USP and USP compliance are not as frequently talked about recently, yet they are as important as ever. Compliance to USP had always been a must for all compounding pharmacies to address in regards to strict adherence in their policies and procedures manuals and operating standards. What Has Changed Regarding USP Compliance The primary answer in what has changed is that there is now much stricter legislation, regulation and monitoring of compounding pharmacies on both the both the federal and state levels. Prior to the DQSA, the FDA was limited in their abilities to monitor pharmaceutical compounding operations in regards to inspections, regulating and overseeing the manufacturing facilities operating procedures. Now the game has changed with the requirement that compounding facilities producing in bulk and shipping across state lines must register with the FDA. This law gave the FDA a great deal of power to ensure that compliance to best manufacturing standards were strictly being adhered to.
Analysis of 72-Hour Sterility of Common Pediatric Continuous Intravenous Infusions
The current USP Chapter on sterile compounding had three levels of safety protocols for compounding reflecting increasing levels of potential risk to patients. Aside from high, medium and lower risk categories, a separate section detailed standards for compounding of allergen immunotherapy, reflecting both how allergen immunotherapy is fundamentally different in nature from other compound administration processes and the comparative safety of the allergen extract compounding and administration.
The draft issued in abandoned the risk-relational approach and characterized all compounding for human injection as equally and inherently dangerous, thus treating allergen immunotherapy the same as radioactive and high-risk compounds. The extraordinary measures required would have made in-office compounding of allergen essentially impossible. The College, AAAAI, AAOA and others immediately responded by submitting thousands of comments expressing concern for both the patient safety and patient access to allergen immunotherapy unless in-office compounding remained feasible.
Extensive feedback focused on the increased risk of anaphylactic shock presented by lack of control of source material, the necessity of extended beyond use dates to make allergen immunotherapy feasible, and the likelihood of significantly increased patient costs and delays of treatment if control over compounding in the office setting was lost.
model standards for pharmacy compounding of hazardous sterile preparations national association of pharmacy regulatory authorities napra 1 contents.
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. 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.
Category 2 CSPs can have controlled room temperature BUDs ranging from 4 days to 42 days depending on preparation characteristics, however, regardless of the preparation characteristics, the BUD can be extended to 45 days after preparation if the CSP is stored in a freezer. Increasing the length of time that the CSP can be used from 4 days to 45 days provides tremendous benefits such as less waste from expired CSPs and greater protection from administering expired CSPs 2.
Medical grade refrigerators and freezers provide a uniform environment, as well as help stabilize and maintain temperatures during and after door openings allowing the correct BUDs to be assigned. Medical grade units will ensure a safe, reliable, and effective way to extend the BUD of a CSP leading to safer administration and reduced costs related to less waste.
3 Options to Meet USP 797 Requirements for Combination Ophthalmic Dilating Drops
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Beyond-Use Dates for all CSPs are assigned on the basis of direct testing or extrapolation from reliable literature and other documentation. Procedures for .
Click any price to add to cart. Blue Prices show stock on hand. Compounded drugs are not mass-produced, but rather mixed from ingredients in specific doses for individual patients. USP chapter covers the regulations for non-sterile drug compounding, forms of which include ointments, salves or liquid versions of drugs typically sold as tablets. USP outlines the requirements for mixing hazardous drugs sterile or non-sterile ; common example of these are chemotherapy drugs or radiopharmaceuticals.
Sterile drug blending, regulated under the USP chapter, is the third category of compounding. Compliance is critical, and aseptic practices benefit both patients and technicians; bacterial, viral or fungal contamination can affect safety and efficacy. Preparations such as total parenteral nutrition TPN , drug infusions and antibiotics injections are examples of sterile medications mixed in a compounding pharmacy. Aseptic procedures require specialized equipment. During the sterile preparation, labs also need supplies and equipment to store, handle, and package drugs, as well as dispose of waste and used materials.
Destruction of Unwanted Medications 1. What are my options for disposing of unwanted medications? A small number of medicines may be especially harmful if taken by someone other than the person for whom the medicine was prescribed. Many of these medicines have specific disposal instructions on their labeling or patient information leaflet. Are there guidelines in place for proper disposal of unwanted medications?
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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.
• The Pharmacy Quality Assurance Commission recognizes that USP > and are currently being revised, and recommends your pharmacy to keep abreast of the any developments and proposals with the revision, specifically if remodeling your facility.
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. USP – USP Chapter , Pharmaceutical Compounding-Nonsterile Preparations, codifies the rules pharmacists and pharmacy technicians must follow when compounding nonsterile formulations intended for humans and animals.
USP Chapter describes the procedures and requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded. USP – USP Chapter , Pharmaceutical Calculations in Prescription Compounding, provides general information on the mathematical concepts required for compounding pharmaceutical preparations. The BOP sets standards, roles, and requirements for pharmacy personnel and practice setting in their state.
Trituration is achieved by firmly holding the pestle and exerting a downward pressure with it while moving it in successively larger circles starting at the center of the mortar, moving outward to the side of the mortar, then back again toward the center. With this method there is no particle size reduction, so the powders to be mixed must be fine and of uniform size.
When using this method, the smallest quantity of active ingredient is mixed thoroughly with a proportion quantity of the diluent or base on the ointment slab.
Classification of air cleanliness. For example, particles of 0. Barrier isolators provide a suitable environment by restricting any ambient air from the work chamber. These systems are not as sensitive to external environments as the HEPA-filtered unidirectional airflow units. Several aspects of barrier isolation and filtered unidirectional airflow in work environment must be understood and practiced in the compounding process.
• Beyond Use Dates (BUDs) for STERILE drugs: – if approved product has an in use time, BUD is in accordance with in use time or expiration date, whichever shorter.
This incident was attributed as a direct link to the lack of proper oversight provided by the state boards of pharmacy. As a result, the Food and Drug Administration FDA has stepped in as the primary regulatory body for regulating the compounding pharmacies and have divided the pharmacies into two sectors: What is A Compounding Pharmacy? In this business model, the facility is prohibited from dispensing for office use which limits the product line to items that the patient can use in their home.
In addition, the facility may not compound large batches which can lead to increased product cost. A solution to the presented limitations was to add the ability to create exemptions for a compounding pharmacy as a B. What is a B Compounding Pharmacy? In this model, pharmacies are able to produce larger scale batches to drive down production cost to provide affordable medication to the consumer.
Although not required to provide patient specific medications, the facility is then held to a higher standard as a manufacturer requiring full current good manufacturing practice CGMP compliance.