, or other robot or automated program or device to obtain data from the website. You agree that you will not sell or license anything that you download, print, or copy from this website. In the case where a quantity of compounded drug preparation is in excess of that to be initially dispensed is prepared, the excess preparation shall be labeled or documentation referenced with the complete list of ingredients components , the preparation date, and the assigned beyond-use date based upon the pharmacist’s professional judgment, appropriate testing, or published data.
It shall also be stored and accounted for under conditions dictated by its composition and stability characteristics e. The requirements of this chapter do no apply to the compounding or mixing of FDA-approved drugs preparations pursuant to the manufacturer’s directions for dispensing including but not limited to the reconstitution of oral suspensions, combination of the components of topical preparations, etc.
R oute : S earch tips. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine and regularly observed prescribing patterns. Compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling.
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.
The addition of flavoring including the flavor manufacturer or product, lot number, and expiration date must be documented in the patient record notes for the prescription. A: Domperidone compounding is permissible only as part of an investigational new drug application IND.
(4) Beyond-use date. § Production record. The pharmacist shall prepare and keep a production record for a minimum of 2 years for each drug product.
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.
Interactive Handbook On Injectable Drugs
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Q: What purpose does the beyond-use date of a compounded sterile use date serves to alert pharmacists and caregivers to the time after.
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. Things to consider when assigning BUD include:. Beyond use dating must be carefully interpreted with respect to the actual compounded formulation and conditions for storage and use. Predictions based on literature are considered theoretical beyond-use dates as the published data introduces varying degrees of assumptions with a likelihood of error or inaccuracy.
State and federal regulations also require pharmacists to have written justification for a beyond use date assignment. The only truly valid beyond use date is obtained through product-specific studies supported by scientific data. These direct testing studies use stability indicating methods SIM to ensure therapeutic effectiveness of compounded drug products. A SIM is a reliable, meaningful, and specific analytical procedure that accurately and precisely measures active pharmaceutical ingredients API by separating the API from its degradation products and excipients.
A SIM must be validated for the exact formulation being tested. High performance liquid chromatograph HPLC is one of the most commonly used techniques for examining the chemical stability of compounded product, but not all HPLC tests are stability indicating.
Viewpoint: Should an RX label require a use-by date or an expiration date?
The chemical stability must also be cross-referenced with beyond US Pharmacopeial Convention standards date pharmacy that sterility is maintained throughout the storage period. Differences is important to note that BUDs and beyond dates are not the same. Beyond differences dating applies the for expiration dating principles, but adds the consideration expiration sterility.
Each category differs in the potential for microbial contamination during the compounding of the admixture. Beyond following this guideline, compounding personnel ensure consistent compounding practices. The guideline also serves as quick reference of stability information for appropriate assignment of beyond dating dating.
These standards require pharmacies to have ISO. 7 cleanrooms, strict aseptic handling procedures, quality assurance testing, and limit the Beyond. Use Dating.
Beyond-use Date: Establishment and Maintenance. This includes the issue of increased waste and the cost associated with it. Many facilities opined that this would cause irreparable harm to both the care of the patient and the fiscal well-being of the institution. One of the first issues dealt with was the terminology. Expiration dates are associated with commercially available products, while beyond-use dates are assigned to pharmacy compounded preparations.
The pre-administration storage duration and temperature limits specified apply in the absence of direct sterility testing results that justify different limits for specific CSPs. The risk levels defined in the USP apply to the quality of CSPs immediately after the final aseptic mixing or filling or immediately after the final sterilization, unless precluded by the specific characteristics of the preparation.
Upon subsequent storage and shipping of freshly finished CSPs, an increase in the risks of chemical degradation of ingredients, contamination from physical damage to packaging, and permeability of plastic and elastomeric packaging is expected. In such cases, compounding personnel are responsible for considering the potential additional risks to the integrity of CSPs when assigning BUDs. The direct “end preparation sterility testing” must test for both microbial and fungal contamination.
Beyond-use dates for CSPs are rarely based on preparation-specific chemical assay results, which are used with the Arrhenius equation to determine expiration dates see General Notices and Requirements for manufactured products. The majority of CSPs are aqueous solutions in which hydrolysis of dissolved ingredients is the most common chemical degradation reaction.
The extent of hydrolysis and other heat-catalyzed degradation reactions at any particular time point in the life of a CSP represents the thermodynamic sum of exposure temperatures and durations. Such lifetime stability exposure is represented in the mean kinetic temperature calculation see Pharmaceutical Calculations in Prescription Compounding Drug hydrolysis rates increase exponentially with arithmetic temperature increase; thus, exposure of a beta-lactam antibiotic solution for one day at controlled room temperature see General Notices and Requirements will have an equivalent effect on the extent of hydrolysis of approximately 3 to 5 days in cold temperatures see General Notices and Requirements.
Personnel who prepare, dispense, and administer CSPs must store them strictly in accordance with the conditions stated on the label of ingredient products and finished CSPs.
perform sterile compounding include pharmacists, pharmacists in pharmacies and also that this chap- Beyond-Use Date (BUD) (see General Notices.
Q: What is compounding? A: Simply put, compounding is any manipulation of a drug beyond that stipulated on the drug label. Veterinary drugs should only be compounded based on a licensed veterinarian’s prescription, and to meet the medical needs of a specific patient. Manipulation might include mixing, diluting, concentrating, flavoring, or changing a drug’s dosage form. Some states allow veterinarians to prescribe compounds for administration to patients in the practice; but depending on state rules, it is typically not legal to dispense medications previously compounded by a pharmacy to leave the veterinary practice with clients, so state rules should be reviewed and followed.
Examples of compounding include:. A: It’s regulated by both the U. The FDA says it generally defers day-to-day regulation of compounding by veterinarians and pharmacists to state authorities. The state boards of pharmacy oversee pharmacy practices within the states, while the state veterinary medical boards oversee the practice of veterinary medicine, including prescribing. Generic drugs are approved by the FDA.