Additional functionality can be achieved through the optional Oral Solid Feeder attachment, which packages bulk medication from the bottle into individual unit dose packages, the Variable Length Option, which allows for adjustment to the package length to accommodate packaging of non-standard sized tablets or capsules, and the Barcode Verifier Option, which automatically scans each package to assure that the printed barcode can be accurately scanned at the bedside. Additional functionality can be achieved through the Barcode Verifier Option, which automatically scans each package to assure that the printed barcode can be accurately scanned at the bedside. Filling operations can be completed in a manner of seconds and no additional software is required. Labeling and barcoding is done directly on the bag, eliminating costly labels and allowing for customization of the barcode. Bags are available in several different sizes to accommodate even the most irregularly sized items. Labels are available in several different styles to accommodate all labeling needs. Open-faced design allows for easy loading of label stock and access to all controls.
Results of our survey on drug storage, stability, compatibility, and beyond use dating March 22, ISMP would like to thank the practitioners, mostly pharmacy directors and managers, staff pharmacists, clinical pharmacists, and medication safety pharmacists, who responded to our recent survey on drug storage, stability, and beyond use dating of injectable drugs. We conducted the survey to learn more about what resources pharmacists rely on to guide drug storage, stability, and beyond use dating.
We were specifically interested in learning about conditions that may result in unnecessary waste of drugs during the ongoing drug shortage crisis or waste of very expensive medications given the ever rising cost associated with healthcare.
2. Define and explain beyond use date (BUD) and stability studies. 3. Compare and contrast stability criteria for sterile and non-sterile preparations. 4. Identify .
Compounding pharmacists are expected to prepare safe and efficacious doses of medication under time and economical constraints while protecting pharmacy staff and caregivers from inadvertent exposure to the drug. The pharmacist has the additional responsibility to ensure that the product is stable in the final-administrated form as the time between drug preparation and administration is considerable.
Physical and chemical stability of the CSP can be difficult to maintain over extended storage, especially since the formulation components are diluted within the intravenous i. Recent published reports have suggested the use of extended time, beyond that recommended by the manufacturer, for the storage and administration of CSP. These recommendations were based on inadequate analytical testing of the CSP. Herein, we demonstrate that setting of the beyond-use date should be carefully assessed using the appropriate analytical methods and testing.
USP 797 Clean Room Guidelines & Standards
Knowing the level of risk corresponding to each compounded preparation is important because different rules apply to the compounding process depending on the level of risk. Low-risk conditions—Compounding with aseptic manipulations using only sterile ingredients, products and devices in ISO Class 5 or higher air quality will generally fall in a low-risk category. Without performing a sterility test, CSPs should not be stored longer than 48 hours at a controlled room temperature, 14 days in refrigerated settings or 45 days if frozen solid at degrees Fahrenheit or colder.
Low-risk compounding includes using sterile needles and syringes to transfer sterile liquids from manufacturer-sealed ampules or vials to sterile devices or other sterile packages. It also covers manually mixing and measuring up to three manufactured products to create a CSP or nutritional solution.
USP is a far-reaching regulation that applies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound .
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. When CSPs are known to have been exposed to temperatures warmer than the warmest labeled limit, but not exceeding 40 see General Notices and Requirements for more than 4 hours, such CSPs should be discarded, unless appropriate documentation or direct assay data confirms their continued stability.
Determining Beyond-Use Dates When CSPs deviate from conditions in the approved labeling of manufactured products contained in CSPs, compounding personnel may consult the manufacturer of particular products for advice on assigning beyond-use dates based on chemical and physical stability parameters. Beyond-use dates for CSPs that are prepared strictly in accordance with manufacturers’ product labeling must be those specified in that labeling, or from appropriate literature sources or direct testing.
In addition, the pharmacist may refer to applicable publications to obtain relevant stability, compatibility, and degradation information regarding the drug or its congeners. When assigning a beyond-use date, pharmacists should consult and apply drug-specific and general stability documentation and literature where available, and they should consider the nature of drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy see Expiration Date and Beyond-Use Date under Labeling in the General Notices and Requirements.
Stability information must be carefully interpreted in relation to the actual compounded formulation and conditions for storage and use.
Find A Test
Relates to State Board of Pharmacy, relates to sterile compounding, relates to permits. The bill contains the following provisions. The bill provides a definition for “compounding pharmacy” and describes sterile compounding pharmacies and non sterile compounding pharmacies.
Joint Commission Medication Management Update Jeannell Mansur,Pharm.D., FASHP, FSMSO, CJCP [email protected] quantities, lot number and expiration date are noted when samples are received; and patient name, (USP ); but must.
Tweet Occasionally I get asked why a compounded product does not have an expiration date as long as that of a manufactured product. Most expiration dates are expressed in years for commercial products. BUDs are generally days or month long and are determined after careful interpretation of appropriate information sources for the same or similar formulations. The BUDs, for products produced by those pharmacies that do not test drug strength or stability, are strictly limited to USP guidelines resulting in BUDs of as little as 24 hours to a maximum of 45 days.
When pharmacies send their products to a lab for strength and stability testing, like JCB does, BUDs as long as 6 months can be assigned. So, while a compounded product will have a BUD based on sound clinical information and testing, it will not have a BUD equal to that of a manufactured product. Ensure confidence with your staff and patients by performing the necessary due diligence to make sure that your sterile compounding pharmacy uses sound procedures to determine Beyond Use Dates.
Terminology To get started in this article, there are some terms that should be defined. Prescriptions and over-the-counter medicines and other healthcare products sold in the United States are required to follow the standards in the USP-NF. The USP also sets standards for food ingredients and dietary supplements. Chapters in the USP that are listed as below are considered enforceable, while chapters enumerated as or greater are considered guidelines.
want to take advantage of the full expiration dating permitted by USP If it is not, you are limited to 12 hour dating for low and medium risk sterile compounds. Air Pressure Monitoring and Documentation: In the September article they discuss air pressure monitoring required for the compounding buffer area.
Our hospital wants the mixing to be done by a pharmacist, that it is safer and more standardized for patients. What is your take on this? USP is a private entity that develops guidelines for compounding of medications. The Code of Pharmacy has endorsed the USP recommendations and preparation of vaccines is under pharmacy supervision in hospitals. The practice parameters and independent legal review judged that if the policies recommended in the practice parameters are followed these are equivalent to the USP guidelines for allergy vaccines.
I have copied a series of questions from the archives of Ask The Expert that address some of the issues raised by your question. If so, how does one advance the dose if there is a new mix every 30 days? The individual allergist who componds vaccines in the office is not under these guidelines but under the recommendtions of the Joint Task Force who is responsible for our Allergy Parameters. We have dealt with this issue on several occasions previously on our website.
Drug Expiration Dates – Are Expired Drugs Still Safe to Take?
The CAPSLink online portal allows secure ordering via the web, offering built-in safety checks throughout the ordering process. There is no equipment to install, so you can be set up to order your prescription solutions from CAPS in as little as a day. Pharmacists review orders upon receipt and prepare your order using our automated compounding process featuring a barcoded manual add system MAS to verify ingredient accuracy.
Stability is more than a simple potency test at CAPS. Our BUD is assigned to compounded solutions based on advanced techniques. CAPS uses method development and validation procedures, including forced degradation or specificity studies to ensure that no false positives from impurities occur when testing for stability.
references page numbers in the original USP document 1 Summary of USP Proposed Changes July 77 Pursuant to General Notices, Legal Recognition, assuring compliance with USP standards is the responsibility of regulatory bodies. Accreditation or credentialing organizations may adopt and enforce USP standards. USP has no role in enforcement.
Thursday, November 16, Closing Date: Continuous until position filled Job Therapist Division: Schedule is subject to change dependent on rotational shifts and hours of operation. Responsible for the safe and effective administration of medically prescribed medications, knowing their indications and contraindications. Knows and follows the indications and contraindications, the policy and procedures in administering therapeutic modalities to include: Sets up and monitors oxygen administration.
Sets up oxygen cylinders and assures proper usage and safety measures are in place. Performs bedside PFT tests. Performs arterial punctures using radial, brachial, and femoral sites independently. Draws off arterial lines to obtain sample for blood gas analysis. As part of the team may be expected to perform CPR compression. Must be certified in CPR procedures annually.
Unit Dose & Multi-Dose Packaging
An official dosage form is required to bear on its label an expiration date assigned for the particular formulation and package of the article. This date limits the time during which the product may be dispensed or used. However, under no circumstance should the repackaged pharmaceutical preparation’s expiration date exceed the original manufacturer’s expiration date.
Drug Expiration Dates Patients often have questions about drug expiration dates: Can they take a medication if it The expiration date of a drug is estimated using stability testing under good manufacturing (). Q&A on Proposed USP Chapter Revisions with E. Clyde Buchanan. Accessed November 20,
We bring the highest level of quality and attention to detail to our clients to assure that their analytical method development and validation projects are successfully executed. There are standard organisms used for this test. Testing to show the preservative is effective should include out to and including the beyond use date. In addition to the standard organisms, it is always good practice but not required to test the effectiveness of the preservative against organisms isolated from the facility in which the product is compounded.
DYNALABS can work with the customer to help determine if testing of resident organisms found within the compounding facility is feasible and beneficial to them. The criteria that can directly impact stability are: Compound Formula Container Closure System Handling and Storage Conditions Once a claim has been validated, any significant changes in these criteria may require some level of revalidation.
This may not mean all the original validation testing be conducted, however there may need to be some smaller subset of the testing that needs to be repeated. In additions to claims made on end use doses, there may also be claims made on intermediate materials that are maintained within the pharmacy, that are used in the compounding of end use doses. These must also be included in the design of the stability testing program.