Millions of medications are compounded each year in the US to meet the unique needs of patient, including vulnerable populations such as seniors and children. Compounding provides tailored therapy to patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases. Compounded medications made without the guidance of standards may be sub-potent, super potent or contaminated, exposing patients to significant risk of adverse events or even death. USP develops standards for compounding nonsterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. USP is a not-for-profit, science-driven organization that has an established process for convening independent experts for the development and maintenance of healthcare quality standards. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard setting process. Review their work plan and past meeting summaries.
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Learn more. Mobile App. Antineoplastic agents in NIOSH Table 1 must be compounded in facilities that protect the compounder from contamination. The anteroom for HD preparation requires a higher level of cleanliness ISO 7 than required for nonhazardous drugs ISO 8 because the air entering the negative buffer room needs to be at least as clean as the air in the buffer room.
All HDs except those agents other than antineoplastics that are specifically exempted by the facility must be compounded in a negative pressure room to protect compounding personnel. Other considerations for facilities include design, air handling, sink placement, and finishes.
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Facilities must be designed to minimize contamination of surfaces, to promote effective cleaning, to limit unnecessary personnel and materials traffic, and to include only furniture and equipment that is necessary for compounding. A key component is airflow and control of particulate matter.
This is achieved using HEPA filtering and air handling systems that are designed to meet ISO classification standards, sweep away the particles from the compounding area and the compounders, and maintain the required facility pressure differentials. Water sources sinks and drains may not be placed in the buffer area. Finishes on ceiling, wall, and floor surfaces must be easily cleaned and disinfected, smooth, and impervious.
Training and monitoring of compounding personnel are critical components for safe and effective sterile compounding. Training must be conducted by expert sterile compounding personnel and must be documented. As with any personnel training, documentation of the training is crucial for recordkeeping purposes and certification. Media fill testing shows that a compounder can aseptically mix a CSP at the facility using sterile fluid culture media.
The media fill test is completed before personnel are allowed to compound independently. It must then be conducted at least every 6 months.
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Initially, it must be passed before personnel are allowed to compound independently. Direct touch contamination is the most likely source of introducing microorganisms into CSPs.
On January 1, , USP chapter , Pharmaceutical Compounding-Sterile Preparations,15 became official, re-placing USP chapter , Sterile Drug Products for Home Use The change from a chapter numbered above to a chapter below marked a change from an advisory stan-dard to an enforceable one. USP chapter has since been. BEYOND USE DATING FOR STERILE COMPOUNDING Beyond Use Date (BUD) is very different from expiration date. USP Chapter defines BUD as the date or time after which a compounded sterile preparation (CSP) may not be stored or transported and is calculated from the date or time of compounding. Expiration date is aFile Size: KB. Important ates. May 26, - ate on stakeholder engagement activities related to beyond-use-date (BUD) provisions in General Chapters & > March 12, - Appeals Panel issues decisions on the Appeals to USP, >, and (see FAQs on USP Compounding Appeals); September 23, - Revised General Chapter is postponed until further notice.
The initial gloved fingertip test is performed immediately after the compounding employee completes the hand hygiene and garbing procedures. This test must be performed on three separate occasions with absolutely no CFU growth within the required incubation period.
Compounding personnel must requalify every 6 months. For the retesting, the gloved fingertip test is performed following the media fill inside the PEC.
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A skilled compounder must also observe proper garbing and hand hygiene of personnel every 6 months. These simulation tests are critical in determining that personnel are garbed to compound aseptically. A highly structured and monitored environment is critical to ensure that the compounding professional works competently and safely to compound sterile preparations. Four pillars are used to ensure this outcome: following policies and procedures, using appropriate BUDs, wearing personal protective equipment PPEand the proper cleaning of the cleanroom suite and SCA.
When things go wrong with sterile compounding, it is often the results of inadequate attention to policy and procedures. This includes monitoring and documenting daily temperature, humidity and pressure differentials; equipment e. Note that BUDs do not include the infusion time. Naturally, the pharmacist must ensure that the stability of the CSP is retained throughout the intended administration period; this is not the same as the BUD.
Docking and activation of a single proprietary bag and vial system for a single patient, for immediate administration according to the product labeling, is not considered compounding.
Along with hand hygiene, garb helps prevent microbial contamination.
Usp beyond use dating guidelines. Please contact your age, usp ates. My area! How to be used for commercially available products compounded pharmaceuticals. Category 1 and. Iso 5, usp chapter provides specific testing to find a clean room. Section i 3 contamination categories. Ashp guidelines. Is for assistance. Sep 23, 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. Nov 22, In accordance with the Rules and Procedures of the - Council of Experts, USP is postponing the official date of Pharmaceutical Compounding-Nonsterile Preparations. After publication of the. revised on June 1, , USP received appeals on certain provisions in.
Garb includes gloves, gowns, hair covers, face masks, and shoe covers. Compounders need to use a laminate gown intended for use with chemotherapy drugs when compounding HDs unless allowed in the Assessment of Risk. The placement of garb and PPE and the order in which it is donned is determined by the facility design.
Currently, two types of CSTDs are on the market: physical barrier systems and air-cleaning systems.
Beyond Use Date Strategies for Compounded Sterile Preparations
Cleaning and disinfecting practices and frequencies differ for areas used for compounding nonhazardous and HDs. Cleaning and disinfecting includes multiple steps that must be outlined in policies and procedures. The area must then be cleaned with a detergent. Only compounding personnel can clean PECs, but others who are appropriately trained and have documented competency can clean the floors.
Appropriate cleaning and disinfecting solutions and dilutions must be used. Ready-to-use solutions are preferred, since they eliminate the need to mix different concentrations.
Sterile alcohol is used since it has been filtered and irradiated to remove spores. EM programs include testing for viable microbial airborne particles and surface sampling.
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EM testing must be performed by a qualified person, such as a member of the pharmacy staff, a microbiologist, or a certifier. Viable testing includes sampling of surfaces and other areas that might be contaminated through touching in the primary and secondary engineering control areas, as well as electronic air sampling. Viable air testing must be performed at least every 6 months using an impaction device that captures a measured volume of air within the ISO classified areas.
The device includes an agar plate. If microbial contamination is present, it will be captured on the plate, which is then incubated by a laboratory that performs environmental testing. If any growth is found, it must be addressed and corrected.
USP Compounding Standards and Beyond-Use Dates (BUDs) On June 1, , USP published ates to the USP General Chapters on compounding nonsterile and sterile preparations alongside new standards for compounding radiopharmaceutical drugs. The revisions to the chapters, including ates to the beyond-use datesFile Size: KB. prepared for administration). Beyond-use exposure and storage dates or times (see. General Notices and Requirements. and. Pharmaceutical Compounding - Nonsterile Preparations ??) for sterile products that have been either opened or prepared for administration are not specified in all package.
The area is then retested to ensure the correction. Some experts recommend having the outside certifier perform the tests every 6 months and the pharmacy personnel perform the tests in the intervening months. This way, two different laboratories review the data, which enables a system of checks and balances.
If any growth is found, it must be remediated.
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Documentation and records-keeping of these EM records is critical. Certification of the sterile compounding facility hoods and rooms by an independent certifier is required every 6 months. The certifier issues a report that should clearly indicate which areas pass, fail, or need attention.
CETA Guidelines include all existing regulations and standards in a document designed for certification. The certification report must document airflow testing, HEPA filter integrity testing, total particle count testing, and for PECs, a dynamic airflow smoke pattern test. Sterile compounding facilities should be ready to simulate compounding or perform cleaning to simulate the work environment for the certification process.
Once certifiers have completed assessments, they provide written reports of the findings and the areas that need improvement for review with pharmacy management and leadership or other pertinent staff. The boxes include procedures for:.